ACP IM 2013

SAN FRANCISCO – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians this summer. Health insurers will begin sending new contracts to physicians around then too.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums. Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient. "This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Many patients who’ll get coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay attention to the contracts they sign with health insurers participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? When negotiating rates, be aware that many patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

Lawrence Kosinski, M.D., MBA, AGAF, chair of the AGA Institute Practice Management and Economics Committee, said: "The health insurance exchanges created in the ACA will have very significant financial consequences for our practices. It’s time for all of us to become knowledgeable of their ramifications."

On Twitter @aliciaault

SAN FRANCISCO – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians this summer. Health insurers will begin sending new contracts to physicians around then too.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums. Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient. "This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Many patients who’ll get coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay attention to the contracts they sign with health insurers participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? When negotiating rates, be aware that many patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

Lawrence Kosinski, M.D., MBA, AGAF, chair of the AGA Institute Practice Management and Economics Committee, said: "The health insurance exchanges created in the ACA will have very significant financial consequences for our practices. It’s time for all of us to become knowledgeable of their ramifications."

On Twitter @aliciaault

SAN FRANCISCO – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians this summer. Health insurers will begin sending new contracts to physicians around then too.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums. Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient. "This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Many patients who’ll get coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay attention to the contracts they sign with health insurers participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? When negotiating rates, be aware that many patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

Lawrence Kosinski, M.D., MBA, AGAF, chair of the AGA Institute Practice Management and Economics Committee, said: "The health insurance exchanges created in the ACA will have very significant financial consequences for our practices. It’s time for all of us to become knowledgeable of their ramifications."

On Twitter @aliciaault

SAN FRANCISCO – When considering statin therapy for an otherwise healthy patient with elevated cholesterol levels, count the number of cardiovascular risk factors present, Dr. Matthew Sorrentino said.

Even when no single risk factor is way out of line, a "clustering of risk factors" can help identify which patients might most benefit from statin therapy – even if they’re low risk according to Framingham Heart Study criteria or other risk assessment tools.

"It’s really the summation of all of these risk factors together that puts a patient at increased risk," Dr. Sorrentino said at the annual meeting of the American College of Physicians.

He was persuaded by an analysis by other investigators of data from all participants in the Framingham study who had no cardiovascular disease at age 50 years. The lifetime risk for developing cardiovascular disease increased with the number of elevated or major risk factors, from an optimal rate of 5% in men to a rate of 69% in those with two major risk factors, and in women from an optimal rate of 8% to 50% in those with two major risk factors (Circulation 2006;113:791-8).

Dr. Sorrentino gave the example of a patient, a 66-year-old woman, who says she’s worried about her health but has no cardiovascular symptoms. She smokes a few cigarettes a day and has been told in the past that she has borderline or mildly elevated blood pressure. On examination, her blood pressure is 139/92 mm Hg; her body mass index is 30 kg/m²; and fasting lipid results report total cholesterol of 222 mg/dL, a high-density lipoprotein (HDL) level of 42 mg/dL, a triglyceride level of 155 mg/dL, and a low-density lipoprotein (LDL) level of 149 mg/dL*. In sum, she meets three of the five criteria for metabolic syndrome.

By Framingham criteria, she is considered low risk, with an 8% risk for developing cardiovascular disease within 10 years, Dr. Sorrentino noted. But with her cigarette smoking, hypertension, and low HDL – in addition to her elevated LDL level – she has two or more major risk factors, so her lifetime risk for cardiovascular disease is 50%, he said.

"There’s been a lot more interest in thinking about global or lifetime risk," said Dr. Sorrentino, professor of medicine at the University of Chicago. "This can be one way of looking at low-risk patients."

There is some evidence that treating low-risk patients with statins can reduce cardiovascular disease. The best, though controversial, study on the subject was the randomized JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, which found a 44% relative reduction in risk for cardiovascular disease over 5 years in patients treated with the statin, compared with placebo. The study calculated that 25 patients would need to be treated to prevent one myocardial infarction, stroke, revascularization procedure, or cardiovascular death over 5 years (N. Engl. J. Med. 2008;359:2195-2207).

That number needed to treat is similar to findings from two separate primary prevention trials using a statin, and it’s lower than the number needed to treat in many trials of standard blood pressure medications or low-dose aspirin, Dr. Sorrentino said.

Criticism of the JUPITER trial rested on whether it focused on a truly low-risk cohort. Approximately 40% of participants had metabolic syndrome, and 15% smoked, Dr. Sorrentino noted.

That’s why tallying the number of risk factors, as used in the 2008 analysis of lifetime risk, "will be better able to distinguish which low-risk patients would be worthwhile to consider treating," he said.

Dr. Sorrentino has been a speaker for Takeda Pharmaceuticals.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

*Correction, 6/28/2013: An earlier version of this story incorrectly reported the hypothetical patient's LDL level.

SAN FRANCISCO – When considering statin therapy for an otherwise healthy patient with elevated cholesterol levels, count the number of cardiovascular risk factors present, Dr. Matthew Sorrentino said.

Even when no single risk factor is way out of line, a "clustering of risk factors" can help identify which patients might most benefit from statin therapy – even if they’re low risk according to Framingham Heart Study criteria or other risk assessment tools.

"It’s really the summation of all of these risk factors together that puts a patient at increased risk," Dr. Sorrentino said at the annual meeting of the American College of Physicians.

He was persuaded by an analysis by other investigators of data from all participants in the Framingham study who had no cardiovascular disease at age 50 years. The lifetime risk for developing cardiovascular disease increased with the number of elevated or major risk factors, from an optimal rate of 5% in men to a rate of 69% in those with two major risk factors, and in women from an optimal rate of 8% to 50% in those with two major risk factors (Circulation 2006;113:791-8).

Dr. Sorrentino gave the example of a patient, a 66-year-old woman, who says she’s worried about her health but has no cardiovascular symptoms. She smokes a few cigarettes a day and has been told in the past that she has borderline or mildly elevated blood pressure. On examination, her blood pressure is 139/92 mm Hg; her body mass index is 30 kg/m²; and fasting lipid results report total cholesterol of 222 mg/dL, a high-density lipoprotein (HDL) level of 42 mg/dL, a triglyceride level of 155 mg/dL, and a low-density lipoprotein (LDL) level of 149 mg/dL*. In sum, she meets three of the five criteria for metabolic syndrome.

By Framingham criteria, she is considered low risk, with an 8% risk for developing cardiovascular disease within 10 years, Dr. Sorrentino noted. But with her cigarette smoking, hypertension, and low HDL – in addition to her elevated LDL level – she has two or more major risk factors, so her lifetime risk for cardiovascular disease is 50%, he said.

"There’s been a lot more interest in thinking about global or lifetime risk," said Dr. Sorrentino, professor of medicine at the University of Chicago. "This can be one way of looking at low-risk patients."

There is some evidence that treating low-risk patients with statins can reduce cardiovascular disease. The best, though controversial, study on the subject was the randomized JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, which found a 44% relative reduction in risk for cardiovascular disease over 5 years in patients treated with the statin, compared with placebo. The study calculated that 25 patients would need to be treated to prevent one myocardial infarction, stroke, revascularization procedure, or cardiovascular death over 5 years (N. Engl. J. Med. 2008;359:2195-2207).

That number needed to treat is similar to findings from two separate primary prevention trials using a statin, and it’s lower than the number needed to treat in many trials of standard blood pressure medications or low-dose aspirin, Dr. Sorrentino said.

Criticism of the JUPITER trial rested on whether it focused on a truly low-risk cohort. Approximately 40% of participants had metabolic syndrome, and 15% smoked, Dr. Sorrentino noted.

That’s why tallying the number of risk factors, as used in the 2008 analysis of lifetime risk, "will be better able to distinguish which low-risk patients would be worthwhile to consider treating," he said.

Dr. Sorrentino has been a speaker for Takeda Pharmaceuticals.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

*Correction, 6/28/2013: An earlier version of this story incorrectly reported the hypothetical patient's LDL level.

SAN FRANCISCO – When considering statin therapy for an otherwise healthy patient with elevated cholesterol levels, count the number of cardiovascular risk factors present, Dr. Matthew Sorrentino said.

Even when no single risk factor is way out of line, a "clustering of risk factors" can help identify which patients might most benefit from statin therapy – even if they’re low risk according to Framingham Heart Study criteria or other risk assessment tools.

"It’s really the summation of all of these risk factors together that puts a patient at increased risk," Dr. Sorrentino said at the annual meeting of the American College of Physicians.

He was persuaded by an analysis by other investigators of data from all participants in the Framingham study who had no cardiovascular disease at age 50 years. The lifetime risk for developing cardiovascular disease increased with the number of elevated or major risk factors, from an optimal rate of 5% in men to a rate of 69% in those with two major risk factors, and in women from an optimal rate of 8% to 50% in those with two major risk factors (Circulation 2006;113:791-8).

Dr. Sorrentino gave the example of a patient, a 66-year-old woman, who says she’s worried about her health but has no cardiovascular symptoms. She smokes a few cigarettes a day and has been told in the past that she has borderline or mildly elevated blood pressure. On examination, her blood pressure is 139/92 mm Hg; her body mass index is 30 kg/m²; and fasting lipid results report total cholesterol of 222 mg/dL, a high-density lipoprotein (HDL) level of 42 mg/dL, a triglyceride level of 155 mg/dL, and a low-density lipoprotein (LDL) level of 149 mg/dL*. In sum, she meets three of the five criteria for metabolic syndrome.

By Framingham criteria, she is considered low risk, with an 8% risk for developing cardiovascular disease within 10 years, Dr. Sorrentino noted. But with her cigarette smoking, hypertension, and low HDL – in addition to her elevated LDL level – she has two or more major risk factors, so her lifetime risk for cardiovascular disease is 50%, he said.

