Robert Finn

SAN FRANCISCO — Oral contraceptives provide effective birth control in very heavy or obese women, but “OCs are less forgiving of imperfect use among” this population, according to James Trussell, Ph.D., director of the office of population research, Princeton (N.J.) University.

Speaking at a conference on contraceptive technology sponsored by Contemporary Forums, Dr. Trussell said that he based his conclusions on his analysis of the shortcomings of the data from two studies by Victoria Holt, Ph.D., professor of epidemiology at the University of Washington School of Public Health, Seattle. Dr. Holt's studies have formed the basis of the conventional wisdom that OCs fail more often in heavy women.

Findings from the first of her studies, which was a retrospective cohort analysis of 755 HMO enrollees, showed that there was a 60% increase in the risk of OC failure in this population, who were of reproductive age and weighed at least 70.5 kg. That risk was especially high for low-dose and very low-dose formulations, with increases in risk of 2.6-fold and 4.5-fold (Obstet. Gynecol. 2002;99[pt. 1]:820-7).

Dr. Holt's second study was a case-control study with 248 cases and 538 age-matched controls (Obstet. Gynecol. 2005;105:46-52). This study did not find a significant increase in the risk of contraceptive failure among all women in the highest-weight quartile, but it did find a statistically significant 70% increase in risk among consistent OC users weighing 75 kg or more. The increase in risk was also significant among all women in the highest BMI quartile (1.6-fold) and in consistent OC users in the highest BMI quartile (2.2-fold).

Findings from six other studies found no association between high weight, BMI, and OC failure. Dr. Trussell conceded that all of the studies had limitations, and he said that the question was unlikely to be settled convincingly except in large prospective studies. Even then the question might never be answered for perfect use because it's difficult to assess adherence.

Even if the increases in relative risk found in the Holt studies prove to be reproducible, the absolute risk of failure is still likely to be modest, Dr. Trussell said.

“Beware of relative risk,” he said. A 120% increase in the relative risk of contraceptive failure during perfect use implies an increase in the absolute risk of contraceptive failure only from 0.23% to 0.51%. A 60% increase in relative risk during typical use implies an increase in contraceptive failure from 8% to 12% during the first year, which is still lower than the failure rate of condoms.

There is little evidence that high BMI affects the failure rate of Implanon (etonogestrel) or Depo-Provera (medroxyprogesterone). But it's hard to draw a firm conclusion from this because there were no pregnancies at all in either product's clinical trials, whether the women were obese or not. Furthermore, the Implanon trials excluded women who were heavier than 130% of ideal body weight. New Food and Drug Administration rules require that drugmakers include obese women in contraceptive trials.

The situation with the contraceptive patch is different. Women weighing 80 kg or more have almost eight times the risk of contraceptive failure as do women weighing less, perhaps because of difficulties in hormone transit through subcutaneous fat, he said.

Whether hormonal contraception, which is reasonably effective in obese women, is also safe is another question. Several studies have made it clear that obesity by itself is a risk factor for pulmonary embolism and for deep venous thrombosis, with fivefold increases in risk. Oral contraceptives further increase the effect of obesity on deep venous thrombosis.

A study of OC safety in women with a BMI over 40 has never been done. There's only one study in the literature of women in the BMI category of greater than or equal to 35.

Dr. Trussell said he had no conflicts of interest related to his presentation. Contemporary Forums and this news organization are both owned by Elsevier.

SAN FRANCISCO — Oral contraceptives provide effective birth control in very heavy or obese women, but “OCs are less forgiving of imperfect use among” this population, according to James Trussell, Ph.D., director of the office of population research, Princeton (N.J.) University.

Speaking at a conference on contraceptive technology sponsored by Contemporary Forums, Dr. Trussell said that he based his conclusions on his analysis of the shortcomings of the data from two studies by Victoria Holt, Ph.D., professor of epidemiology at the University of Washington School of Public Health, Seattle. Dr. Holt's studies have formed the basis of the conventional wisdom that OCs fail more often in heavy women.

Findings from the first of her studies, which was a retrospective cohort analysis of 755 HMO enrollees, showed that there was a 60% increase in the risk of OC failure in this population, who were of reproductive age and weighed at least 70.5 kg. That risk was especially high for low-dose and very low-dose formulations, with increases in risk of 2.6-fold and 4.5-fold (Obstet. Gynecol. 2002;99[pt. 1]:820-7).

Dr. Holt's second study was a case-control study with 248 cases and 538 age-matched controls (Obstet. Gynecol. 2005;105:46-52). This study did not find a significant increase in the risk of contraceptive failure among all women in the highest-weight quartile, but it did find a statistically significant 70% increase in risk among consistent OC users weighing 75 kg or more. The increase in risk was also significant among all women in the highest BMI quartile (1.6-fold) and in consistent OC users in the highest BMI quartile (2.2-fold).

Findings from six other studies found no association between high weight, BMI, and OC failure. Dr. Trussell conceded that all of the studies had limitations, and he said that the question was unlikely to be settled convincingly except in large prospective studies. Even then the question might never be answered for perfect use because it's difficult to assess adherence.

Even if the increases in relative risk found in the Holt studies prove to be reproducible, the absolute risk of failure is still likely to be modest, Dr. Trussell said.

“Beware of relative risk,” he said. A 120% increase in the relative risk of contraceptive failure during perfect use implies an increase in the absolute risk of contraceptive failure only from 0.23% to 0.51%. A 60% increase in relative risk during typical use implies an increase in contraceptive failure from 8% to 12% during the first year, which is still lower than the failure rate of condoms.

There is little evidence that high BMI affects the failure rate of Implanon (etonogestrel) or Depo-Provera (medroxyprogesterone). But it's hard to draw a firm conclusion from this because there were no pregnancies at all in either product's clinical trials, whether the women were obese or not. Furthermore, the Implanon trials excluded women who were heavier than 130% of ideal body weight. New Food and Drug Administration rules require that drugmakers include obese women in contraceptive trials.

The situation with the contraceptive patch is different. Women weighing 80 kg or more have almost eight times the risk of contraceptive failure as do women weighing less, perhaps because of difficulties in hormone transit through subcutaneous fat, he said.

Whether hormonal contraception, which is reasonably effective in obese women, is also safe is another question. Several studies have made it clear that obesity by itself is a risk factor for pulmonary embolism and for deep venous thrombosis, with fivefold increases in risk. Oral contraceptives further increase the effect of obesity on deep venous thrombosis.

A study of OC safety in women with a BMI over 40 has never been done. There's only one study in the literature of women in the BMI category of greater than or equal to 35.

Dr. Trussell said he had no conflicts of interest related to his presentation. Contemporary Forums and this news organization are both owned by Elsevier.

SAN FRANCISCO — Oral contraceptives provide effective birth control in very heavy or obese women, but “OCs are less forgiving of imperfect use among” this population, according to James Trussell, Ph.D., director of the office of population research, Princeton (N.J.) University.

Speaking at a conference on contraceptive technology sponsored by Contemporary Forums, Dr. Trussell said that he based his conclusions on his analysis of the shortcomings of the data from two studies by Victoria Holt, Ph.D., professor of epidemiology at the University of Washington School of Public Health, Seattle. Dr. Holt's studies have formed the basis of the conventional wisdom that OCs fail more often in heavy women.

Findings from the first of her studies, which was a retrospective cohort analysis of 755 HMO enrollees, showed that there was a 60% increase in the risk of OC failure in this population, who were of reproductive age and weighed at least 70.5 kg. That risk was especially high for low-dose and very low-dose formulations, with increases in risk of 2.6-fold and 4.5-fold (Obstet. Gynecol. 2002;99[pt. 1]:820-7).

Dr. Holt's second study was a case-control study with 248 cases and 538 age-matched controls (Obstet. Gynecol. 2005;105:46-52). This study did not find a significant increase in the risk of contraceptive failure among all women in the highest-weight quartile, but it did find a statistically significant 70% increase in risk among consistent OC users weighing 75 kg or more. The increase in risk was also significant among all women in the highest BMI quartile (1.6-fold) and in consistent OC users in the highest BMI quartile (2.2-fold).

Findings from six other studies found no association between high weight, BMI, and OC failure. Dr. Trussell conceded that all of the studies had limitations, and he said that the question was unlikely to be settled convincingly except in large prospective studies. Even then the question might never be answered for perfect use because it's difficult to assess adherence.

Even if the increases in relative risk found in the Holt studies prove to be reproducible, the absolute risk of failure is still likely to be modest, Dr. Trussell said.

“Beware of relative risk,” he said. A 120% increase in the relative risk of contraceptive failure during perfect use implies an increase in the absolute risk of contraceptive failure only from 0.23% to 0.51%. A 60% increase in relative risk during typical use implies an increase in contraceptive failure from 8% to 12% during the first year, which is still lower than the failure rate of condoms.

There is little evidence that high BMI affects the failure rate of Implanon (etonogestrel) or Depo-Provera (medroxyprogesterone). But it's hard to draw a firm conclusion from this because there were no pregnancies at all in either product's clinical trials, whether the women were obese or not. Furthermore, the Implanon trials excluded women who were heavier than 130% of ideal body weight. New Food and Drug Administration rules require that drugmakers include obese women in contraceptive trials.

The situation with the contraceptive patch is different. Women weighing 80 kg or more have almost eight times the risk of contraceptive failure as do women weighing less, perhaps because of difficulties in hormone transit through subcutaneous fat, he said.

Whether hormonal contraception, which is reasonably effective in obese women, is also safe is another question. Several studies have made it clear that obesity by itself is a risk factor for pulmonary embolism and for deep venous thrombosis, with fivefold increases in risk. Oral contraceptives further increase the effect of obesity on deep venous thrombosis.

A study of OC safety in women with a BMI over 40 has never been done. There's only one study in the literature of women in the BMI category of greater than or equal to 35.

Dr. Trussell said he had no conflicts of interest related to his presentation. Contemporary Forums and this news organization are both owned by Elsevier.

LONG BEACH, CALIF. — People with diabetes have far higher scores on a depression scale than do those without diabetes, according to a large epidemiologic study.

Furthermore, depression is associated with increased 10-year mortality in people with diabetes, but not in those without the condition.

