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Vemurafenib Will Open Floodgates for Melanoma Genotyping

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Vemurafenib Will Open Floodgates for Melanoma Genotyping

NEW YORK – The genotyping era of melanoma management is poised to launch.

The era will start with genetic assessment of every patient with advanced-stage melanoma becoming the standard of care, as soon as the Food and Drug Administration approves marketing of vemurafenib, the small-molecule inhibitor of a mutated form of the BRAF gene. Reuters reports that approval is imminent, based on strikingly good results from a phase III study presented in June at the annual meeting of the American Society of Clinical Oncology, and published in the New England Journal of Medicine (2011;364:2507-16).

"If and when [vemurafenib] is approved by the FDA, we will need some sort of commercially available test to assess patients [with unresectable stage IIIC or stage IV melanoma] for BRAF [mutations]," Dr. Richard D. Carvajal said in an interview after speaking at the American Academy of Dermatology’s Summer Academy meeting. "In a large, phase III trial, vemurafenib impacted survival in patients with tumors with a BRAF mutation. You’ll need to know the BRAF status to use [vemurafenib]."

Dr. Richard D. Carvajal    

In May, Genentech, a Roche subsidiary developing vemurafenib with Daiichi Sankyo subsidiary Plexxikon, announced that it had submitted a new drug approval application to the FDA.

"At my institution and at others, it’s becoming standard of care to do genotyping on these patients. We need to know how to prioritize them to experimental or standard treatments," said Dr. Carvajal, a medical oncologist specializing in melanoma and sarcomas at Memorial Sloan-Kettering Cancer Center in New York. "In the not too distant future, it will be standard to get a panel" of genotyping results, probably also including NRAS, KIT, and several other oncogenes now emerging as important players in the genetic progression of metastatic melanoma.

"As these markers become relevant for choosing treatment, they will be available in CLIA-certified tests," Dr. Carvajal said. Genotyping "should be done on all [advanced melanoma] patients; it’s just a matter of how you pay for it. The panel of genes we’ll need to look at will grow with time."

Results from genotyping studies of metastatic melanoma tumors have shown a BRAF mutation prevalence of about 43% and a NRAS mutation prevalence of about 14%, with the remaining 43% of tumors having wild type forms of both genes, Dr. Nancy E. Thomas said in a separate talk at the meeting.

The BRAF and NRAS mutations, as well as several others found with less frequency, appear mutually exclusive, so that, for example, essentially all studied tumors with BRAF mutations are wild type for NRAS, and essentially all tumors with a NRAS mutation have wild type BRAF, said Dr. Thomas, professor of dermatology at the University of North Carolina at Chapel Hill.

When vemurafenib gets U.S. marketing approval, it will also muddy the treatment algorithm for metastatic melanoma. For the time being, ipilimumab (Yervoy), an immunotherapy approved for treating advanced-stage melanoma in March 2011, is unrivaled for survival benefits as first-line therapy.

"Ipilimumab is the only FDA-approved drug [for advanced melanoma] that has demonstrated an improvement in overall survival. Right now, it’s the standard of care," Dr. Carvajal said.

But ipilimumab also has some drawbacks. The evidence base to date gives no guidance on whether ipilimumab can be targeted to certain genotypic subgroups of melanoma, and it works relatively slowly, which makes it problematic for patients with rapidly progressing disease or a large disease burden. The ipilimumab studies done so far enrolled patients regardless of their genotype status, so no information exists on whether tumors with specific gene mutations respond especially well or poorly.

"When vemurafenib is approved, the question will be how to sequence these two drugs in patients with BRAF mutations. That’s something we’re struggling with," Dr. Carvajal said.

Despite that, the success scored so far by both ipilimumab and vemurafenib represents major advances at least for certain, responsive patients, Dr. Carvajal said. "For both drugs we can see tumor shrinkage, but what we really look for is prolongation of life. A significant proportion of patients will have benefit from treatment that lasts years and years."

Dr. Carvajal said that he has been a consultant to Novartis.

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NEW YORK – The genotyping era of melanoma management is poised to launch.