"There’s been a lot more interest in thinking about global or lifetime risk," said Dr. Sorrentino, professor of medicine at the University of Chicago. "This can be one way of looking at low-risk patients."

There is some evidence that treating low-risk patients with statins can reduce cardiovascular disease. The best, though controversial, study on the subject was the randomized JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, which found a 44% relative reduction in risk for cardiovascular disease over 5 years in patients treated with the statin, compared with placebo. The study calculated that 25 patients would need to be treated to prevent one myocardial infarction, stroke, revascularization procedure, or cardiovascular death over 5 years (N. Engl. J. Med. 2008;359:2195-2207).

That number needed to treat is similar to findings from two separate primary prevention trials using a statin, and it’s lower than the number needed to treat in many trials of standard blood pressure medications or low-dose aspirin, Dr. Sorrentino said.

Criticism of the JUPITER trial rested on whether it focused on a truly low-risk cohort. Approximately 40% of participants had metabolic syndrome, and 15% smoked, Dr. Sorrentino noted.

That’s why tallying the number of risk factors, as used in the 2008 analysis of lifetime risk, "will be better able to distinguish which low-risk patients would be worthwhile to consider treating," he said.

Dr. Sorrentino has been a speaker for Takeda Pharmaceuticals.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

*Correction, 6/28/2013: An earlier version of this story incorrectly reported the hypothetical patient's LDL level.

SAN FRANCISCO – When patients develop myalgia on statin therapy, consider lowering the statin dose and adding ubiquinone, or switching them from a statin to red yeast rice, Dr. Douglas S. Paauw said.

Statin-related myalgias are more common in patients with low body mass and, because of metabolic variations, in patients of Asian descent.

Training emphasized the potential for liver effects and rhabdomyolysis from statins, but 20 years of evidence now shows that statins do not cause chronic liver disease, rare patients get acute liver injury, and about 0.01% of patients develop rhabdomyolysis from drug interactions with statins.

Muscle pain is the most common statin side effect, he said. Studies suggest that 5%-18% of patients on the highest doses of statins will develop myalgia.

In one recent prospective, blinded study, 420 healthy, statin-naïve participants were randomized to 80 mg of atorvastatin or placebo for 6 months. Significantly more statin users (19) developed myalgia than did those on placebo (10). Creatine kinase levels increased significantly by an average of 21 U/L in atorvastatin users, suggesting that, even without symptoms, statins cause mild muscle injury (Circulation 2013;127:96-103).

Statin package inserts suggest that 1%-2% of patients will develop myalgia; however, early studies of statins did not look for myalgia, and the real-world rates of statin-related myalgia may be as high as 20%-30%, Dr. Paauw said at the annual meeting of the American College of Physicians.

The trick to avoiding this side effect is titrating the dose upward until you achieve lipid control. "Cardiologists often want to start people at high doses, and they have reasons for that. In general medicine, I certainly am a believer in getting patients started on a reasonable dose and then pushing up the dose. Once they get myalgias, patients are often reluctant to trust taking more statins. I like to prevent myalgias from happening in the first place," said Dr. Paauw, professor of medicine at the University of Washington, Seattle.

When a patient on a statin complains of muscle pain, check the creatine kinase level to see how big the problem is, and check the patient’s thyroid-stimulating hormone (TSH) level. Severe hypothyroidism can raise lipid levels and cause myalgia that looks just like statin-related myalgia. "When you treat the hypothyroidism, you may have much more success with a statin," he said.

The next step is to stop the statin to see if the myalgia goes away. "Patients should get better in a few weeks if it’s statin-related myalgia," he said. If symptoms disappear, restart the statin at a lower dose or switch to a different statin. One study found that myalgia rates on the highest dose of each respective drug ranged from a low of 5% with extended-release fluvastatin to 11% with pravastatin, 15% with atorvastatin, and 18% with simvastatin (Cardiovasc. Drugs Ther. 2005;19:403-14).

If myalgia recurs after switching, try switching again. Consider specific low dosages: extended-release fluvastatin 80 mg daily or every other day, or twice-weekly atorvastatin 10 mg, or low-dose rosuvastatin daily every other day or weekly, Dr. Paauw said.

But don’t completely sacrifice lipid control for side-effect management, he added. "The problem is that fluvastatin is about equal to giving jelly beans" for lipid control. "My view is that a little statin is probably better than no statin. Many of these patients have gotten to the point where we can’t use anything" at normal statin dosages, he said.

When switching statins doesn’t make a difference, it may simply mean that some patients are going to get myalgias with statins or they won’t, he added.

Discuss with the patient whether they want to consider adding ubiquinone (coenzyme Q10) to statin therapy. One positive study suggesting that coenzyme Q10 may reduce statin-related myalgia has been followed by several negative studies. One recent study randomized 76 statin users who developed myalgia in two or more extremities to statin treatment with twice-daily placebo or coenzyme Q10 at 60 mg. Visual analog pain scores did not differ significantly between groups after 1 month (Am. J. Cardiol. 2012;110:526-9).

"I think it’s still okay to try [coenzyme Q10]. It’s benign, and you may get a placebo effect," and there’s some scientific basis for why it might work, he said. Patients on statins have low ubiquinone levels, and coenzyme Q adds it back. "I think the jury is still out in this."

Another reasonable option to consider is to switch from a statin to red yeast rice, whose active ingredient is 4-5 mg of lovastatin, he said. One study randomized 62 patients who stopped statins due to myalgias to 24 weeks of twice-daily placebo or 1,800 mg of red yeast rice. The red yeast rice group had a significantly greater decrease in LDL cholesterol levels (35 mg/dL) than did the placebo group (15 mg/dL). Pain severity scores did not differ significantly between the two groups (Ann. Intern. Med. 2009;150:830-39).

"It may well be a positive placebo effect from getting a natural product. ... We’ll do whatever it takes to get our patients on therapy," he said.

Dr. Paauw reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – When patients develop myalgia on statin therapy, consider lowering the statin dose and adding ubiquinone, or switching them from a statin to red yeast rice, Dr. Douglas S. Paauw said.

Statin-related myalgias are more common in patients with low body mass and, because of metabolic variations, in patients of Asian descent.

Training emphasized the potential for liver effects and rhabdomyolysis from statins, but 20 years of evidence now shows that statins do not cause chronic liver disease, rare patients get acute liver injury, and about 0.01% of patients develop rhabdomyolysis from drug interactions with statins.

Muscle pain is the most common statin side effect, he said. Studies suggest that 5%-18% of patients on the highest doses of statins will develop myalgia.

In one recent prospective, blinded study, 420 healthy, statin-naïve participants were randomized to 80 mg of atorvastatin or placebo for 6 months. Significantly more statin users (19) developed myalgia than did those on placebo (10). Creatine kinase levels increased significantly by an average of 21 U/L in atorvastatin users, suggesting that, even without symptoms, statins cause mild muscle injury (Circulation 2013;127:96-103).

Statin package inserts suggest that 1%-2% of patients will develop myalgia; however, early studies of statins did not look for myalgia, and the real-world rates of statin-related myalgia may be as high as 20%-30%, Dr. Paauw said at the annual meeting of the American College of Physicians.

The trick to avoiding this side effect is titrating the dose upward until you achieve lipid control. "Cardiologists often want to start people at high doses, and they have reasons for that. In general medicine, I certainly am a believer in getting patients started on a reasonable dose and then pushing up the dose. Once they get myalgias, patients are often reluctant to trust taking more statins. I like to prevent myalgias from happening in the first place," said Dr. Paauw, professor of medicine at the University of Washington, Seattle.

When a patient on a statin complains of muscle pain, check the creatine kinase level to see how big the problem is, and check the patient’s thyroid-stimulating hormone (TSH) level. Severe hypothyroidism can raise lipid levels and cause myalgia that looks just like statin-related myalgia. "When you treat the hypothyroidism, you may have much more success with a statin," he said.

The next step is to stop the statin to see if the myalgia goes away. "Patients should get better in a few weeks if it’s statin-related myalgia," he said. If symptoms disappear, restart the statin at a lower dose or switch to a different statin. One study found that myalgia rates on the highest dose of each respective drug ranged from a low of 5% with extended-release fluvastatin to 11% with pravastatin, 15% with atorvastatin, and 18% with simvastatin (Cardiovasc. Drugs Ther. 2005;19:403-14).

If myalgia recurs after switching, try switching again. Consider specific low dosages: extended-release fluvastatin 80 mg daily or every other day, or twice-weekly atorvastatin 10 mg, or low-dose rosuvastatin daily every other day or weekly, Dr. Paauw said.

But don’t completely sacrifice lipid control for side-effect management, he added. "The problem is that fluvastatin is about equal to giving jelly beans" for lipid control. "My view is that a little statin is probably better than no statin. Many of these patients have gotten to the point where we can’t use anything" at normal statin dosages, he said.

When switching statins doesn’t make a difference, it may simply mean that some patients are going to get myalgias with statins or they won’t, he added.

Discuss with the patient whether they want to consider adding ubiquinone (coenzyme Q10) to statin therapy. One positive study suggesting that coenzyme Q10 may reduce statin-related myalgia has been followed by several negative studies. One recent study randomized 76 statin users who developed myalgia in two or more extremities to statin treatment with twice-daily placebo or coenzyme Q10 at 60 mg. Visual analog pain scores did not differ significantly between groups after 1 month (Am. J. Cardiol. 2012;110:526-9).

"I think it’s still okay to try [coenzyme Q10]. It’s benign, and you may get a placebo effect," and there’s some scientific basis for why it might work, he said. Patients on statins have low ubiquinone levels, and coenzyme Q adds it back. "I think the jury is still out in this."