The mortality risk goes up 54% in diabetic patients with clinical depression, compared with those without depression, after adjustment for a large number of covariates, according to Xuanping Zhang, Ph.D., of the Centers for Disease Control and Prevention, and his colleagues. Dr. Zhang presented the results at a conference on diabetes sponsored by the CDC.

The study used data collected between 1982 and 1992 by the National Health and Nutrition Examination Survey I Epidemiologic Follow-Up Survey (NHEFS). The investigators compared 558 people with diabetes to 7,063 people without the disease, and included all individuals for whom they had complete survival data and scores on the Centers for Epidemiologic Studies Depression (CES-D) scale. Scores of 16 and above indicate clinical depression, scores of 16–21 indicate moderate depression, and scores of 22 or greater indicate severe depression.

Among people with diabetes, the mean CES-D score was 26.3, compared with 15.8 among those without diabetes, a statistically significant difference.

In a multivariate analysis that adjusted for age, sex, race, marital status, education, working status, smoking status, physical activity, alcohol consumption, body mass index, self-rated health, and the presence of other serious diseases, people with diabetes who also had a CES-D score of 16 or above were 54% more likely to die over 10 years than were those with lower depression scores, a statistically significant increase in risk.

Among people who did not have diabetes, high depression scores conferred a 3% increase in mortality risk, and that increase was not statistically significant.

In an attempt to avoid the possible bias of including people with very severe disease in the analysis, the investigators also performed the analysis after excluding all those who died within 1 year of the start of the study. In that analysis, people with diabetes experienced a significant increase in the risk of mortality if their CES-D scores were 22 and above, not if they were between 16 and 21.

Dr. Zhang stated that he had no conflicts of interest regarding the study.

LONG BEACH, CALIF. — People with diabetes have far higher scores on a depression scale than do those without diabetes, according to a large epidemiologic study.

Furthermore, depression is associated with increased 10-year mortality in people with diabetes, but not in those without the condition.

The mortality risk goes up 54% in diabetic patients with clinical depression, compared with those without depression, after adjustment for a large number of covariates, according to Xuanping Zhang, Ph.D., of the Centers for Disease Control and Prevention, and his colleagues. Dr. Zhang presented the results at a conference on diabetes sponsored by the CDC.

The study used data collected between 1982 and 1992 by the National Health and Nutrition Examination Survey I Epidemiologic Follow-Up Survey (NHEFS). The investigators compared 558 people with diabetes to 7,063 people without the disease, and included all individuals for whom they had complete survival data and scores on the Centers for Epidemiologic Studies Depression (CES-D) scale. Scores of 16 and above indicate clinical depression, scores of 16–21 indicate moderate depression, and scores of 22 or greater indicate severe depression.

Among people with diabetes, the mean CES-D score was 26.3, compared with 15.8 among those without diabetes, a statistically significant difference.

In a multivariate analysis that adjusted for age, sex, race, marital status, education, working status, smoking status, physical activity, alcohol consumption, body mass index, self-rated health, and the presence of other serious diseases, people with diabetes who also had a CES-D score of 16 or above were 54% more likely to die over 10 years than were those with lower depression scores, a statistically significant increase in risk.

Among people who did not have diabetes, high depression scores conferred a 3% increase in mortality risk, and that increase was not statistically significant.

In an attempt to avoid the possible bias of including people with very severe disease in the analysis, the investigators also performed the analysis after excluding all those who died within 1 year of the start of the study. In that analysis, people with diabetes experienced a significant increase in the risk of mortality if their CES-D scores were 22 and above, not if they were between 16 and 21.

Dr. Zhang stated that he had no conflicts of interest regarding the study.

LONG BEACH, CALIF. — People with diabetes have far higher scores on a depression scale than do those without diabetes, according to a large epidemiologic study.

Furthermore, depression is associated with increased 10-year mortality in people with diabetes, but not in those without the condition.

The mortality risk goes up 54% in diabetic patients with clinical depression, compared with those without depression, after adjustment for a large number of covariates, according to Xuanping Zhang, Ph.D., of the Centers for Disease Control and Prevention, and his colleagues. Dr. Zhang presented the results at a conference on diabetes sponsored by the CDC.

The study used data collected between 1982 and 1992 by the National Health and Nutrition Examination Survey I Epidemiologic Follow-Up Survey (NHEFS). The investigators compared 558 people with diabetes to 7,063 people without the disease, and included all individuals for whom they had complete survival data and scores on the Centers for Epidemiologic Studies Depression (CES-D) scale. Scores of 16 and above indicate clinical depression, scores of 16–21 indicate moderate depression, and scores of 22 or greater indicate severe depression.

Among people with diabetes, the mean CES-D score was 26.3, compared with 15.8 among those without diabetes, a statistically significant difference.

In a multivariate analysis that adjusted for age, sex, race, marital status, education, working status, smoking status, physical activity, alcohol consumption, body mass index, self-rated health, and the presence of other serious diseases, people with diabetes who also had a CES-D score of 16 or above were 54% more likely to die over 10 years than were those with lower depression scores, a statistically significant increase in risk.

Among people who did not have diabetes, high depression scores conferred a 3% increase in mortality risk, and that increase was not statistically significant.

In an attempt to avoid the possible bias of including people with very severe disease in the analysis, the investigators also performed the analysis after excluding all those who died within 1 year of the start of the study. In that analysis, people with diabetes experienced a significant increase in the risk of mortality if their CES-D scores were 22 and above, not if they were between 16 and 21.

Dr. Zhang stated that he had no conflicts of interest regarding the study.

LONG BEACH, CALIF. — Modest reductions in medication copayments can encourage patients with diabetes to fill their prescriptions and use their drugs, according to an experiment at the University of Michigan.

As part of the Michigan Healthy Communities Initiative, the university tested the “value-based benefit design” concept, in which cost-sharing is based not just on the acquisition cost of medication, but also on the likelihood of benefit, Dr. William Herman explained at a diabetes meeting sponsored by the Centers for Disease Control and Prevention. The greater the benefit to the patient, the lower the copayment.

The concept provides a financial incentive to targeted patients “to use therapies from which they are most likely to benefit,” said Dr. Herman of the university, in Ann Arbor.

The university identified 1,777 of its employees and dependents with diabetes and offered them copayment reductions on antihyperglycemics, antihypertensives, antihyperlipidemics, and antidepressants.

The price of tier-1 generic medications was reduced 100%, from $7 to zero; tier-2 preferred-brand medications, 50%, from $14 to $7; and tier-3 nonpreferred brand medications, 25%, from $24 to $18.

For controls, investigators identified 3,273 patients with diabetes and similar demographics from the same health plan but with employers other than the university. They were not offered this reduction in copayments.

Over 2 years, patients in the intervention group filled significantly more prescriptions in all medication groups. For example, there was a 3% absolute increase in filled metformin prescriptions and a 5% absolute increase in filled statin prescriptions.

Using the medication possession ratio (MPR) metric, defined as the amount of medication filled divided by the amount needed to fill to take as prescribed, the researchers saw a statistically significant 7% absolute increase in MPR for ACE inhibitors and angiotensin II receptor blockers.

In all, the health system granted copayment relief for 86,655 claims, at a cost of $869,767 over 2 years. Almost three quarters (74%) of the copayment relief went for tier-1 medications; 21% went to tier 2 and 5% went to tier 3.

Neither Dr. Herman nor Dr. Keeler reported any conflicts of interest related to their presentations.

LONG BEACH, CALIF. — Modest reductions in medication copayments can encourage patients with diabetes to fill their prescriptions and use their drugs, according to an experiment at the University of Michigan.

As part of the Michigan Healthy Communities Initiative, the university tested the “value-based benefit design” concept, in which cost-sharing is based not just on the acquisition cost of medication, but also on the likelihood of benefit, Dr. William Herman explained at a diabetes meeting sponsored by the Centers for Disease Control and Prevention. The greater the benefit to the patient, the lower the copayment.

The concept provides a financial incentive to targeted patients “to use therapies from which they are most likely to benefit,” said Dr. Herman of the university, in Ann Arbor.

The university identified 1,777 of its employees and dependents with diabetes and offered them copayment reductions on antihyperglycemics, antihypertensives, antihyperlipidemics, and antidepressants.

The price of tier-1 generic medications was reduced 100%, from $7 to zero; tier-2 preferred-brand medications, 50%, from $14 to $7; and tier-3 nonpreferred brand medications, 25%, from $24 to $18.

For controls, investigators identified 3,273 patients with diabetes and similar demographics from the same health plan but with employers other than the university. They were not offered this reduction in copayments.

Over 2 years, patients in the intervention group filled significantly more prescriptions in all medication groups. For example, there was a 3% absolute increase in filled metformin prescriptions and a 5% absolute increase in filled statin prescriptions.

Using the medication possession ratio (MPR) metric, defined as the amount of medication filled divided by the amount needed to fill to take as prescribed, the researchers saw a statistically significant 7% absolute increase in MPR for ACE inhibitors and angiotensin II receptor blockers.

In all, the health system granted copayment relief for 86,655 claims, at a cost of $869,767 over 2 years. Almost three quarters (74%) of the copayment relief went for tier-1 medications; 21% went to tier 2 and 5% went to tier 3.

Neither Dr. Herman nor Dr. Keeler reported any conflicts of interest related to their presentations.

LONG BEACH, CALIF. — Modest reductions in medication copayments can encourage patients with diabetes to fill their prescriptions and use their drugs, according to an experiment at the University of Michigan.

As part of the Michigan Healthy Communities Initiative, the university tested the “value-based benefit design” concept, in which cost-sharing is based not just on the acquisition cost of medication, but also on the likelihood of benefit, Dr. William Herman explained at a diabetes meeting sponsored by the Centers for Disease Control and Prevention. The greater the benefit to the patient, the lower the copayment.

The concept provides a financial incentive to targeted patients “to use therapies from which they are most likely to benefit,” said Dr. Herman of the university, in Ann Arbor.

The university identified 1,777 of its employees and dependents with diabetes and offered them copayment reductions on antihyperglycemics, antihypertensives, antihyperlipidemics, and antidepressants.

The price of tier-1 generic medications was reduced 100%, from $7 to zero; tier-2 preferred-brand medications, 50%, from $14 to $7; and tier-3 nonpreferred brand medications, 25%, from $24 to $18.

For controls, investigators identified 3,273 patients with diabetes and similar demographics from the same health plan but with employers other than the university. They were not offered this reduction in copayments.