Another reasonable option to consider is to switch from a statin to red yeast rice, whose active ingredient is 4-5 mg of lovastatin, he said. One study randomized 62 patients who stopped statins due to myalgias to 24 weeks of twice-daily placebo or 1,800 mg of red yeast rice. The red yeast rice group had a significantly greater decrease in LDL cholesterol levels (35 mg/dL) than did the placebo group (15 mg/dL). Pain severity scores did not differ significantly between the two groups (Ann. Intern. Med. 2009;150:830-39).

"It may well be a positive placebo effect from getting a natural product. ... We’ll do whatever it takes to get our patients on therapy," he said.

Dr. Paauw reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – When patients develop myalgia on statin therapy, consider lowering the statin dose and adding ubiquinone, or switching them from a statin to red yeast rice, Dr. Douglas S. Paauw said.

Statin-related myalgias are more common in patients with low body mass and, because of metabolic variations, in patients of Asian descent.

Training emphasized the potential for liver effects and rhabdomyolysis from statins, but 20 years of evidence now shows that statins do not cause chronic liver disease, rare patients get acute liver injury, and about 0.01% of patients develop rhabdomyolysis from drug interactions with statins.

Muscle pain is the most common statin side effect, he said. Studies suggest that 5%-18% of patients on the highest doses of statins will develop myalgia.

In one recent prospective, blinded study, 420 healthy, statin-naïve participants were randomized to 80 mg of atorvastatin or placebo for 6 months. Significantly more statin users (19) developed myalgia than did those on placebo (10). Creatine kinase levels increased significantly by an average of 21 U/L in atorvastatin users, suggesting that, even without symptoms, statins cause mild muscle injury (Circulation 2013;127:96-103).

Statin package inserts suggest that 1%-2% of patients will develop myalgia; however, early studies of statins did not look for myalgia, and the real-world rates of statin-related myalgia may be as high as 20%-30%, Dr. Paauw said at the annual meeting of the American College of Physicians.

The trick to avoiding this side effect is titrating the dose upward until you achieve lipid control. "Cardiologists often want to start people at high doses, and they have reasons for that. In general medicine, I certainly am a believer in getting patients started on a reasonable dose and then pushing up the dose. Once they get myalgias, patients are often reluctant to trust taking more statins. I like to prevent myalgias from happening in the first place," said Dr. Paauw, professor of medicine at the University of Washington, Seattle.

When a patient on a statin complains of muscle pain, check the creatine kinase level to see how big the problem is, and check the patient’s thyroid-stimulating hormone (TSH) level. Severe hypothyroidism can raise lipid levels and cause myalgia that looks just like statin-related myalgia. "When you treat the hypothyroidism, you may have much more success with a statin," he said.

The next step is to stop the statin to see if the myalgia goes away. "Patients should get better in a few weeks if it’s statin-related myalgia," he said. If symptoms disappear, restart the statin at a lower dose or switch to a different statin. One study found that myalgia rates on the highest dose of each respective drug ranged from a low of 5% with extended-release fluvastatin to 11% with pravastatin, 15% with atorvastatin, and 18% with simvastatin (Cardiovasc. Drugs Ther. 2005;19:403-14).

If myalgia recurs after switching, try switching again. Consider specific low dosages: extended-release fluvastatin 80 mg daily or every other day, or twice-weekly atorvastatin 10 mg, or low-dose rosuvastatin daily every other day or weekly, Dr. Paauw said.

But don’t completely sacrifice lipid control for side-effect management, he added. "The problem is that fluvastatin is about equal to giving jelly beans" for lipid control. "My view is that a little statin is probably better than no statin. Many of these patients have gotten to the point where we can’t use anything" at normal statin dosages, he said.

When switching statins doesn’t make a difference, it may simply mean that some patients are going to get myalgias with statins or they won’t, he added.

Discuss with the patient whether they want to consider adding ubiquinone (coenzyme Q10) to statin therapy. One positive study suggesting that coenzyme Q10 may reduce statin-related myalgia has been followed by several negative studies. One recent study randomized 76 statin users who developed myalgia in two or more extremities to statin treatment with twice-daily placebo or coenzyme Q10 at 60 mg. Visual analog pain scores did not differ significantly between groups after 1 month (Am. J. Cardiol. 2012;110:526-9).

"I think it’s still okay to try [coenzyme Q10]. It’s benign, and you may get a placebo effect," and there’s some scientific basis for why it might work, he said. Patients on statins have low ubiquinone levels, and coenzyme Q adds it back. "I think the jury is still out in this."

Another reasonable option to consider is to switch from a statin to red yeast rice, whose active ingredient is 4-5 mg of lovastatin, he said. One study randomized 62 patients who stopped statins due to myalgias to 24 weeks of twice-daily placebo or 1,800 mg of red yeast rice. The red yeast rice group had a significantly greater decrease in LDL cholesterol levels (35 mg/dL) than did the placebo group (15 mg/dL). Pain severity scores did not differ significantly between the two groups (Ann. Intern. Med. 2009;150:830-39).

"It may well be a positive placebo effect from getting a natural product. ... We’ll do whatever it takes to get our patients on therapy," he said.

Dr. Paauw reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The main reason older U.S. adults are hospitalized for drug interaction is an interaction with warfarin, so watch out for some of the main culprits: trimethoprim/sulfamethoxazole, acetaminophen, and oral steroids, advised Dr. Douglas S. Paauw.

"The biggest, most serious interaction we’re going to stumble into with warfarin" is with trimethoprim/sulfamethoxazole, he said at the annual meeting of the American College of Physicians.

Nearly 100,000 U.S. adults older than 65 years were hospitalized per year in 2007-2009 because of drug interactions, according to a study of data from the National Electronic Injury Surveillance System’s Cooperative Adverse Drug Event Surveillance Project. Warfarin led the four drug classes that caused 67% of "the mayhem," Dr. Paauw said, and was responsible for nearly three times the number of hospitalizations for drug interactions as any of the runner-ups – insulin, oral antiplatelet drugs, or oral hypoglycemics (N. Engl. J. Med. 2011;365:2002-12).

Trimethoprim/sulfamethoxazole can decrease metabolism and increase prothrombin times in patients on warfarin. So can erythromycin, which "we don’t use much any more," said Dr. Paauw, professor of medicine at the University of Washington, Seattle. "Trimethoprim/sulfamethoxazole has had a resurgence because of MRSA [methicillin-resistant Staphylococcus aureus]" infection.

Other drugs that can cause similar and clinically important interactions with warfarin are amiodarone, propafenone, and three antifungals that can be a problem at high doses but not with single doses – ketoconazole/fluconazole, itraconazole, or metronidazole.

Drugs that possibly can interact with warfarin, especially in elderly patients and those on multiple medications, include quinolones, omeprazole, clarithromycin, and azithromycin.

One retrospective study of 104 patients on stable warfarin therapy found mean increases in the international normalized ratio (INR) of 1.76 in patients who also took trimethoprim/sulfamethoxazole, 0.85 with levofloxacin, and 0.51 with azithromycin, compared with a decrease of 0.15 in patients on terazosin, who served as a control group.

Another way to look at it, Dr. Paauw said, is that the INR increased beyond therapeutic levels in 69% of patients on warfarin plus trimethoprim/sulfamethoxazole, 33% of patients on warfarin plus levofloxacin, 31% on warfarin and azithromycin, or 5% on warfarin and terazosin (J. Gen. Intern. Med. 2005;20:653-6).

To treat a urinary tract infection in an anticoagulated patient, try not to use trimethoprim/sulfamethoxazole, and be worried about using quinolones, Dr. Paauw advised. Penicillins/cephalosporins are acceptable, or use nitrofurantoin, he said.

As for acetaminophen, "we always think of acetaminophen as a safe drug, but if you take enough of it – like three extrastrength Tylenol a day it can affect the INR," he said. Be aware of this, and if a patient on warfarin is taking acetaminophen regularly, check the INR more often than you normally would, he added.

Findings from three studies suggest there are INR effects from interactions of warfarin and acetaminophen.

One study of patients on warfarin who received 2 g or 4 g of acetaminophen or placebo found that 54% of patients on acetaminophen overshot their INR goal, compared with 17% on placebo (Pharmacotherapy 2007;27:675-83). In another study, taking more than 9,100 mg/wk of acetaminophen increased the risk 10-fold for developing an INR above 6.0 (JAMA 1998;279:657-62).

In a separate double-blind crossover trial, patients on warfarin and 4 g/day of acetaminophen had prothrombin times 75% greater than a control group (Clin. Res. 1984;32:698a).

Oral corticosteroids significantly increased the INR by a mean of 1.24 in patients on warfarin, giving 62% of patients an INR above their targeted range, one retrospective study found. The INR became elevated a mean of 7 days after starting steroids (Ann. Pharmacother. 2006;40:2101-6).

When you recognize that this interaction is developing, reduce the steroids but don’t decrease the warfarin dose, Dr. Paauw advised, because the INR will normalize as the steroids disappear. If you simultaneously reduce the warfarin dose, the INR will not be where you want it post corticosteroids.

Dr. Paauw reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The main reason older U.S. adults are hospitalized for drug interaction is an interaction with warfarin, so watch out for some of the main culprits: trimethoprim/sulfamethoxazole, acetaminophen, and oral steroids, advised Dr. Douglas S. Paauw.

"The biggest, most serious interaction we’re going to stumble into with warfarin" is with trimethoprim/sulfamethoxazole, he said at the annual meeting of the American College of Physicians.