Over 2 years, patients in the intervention group filled significantly more prescriptions in all medication groups. For example, there was a 3% absolute increase in filled metformin prescriptions and a 5% absolute increase in filled statin prescriptions.

Using the medication possession ratio (MPR) metric, defined as the amount of medication filled divided by the amount needed to fill to take as prescribed, the researchers saw a statistically significant 7% absolute increase in MPR for ACE inhibitors and angiotensin II receptor blockers.

In all, the health system granted copayment relief for 86,655 claims, at a cost of $869,767 over 2 years. Almost three quarters (74%) of the copayment relief went for tier-1 medications; 21% went to tier 2 and 5% went to tier 3.

Neither Dr. Herman nor Dr. Keeler reported any conflicts of interest related to their presentations.

LONG BEACH, CALIF. — People with diabetes have far higher scores on a depression scale than do those without diabetes, according to a large epidemiologic study.

Furthermore, depression also is associated with increased 10-year mortality in people with diabetes, but not in those without the condition, according to Xuanping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, and his colleagues. Dr. Zhang reported the findings at a conference on diabetes sponsored by the CDC.

The study used data collected between 1982 and 1992 by the National Health and Nutrition Examination Survey I Epidemiologic Follow-Up Survey (NHEFS). The investigators compared 558 people with diabetes to 7,063 people without the disease, and included all individuals for whom they had complete survival data and scores on the Centers for Epidemiologic Studies Depression (CES-D) scale. Scores of 16 and above indicate clinical depression, scores of 16–21 indicate moderate depression, and scores of 22 or greater indicate severe depression.

Among people with diabetes, the mean CES-D score was 26.3, compared with 15.8 among those without diabetes, a statistically significant difference.

In a multivariate analysis that adjusted for age, sex, race, marital status, education, working status, smoking status, physical activity, alcohol consumption, BMI, self-rated health, and the presence of other serious diseases, people with diabetes who also had a CES-D score of 16 or above were 54% more likely to die over 10 years than were those with lower depression scores, a statistically significant increase in risk.

Among people who did not have diabetes, high depression scores conferred a 3% increase in mortality risk, and that increase was not statistically significant.

Dr. Zhang reported that he had no conflicts of interest to disclose.

LONG BEACH, CALIF. — People with diabetes have far higher scores on a depression scale than do those without diabetes, according to a large epidemiologic study.

Furthermore, depression also is associated with increased 10-year mortality in people with diabetes, but not in those without the condition, according to Xuanping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, and his colleagues. Dr. Zhang reported the findings at a conference on diabetes sponsored by the CDC.

The study used data collected between 1982 and 1992 by the National Health and Nutrition Examination Survey I Epidemiologic Follow-Up Survey (NHEFS). The investigators compared 558 people with diabetes to 7,063 people without the disease, and included all individuals for whom they had complete survival data and scores on the Centers for Epidemiologic Studies Depression (CES-D) scale. Scores of 16 and above indicate clinical depression, scores of 16–21 indicate moderate depression, and scores of 22 or greater indicate severe depression.

Among people with diabetes, the mean CES-D score was 26.3, compared with 15.8 among those without diabetes, a statistically significant difference.

In a multivariate analysis that adjusted for age, sex, race, marital status, education, working status, smoking status, physical activity, alcohol consumption, BMI, self-rated health, and the presence of other serious diseases, people with diabetes who also had a CES-D score of 16 or above were 54% more likely to die over 10 years than were those with lower depression scores, a statistically significant increase in risk.

Among people who did not have diabetes, high depression scores conferred a 3% increase in mortality risk, and that increase was not statistically significant.

Dr. Zhang reported that he had no conflicts of interest to disclose.

LONG BEACH, CALIF. — People with diabetes have far higher scores on a depression scale than do those without diabetes, according to a large epidemiologic study.

Furthermore, depression also is associated with increased 10-year mortality in people with diabetes, but not in those without the condition, according to Xuanping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, and his colleagues. Dr. Zhang reported the findings at a conference on diabetes sponsored by the CDC.

The study used data collected between 1982 and 1992 by the National Health and Nutrition Examination Survey I Epidemiologic Follow-Up Survey (NHEFS). The investigators compared 558 people with diabetes to 7,063 people without the disease, and included all individuals for whom they had complete survival data and scores on the Centers for Epidemiologic Studies Depression (CES-D) scale. Scores of 16 and above indicate clinical depression, scores of 16–21 indicate moderate depression, and scores of 22 or greater indicate severe depression.

Among people with diabetes, the mean CES-D score was 26.3, compared with 15.8 among those without diabetes, a statistically significant difference.

In a multivariate analysis that adjusted for age, sex, race, marital status, education, working status, smoking status, physical activity, alcohol consumption, BMI, self-rated health, and the presence of other serious diseases, people with diabetes who also had a CES-D score of 16 or above were 54% more likely to die over 10 years than were those with lower depression scores, a statistically significant increase in risk.

Among people who did not have diabetes, high depression scores conferred a 3% increase in mortality risk, and that increase was not statistically significant.

Dr. Zhang reported that he had no conflicts of interest to disclose.

LONG BEACH, CALIF. — About one-quarter of diabetes patients receiving Medicare Part D drug benefits enter the coverage gap—the so-called doughnut hole—that comes after using $2,250 in medications during a single year.

Although some of these patients have supplemental drug coverage that pays for medications in the gap, many do not. Of diabetic patients with no supplemental coverage, 22% report forgoing medications after entering the coverage gap, and 12% report going without food or withholding rent payment to pay for their drugs, Dr. Carol M. Mangione reported at a meeting on diabetes sponsored by the Centers for Disease Control and Prevention.

“Papers in the literature have shown that cost-related nonadherence can lead to increased hospitalizations and mortality with diabetes,” said Dr. Mangione of the University of California, Los Angeles.

She discussed several studies she and her colleagues conducted using data from surveys of Medicare Part D beneficiaries who were enrolled in free-standing or managed care-based plans in eight states during 2006.

Two of the studies focused on patients older than age 65 with evidence of diabetes, and a third included all Medicare Part D patients enrolled in those plans. The investigators focused on drugs for three chronic conditions: diabetes, high blood pressure, and high cholesterol.

In all, 22%–29% of the patients with diabetes entered the gap, and having a coverage gap was associated with a 4%–7% reduction in total drug costs. This is explained at least partly by nonadherence. Beneficiaries who entered the gap were 17% less adherent with respect to their oral diabetes medications than were nongap beneficiaries.

“Some patients have no coverage in the gap, others have generic-only coverage, and some people have full coverage in the gap,” Dr. Mangione said. “Usually the people with full coverage had a retirement benefit that was filling in that gap coverage.”

Having generic-only gap coverage helped somewhat. Significantly fewer patients with such coverage, 17%, reported nonadherence because of cost, compared with 22% with no gap coverage, but the difference in those who reported going without food or not paying rent between those with and without generic-only gap coverage was not significant, at 10% and 12%, respectively. In contrast, only 1% of the patients with full gap coverage reported nonadherence because of cost, and 1% reported going without food or rent.

Patients also engaged in “rational” approaches to contain costs, said Dr. Mangione. Fifty percent of the patients with no gap coverage and 54% of the patients with generic-only gap coverage used mail-order pharmacies because of costs. In contrast, only 9% of patients with full gap coverage used mail-order pharmacies, a significantly smaller proportion.

Similarly, 44% of the patients with no gap coverage and 45% of those with generic-only gap coverage reported switching to generics, compared with 16% of patients with full gap coverage.

In the third study, the investigators asked whether an earlier switch to generic medications could reduce expenditures enough to keep patients out of the gap.

This analysis included all patients who entered the gap during 2006 (with and without diabetes) from one for-profit plan in eight states.

The investigators found that 87% of patients enrolled in freestanding Part D plans and 78% of patients enrolled in managed care Part D plans had at least one possible cost-saving therapeutic substitution.

If generics had been substituted for brand-name medications, the average patient in a freestanding plan would have saved $377, and the average patient in a managed care plan would have saved $293 in the pregap period. Moreover, this switch would have delayed gap entry by slightly more than 1 month.

Dr. Mangione disclosed no conflicts of interest related to her presentation.

LONG BEACH, CALIF. — About one-quarter of diabetes patients receiving Medicare Part D drug benefits enter the coverage gap—the so-called doughnut hole—that comes after using $2,250 in medications during a single year.

Although some of these patients have supplemental drug coverage that pays for medications in the gap, many do not. Of diabetic patients with no supplemental coverage, 22% report forgoing medications after entering the coverage gap, and 12% report going without food or withholding rent payment to pay for their drugs, Dr. Carol M. Mangione reported at a meeting on diabetes sponsored by the Centers for Disease Control and Prevention.

“Papers in the literature have shown that cost-related nonadherence can lead to increased hospitalizations and mortality with diabetes,” said Dr. Mangione of the University of California, Los Angeles.

She discussed several studies she and her colleagues conducted using data from surveys of Medicare Part D beneficiaries who were enrolled in free-standing or managed care-based plans in eight states during 2006.

Two of the studies focused on patients older than age 65 with evidence of diabetes, and a third included all Medicare Part D patients enrolled in those plans. The investigators focused on drugs for three chronic conditions: diabetes, high blood pressure, and high cholesterol.

In all, 22%–29% of the patients with diabetes entered the gap, and having a coverage gap was associated with a 4%–7% reduction in total drug costs. This is explained at least partly by nonadherence. Beneficiaries who entered the gap were 17% less adherent with respect to their oral diabetes medications than were nongap beneficiaries.

“Some patients have no coverage in the gap, others have generic-only coverage, and some people have full coverage in the gap,” Dr. Mangione said. “Usually the people with full coverage had a retirement benefit that was filling in that gap coverage.”

Having generic-only gap coverage helped somewhat. Significantly fewer patients with such coverage, 17%, reported nonadherence because of cost, compared with 22% with no gap coverage, but the difference in those who reported going without food or not paying rent between those with and without generic-only gap coverage was not significant, at 10% and 12%, respectively. In contrast, only 1% of the patients with full gap coverage reported nonadherence because of cost, and 1% reported going without food or rent.

Patients also engaged in “rational” approaches to contain costs, said Dr. Mangione. Fifty percent of the patients with no gap coverage and 54% of the patients with generic-only gap coverage used mail-order pharmacies because of costs. In contrast, only 9% of patients with full gap coverage used mail-order pharmacies, a significantly smaller proportion.

Similarly, 44% of the patients with no gap coverage and 45% of those with generic-only gap coverage reported switching to generics, compared with 16% of patients with full gap coverage.

In the third study, the investigators asked whether an earlier switch to generic medications could reduce expenditures enough to keep patients out of the gap.

This analysis included all patients who entered the gap during 2006 (with and without diabetes) from one for-profit plan in eight states.

The investigators found that 87% of patients enrolled in freestanding Part D plans and 78% of patients enrolled in managed care Part D plans had at least one possible cost-saving therapeutic substitution.

If generics had been substituted for brand-name medications, the average patient in a freestanding plan would have saved $377, and the average patient in a managed care plan would have saved $293 in the pregap period. Moreover, this switch would have delayed gap entry by slightly more than 1 month.

Dr. Mangione disclosed no conflicts of interest related to her presentation.

LONG BEACH, CALIF. — About one-quarter of diabetes patients receiving Medicare Part D drug benefits enter the coverage gap—the so-called doughnut hole—that comes after using $2,250 in medications during a single year.

Although some of these patients have supplemental drug coverage that pays for medications in the gap, many do not. Of diabetic patients with no supplemental coverage, 22% report forgoing medications after entering the coverage gap, and 12% report going without food or withholding rent payment to pay for their drugs, Dr. Carol M. Mangione reported at a meeting on diabetes sponsored by the Centers for Disease Control and Prevention.

“Papers in the literature have shown that cost-related nonadherence can lead to increased hospitalizations and mortality with diabetes,” said Dr. Mangione of the University of California, Los Angeles.

She discussed several studies she and her colleagues conducted using data from surveys of Medicare Part D beneficiaries who were enrolled in free-standing or managed care-based plans in eight states during 2006.

Two of the studies focused on patients older than age 65 with evidence of diabetes, and a third included all Medicare Part D patients enrolled in those plans. The investigators focused on drugs for three chronic conditions: diabetes, high blood pressure, and high cholesterol.

In all, 22%–29% of the patients with diabetes entered the gap, and having a coverage gap was associated with a 4%–7% reduction in total drug costs. This is explained at least partly by nonadherence. Beneficiaries who entered the gap were 17% less adherent with respect to their oral diabetes medications than were nongap beneficiaries.

“Some patients have no coverage in the gap, others have generic-only coverage, and some people have full coverage in the gap,” Dr. Mangione said. “Usually the people with full coverage had a retirement benefit that was filling in that gap coverage.”

Having generic-only gap coverage helped somewhat. Significantly fewer patients with such coverage, 17%, reported nonadherence because of cost, compared with 22% with no gap coverage, but the difference in those who reported going without food or not paying rent between those with and without generic-only gap coverage was not significant, at 10% and 12%, respectively. In contrast, only 1% of the patients with full gap coverage reported nonadherence because of cost, and 1% reported going without food or rent.

Patients also engaged in “rational” approaches to contain costs, said Dr. Mangione. Fifty percent of the patients with no gap coverage and 54% of the patients with generic-only gap coverage used mail-order pharmacies because of costs. In contrast, only 9% of patients with full gap coverage used mail-order pharmacies, a significantly smaller proportion.

Similarly, 44% of the patients with no gap coverage and 45% of those with generic-only gap coverage reported switching to generics, compared with 16% of patients with full gap coverage.

In the third study, the investigators asked whether an earlier switch to generic medications could reduce expenditures enough to keep patients out of the gap.

This analysis included all patients who entered the gap during 2006 (with and without diabetes) from one for-profit plan in eight states.

The investigators found that 87% of patients enrolled in freestanding Part D plans and 78% of patients enrolled in managed care Part D plans had at least one possible cost-saving therapeutic substitution.

If generics had been substituted for brand-name medications, the average patient in a freestanding plan would have saved $377, and the average patient in a managed care plan would have saved $293 in the pregap period. Moreover, this switch would have delayed gap entry by slightly more than 1 month.

Dr. Mangione disclosed no conflicts of interest related to her presentation.

SAN FRANCISCO — Oral contraceptives provide effective birth control in very heavy or obese women, but “OCs are less forgiving of imperfect use among” this population, according to James Trussell, Ph.D., director of the office of population research, Princeton (N.J.) University.

Speaking at a conference on contraceptive technology sponsored by Contemporary Forums, Dr. Trussell said he based his conclusions on his analysis of the shortcomings of the data from two studies by Victoria Holt, Ph.D., professor of epidemiology at the University of Washington School of Public Health, Seattle. Dr. Holt's studies have formed the basis of the conventional wisdom that OCs fail more often in heavy women.

Findings from the first of her studies, which was a retrospective cohort analysis of 755 HMO enrollees, showed that there was a 60% increase in the risk of OC failure in this population, who were of reproductive age and weighed at least 70.5 kg. That risk was especially high for low-dose and very low-dose formulations, with increases in risk of 2.6-fold and 4.5-fold (Obstet. Gynecol. 2002; 99[pt. 1]:820–7).

The study's flaws were its reliance on self-reports of confirmed pregnancies, because that allowed for the possibility that abortions might have been underreported.

Each patient's weight just before pregnancy was unknown.

The weight used in the analysis was a single self-reported measurement taken an average of 77 months after the last use of oral contraceptives. Finally, the study did not detail OC use patterns.

Dr. Holt's second study was a case-control study with 248 cases and 538 age-matched controls (Obstet. Gynecol. 2005;105:46–52). This study did not find a significant increase in the risk of contraceptive failure among all women in the highest-weight quartile, but it did find a statistically significant 70% increase in risk among consistent OC users weighing 75 kg or greater.

The increase in risk was also significant among all women in the highest BMI quartile (1.6-fold) and in consistent OC users in the highest BMI quartile (2.2-fold).

This study's flaws included self-reporting of weight, retrospective reporting of pill taking an average of 7 months after the reference month, and statistically significant differences between cases and controls in the number of previous pregnancies and the number of those previous pregnancies that occurred during OC use. In addition, women who missed more than five pills during the reference month were excluded from the study.

Findings from six other studies found no association between high weight, BMI, and OC failure. Dr. Trussell conceded that each of those studies had limitations as well, and he said that the question was unlikely to be settled convincingly except in large prospective studies. Even then the question might never be answered for perfect use because it's very difficult to assess adherence.

Even if the increases in relative risk found in the Holt studies prove to be reproducible, the absolute risk of failure is still likely to be modest, Dr. Trussell said.

“Beware of relative risk,” he said. A 120% increase in the relative risk of contraceptive failure during perfect use implies an increase in the absolute risk of contraceptive failure only from 0.23% to 0.51%.

A 60% increase in relative risk during typical use implies an increase in contraceptive failure from 8% to 12% during the first year, which is still lower than the failure rate of condoms.

There is little evidence that high BMI affects the failure rate of Implanon (etonogestrel) or Depo-Provera (med-roxyprogesterone). But it's hard to draw a firm conclusion from this because there were no pregnancies at all in either product's clinical trials, whether the women were obese or not.

Furthermore, the Implanon trials excluded women who were heavier than 130% of ideal body weight. New Food and Drug Administration rules require that drugmakers include obese women in contraceptive trials.

Obese women were included in the phase III efficacy trials of NuvaRing (etonogestrel/ethinyl estradiol), and there were no pregnancies among 74 women weighing 189–272 lb (86–123 kg).

But the situation with the contraceptive patch is different.

Women weighing 80 kg or more have almost eight times the risk of contraceptive failure as do women weighing less, perhaps because of difficulties in hormone transit through subcutaneous fat, he said.

Whether hormonal contraception, which is reasonably effective in obese women, is also safe is another question. Several studies have made it clear that obesity by itself is a risk factor for pulmonary embolism and for deep venous thrombosis, with fivefold increases in risk.

Oral contraceptives further increase the effect of obesity on deep venous thrombosis.

Although those increases in serious side effects are real, Dr. Trussell said that they are not as clinically significant as some fear.

According to the World Health Organization Medical Eligibility Criteria, combined hormonal contraceptives are given a rating of 1 (no restrictions on use) for women with BMIs less than 30 kg/m

The version of these Medical Eligibility Criteria adopted in the United Kingdom, on the other hand, give a rating of 3 (risks generally outweigh benefits) for women with BMIs between 35 and 39, and a rating of 4 (unacceptable risk) for women with BMIs of 40 and above, said Dr. Trussell, who also is the John Foster Dulles Professor in International Affairs and Professor of Economics and Public Affairs at Princeton.

A study of OC safety in women with a BMI over 40 has never been done. There's only one study in the literature of women in the BMI category of greater than or equal to 35. The WHO ratings have a firmer evidence base than the U.K. ratings, according to Dr. Trussell.

Dr. Trussell stated that he had no conflicts of interest related to his presentation.

Contemporary Forums and this news organization are both owned by Elsevier.

SAN FRANCISCO — Oral contraceptives provide effective birth control in very heavy or obese women, but “OCs are less forgiving of imperfect use among” this population, according to James Trussell, Ph.D., director of the office of population research, Princeton (N.J.) University.

Speaking at a conference on contraceptive technology sponsored by Contemporary Forums, Dr. Trussell said he based his conclusions on his analysis of the shortcomings of the data from two studies by Victoria Holt, Ph.D., professor of epidemiology at the University of Washington School of Public Health, Seattle. Dr. Holt's studies have formed the basis of the conventional wisdom that OCs fail more often in heavy women.

Findings from the first of her studies, which was a retrospective cohort analysis of 755 HMO enrollees, showed that there was a 60% increase in the risk of OC failure in this population, who were of reproductive age and weighed at least 70.5 kg. That risk was especially high for low-dose and very low-dose formulations, with increases in risk of 2.6-fold and 4.5-fold (Obstet. Gynecol. 2002; 99[pt. 1]:820–7).

The study's flaws were its reliance on self-reports of confirmed pregnancies, because that allowed for the possibility that abortions might have been underreported.

Each patient's weight just before pregnancy was unknown.

The weight used in the analysis was a single self-reported measurement taken an average of 77 months after the last use of oral contraceptives. Finally, the study did not detail OC use patterns.