Nearly 100,000 U.S. adults older than 65 years were hospitalized per year in 2007-2009 because of drug interactions, according to a study of data from the National Electronic Injury Surveillance System’s Cooperative Adverse Drug Event Surveillance Project. Warfarin led the four drug classes that caused 67% of "the mayhem," Dr. Paauw said, and was responsible for nearly three times the number of hospitalizations for drug interactions as any of the runner-ups – insulin, oral antiplatelet drugs, or oral hypoglycemics (N. Engl. J. Med. 2011;365:2002-12).

Trimethoprim/sulfamethoxazole can decrease metabolism and increase prothrombin times in patients on warfarin. So can erythromycin, which "we don’t use much any more," said Dr. Paauw, professor of medicine at the University of Washington, Seattle. "Trimethoprim/sulfamethoxazole has had a resurgence because of MRSA [methicillin-resistant Staphylococcus aureus]" infection.

Other drugs that can cause similar and clinically important interactions with warfarin are amiodarone, propafenone, and three antifungals that can be a problem at high doses but not with single doses – ketoconazole/fluconazole, itraconazole, or metronidazole.

Drugs that possibly can interact with warfarin, especially in elderly patients and those on multiple medications, include quinolones, omeprazole, clarithromycin, and azithromycin.

One retrospective study of 104 patients on stable warfarin therapy found mean increases in the international normalized ratio (INR) of 1.76 in patients who also took trimethoprim/sulfamethoxazole, 0.85 with levofloxacin, and 0.51 with azithromycin, compared with a decrease of 0.15 in patients on terazosin, who served as a control group.

Another way to look at it, Dr. Paauw said, is that the INR increased beyond therapeutic levels in 69% of patients on warfarin plus trimethoprim/sulfamethoxazole, 33% of patients on warfarin plus levofloxacin, 31% on warfarin and azithromycin, or 5% on warfarin and terazosin (J. Gen. Intern. Med. 2005;20:653-6).

To treat a urinary tract infection in an anticoagulated patient, try not to use trimethoprim/sulfamethoxazole, and be worried about using quinolones, Dr. Paauw advised. Penicillins/cephalosporins are acceptable, or use nitrofurantoin, he said.

As for acetaminophen, "we always think of acetaminophen as a safe drug, but if you take enough of it – like three extrastrength Tylenol a day it can affect the INR," he said. Be aware of this, and if a patient on warfarin is taking acetaminophen regularly, check the INR more often than you normally would, he added.

Findings from three studies suggest there are INR effects from interactions of warfarin and acetaminophen.

One study of patients on warfarin who received 2 g or 4 g of acetaminophen or placebo found that 54% of patients on acetaminophen overshot their INR goal, compared with 17% on placebo (Pharmacotherapy 2007;27:675-83). In another study, taking more than 9,100 mg/wk of acetaminophen increased the risk 10-fold for developing an INR above 6.0 (JAMA 1998;279:657-62).

In a separate double-blind crossover trial, patients on warfarin and 4 g/day of acetaminophen had prothrombin times 75% greater than a control group (Clin. Res. 1984;32:698a).

Oral corticosteroids significantly increased the INR by a mean of 1.24 in patients on warfarin, giving 62% of patients an INR above their targeted range, one retrospective study found. The INR became elevated a mean of 7 days after starting steroids (Ann. Pharmacother. 2006;40:2101-6).

When you recognize that this interaction is developing, reduce the steroids but don’t decrease the warfarin dose, Dr. Paauw advised, because the INR will normalize as the steroids disappear. If you simultaneously reduce the warfarin dose, the INR will not be where you want it post corticosteroids.

Dr. Paauw reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The main reason older U.S. adults are hospitalized for drug interaction is an interaction with warfarin, so watch out for some of the main culprits: trimethoprim/sulfamethoxazole, acetaminophen, and oral steroids, advised Dr. Douglas S. Paauw.

"The biggest, most serious interaction we’re going to stumble into with warfarin" is with trimethoprim/sulfamethoxazole, he said at the annual meeting of the American College of Physicians.

Nearly 100,000 U.S. adults older than 65 years were hospitalized per year in 2007-2009 because of drug interactions, according to a study of data from the National Electronic Injury Surveillance System’s Cooperative Adverse Drug Event Surveillance Project. Warfarin led the four drug classes that caused 67% of "the mayhem," Dr. Paauw said, and was responsible for nearly three times the number of hospitalizations for drug interactions as any of the runner-ups – insulin, oral antiplatelet drugs, or oral hypoglycemics (N. Engl. J. Med. 2011;365:2002-12).

Trimethoprim/sulfamethoxazole can decrease metabolism and increase prothrombin times in patients on warfarin. So can erythromycin, which "we don’t use much any more," said Dr. Paauw, professor of medicine at the University of Washington, Seattle. "Trimethoprim/sulfamethoxazole has had a resurgence because of MRSA [methicillin-resistant Staphylococcus aureus]" infection.

Other drugs that can cause similar and clinically important interactions with warfarin are amiodarone, propafenone, and three antifungals that can be a problem at high doses but not with single doses – ketoconazole/fluconazole, itraconazole, or metronidazole.

Drugs that possibly can interact with warfarin, especially in elderly patients and those on multiple medications, include quinolones, omeprazole, clarithromycin, and azithromycin.

One retrospective study of 104 patients on stable warfarin therapy found mean increases in the international normalized ratio (INR) of 1.76 in patients who also took trimethoprim/sulfamethoxazole, 0.85 with levofloxacin, and 0.51 with azithromycin, compared with a decrease of 0.15 in patients on terazosin, who served as a control group.

Another way to look at it, Dr. Paauw said, is that the INR increased beyond therapeutic levels in 69% of patients on warfarin plus trimethoprim/sulfamethoxazole, 33% of patients on warfarin plus levofloxacin, 31% on warfarin and azithromycin, or 5% on warfarin and terazosin (J. Gen. Intern. Med. 2005;20:653-6).

To treat a urinary tract infection in an anticoagulated patient, try not to use trimethoprim/sulfamethoxazole, and be worried about using quinolones, Dr. Paauw advised. Penicillins/cephalosporins are acceptable, or use nitrofurantoin, he said.

As for acetaminophen, "we always think of acetaminophen as a safe drug, but if you take enough of it – like three extrastrength Tylenol a day it can affect the INR," he said. Be aware of this, and if a patient on warfarin is taking acetaminophen regularly, check the INR more often than you normally would, he added.

Findings from three studies suggest there are INR effects from interactions of warfarin and acetaminophen.

One study of patients on warfarin who received 2 g or 4 g of acetaminophen or placebo found that 54% of patients on acetaminophen overshot their INR goal, compared with 17% on placebo (Pharmacotherapy 2007;27:675-83). In another study, taking more than 9,100 mg/wk of acetaminophen increased the risk 10-fold for developing an INR above 6.0 (JAMA 1998;279:657-62).

In a separate double-blind crossover trial, patients on warfarin and 4 g/day of acetaminophen had prothrombin times 75% greater than a control group (Clin. Res. 1984;32:698a).

Oral corticosteroids significantly increased the INR by a mean of 1.24 in patients on warfarin, giving 62% of patients an INR above their targeted range, one retrospective study found. The INR became elevated a mean of 7 days after starting steroids (Ann. Pharmacother. 2006;40:2101-6).

When you recognize that this interaction is developing, reduce the steroids but don’t decrease the warfarin dose, Dr. Paauw advised, because the INR will normalize as the steroids disappear. If you simultaneously reduce the warfarin dose, the INR will not be where you want it post corticosteroids.

Dr. Paauw reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Maintaining balance and enthusiasm – at home and at your practice – can seem to be an impossible challenge. And yet, without it – in every aspect of your life – you will be a less-capable physician, a less-engaged and happy spouse or friend, a less satisfied person, and not on top of your game.

That’s according to Dr. Linda Clever, an internist who is president of Renew, a project of the Institute for Health & Healing at California Pacific Medical Center in San Francisco.

"It turns out that if we’re bored, if we’re sad, if we’re frightened, it leads to a loss of creativity, a loss of enthusiasm and engagement, and resilience and effectiveness, not just at work, but at home," Dr. Clever told attendees at the annual meeting of the American College of Physicians.

She was not discussing burnout, but something different. "If you’re rushing through the day just to get through the day, that’s an incipient sign of not being engaged," she said, calling that "a danger signal."

The key is to use your values as your foundation. "What gets you to happiness is living your values."

Dr. Clever said that people who are balanced, and at the top of their game:

• Have strong relationships.

• Have a religious or spiritual life of some sort, which might just be having a constant sense of wonder at the world.

• Take care of themselves.

• Like their work.

• Have the basic conviction that they can play the hand that’s dealt them. That is, the ways things are might not be the preferred way, but life is manageable.

During her presentation at the meeting, Dr. Clever led attendees through a variation on the workshops she gives at Renew. The program helps people identify and define their personal values, and offers ways to live out those values even while managing complex responsibilities and priorities. She asked attendees for their definition of success. Among the terms she collected: balance, happiness, peace, wellness, making a difference, money, and positive feedback. Control was also mentioned.

Dr. Clever said that control is a common term among physicians. Doctors "like to control things," she said. It’s not surprising, as they really have to be obsessive-compulsive, said Dr. Clever. "Who else is going to get a second creatinine? Who else is going to take a picture of that lesion and follow it for 3 days? Who else is going to draw a circle around that erythema and look at it again in 2 hours?" she asked.

But that creates what she called a "soft underbelly." The desire for control is a vulnerability because "when we aren’t perfect, it’s very hard on us, and it’s very disturbing," said Dr. Clever.

There are some things that physicians can control. The most important thing is to live your values. Values are what someone believes is good or bad, right or wrong, and what gives meaning, fuel, and joy. Once you know your values, then you can define success, and know how you will spend your time," she said.