Dr. Holt's second study was a case-control study with 248 cases and 538 age-matched controls (Obstet. Gynecol. 2005;105:46–52). This study did not find a significant increase in the risk of contraceptive failure among all women in the highest-weight quartile, but it did find a statistically significant 70% increase in risk among consistent OC users weighing 75 kg or greater.

The increase in risk was also significant among all women in the highest BMI quartile (1.6-fold) and in consistent OC users in the highest BMI quartile (2.2-fold).

This study's flaws included self-reporting of weight, retrospective reporting of pill taking an average of 7 months after the reference month, and statistically significant differences between cases and controls in the number of previous pregnancies and the number of those previous pregnancies that occurred during OC use. In addition, women who missed more than five pills during the reference month were excluded from the study.

Findings from six other studies found no association between high weight, BMI, and OC failure. Dr. Trussell conceded that each of those studies had limitations as well, and he said that the question was unlikely to be settled convincingly except in large prospective studies. Even then the question might never be answered for perfect use because it's very difficult to assess adherence.

Even if the increases in relative risk found in the Holt studies prove to be reproducible, the absolute risk of failure is still likely to be modest, Dr. Trussell said.

“Beware of relative risk,” he said. A 120% increase in the relative risk of contraceptive failure during perfect use implies an increase in the absolute risk of contraceptive failure only from 0.23% to 0.51%.

A 60% increase in relative risk during typical use implies an increase in contraceptive failure from 8% to 12% during the first year, which is still lower than the failure rate of condoms.

There is little evidence that high BMI affects the failure rate of Implanon (etonogestrel) or Depo-Provera (med-roxyprogesterone). But it's hard to draw a firm conclusion from this because there were no pregnancies at all in either product's clinical trials, whether the women were obese or not.

Furthermore, the Implanon trials excluded women who were heavier than 130% of ideal body weight. New Food and Drug Administration rules require that drugmakers include obese women in contraceptive trials.

Obese women were included in the phase III efficacy trials of NuvaRing (etonogestrel/ethinyl estradiol), and there were no pregnancies among 74 women weighing 189–272 lb (86–123 kg).

But the situation with the contraceptive patch is different.

Women weighing 80 kg or more have almost eight times the risk of contraceptive failure as do women weighing less, perhaps because of difficulties in hormone transit through subcutaneous fat, he said.

Whether hormonal contraception, which is reasonably effective in obese women, is also safe is another question. Several studies have made it clear that obesity by itself is a risk factor for pulmonary embolism and for deep venous thrombosis, with fivefold increases in risk.

Oral contraceptives further increase the effect of obesity on deep venous thrombosis.

Although those increases in serious side effects are real, Dr. Trussell said that they are not as clinically significant as some fear.

According to the World Health Organization Medical Eligibility Criteria, combined hormonal contraceptives are given a rating of 1 (no restrictions on use) for women with BMIs less than 30 kg/m

The version of these Medical Eligibility Criteria adopted in the United Kingdom, on the other hand, give a rating of 3 (risks generally outweigh benefits) for women with BMIs between 35 and 39, and a rating of 4 (unacceptable risk) for women with BMIs of 40 and above, said Dr. Trussell, who also is the John Foster Dulles Professor in International Affairs and Professor of Economics and Public Affairs at Princeton.

A study of OC safety in women with a BMI over 40 has never been done. There's only one study in the literature of women in the BMI category of greater than or equal to 35. The WHO ratings have a firmer evidence base than the U.K. ratings, according to Dr. Trussell.

Dr. Trussell stated that he had no conflicts of interest related to his presentation.

Contemporary Forums and this news organization are both owned by Elsevier.

SAN FRANCISCO — Oral contraceptives provide effective birth control in very heavy or obese women, but “OCs are less forgiving of imperfect use among” this population, according to James Trussell, Ph.D., director of the office of population research, Princeton (N.J.) University.

Speaking at a conference on contraceptive technology sponsored by Contemporary Forums, Dr. Trussell said he based his conclusions on his analysis of the shortcomings of the data from two studies by Victoria Holt, Ph.D., professor of epidemiology at the University of Washington School of Public Health, Seattle. Dr. Holt's studies have formed the basis of the conventional wisdom that OCs fail more often in heavy women.

Findings from the first of her studies, which was a retrospective cohort analysis of 755 HMO enrollees, showed that there was a 60% increase in the risk of OC failure in this population, who were of reproductive age and weighed at least 70.5 kg. That risk was especially high for low-dose and very low-dose formulations, with increases in risk of 2.6-fold and 4.5-fold (Obstet. Gynecol. 2002; 99[pt. 1]:820–7).

The study's flaws were its reliance on self-reports of confirmed pregnancies, because that allowed for the possibility that abortions might have been underreported.

Each patient's weight just before pregnancy was unknown.

The weight used in the analysis was a single self-reported measurement taken an average of 77 months after the last use of oral contraceptives. Finally, the study did not detail OC use patterns.

Dr. Holt's second study was a case-control study with 248 cases and 538 age-matched controls (Obstet. Gynecol. 2005;105:46–52). This study did not find a significant increase in the risk of contraceptive failure among all women in the highest-weight quartile, but it did find a statistically significant 70% increase in risk among consistent OC users weighing 75 kg or greater.

The increase in risk was also significant among all women in the highest BMI quartile (1.6-fold) and in consistent OC users in the highest BMI quartile (2.2-fold).

This study's flaws included self-reporting of weight, retrospective reporting of pill taking an average of 7 months after the reference month, and statistically significant differences between cases and controls in the number of previous pregnancies and the number of those previous pregnancies that occurred during OC use. In addition, women who missed more than five pills during the reference month were excluded from the study.

Findings from six other studies found no association between high weight, BMI, and OC failure. Dr. Trussell conceded that each of those studies had limitations as well, and he said that the question was unlikely to be settled convincingly except in large prospective studies. Even then the question might never be answered for perfect use because it's very difficult to assess adherence.

Even if the increases in relative risk found in the Holt studies prove to be reproducible, the absolute risk of failure is still likely to be modest, Dr. Trussell said.

“Beware of relative risk,” he said. A 120% increase in the relative risk of contraceptive failure during perfect use implies an increase in the absolute risk of contraceptive failure only from 0.23% to 0.51%.

A 60% increase in relative risk during typical use implies an increase in contraceptive failure from 8% to 12% during the first year, which is still lower than the failure rate of condoms.

There is little evidence that high BMI affects the failure rate of Implanon (etonogestrel) or Depo-Provera (med-roxyprogesterone). But it's hard to draw a firm conclusion from this because there were no pregnancies at all in either product's clinical trials, whether the women were obese or not.

Furthermore, the Implanon trials excluded women who were heavier than 130% of ideal body weight. New Food and Drug Administration rules require that drugmakers include obese women in contraceptive trials.

Obese women were included in the phase III efficacy trials of NuvaRing (etonogestrel/ethinyl estradiol), and there were no pregnancies among 74 women weighing 189–272 lb (86–123 kg).

But the situation with the contraceptive patch is different.

Women weighing 80 kg or more have almost eight times the risk of contraceptive failure as do women weighing less, perhaps because of difficulties in hormone transit through subcutaneous fat, he said.

Whether hormonal contraception, which is reasonably effective in obese women, is also safe is another question. Several studies have made it clear that obesity by itself is a risk factor for pulmonary embolism and for deep venous thrombosis, with fivefold increases in risk.

Oral contraceptives further increase the effect of obesity on deep venous thrombosis.

Although those increases in serious side effects are real, Dr. Trussell said that they are not as clinically significant as some fear.

According to the World Health Organization Medical Eligibility Criteria, combined hormonal contraceptives are given a rating of 1 (no restrictions on use) for women with BMIs less than 30 kg/m

The version of these Medical Eligibility Criteria adopted in the United Kingdom, on the other hand, give a rating of 3 (risks generally outweigh benefits) for women with BMIs between 35 and 39, and a rating of 4 (unacceptable risk) for women with BMIs of 40 and above, said Dr. Trussell, who also is the John Foster Dulles Professor in International Affairs and Professor of Economics and Public Affairs at Princeton.

A study of OC safety in women with a BMI over 40 has never been done. There's only one study in the literature of women in the BMI category of greater than or equal to 35. The WHO ratings have a firmer evidence base than the U.K. ratings, according to Dr. Trussell.

Dr. Trussell stated that he had no conflicts of interest related to his presentation.

Contemporary Forums and this news organization are both owned by Elsevier.

LONG BEACH, CALIF. — Modest reductions in medication copayments can encourage patients with diabetes to fill their prescriptions and use their drugs, according to researchers at the University of Michigan.

As part of the Michigan Healthy Communities Initiative, the university chose to test a concept called “value-based benefit design.” According to this concept, cost sharing is based not just on the acquisition cost of medication, but also on the likelihood of benefit, Dr. William Herman explained at a diabetes meeting sponsored by the Centers for Disease Control and Prevention. The greater the benefit to the patient, the lower would be his or her copayment.

“Value-based benefit design provides a financial incentive, therefore, to targeted patients to use therapies from which they are most likely to benefit,” said Dr. Herman of the university, in Ann Arbor.

To test this concept, 1,777 university employees and dependents with diabetes were identified and offered copayment reductions on antihyperglycemics, antihypertensives, antihyperlipidemics, and antidepressants.

The price of tier 1 generic medications was reduced 100%, from $7 to zero; the price of tier 2 preferred brand medications was reduced 50%, from $14 to $7; and the price of tier 3 nonpreferred brand medications was reduced 25%, from $24 to $18.

As a control group, investigators identified 3,273 patients with diabetes from the same health plan but with employers other than the University of Michigan. These patients were not offered this reduction in copayments.

Over a 2-year period, patients in the intervention group filled significantly more prescriptions in all medication groups than did those in the control group. For example, there was a 3% absolute increase in filled metformin prescriptions and a 5% absolute increase in filled statin prescriptions.

The investigators measured adherence using a metric called the medication possession ratio (MPR), defined as the amount of medication filled divided by the amount needed to fill to take as prescribed.

Investigators saw a statistically significant 7% absolute increase in MPR for ACE inhibitors and angiotensin II receptor blockers. There was also a 4% absolute increase in the MPR for statins, but that did not reach statistical significance. There were no significant changes in MPR for metformin or SSRIs.

The investigators were concerned that reductions in copayments across the board might encourage use of the more expensive tier 2 and tier 3 medications, but that did not happen. Use of tier 2 medications actually decreased from about 30% to about 15% of all claims, while the use of generic medications increased from 65% to 80%.