When physician attendees were asked to share some of their values, they mentioned honesty, integrity, humor, empathy, compassion, self-sacrifice, tolerance, service, humility, charity, sustainability, spirituality, and respect for self and others. Values should be written down, discussed out loud and shared with loved ones, advised Dr. Clever.

Physicians, like anyone striving for balance, can also control their attitudes and how they respond and cope when faced with adversity. In that vein, she said, many people have been inspired by "Man's Search for Meaning," (Boston: Beacon Press, 2006) a memoir by psychiatrist Viktor Frankl, who spent several years in Nazi concentration camps.

"Frankl wrote that the last human freedom is the freedom to choose your attitude in a given set of circumstances," said Dr. Clever. She said that physicians could adopt this philosophy and talk to their patients, or to their teenagers, about this concept. "You can choose to be a victim and you can choose to be a winner."

If you’re feeling overwhelmed, get help, advised Dr. Clever, adding, "That’s what money is for." Consider a gardener or a housekeeper or even a life coach. And, if things aren’t going well, don’t just complain. Also, give up what Dr. Clever calls "BMW": bitching, moaning, and whining.

Learn new tricks, she advised, especially if the old way isn’t working. "We have to get more comfortable with change."

"One new trick is to learn how to say ‘no,’ " Dr. Clever said. Physicians like to please and "it turns out if we’re doing too much, we can’t do anything well."

One tip for saying no gracefully is to employ what she called the "no sandwich." On the top, you thank the person for asking you. In the middle is the "no," and on the bottom, you thank the person again and say that you are honored to have been asked.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Maintaining balance and enthusiasm – at home and at your practice – can seem to be an impossible challenge. And yet, without it – in every aspect of your life – you will be a less-capable physician, a less-engaged and happy spouse or friend, a less satisfied person, and not on top of your game.

That’s according to Dr. Linda Clever, an internist who is president of Renew, a project of the Institute for Health & Healing at California Pacific Medical Center in San Francisco.

"It turns out that if we’re bored, if we’re sad, if we’re frightened, it leads to a loss of creativity, a loss of enthusiasm and engagement, and resilience and effectiveness, not just at work, but at home," Dr. Clever told attendees at the annual meeting of the American College of Physicians.

She was not discussing burnout, but something different. "If you’re rushing through the day just to get through the day, that’s an incipient sign of not being engaged," she said, calling that "a danger signal."

The key is to use your values as your foundation. "What gets you to happiness is living your values."

Dr. Clever said that people who are balanced, and at the top of their game:

• Have strong relationships.

• Have a religious or spiritual life of some sort, which might just be having a constant sense of wonder at the world.

• Take care of themselves.

• Like their work.

• Have the basic conviction that they can play the hand that’s dealt them. That is, the ways things are might not be the preferred way, but life is manageable.

During her presentation at the meeting, Dr. Clever led attendees through a variation on the workshops she gives at Renew. The program helps people identify and define their personal values, and offers ways to live out those values even while managing complex responsibilities and priorities. She asked attendees for their definition of success. Among the terms she collected: balance, happiness, peace, wellness, making a difference, money, and positive feedback. Control was also mentioned.

Dr. Clever said that control is a common term among physicians. Doctors "like to control things," she said. It’s not surprising, as they really have to be obsessive-compulsive, said Dr. Clever. "Who else is going to get a second creatinine? Who else is going to take a picture of that lesion and follow it for 3 days? Who else is going to draw a circle around that erythema and look at it again in 2 hours?" she asked.

But that creates what she called a "soft underbelly." The desire for control is a vulnerability because "when we aren’t perfect, it’s very hard on us, and it’s very disturbing," said Dr. Clever.

There are some things that physicians can control. The most important thing is to live your values. Values are what someone believes is good or bad, right or wrong, and what gives meaning, fuel, and joy. Once you know your values, then you can define success, and know how you will spend your time," she said.

When physician attendees were asked to share some of their values, they mentioned honesty, integrity, humor, empathy, compassion, self-sacrifice, tolerance, service, humility, charity, sustainability, spirituality, and respect for self and others. Values should be written down, discussed out loud and shared with loved ones, advised Dr. Clever.

Physicians, like anyone striving for balance, can also control their attitudes and how they respond and cope when faced with adversity. In that vein, she said, many people have been inspired by "Man's Search for Meaning," (Boston: Beacon Press, 2006) a memoir by psychiatrist Viktor Frankl, who spent several years in Nazi concentration camps.

"Frankl wrote that the last human freedom is the freedom to choose your attitude in a given set of circumstances," said Dr. Clever. She said that physicians could adopt this philosophy and talk to their patients, or to their teenagers, about this concept. "You can choose to be a victim and you can choose to be a winner."

If you’re feeling overwhelmed, get help, advised Dr. Clever, adding, "That’s what money is for." Consider a gardener or a housekeeper or even a life coach. And, if things aren’t going well, don’t just complain. Also, give up what Dr. Clever calls "BMW": bitching, moaning, and whining.

Learn new tricks, she advised, especially if the old way isn’t working. "We have to get more comfortable with change."

"One new trick is to learn how to say ‘no,’ " Dr. Clever said. Physicians like to please and "it turns out if we’re doing too much, we can’t do anything well."

One tip for saying no gracefully is to employ what she called the "no sandwich." On the top, you thank the person for asking you. In the middle is the "no," and on the bottom, you thank the person again and say that you are honored to have been asked.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Maintaining balance and enthusiasm – at home and at your practice – can seem to be an impossible challenge. And yet, without it – in every aspect of your life – you will be a less-capable physician, a less-engaged and happy spouse or friend, a less satisfied person, and not on top of your game.

That’s according to Dr. Linda Clever, an internist who is president of Renew, a project of the Institute for Health & Healing at California Pacific Medical Center in San Francisco.

"It turns out that if we’re bored, if we’re sad, if we’re frightened, it leads to a loss of creativity, a loss of enthusiasm and engagement, and resilience and effectiveness, not just at work, but at home," Dr. Clever told attendees at the annual meeting of the American College of Physicians.

She was not discussing burnout, but something different. "If you’re rushing through the day just to get through the day, that’s an incipient sign of not being engaged," she said, calling that "a danger signal."

The key is to use your values as your foundation. "What gets you to happiness is living your values."

Dr. Clever said that people who are balanced, and at the top of their game:

• Have strong relationships.

• Have a religious or spiritual life of some sort, which might just be having a constant sense of wonder at the world.

• Take care of themselves.

• Like their work.

• Have the basic conviction that they can play the hand that’s dealt them. That is, the ways things are might not be the preferred way, but life is manageable.

During her presentation at the meeting, Dr. Clever led attendees through a variation on the workshops she gives at Renew. The program helps people identify and define their personal values, and offers ways to live out those values even while managing complex responsibilities and priorities. She asked attendees for their definition of success. Among the terms she collected: balance, happiness, peace, wellness, making a difference, money, and positive feedback. Control was also mentioned.

Dr. Clever said that control is a common term among physicians. Doctors "like to control things," she said. It’s not surprising, as they really have to be obsessive-compulsive, said Dr. Clever. "Who else is going to get a second creatinine? Who else is going to take a picture of that lesion and follow it for 3 days? Who else is going to draw a circle around that erythema and look at it again in 2 hours?" she asked.

But that creates what she called a "soft underbelly." The desire for control is a vulnerability because "when we aren’t perfect, it’s very hard on us, and it’s very disturbing," said Dr. Clever.

There are some things that physicians can control. The most important thing is to live your values. Values are what someone believes is good or bad, right or wrong, and what gives meaning, fuel, and joy. Once you know your values, then you can define success, and know how you will spend your time," she said.

When physician attendees were asked to share some of their values, they mentioned honesty, integrity, humor, empathy, compassion, self-sacrifice, tolerance, service, humility, charity, sustainability, spirituality, and respect for self and others. Values should be written down, discussed out loud and shared with loved ones, advised Dr. Clever.

Physicians, like anyone striving for balance, can also control their attitudes and how they respond and cope when faced with adversity. In that vein, she said, many people have been inspired by "Man's Search for Meaning," (Boston: Beacon Press, 2006) a memoir by psychiatrist Viktor Frankl, who spent several years in Nazi concentration camps.

"Frankl wrote that the last human freedom is the freedom to choose your attitude in a given set of circumstances," said Dr. Clever. She said that physicians could adopt this philosophy and talk to their patients, or to their teenagers, about this concept. "You can choose to be a victim and you can choose to be a winner."

If you’re feeling overwhelmed, get help, advised Dr. Clever, adding, "That’s what money is for." Consider a gardener or a housekeeper or even a life coach. And, if things aren’t going well, don’t just complain. Also, give up what Dr. Clever calls "BMW": bitching, moaning, and whining.

Learn new tricks, she advised, especially if the old way isn’t working. "We have to get more comfortable with change."

"One new trick is to learn how to say ‘no,’ " Dr. Clever said. Physicians like to please and "it turns out if we’re doing too much, we can’t do anything well."

One tip for saying no gracefully is to employ what she called the "no sandwich." On the top, you thank the person for asking you. In the middle is the "no," and on the bottom, you thank the person again and say that you are honored to have been asked.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The American College of Physicians plans to issue an exhaustive, evidence-based review of firearms policy and gun violence later this year.

The current policies are "a little dated," so "we’re going through an evidence-based review on firearms policy and gun violence [to] come up with more contemporary recommendations," said Dr. David L. Bronson, immediate past president of the ACP.

"We are aware that firearms are part of the American culture, and this can be a divisive issue for this country and for some of our members," said Dr. Bronson at the annual meeting of the ACP. He said that’s one reason why the college will take an evidence-based approach to formulating its new recommendations.