In all, the health system granted copayment relief for 86,655 claims, at a cost of $869,767 over 2 years. Antihypertensives represented 36% of this, antihyperglycemics represented 35%, antihyperlipidemics 19%, and antidepressants 10%.

Almost three-quarters (74%) of the copayment relief went for tier 1 medications; 21% went to tier 2 and 5% to tier 3.

“We concluded that value-based benefit design is a useful adjunct to interventions designed to increase patient initiation of and adherence to evidence-based medications,” Dr. Herman said.

Dr. Herman did not report any conflicts of interest related to his presentation. Dr. Herman is the Stefan S. Fajans/GlaxoSmithKline Professor of Diabetes at the University of Michigan.

Use of more expensive tier 2 medications actually decreased from 30% to 15% of all claims. DR. HERMAN

LONG BEACH, CALIF. — Modest reductions in medication copayments can encourage patients with diabetes to fill their prescriptions and use their drugs, according to researchers at the University of Michigan.

As part of the Michigan Healthy Communities Initiative, the university chose to test a concept called “value-based benefit design.” According to this concept, cost sharing is based not just on the acquisition cost of medication, but also on the likelihood of benefit, Dr. William Herman explained at a diabetes meeting sponsored by the Centers for Disease Control and Prevention. The greater the benefit to the patient, the lower would be his or her copayment.

“Value-based benefit design provides a financial incentive, therefore, to targeted patients to use therapies from which they are most likely to benefit,” said Dr. Herman of the university, in Ann Arbor.

To test this concept, 1,777 university employees and dependents with diabetes were identified and offered copayment reductions on antihyperglycemics, antihypertensives, antihyperlipidemics, and antidepressants.

The price of tier 1 generic medications was reduced 100%, from $7 to zero; the price of tier 2 preferred brand medications was reduced 50%, from $14 to $7; and the price of tier 3 nonpreferred brand medications was reduced 25%, from $24 to $18.

As a control group, investigators identified 3,273 patients with diabetes from the same health plan but with employers other than the University of Michigan. These patients were not offered this reduction in copayments.

Over a 2-year period, patients in the intervention group filled significantly more prescriptions in all medication groups than did those in the control group. For example, there was a 3% absolute increase in filled metformin prescriptions and a 5% absolute increase in filled statin prescriptions.

The investigators measured adherence using a metric called the medication possession ratio (MPR), defined as the amount of medication filled divided by the amount needed to fill to take as prescribed.

Investigators saw a statistically significant 7% absolute increase in MPR for ACE inhibitors and angiotensin II receptor blockers. There was also a 4% absolute increase in the MPR for statins, but that did not reach statistical significance. There were no significant changes in MPR for metformin or SSRIs.

The investigators were concerned that reductions in copayments across the board might encourage use of the more expensive tier 2 and tier 3 medications, but that did not happen. Use of tier 2 medications actually decreased from about 30% to about 15% of all claims, while the use of generic medications increased from 65% to 80%.

In all, the health system granted copayment relief for 86,655 claims, at a cost of $869,767 over 2 years. Antihypertensives represented 36% of this, antihyperglycemics represented 35%, antihyperlipidemics 19%, and antidepressants 10%.

Almost three-quarters (74%) of the copayment relief went for tier 1 medications; 21% went to tier 2 and 5% to tier 3.

“We concluded that value-based benefit design is a useful adjunct to interventions designed to increase patient initiation of and adherence to evidence-based medications,” Dr. Herman said.

Dr. Herman did not report any conflicts of interest related to his presentation. Dr. Herman is the Stefan S. Fajans/GlaxoSmithKline Professor of Diabetes at the University of Michigan.

Use of more expensive tier 2 medications actually decreased from 30% to 15% of all claims. DR. HERMAN

LONG BEACH, CALIF. — Modest reductions in medication copayments can encourage patients with diabetes to fill their prescriptions and use their drugs, according to researchers at the University of Michigan.

As part of the Michigan Healthy Communities Initiative, the university chose to test a concept called “value-based benefit design.” According to this concept, cost sharing is based not just on the acquisition cost of medication, but also on the likelihood of benefit, Dr. William Herman explained at a diabetes meeting sponsored by the Centers for Disease Control and Prevention. The greater the benefit to the patient, the lower would be his or her copayment.

“Value-based benefit design provides a financial incentive, therefore, to targeted patients to use therapies from which they are most likely to benefit,” said Dr. Herman of the university, in Ann Arbor.

To test this concept, 1,777 university employees and dependents with diabetes were identified and offered copayment reductions on antihyperglycemics, antihypertensives, antihyperlipidemics, and antidepressants.

The price of tier 1 generic medications was reduced 100%, from $7 to zero; the price of tier 2 preferred brand medications was reduced 50%, from $14 to $7; and the price of tier 3 nonpreferred brand medications was reduced 25%, from $24 to $18.

As a control group, investigators identified 3,273 patients with diabetes from the same health plan but with employers other than the University of Michigan. These patients were not offered this reduction in copayments.

Over a 2-year period, patients in the intervention group filled significantly more prescriptions in all medication groups than did those in the control group. For example, there was a 3% absolute increase in filled metformin prescriptions and a 5% absolute increase in filled statin prescriptions.

The investigators measured adherence using a metric called the medication possession ratio (MPR), defined as the amount of medication filled divided by the amount needed to fill to take as prescribed.

Investigators saw a statistically significant 7% absolute increase in MPR for ACE inhibitors and angiotensin II receptor blockers. There was also a 4% absolute increase in the MPR for statins, but that did not reach statistical significance. There were no significant changes in MPR for metformin or SSRIs.

The investigators were concerned that reductions in copayments across the board might encourage use of the more expensive tier 2 and tier 3 medications, but that did not happen. Use of tier 2 medications actually decreased from about 30% to about 15% of all claims, while the use of generic medications increased from 65% to 80%.

In all, the health system granted copayment relief for 86,655 claims, at a cost of $869,767 over 2 years. Antihypertensives represented 36% of this, antihyperglycemics represented 35%, antihyperlipidemics 19%, and antidepressants 10%.

Almost three-quarters (74%) of the copayment relief went for tier 1 medications; 21% went to tier 2 and 5% to tier 3.

“We concluded that value-based benefit design is a useful adjunct to interventions designed to increase patient initiation of and adherence to evidence-based medications,” Dr. Herman said.

Dr. Herman did not report any conflicts of interest related to his presentation. Dr. Herman is the Stefan S. Fajans/GlaxoSmithKline Professor of Diabetes at the University of Michigan.

Use of more expensive tier 2 medications actually decreased from 30% to 15% of all claims. DR. HERMAN

LONG BEACH, CALIF. — About one-quarter of diabetes patients receiving Medicare Part D drug benefits enter the coverage gap—the so-called “doughnut hole”—that comes after using $2,250 in medications during a single year.

Although some of these patients have supplemental drug coverage that pays for medications in the gap, many do not. Of diabetic patients with no supplemental coverage, 22% report forgoing medications after entering the coverage gap, and 12% report going without food or withholding rent payment to pay for their drugs, Dr. Carol M. Mangione reported at a meeting on diabetes sponsored by the Centers for Disease Control and Prevention.

“Papers in the literature have shown that cost-related nonadherence can lead to increased hospitalizations and mortality with diabetes,” said Dr. Mangione of the University of California, Los Angeles. She discussed several studies she and her colleagues conducted using data from surveys of Medicare Part D beneficiaries enrolled in free-standing or managed care-based plans in eight states during 2006. Two of the studies focused on patients aged older than 65 years with evidence of diabetes, and a third included all Medicare Part D patients enrolled in those plans.

In all, 22%–29% of the patients with diabetes entered the gap, and having a coverage gap was associated with a 4%–7% reduction in total drug costs. This is explained at least partly by nonadherence. Beneficiaries who entered the gap were 17% less adherent with respect to their oral diabetes medications than were non-gap beneficiaries.

“Some patients have no coverage in the gap, others have generic-only coverage, and some people have full coverage,” Dr. Mangione said.

Having generic-only gap coverage helped somewhat. Significantly fewer patients with such coverage, 17%, reported nonadherence due to cost, than the 22% with no gap coverage, but the difference in those who reported going without food or not paying rent between those with and without generic-only gap coverage was not significant, at 10% and 12%, respectively. In contrast, only 1% of the patients with full gap coverage reported nonadherence due to cost, and 1% reported going without food or rent.

Patients also engaged in “rational” approaches to contain costs, said Dr. Mangione. Fifty percent of the patients with no gap coverage and 54% of the patients with generic-only gap coverage used mail-order pharmacies because of costs. In contrast, only 9% of patients with full gap coverage used mail-order pharmacies.

In the third study, the investigators asked whether an earlier switch to generic medications could reduce expenditures enough to keep patients out of the gap. This analysis included all patients who entered the gap during 2006 (with and without diabetes) from one for-profit plan.

The investigators found that 87% of patients enrolled in freestanding Part D plans and 78% of patients enrolled in managed care Part D plans had at least one possible cost-saving therapeutic substitution.

If generics had been substituted for brand-name drugs, the average patient in a freestanding plan would have saved $377; the average patient in a managed care plan would have saved $293 in the pregap period.

Dr. Mangione disclosed no conflicts of interest related to her presentation.

LONG BEACH, CALIF. — About one-quarter of diabetes patients receiving Medicare Part D drug benefits enter the coverage gap—the so-called “doughnut hole”—that comes after using $2,250 in medications during a single year.

Although some of these patients have supplemental drug coverage that pays for medications in the gap, many do not. Of diabetic patients with no supplemental coverage, 22% report forgoing medications after entering the coverage gap, and 12% report going without food or withholding rent payment to pay for their drugs, Dr. Carol M. Mangione reported at a meeting on diabetes sponsored by the Centers for Disease Control and Prevention.

“Papers in the literature have shown that cost-related nonadherence can lead to increased hospitalizations and mortality with diabetes,” said Dr. Mangione of the University of California, Los Angeles. She discussed several studies she and her colleagues conducted using data from surveys of Medicare Part D beneficiaries enrolled in free-standing or managed care-based plans in eight states during 2006. Two of the studies focused on patients aged older than 65 years with evidence of diabetes, and a third included all Medicare Part D patients enrolled in those plans.

In all, 22%–29% of the patients with diabetes entered the gap, and having a coverage gap was associated with a 4%–7% reduction in total drug costs. This is explained at least partly by nonadherence. Beneficiaries who entered the gap were 17% less adherent with respect to their oral diabetes medications than were non-gap beneficiaries.

“Some patients have no coverage in the gap, others have generic-only coverage, and some people have full coverage,” Dr. Mangione said.

Having generic-only gap coverage helped somewhat. Significantly fewer patients with such coverage, 17%, reported nonadherence due to cost, than the 22% with no gap coverage, but the difference in those who reported going without food or not paying rent between those with and without generic-only gap coverage was not significant, at 10% and 12%, respectively. In contrast, only 1% of the patients with full gap coverage reported nonadherence due to cost, and 1% reported going without food or rent.

Patients also engaged in “rational” approaches to contain costs, said Dr. Mangione. Fifty percent of the patients with no gap coverage and 54% of the patients with generic-only gap coverage used mail-order pharmacies because of costs. In contrast, only 9% of patients with full gap coverage used mail-order pharmacies.

In the third study, the investigators asked whether an earlier switch to generic medications could reduce expenditures enough to keep patients out of the gap. This analysis included all patients who entered the gap during 2006 (with and without diabetes) from one for-profit plan.

The investigators found that 87% of patients enrolled in freestanding Part D plans and 78% of patients enrolled in managed care Part D plans had at least one possible cost-saving therapeutic substitution.

If generics had been substituted for brand-name drugs, the average patient in a freestanding plan would have saved $377; the average patient in a managed care plan would have saved $293 in the pregap period.

Dr. Mangione disclosed no conflicts of interest related to her presentation.

LONG BEACH, CALIF. — About one-quarter of diabetes patients receiving Medicare Part D drug benefits enter the coverage gap—the so-called “doughnut hole”—that comes after using $2,250 in medications during a single year.

Although some of these patients have supplemental drug coverage that pays for medications in the gap, many do not. Of diabetic patients with no supplemental coverage, 22% report forgoing medications after entering the coverage gap, and 12% report going without food or withholding rent payment to pay for their drugs, Dr. Carol M. Mangione reported at a meeting on diabetes sponsored by the Centers for Disease Control and Prevention.

“Papers in the literature have shown that cost-related nonadherence can lead to increased hospitalizations and mortality with diabetes,” said Dr. Mangione of the University of California, Los Angeles. She discussed several studies she and her colleagues conducted using data from surveys of Medicare Part D beneficiaries enrolled in free-standing or managed care-based plans in eight states during 2006. Two of the studies focused on patients aged older than 65 years with evidence of diabetes, and a third included all Medicare Part D patients enrolled in those plans.

In all, 22%–29% of the patients with diabetes entered the gap, and having a coverage gap was associated with a 4%–7% reduction in total drug costs. This is explained at least partly by nonadherence. Beneficiaries who entered the gap were 17% less adherent with respect to their oral diabetes medications than were non-gap beneficiaries.

“Some patients have no coverage in the gap, others have generic-only coverage, and some people have full coverage,” Dr. Mangione said.

Having generic-only gap coverage helped somewhat. Significantly fewer patients with such coverage, 17%, reported nonadherence due to cost, than the 22% with no gap coverage, but the difference in those who reported going without food or not paying rent between those with and without generic-only gap coverage was not significant, at 10% and 12%, respectively. In contrast, only 1% of the patients with full gap coverage reported nonadherence due to cost, and 1% reported going without food or rent.

Patients also engaged in “rational” approaches to contain costs, said Dr. Mangione. Fifty percent of the patients with no gap coverage and 54% of the patients with generic-only gap coverage used mail-order pharmacies because of costs. In contrast, only 9% of patients with full gap coverage used mail-order pharmacies.

In the third study, the investigators asked whether an earlier switch to generic medications could reduce expenditures enough to keep patients out of the gap. This analysis included all patients who entered the gap during 2006 (with and without diabetes) from one for-profit plan.

The investigators found that 87% of patients enrolled in freestanding Part D plans and 78% of patients enrolled in managed care Part D plans had at least one possible cost-saving therapeutic substitution.

If generics had been substituted for brand-name drugs, the average patient in a freestanding plan would have saved $377; the average patient in a managed care plan would have saved $293 in the pregap period.

Dr. Mangione disclosed no conflicts of interest related to her presentation.

SAN FRANCISCO — When used intravaginally in combination with a condom, the investigational microbicide PRO 2000/5 gel appeared to reduce HIV transmission by 30% in a large, international, randomized clinical trial.

The finding, which fell short of statistical significance, was seen in a study called HPTN 035 (Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel [P] for the Prevention of HIV Infection in Women). A reduction of 33% would have reached statistical significance, according to Dr. Willard Cates Jr., president of research at Family Health International, which designed and launched the trial. FHI is a nonprofit foundation in Research Triangle Park. N.C.

The study followed 3,099 women at one U.S. site and at sites in five African countries. All women were given free condoms, HIV risk reduction counseling, and diagnosis and treatment of sexually transmitted diseases. The study participants were then randomized to one of four groups. One-quarter were given PRO 2000/5 gel, one-quarter were given another microbicide called BufferGel, one-quarter were given a placebo gel, and the remaining women did not receive any gel. The gels were provided as single-use, prefilled applicators and the study participants were instructed to apply one dose of the contents intravaginally up to 60 minutes before each vaginal intercourse. The women were followed for an average of 20 months and were evaluated monthly; 94% of the women completed study visits through the follow-up period.

Participants in the three gel groups reported using the gel during 81% of all sex acts, and nearly all women (99%) said they would use the products if approved for HIV prevention. Women in the three gel groups reported using condoms 72% of the time, and women in the no-gel group reported using condoms 81% of the time.

In all, 194 of the women acquired HIV; 36 women in the PRO 2000/5 group, 54 in the BufferGel group, 51 in the placebo gel group, and 53 among participants who used no gel. This corresponds to an effectiveness rate of 30% for PRO 2000/5; a rate of 33% would have been statistically significant. In a subanalysis based on reliability of condom use, there was little difference in the infection rate among women who used condoms more than 85% of the time. However, the infection rate was 4.6 per 100 person-years among the low-condom-use women given the placebo gel compared with 1.0 per 100 person-years among the low-condom-use women given PRO 2000/5 gel. The variation corresponded to an effectiveness rate of 78% for the microbicide.

Dr. Cates acknowledged at a meeting on contraceptive technology sponsored by Contemporary Forums that this post hoc subanalysis did not carry the statistical weight of a primary outcome. "It's not conclusive, not etiologic reasoning in its purest, but at least it's a hint and a ray of hope in a field that was looking for any good news," he said.

Dr. Cates said that a separate trial of PRO 2000/5 gel, involving about 9,000 women, is expected to be completed by the end of 2009, with data available early in 2010.

The investigational microbicide PRO 2000/5 gel (0.5% dose) was developed by Indevus Pharmaceuticals Inc. of Lexington, Mass., and is an entry/fusion inhibitor designed to make it difficult for HIV to attach to and infect healthy cells. The investigational microbicide BufferGel was developed by ReProtect, Inc. of Baltimore, and is thought to work by boosting the natural acidity of the vagina in the presence of seminal fluid.

The study was funded by the National Institute of Allergy and Infectious Diseases [NCT00074425

Dr. Cates disclosed that he had no conflicts of interest. Contemporary Forums and this newspaper are both subsidiaries of Elsevier.

SAN FRANCISCO — When used intravaginally in combination with a condom, the investigational microbicide PRO 2000/5 gel appeared to reduce HIV transmission by 30% in a large, international, randomized clinical trial.

The finding, which fell short of statistical significance, was seen in a study called HPTN 035 (Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel [P] for the Prevention of HIV Infection in Women). A reduction of 33% would have reached statistical significance, according to Dr. Willard Cates Jr., president of research at Family Health International, which designed and launched the trial. FHI is a nonprofit foundation in Research Triangle Park. N.C.

The study followed 3,099 women at one U.S. site and at sites in five African countries. All women were given free condoms, HIV risk reduction counseling, and diagnosis and treatment of sexually transmitted diseases. The study participants were then randomized to one of four groups. One-quarter were given PRO 2000/5 gel, one-quarter were given another microbicide called BufferGel, one-quarter were given a placebo gel, and the remaining women did not receive any gel. The gels were provided as single-use, prefilled applicators and the study participants were instructed to apply one dose of the contents intravaginally up to 60 minutes before each vaginal intercourse. The women were followed for an average of 20 months and were evaluated monthly; 94% of the women completed study visits through the follow-up period.

Participants in the three gel groups reported using the gel during 81% of all sex acts, and nearly all women (99%) said they would use the products if approved for HIV prevention. Women in the three gel groups reported using condoms 72% of the time, and women in the no-gel group reported using condoms 81% of the time.

In all, 194 of the women acquired HIV; 36 women in the PRO 2000/5 group, 54 in the BufferGel group, 51 in the placebo gel group, and 53 among participants who used no gel. This corresponds to an effectiveness rate of 30% for PRO 2000/5; a rate of 33% would have been statistically significant. In a subanalysis based on reliability of condom use, there was little difference in the infection rate among women who used condoms more than 85% of the time. However, the infection rate was 4.6 per 100 person-years among the low-condom-use women given the placebo gel compared with 1.0 per 100 person-years among the low-condom-use women given PRO 2000/5 gel. The variation corresponded to an effectiveness rate of 78% for the microbicide.

Dr. Cates acknowledged at a meeting on contraceptive technology sponsored by Contemporary Forums that this post hoc subanalysis did not carry the statistical weight of a primary outcome. "It's not conclusive, not etiologic reasoning in its purest, but at least it's a hint and a ray of hope in a field that was looking for any good news," he said.

Dr. Cates said that a separate trial of PRO 2000/5 gel, involving about 9,000 women, is expected to be completed by the end of 2009, with data available early in 2010.

The investigational microbicide PRO 2000/5 gel (0.5% dose) was developed by Indevus Pharmaceuticals Inc. of Lexington, Mass., and is an entry/fusion inhibitor designed to make it difficult for HIV to attach to and infect healthy cells. The investigational microbicide BufferGel was developed by ReProtect, Inc. of Baltimore, and is thought to work by boosting the natural acidity of the vagina in the presence of seminal fluid.