The college plans to issue a series of policy recommendations for state, local, and federal agencies, and for the medical and public health communities, noted Bob Doherty, ACP’s senior vice president for governmental affairs and public policy.

To get those recommendations, the ACP will analyze peer-reviewed literature on the causes and effects of firearm injuries and death, and on the effectiveness of various policy interventions to reduce preventable injuries and deaths, said Mr. Doherty.

It will be a multifaceted statement, "looking not only at laws on access to firearms and ammunition, but also public health interventions, mental health, substance abuse, culture, video games that simulate gun violence, and other contributing factors – as well as the role of physicians in asking patients about firearms and counseling them on how to reduce the risks," he said.

The ACP last reviewed evidence on gun violence in 1996.

Even as the ACP reformulates its policy recommendations, a bill aimed at preventing gun violence failed to pass the Senate April 17. The Safe Communities, Safe Schools Act of 2013 (S. 649) was introduced March 21 by Sen. Harry Reid (D-Nev.) and was supported by the ACP. The college wrote to Sen. Reid April 5 stating that it backed the bill’s provisions to improve the National Instant Criminal Background Check System (NICS), require a background check for every firearm sale, and to levy stricter penalties for "straw man" purchases of guns.

The bill did not, however, include a ban on assault weapons or high-capacity magazines, which the ACP would like to see, said Mr. Doherty.

Even if the Senate tries again to pass gun violence legislation, the House has not yet indicated whether it would take up any such bill that the Senate might pass. In any case, a gun violence bill would face a tougher road in the House, Mr. Doherty said. First, it would have to go through the House Judiciary Committee, "which is very conservative," he said. To pass the full House, a proposal would need the support of almost all Democrats and at least a few Republicans, he said.

"We are going to just keep pushing it and hope we prevail," said Mr. Doherty.

Dr. Bronson noted that opponents of proposals to rein in firearms may also find ways to reassert their rights and desires in legislation unrelated to gun violence. "You have to keep your eye on the ball," he said, adding, "they have a relentless lobby."

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – The American College of Physicians plans to issue an exhaustive, evidence-based review of firearms policy and gun violence later this year.

The current policies are "a little dated," so "we’re going through an evidence-based review on firearms policy and gun violence [to] come up with more contemporary recommendations," said Dr. David L. Bronson, immediate past president of the ACP.

"We are aware that firearms are part of the American culture, and this can be a divisive issue for this country and for some of our members," said Dr. Bronson at the annual meeting of the ACP. He said that’s one reason why the college will take an evidence-based approach to formulating its new recommendations.

The college plans to issue a series of policy recommendations for state, local, and federal agencies, and for the medical and public health communities, noted Bob Doherty, ACP’s senior vice president for governmental affairs and public policy.

To get those recommendations, the ACP will analyze peer-reviewed literature on the causes and effects of firearm injuries and death, and on the effectiveness of various policy interventions to reduce preventable injuries and deaths, said Mr. Doherty.

It will be a multifaceted statement, "looking not only at laws on access to firearms and ammunition, but also public health interventions, mental health, substance abuse, culture, video games that simulate gun violence, and other contributing factors – as well as the role of physicians in asking patients about firearms and counseling them on how to reduce the risks," he said.

The ACP last reviewed evidence on gun violence in 1996.

Even as the ACP reformulates its policy recommendations, a bill aimed at preventing gun violence failed to pass the Senate April 17. The Safe Communities, Safe Schools Act of 2013 (S. 649) was introduced March 21 by Sen. Harry Reid (D-Nev.) and was supported by the ACP. The college wrote to Sen. Reid April 5 stating that it backed the bill’s provisions to improve the National Instant Criminal Background Check System (NICS), require a background check for every firearm sale, and to levy stricter penalties for "straw man" purchases of guns.

The bill did not, however, include a ban on assault weapons or high-capacity magazines, which the ACP would like to see, said Mr. Doherty.

Even if the Senate tries again to pass gun violence legislation, the House has not yet indicated whether it would take up any such bill that the Senate might pass. In any case, a gun violence bill would face a tougher road in the House, Mr. Doherty said. First, it would have to go through the House Judiciary Committee, "which is very conservative," he said. To pass the full House, a proposal would need the support of almost all Democrats and at least a few Republicans, he said.

"We are going to just keep pushing it and hope we prevail," said Mr. Doherty.

Dr. Bronson noted that opponents of proposals to rein in firearms may also find ways to reassert their rights and desires in legislation unrelated to gun violence. "You have to keep your eye on the ball," he said, adding, "they have a relentless lobby."

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – The American College of Physicians plans to issue an exhaustive, evidence-based review of firearms policy and gun violence later this year.

The current policies are "a little dated," so "we’re going through an evidence-based review on firearms policy and gun violence [to] come up with more contemporary recommendations," said Dr. David L. Bronson, immediate past president of the ACP.

"We are aware that firearms are part of the American culture, and this can be a divisive issue for this country and for some of our members," said Dr. Bronson at the annual meeting of the ACP. He said that’s one reason why the college will take an evidence-based approach to formulating its new recommendations.

The college plans to issue a series of policy recommendations for state, local, and federal agencies, and for the medical and public health communities, noted Bob Doherty, ACP’s senior vice president for governmental affairs and public policy.

To get those recommendations, the ACP will analyze peer-reviewed literature on the causes and effects of firearm injuries and death, and on the effectiveness of various policy interventions to reduce preventable injuries and deaths, said Mr. Doherty.

It will be a multifaceted statement, "looking not only at laws on access to firearms and ammunition, but also public health interventions, mental health, substance abuse, culture, video games that simulate gun violence, and other contributing factors – as well as the role of physicians in asking patients about firearms and counseling them on how to reduce the risks," he said.

The ACP last reviewed evidence on gun violence in 1996.

Even as the ACP reformulates its policy recommendations, a bill aimed at preventing gun violence failed to pass the Senate April 17. The Safe Communities, Safe Schools Act of 2013 (S. 649) was introduced March 21 by Sen. Harry Reid (D-Nev.) and was supported by the ACP. The college wrote to Sen. Reid April 5 stating that it backed the bill’s provisions to improve the National Instant Criminal Background Check System (NICS), require a background check for every firearm sale, and to levy stricter penalties for "straw man" purchases of guns.

The bill did not, however, include a ban on assault weapons or high-capacity magazines, which the ACP would like to see, said Mr. Doherty.

Even if the Senate tries again to pass gun violence legislation, the House has not yet indicated whether it would take up any such bill that the Senate might pass. In any case, a gun violence bill would face a tougher road in the House, Mr. Doherty said. First, it would have to go through the House Judiciary Committee, "which is very conservative," he said. To pass the full House, a proposal would need the support of almost all Democrats and at least a few Republicans, he said.

"We are going to just keep pushing it and hope we prevail," said Mr. Doherty.

Dr. Bronson noted that opponents of proposals to rein in firearms may also find ways to reassert their rights and desires in legislation unrelated to gun violence. "You have to keep your eye on the ball," he said, adding, "they have a relentless lobby."

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO – Women who were referred to an electrophysiologist were just as likely as men to get an implantable cardioverter-defibrillator, but women developed more complications and were less likely to receive an appropriate ICD shock or appropriate ICD-delivered therapy, a study of 6,902 patients found.

Previous studies have suggested that women are less likely than men are to get ICDs. If that’s true, the disparity may be happening before patients are referred for consideration of ICD implantation, Dr. Derek R. MacFadden said at the annual meeting of the American College of Physicians.

He and his associates analyzed data from a prospective registry of all 6,902 patients in the province of Ont., Canada, who were referred for consideration of an ICD or had one implanted between February 2007 and July 2010. Men and women were equally likely to be among the 5,450 patients who received ICDs and the 571 who did not receive ICDs (because they did not meet implantation criteria, refused implantation, or deferred a decision until after therapy could be optimized), reported Dr. MacFadden of the University of Toronto. The analysis excluded 881 patients with missing data.

Previous studies have reported higher risks for complications in women who get ICDs, as well as sex differences in arrhythmia patterns after implantation. Follow-up data on complications at 45 days in the current study were available in 4,830 patients, and an analysis of outcomes and complications at 1 year included 5,213 patients (Ann. Intern. Med. 2012;156:195-203).

At 45 days, rates of any major or minor complication were significantly higher in women (5.4% and 5.8%), compared with men (3.3% and 3.8%), Dr. MacFadden reported. These included significantly higher rates of lead replacement in women, compared with men (1.9% vs. 0.7%, respectively), and of pulmonary edema (0.6% and 0.2%, respectively).

At the 1-year follow-up, women were 91% more likely than were men to have a major complication, 56% more likely to have a minor complication, and 55% more likely to have any complication, compared with men, after researchers adjusted for confounding factors.

Women were significantly less likely at 1 year to have received an appropriate shock (5%) or appropriate therapy (11%), compared with men (8% and 15%, respectively). When appropriate shocks or therapy were delivered, men received it significantly sooner than did women, he said. The rates of inappropriate shocks (3%) or death (3%) were similar between the sexes.

"Greater risk of complications and the possibility of decreased therapeutic benefit should be considered in women who are referred for ICD implantation," Dr. MacFadden said.

The higher rates of complications in women may be due to bodily differences or physical characteristics, compared with men, he speculated.

At the time of referral for consideration of an ICD, the women were significantly younger than the men were (63 years vs. 65 years). Women had a significantly higher left ventricular ejection fraction (31% vs. 29%). Rates for many cardiac and noncardiac conditions differed significantly by sex. Women were less likely to have had percutaneous coronary intervention, coronary artery bypass graft surgery, atrial fibrillation, dyslipidemia, hypertension, stroke, and peripheral vascular disease, and they were more likely to have a family history of sudden cardiac death, severe valvular disease, or inactive cancer.