The study was funded by the National Institute of Allergy and Infectious Diseases [NCT00074425

Dr. Cates disclosed that he had no conflicts of interest. Contemporary Forums and this newspaper are both subsidiaries of Elsevier.

SAN FRANCISCO — When used intravaginally in combination with a condom, the investigational microbicide PRO 2000/5 gel appeared to reduce HIV transmission by 30% in a large, international, randomized clinical trial.

The finding, which fell short of statistical significance, was seen in a study called HPTN 035 (Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel [P] for the Prevention of HIV Infection in Women). A reduction of 33% would have reached statistical significance, according to Dr. Willard Cates Jr., president of research at Family Health International, which designed and launched the trial. FHI is a nonprofit foundation in Research Triangle Park. N.C.

The study followed 3,099 women at one U.S. site and at sites in five African countries. All women were given free condoms, HIV risk reduction counseling, and diagnosis and treatment of sexually transmitted diseases. The study participants were then randomized to one of four groups. One-quarter were given PRO 2000/5 gel, one-quarter were given another microbicide called BufferGel, one-quarter were given a placebo gel, and the remaining women did not receive any gel. The gels were provided as single-use, prefilled applicators and the study participants were instructed to apply one dose of the contents intravaginally up to 60 minutes before each vaginal intercourse. The women were followed for an average of 20 months and were evaluated monthly; 94% of the women completed study visits through the follow-up period.

Participants in the three gel groups reported using the gel during 81% of all sex acts, and nearly all women (99%) said they would use the products if approved for HIV prevention. Women in the three gel groups reported using condoms 72% of the time, and women in the no-gel group reported using condoms 81% of the time.

In all, 194 of the women acquired HIV; 36 women in the PRO 2000/5 group, 54 in the BufferGel group, 51 in the placebo gel group, and 53 among participants who used no gel. This corresponds to an effectiveness rate of 30% for PRO 2000/5; a rate of 33% would have been statistically significant. In a subanalysis based on reliability of condom use, there was little difference in the infection rate among women who used condoms more than 85% of the time. However, the infection rate was 4.6 per 100 person-years among the low-condom-use women given the placebo gel compared with 1.0 per 100 person-years among the low-condom-use women given PRO 2000/5 gel. The variation corresponded to an effectiveness rate of 78% for the microbicide.

Dr. Cates acknowledged at a meeting on contraceptive technology sponsored by Contemporary Forums that this post hoc subanalysis did not carry the statistical weight of a primary outcome. "It's not conclusive, not etiologic reasoning in its purest, but at least it's a hint and a ray of hope in a field that was looking for any good news," he said.

Dr. Cates said that a separate trial of PRO 2000/5 gel, involving about 9,000 women, is expected to be completed by the end of 2009, with data available early in 2010.

The investigational microbicide PRO 2000/5 gel (0.5% dose) was developed by Indevus Pharmaceuticals Inc. of Lexington, Mass., and is an entry/fusion inhibitor designed to make it difficult for HIV to attach to and infect healthy cells. The investigational microbicide BufferGel was developed by ReProtect, Inc. of Baltimore, and is thought to work by boosting the natural acidity of the vagina in the presence of seminal fluid.

The study was funded by the National Institute of Allergy and Infectious Diseases [NCT00074425

Dr. Cates disclosed that he had no conflicts of interest. Contemporary Forums and this newspaper are both subsidiaries of Elsevier.

The National Foundation for Infectious Diseases has unveiled a Web site that takes a multipronged approach to increasing the rate of adult vaccination in the United States.

Revealed during a Webcast for reporters, www.adultvaccination.com

Adult immunization rates are far too low, Dr. Rehm said during the Webcast: "Most vaccination rates in adults are below 50%. The highest rates are for influenza and pneumococcal vaccines in people 65 and older, but even in these groups vaccination rates are below 70%."

Dr. Rehm attributed those higher rates to long-standing, comprehensive educational and awareness efforts aimed at the public and health care providers. "Our mission here is to focus the same type of concentrated efforts on all adult vaccines, to support increases in vaccination rates across the entire adult spectrum. While we're at it we'll also aim to increase the influenza and pneumococcal vaccination rates to new target levels," she said.

For patients, the Web site includes basic information on 13 vaccine-preventable diseases along with a short quiz that helps discern which vaccines they need. It also includes a simple fact sheet and the full schedule of adult immunizations recommended by the U.S. Centers for Disease Control and Prevention.

For health care providers, the Web site includes a "Professional Practice Toolkit," with numerous resources. These include suggested text for reminder postcards, text to be added to the back of appointment reminder cards, and scripts for recorded telephone messages to be played when patients are on hold or when the office is closed. (See box below.)

Dr. Rehm has used a number of these resources in her own practice, and has implemented other strategies as well. "We have posters in our waiting room regarding various immunizations, and in each of the individual examination rooms we have posted the adult vaccination recommendations from the CDC. People can take a look at those and then it's also a stimulus for us to talk about them," she explained. "We have built in questions about vaccinations into our intake, so that when our assistants ask patients what medicines they're taking and they get their vital signs … they also update their vaccination immunization [records] and cue us to talk with patients about vaccines."

The Web site is supported by unrestricted educational grants to the National Foundation for Infectious Diseases from GlaxoSmithKline, Merck, Sanofi Pasteur, and Wyeth Pharmaceuticals.

Items in the Online Toolkit

▸ Appointment reminder cards

▸ "Office closed" message script

▸ "On hold" message script

▸ Patient fact sheet

▸ Patient Q&A

▸ Poster

▸ Tabletop tent cards

▸ Article for practice newsletter or physician's Web site

▸ Reminder postcards

▸ Resource list

▸ Sample standing orders

Source:

www.adultvaccination.com

The National Foundation for Infectious Diseases has unveiled a Web site that takes a multipronged approach to increasing the rate of adult vaccination in the United States.

Revealed during a Webcast for reporters, www.adultvaccination.com

Adult immunization rates are far too low, Dr. Rehm said during the Webcast: "Most vaccination rates in adults are below 50%. The highest rates are for influenza and pneumococcal vaccines in people 65 and older, but even in these groups vaccination rates are below 70%."

Dr. Rehm attributed those higher rates to long-standing, comprehensive educational and awareness efforts aimed at the public and health care providers. "Our mission here is to focus the same type of concentrated efforts on all adult vaccines, to support increases in vaccination rates across the entire adult spectrum. While we're at it we'll also aim to increase the influenza and pneumococcal vaccination rates to new target levels," she said.

For patients, the Web site includes basic information on 13 vaccine-preventable diseases along with a short quiz that helps discern which vaccines they need. It also includes a simple fact sheet and the full schedule of adult immunizations recommended by the U.S. Centers for Disease Control and Prevention.

For health care providers, the Web site includes a "Professional Practice Toolkit," with numerous resources. These include suggested text for reminder postcards, text to be added to the back of appointment reminder cards, and scripts for recorded telephone messages to be played when patients are on hold or when the office is closed. (See box below.)

Dr. Rehm has used a number of these resources in her own practice, and has implemented other strategies as well. "We have posters in our waiting room regarding various immunizations, and in each of the individual examination rooms we have posted the adult vaccination recommendations from the CDC. People can take a look at those and then it's also a stimulus for us to talk about them," she explained. "We have built in questions about vaccinations into our intake, so that when our assistants ask patients what medicines they're taking and they get their vital signs … they also update their vaccination immunization [records] and cue us to talk with patients about vaccines."

The Web site is supported by unrestricted educational grants to the National Foundation for Infectious Diseases from GlaxoSmithKline, Merck, Sanofi Pasteur, and Wyeth Pharmaceuticals.

Items in the Online Toolkit

▸ Appointment reminder cards

▸ "Office closed" message script

▸ "On hold" message script

▸ Patient fact sheet

▸ Patient Q&A

▸ Poster

▸ Tabletop tent cards

▸ Article for practice newsletter or physician's Web site

▸ Reminder postcards

▸ Resource list

▸ Sample standing orders

Source:

www.adultvaccination.com

The National Foundation for Infectious Diseases has unveiled a Web site that takes a multipronged approach to increasing the rate of adult vaccination in the United States.

Revealed during a Webcast for reporters, www.adultvaccination.com

Adult immunization rates are far too low, Dr. Rehm said during the Webcast: "Most vaccination rates in adults are below 50%. The highest rates are for influenza and pneumococcal vaccines in people 65 and older, but even in these groups vaccination rates are below 70%."

Dr. Rehm attributed those higher rates to long-standing, comprehensive educational and awareness efforts aimed at the public and health care providers. "Our mission here is to focus the same type of concentrated efforts on all adult vaccines, to support increases in vaccination rates across the entire adult spectrum. While we're at it we'll also aim to increase the influenza and pneumococcal vaccination rates to new target levels," she said.

For patients, the Web site includes basic information on 13 vaccine-preventable diseases along with a short quiz that helps discern which vaccines they need. It also includes a simple fact sheet and the full schedule of adult immunizations recommended by the U.S. Centers for Disease Control and Prevention.

For health care providers, the Web site includes a "Professional Practice Toolkit," with numerous resources. These include suggested text for reminder postcards, text to be added to the back of appointment reminder cards, and scripts for recorded telephone messages to be played when patients are on hold or when the office is closed. (See box below.)

Dr. Rehm has used a number of these resources in her own practice, and has implemented other strategies as well. "We have posters in our waiting room regarding various immunizations, and in each of the individual examination rooms we have posted the adult vaccination recommendations from the CDC. People can take a look at those and then it's also a stimulus for us to talk about them," she explained. "We have built in questions about vaccinations into our intake, so that when our assistants ask patients what medicines they're taking and they get their vital signs … they also update their vaccination immunization [records] and cue us to talk with patients about vaccines."

The Web site is supported by unrestricted educational grants to the National Foundation for Infectious Diseases from GlaxoSmithKline, Merck, Sanofi Pasteur, and Wyeth Pharmaceuticals.

Items in the Online Toolkit

▸ Appointment reminder cards

▸ "Office closed" message script

▸ "On hold" message script

▸ Patient fact sheet

▸ Patient Q&A

▸ Poster

▸ Tabletop tent cards

▸ Article for practice newsletter or physician's Web site

▸ Reminder postcards

▸ Resource list

▸ Sample standing orders

Source:

www.adultvaccination.com