The ICDs were implanted for primary prevention in 3,822 patients and for secondary prevention in 1,628 patients.

Women account for approximately 43% of sudden cardiac deaths. Guidelines for ICD implantation to prevent sudden cardiac death are the same for women and men, and are based on randomized, controlled trials with only small percentages of women in their cohorts, he said.

Dr. MacFadden reported having no financial disclosures. Some of his associates reported financial relationships with Biosense, Boehringer, Boston Scientific, Medtronic, and Sanofi.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Women who were referred to an electrophysiologist were just as likely as men to get an implantable cardioverter-defibrillator, but women developed more complications and were less likely to receive an appropriate ICD shock or appropriate ICD-delivered therapy, a study of 6,902 patients found.

Previous studies have suggested that women are less likely than men are to get ICDs. If that’s true, the disparity may be happening before patients are referred for consideration of ICD implantation, Dr. Derek R. MacFadden said at the annual meeting of the American College of Physicians.

He and his associates analyzed data from a prospective registry of all 6,902 patients in the province of Ont., Canada, who were referred for consideration of an ICD or had one implanted between February 2007 and July 2010. Men and women were equally likely to be among the 5,450 patients who received ICDs and the 571 who did not receive ICDs (because they did not meet implantation criteria, refused implantation, or deferred a decision until after therapy could be optimized), reported Dr. MacFadden of the University of Toronto. The analysis excluded 881 patients with missing data.

Previous studies have reported higher risks for complications in women who get ICDs, as well as sex differences in arrhythmia patterns after implantation. Follow-up data on complications at 45 days in the current study were available in 4,830 patients, and an analysis of outcomes and complications at 1 year included 5,213 patients (Ann. Intern. Med. 2012;156:195-203).

At 45 days, rates of any major or minor complication were significantly higher in women (5.4% and 5.8%), compared with men (3.3% and 3.8%), Dr. MacFadden reported. These included significantly higher rates of lead replacement in women, compared with men (1.9% vs. 0.7%, respectively), and of pulmonary edema (0.6% and 0.2%, respectively).

At the 1-year follow-up, women were 91% more likely than were men to have a major complication, 56% more likely to have a minor complication, and 55% more likely to have any complication, compared with men, after researchers adjusted for confounding factors.

Women were significantly less likely at 1 year to have received an appropriate shock (5%) or appropriate therapy (11%), compared with men (8% and 15%, respectively). When appropriate shocks or therapy were delivered, men received it significantly sooner than did women, he said. The rates of inappropriate shocks (3%) or death (3%) were similar between the sexes.

"Greater risk of complications and the possibility of decreased therapeutic benefit should be considered in women who are referred for ICD implantation," Dr. MacFadden said.

The higher rates of complications in women may be due to bodily differences or physical characteristics, compared with men, he speculated.

At the time of referral for consideration of an ICD, the women were significantly younger than the men were (63 years vs. 65 years). Women had a significantly higher left ventricular ejection fraction (31% vs. 29%). Rates for many cardiac and noncardiac conditions differed significantly by sex. Women were less likely to have had percutaneous coronary intervention, coronary artery bypass graft surgery, atrial fibrillation, dyslipidemia, hypertension, stroke, and peripheral vascular disease, and they were more likely to have a family history of sudden cardiac death, severe valvular disease, or inactive cancer.

The ICDs were implanted for primary prevention in 3,822 patients and for secondary prevention in 1,628 patients.

Women account for approximately 43% of sudden cardiac deaths. Guidelines for ICD implantation to prevent sudden cardiac death are the same for women and men, and are based on randomized, controlled trials with only small percentages of women in their cohorts, he said.

Dr. MacFadden reported having no financial disclosures. Some of his associates reported financial relationships with Biosense, Boehringer, Boston Scientific, Medtronic, and Sanofi.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Women who were referred to an electrophysiologist were just as likely as men to get an implantable cardioverter-defibrillator, but women developed more complications and were less likely to receive an appropriate ICD shock or appropriate ICD-delivered therapy, a study of 6,902 patients found.

Previous studies have suggested that women are less likely than men are to get ICDs. If that’s true, the disparity may be happening before patients are referred for consideration of ICD implantation, Dr. Derek R. MacFadden said at the annual meeting of the American College of Physicians.

He and his associates analyzed data from a prospective registry of all 6,902 patients in the province of Ont., Canada, who were referred for consideration of an ICD or had one implanted between February 2007 and July 2010. Men and women were equally likely to be among the 5,450 patients who received ICDs and the 571 who did not receive ICDs (because they did not meet implantation criteria, refused implantation, or deferred a decision until after therapy could be optimized), reported Dr. MacFadden of the University of Toronto. The analysis excluded 881 patients with missing data.

Previous studies have reported higher risks for complications in women who get ICDs, as well as sex differences in arrhythmia patterns after implantation. Follow-up data on complications at 45 days in the current study were available in 4,830 patients, and an analysis of outcomes and complications at 1 year included 5,213 patients (Ann. Intern. Med. 2012;156:195-203).

At 45 days, rates of any major or minor complication were significantly higher in women (5.4% and 5.8%), compared with men (3.3% and 3.8%), Dr. MacFadden reported. These included significantly higher rates of lead replacement in women, compared with men (1.9% vs. 0.7%, respectively), and of pulmonary edema (0.6% and 0.2%, respectively).

At the 1-year follow-up, women were 91% more likely than were men to have a major complication, 56% more likely to have a minor complication, and 55% more likely to have any complication, compared with men, after researchers adjusted for confounding factors.

Women were significantly less likely at 1 year to have received an appropriate shock (5%) or appropriate therapy (11%), compared with men (8% and 15%, respectively). When appropriate shocks or therapy were delivered, men received it significantly sooner than did women, he said. The rates of inappropriate shocks (3%) or death (3%) were similar between the sexes.

"Greater risk of complications and the possibility of decreased therapeutic benefit should be considered in women who are referred for ICD implantation," Dr. MacFadden said.

The higher rates of complications in women may be due to bodily differences or physical characteristics, compared with men, he speculated.

At the time of referral for consideration of an ICD, the women were significantly younger than the men were (63 years vs. 65 years). Women had a significantly higher left ventricular ejection fraction (31% vs. 29%). Rates for many cardiac and noncardiac conditions differed significantly by sex. Women were less likely to have had percutaneous coronary intervention, coronary artery bypass graft surgery, atrial fibrillation, dyslipidemia, hypertension, stroke, and peripheral vascular disease, and they were more likely to have a family history of sudden cardiac death, severe valvular disease, or inactive cancer.

The ICDs were implanted for primary prevention in 3,822 patients and for secondary prevention in 1,628 patients.

Women account for approximately 43% of sudden cardiac deaths. Guidelines for ICD implantation to prevent sudden cardiac death are the same for women and men, and are based on randomized, controlled trials with only small percentages of women in their cohorts, he said.

Dr. MacFadden reported having no financial disclosures. Some of his associates reported financial relationships with Biosense, Boehringer, Boston Scientific, Medtronic, and Sanofi.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The American College of Physicians released new, free, print handouts for patients and clinicians to help reduce the approximately 20% rate of readmissions after hospitalizations for acute coronary events.

Studies have shown reduced readmission rates in patients who have a follow-up visit within 7 days of discharge for an acute coronary syndrome event such as a heart attacks or unstable angina.

The new tools should help patients transition from the hospital to home and then to the first post-discharge visit, and help clinicians be ready to make the most of the post-discharge visit, leaders of the American College of Physicians (ACP) said at the college’s annual meeting.

Previous handouts for patients with acute coronary events didn’t address this crucial transition, instead giving patients general tips on how to keep their hearts healthy, said Dr. Doron Schneider, a leader on the ACP team that created the tools.

For physicians, the tools could help them meet increasing expectations to reduce costs by reducing rehospitalizations. "These patients are at very high risk of readmission," said Dr. Steven E. Weinberger, ACP chief executive officer.

Clinicians can download the handouts or order copies through the ACP website. Videos to complement the tools should be posted on YouTube and the ACP site next week, one to be viewed before or shortly after leaving the hospital, and another focusing on medications. "Many patients don’t fill their first prescription or don’t adhere to their first prescription" after an acute coronary event, Dr. Schneider noted.

The 22-page patient pamphlet’s large print, simple layout, and checklists reflect the patient-centered approach that the ACP used in developing it. The group conducted four focus groups of patients who’d had an acute coronary syndrome event in the past year and their spouses or significant others, to find out what they felt patients and families needed to know. The pamphlet uses patients’ words and its photos are of real patients, said Dr. Schneider, chief patient safety and quality officer at Abington (Pa.) Memorial Hospital.

The two-page handout for clinicians lists core aspects to be addressed in the first post-hospitalization visit and suggests concrete steps to make sure the key areas get covered. For example, it suggests having a morning staff huddle to make sure patient charts have what’s needed before the patient arrives for the first follow-up visit, including a discharge summary, discharge instructions, and lab test results that were pending at the time of discharge.

The patient pamphlet starts with information on "What happened to me?" and discusses how patients can take charge of their health, and how to stay healthy.

Six pages are devoted to medicines, with room for patients to write down their own and check off reasons why they have stopped or changed any medicines.

Four pages discuss aspects of recovery, including feelings, work, activities, and sex. Symptoms described in a "Red Zone" help patients decide when they need to call 911, a "Yellow Zone" suggests when to call their doctors, and a "Green Zone" describes what "going well" looks like.

Three separate checklists help patients "Before you leave the hospital," "When you get home," and at "Your first follow-up visit."

A grant from Janssen Pharmaceuticals funded creation of the new tools.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The American College of Physicians released new, free, print handouts for patients and clinicians to help reduce the approximately 20% rate of readmissions after hospitalizations for acute coronary events.

Studies have shown reduced readmission rates in patients who have a follow-up visit within 7 days of discharge for an acute coronary syndrome event such as a heart attacks or unstable angina.

The new tools should help patients transition from the hospital to home and then to the first post-discharge visit, and help clinicians be ready to make the most of the post-discharge visit, leaders of the American College of Physicians (ACP) said at the college’s annual meeting.

Previous handouts for patients with acute coronary events didn’t address this crucial transition, instead giving patients general tips on how to keep their hearts healthy, said Dr. Doron Schneider, a leader on the ACP team that created the tools.

For physicians, the tools could help them meet increasing expectations to reduce costs by reducing rehospitalizations. "These patients are at very high risk of readmission," said Dr. Steven E. Weinberger, ACP chief executive officer.

Clinicians can download the handouts or order copies through the ACP website. Videos to complement the tools should be posted on YouTube and the ACP site next week, one to be viewed before or shortly after leaving the hospital, and another focusing on medications. "Many patients don’t fill their first prescription or don’t adhere to their first prescription" after an acute coronary event, Dr. Schneider noted.

The 22-page patient pamphlet’s large print, simple layout, and checklists reflect the patient-centered approach that the ACP used in developing it. The group conducted four focus groups of patients who’d had an acute coronary syndrome event in the past year and their spouses or significant others, to find out what they felt patients and families needed to know. The pamphlet uses patients’ words and its photos are of real patients, said Dr. Schneider, chief patient safety and quality officer at Abington (Pa.) Memorial Hospital.

The two-page handout for clinicians lists core aspects to be addressed in the first post-hospitalization visit and suggests concrete steps to make sure the key areas get covered. For example, it suggests having a morning staff huddle to make sure patient charts have what’s needed before the patient arrives for the first follow-up visit, including a discharge summary, discharge instructions, and lab test results that were pending at the time of discharge.

The patient pamphlet starts with information on "What happened to me?" and discusses how patients can take charge of their health, and how to stay healthy.

Six pages are devoted to medicines, with room for patients to write down their own and check off reasons why they have stopped or changed any medicines.

Four pages discuss aspects of recovery, including feelings, work, activities, and sex. Symptoms described in a "Red Zone" help patients decide when they need to call 911, a "Yellow Zone" suggests when to call their doctors, and a "Green Zone" describes what "going well" looks like.

Three separate checklists help patients "Before you leave the hospital," "When you get home," and at "Your first follow-up visit."

A grant from Janssen Pharmaceuticals funded creation of the new tools.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The American College of Physicians released new, free, print handouts for patients and clinicians to help reduce the approximately 20% rate of readmissions after hospitalizations for acute coronary events.

Studies have shown reduced readmission rates in patients who have a follow-up visit within 7 days of discharge for an acute coronary syndrome event such as a heart attacks or unstable angina.

The new tools should help patients transition from the hospital to home and then to the first post-discharge visit, and help clinicians be ready to make the most of the post-discharge visit, leaders of the American College of Physicians (ACP) said at the college’s annual meeting.

Previous handouts for patients with acute coronary events didn’t address this crucial transition, instead giving patients general tips on how to keep their hearts healthy, said Dr. Doron Schneider, a leader on the ACP team that created the tools.

For physicians, the tools could help them meet increasing expectations to reduce costs by reducing rehospitalizations. "These patients are at very high risk of readmission," said Dr. Steven E. Weinberger, ACP chief executive officer.

Clinicians can download the handouts or order copies through the ACP website. Videos to complement the tools should be posted on YouTube and the ACP site next week, one to be viewed before or shortly after leaving the hospital, and another focusing on medications. "Many patients don’t fill their first prescription or don’t adhere to their first prescription" after an acute coronary event, Dr. Schneider noted.

The 22-page patient pamphlet’s large print, simple layout, and checklists reflect the patient-centered approach that the ACP used in developing it. The group conducted four focus groups of patients who’d had an acute coronary syndrome event in the past year and their spouses or significant others, to find out what they felt patients and families needed to know. The pamphlet uses patients’ words and its photos are of real patients, said Dr. Schneider, chief patient safety and quality officer at Abington (Pa.) Memorial Hospital.

The two-page handout for clinicians lists core aspects to be addressed in the first post-hospitalization visit and suggests concrete steps to make sure the key areas get covered. For example, it suggests having a morning staff huddle to make sure patient charts have what’s needed before the patient arrives for the first follow-up visit, including a discharge summary, discharge instructions, and lab test results that were pending at the time of discharge.

The patient pamphlet starts with information on "What happened to me?" and discusses how patients can take charge of their health, and how to stay healthy.

Six pages are devoted to medicines, with room for patients to write down their own and check off reasons why they have stopped or changed any medicines.

Four pages discuss aspects of recovery, including feelings, work, activities, and sex. Symptoms described in a "Red Zone" help patients decide when they need to call 911, a "Yellow Zone" suggests when to call their doctors, and a "Green Zone" describes what "going well" looks like.

Three separate checklists help patients "Before you leave the hospital," "When you get home," and at "Your first follow-up visit."

A grant from Janssen Pharmaceuticals funded creation of the new tools.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO  – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians as soon as this summer. Health insurers will begin sending new contracts to physicians at around the same time.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums.

Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient.

"This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Ms. McNeil added in an interview later, "Why would a doctor sign up if they are going to be completely at risk and have to collect from the patient for the care?"

The CMA is seeking a change in the federal regulation on the grace period, which was included in the overall health insurance regulations issued in November 2012.

So far, none of the California insurers who have issued materials about their health insurance exchange plans have mentioned the grace period, Ms. McNeil said. She added that 33 health plans have said they were interested in participating in the California exchange, which is called Covered California.

Many patients who get insurance coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates that an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay close attention to the contracts they sign with health insurers that are participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? Can the practice opt in or out of a network? Many plans in California still have not determined their premiums or benefits for the exchange policies, which means they also have not set their reimbursement rates, Ms. McNeil said.

When negotiating rates, be aware that many of the patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have previously been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

"There are a lot of issues here. You’re going to have to watch your practice and the big picture," she said.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO  – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians as soon as this summer. Health insurers will begin sending new contracts to physicians at around the same time.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums.

Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient.

"This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Ms. McNeil added in an interview later, "Why would a doctor sign up if they are going to be completely at risk and have to collect from the patient for the care?"

The CMA is seeking a change in the federal regulation on the grace period, which was included in the overall health insurance regulations issued in November 2012.

So far, none of the California insurers who have issued materials about their health insurance exchange plans have mentioned the grace period, Ms. McNeil said. She added that 33 health plans have said they were interested in participating in the California exchange, which is called Covered California.

Many patients who get insurance coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates that an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay close attention to the contracts they sign with health insurers that are participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? Can the practice opt in or out of a network? Many plans in California still have not determined their premiums or benefits for the exchange policies, which means they also have not set their reimbursement rates, Ms. McNeil said.

When negotiating rates, be aware that many of the patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have previously been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

"There are a lot of issues here. You’re going to have to watch your practice and the big picture," she said.

aault@frontlinemedcom.com

On Twitter @aliciaault

SAN FRANCISCO  – Stand by for some unexpected and potentially nasty surprises when the health insurance exchanges start up in 2014.

The exchanges will start enrolling patients this fall and begin sending information to patients and physicians as soon as this summer. Health insurers will begin sending new contracts to physicians at around the same time.

But there’s information available now that should send shivers up physicians’ spines, Elizabeth McNeil, vice president of the center for federal government relations at the California Medical Association, said at the annual meeting of the American College of Physicians.

A little-noticed provision of the Affordable Care Act gives exchange participants a 90-day grace period to pay their premiums. This was designed to provide a cushion for people who might not be used to paying health insurance premiums.

Insurers have to pay all claims incurred by the patient in the first month, but in the second month, if the patient is still delinquent, all claims can be held as pending. By the third month, if the patient still has not paid, the insurer can terminate him or her.

The physician then has to collect payment for all outstanding claims from the patient.

"This is going to put you at a lot of risk," Ms. McNeil said. "You’re going to have to be very vigilant with the exchange patients in watching what’s going on."

Ms. McNeil added in an interview later, "Why would a doctor sign up if they are going to be completely at risk and have to collect from the patient for the care?"

The CMA is seeking a change in the federal regulation on the grace period, which was included in the overall health insurance regulations issued in November 2012.

So far, none of the California insurers who have issued materials about their health insurance exchange plans have mentioned the grace period, Ms. McNeil said. She added that 33 health plans have said they were interested in participating in the California exchange, which is called Covered California.

Many patients who get insurance coverage through the health insurance exchanges will also have much larger out-of-pocket costs than they are used to paying, Ms. McNeil said. In California, the CMA estimates that an individual could face as much as $6,400 in uncovered expenses, and a family, up to $12,800.

Physicians also will need to pay close attention to the contracts they sign with health insurers that are participating in the exchanges. The exchange could bring a large number of new patients to the practice and physicians need to think about how many additional patients they can actually accommodate, she said.

Another thing to keep in mind: Does the contract have an all-payer clause that requires your practice to accept exchange patients? Can the practice opt in or out of a network? Many plans in California still have not determined their premiums or benefits for the exchange policies, which means they also have not set their reimbursement rates, Ms. McNeil said.

When negotiating rates, be aware that many of the patients who gain coverage via the health insurance exchanges will have pent-up demand for health care because they have previously been uninsured or underinsured, Ms. McNeil advised. Their care could be more complex and time consuming, so doctors will want to be sure that reimbursement rates are adequate to cover this care.

"There are a lot of issues here. You’re going to have to watch your practice and the big picture," she said.

aault@frontlinemedcom.com

On Twitter @aliciaault