The era will start with genetic assessment of every patient with advanced-stage melanoma becoming the standard of care, as soon as the Food and Drug Administration approves marketing of vemurafenib, the small-molecule inhibitor of a mutated form of the BRAF gene. Reuters reports that approval is imminent, based on strikingly good results from a phase III study presented in June at the annual meeting of the American Society of Clinical Oncology, and published in the New England Journal of Medicine (2011;364:2507-16).

"If and when [vemurafenib] is approved by the FDA, we will need some sort of commercially available test to assess patients [with unresectable stage IIIC or stage IV melanoma] for BRAF [mutations]," Dr. Richard D. Carvajal said in an interview after speaking at the American Academy of Dermatology’s Summer Academy meeting. "In a large, phase III trial, vemurafenib impacted survival in patients with tumors with a BRAF mutation. You’ll need to know the BRAF status to use [vemurafenib]."

Dr. Richard D. Carvajal    

In May, Genentech, a Roche subsidiary developing vemurafenib with Daiichi Sankyo subsidiary Plexxikon, announced that it had submitted a new drug approval application to the FDA.

"At my institution and at others, it’s becoming standard of care to do genotyping on these patients. We need to know how to prioritize them to experimental or standard treatments," said Dr. Carvajal, a medical oncologist specializing in melanoma and sarcomas at Memorial Sloan-Kettering Cancer Center in New York. "In the not too distant future, it will be standard to get a panel" of genotyping results, probably also including NRAS, KIT, and several other oncogenes now emerging as important players in the genetic progression of metastatic melanoma.

"As these markers become relevant for choosing treatment, they will be available in CLIA-certified tests," Dr. Carvajal said. Genotyping "should be done on all [advanced melanoma] patients; it’s just a matter of how you pay for it. The panel of genes we’ll need to look at will grow with time."

Results from genotyping studies of metastatic melanoma tumors have shown a BRAF mutation prevalence of about 43% and a NRAS mutation prevalence of about 14%, with the remaining 43% of tumors having wild type forms of both genes, Dr. Nancy E. Thomas said in a separate talk at the meeting.

The BRAF and NRAS mutations, as well as several others found with less frequency, appear mutually exclusive, so that, for example, essentially all studied tumors with BRAF mutations are wild type for NRAS, and essentially all tumors with a NRAS mutation have wild type BRAF, said Dr. Thomas, professor of dermatology at the University of North Carolina at Chapel Hill.

When vemurafenib gets U.S. marketing approval, it will also muddy the treatment algorithm for metastatic melanoma. For the time being, ipilimumab (Yervoy), an immunotherapy approved for treating advanced-stage melanoma in March 2011, is unrivaled for survival benefits as first-line therapy.

"Ipilimumab is the only FDA-approved drug [for advanced melanoma] that has demonstrated an improvement in overall survival. Right now, it’s the standard of care," Dr. Carvajal said.

But ipilimumab also has some drawbacks. The evidence base to date gives no guidance on whether ipilimumab can be targeted to certain genotypic subgroups of melanoma, and it works relatively slowly, which makes it problematic for patients with rapidly progressing disease or a large disease burden. The ipilimumab studies done so far enrolled patients regardless of their genotype status, so no information exists on whether tumors with specific gene mutations respond especially well or poorly.

"When vemurafenib is approved, the question will be how to sequence these two drugs in patients with BRAF mutations. That’s something we’re struggling with," Dr. Carvajal said.

Despite that, the success scored so far by both ipilimumab and vemurafenib represents major advances at least for certain, responsive patients, Dr. Carvajal said. "For both drugs we can see tumor shrinkage, but what we really look for is prolongation of life. A significant proportion of patients will have benefit from treatment that lasts years and years."

Dr. Carvajal said that he has been a consultant to Novartis.

NEW YORK – The genotyping era of melanoma management is poised to launch.

The era will start with genetic assessment of every patient with advanced-stage melanoma becoming the standard of care, as soon as the Food and Drug Administration approves marketing of vemurafenib, the small-molecule inhibitor of a mutated form of the BRAF gene. Reuters reports that approval is imminent, based on strikingly good results from a phase III study presented in June at the annual meeting of the American Society of Clinical Oncology, and published in the New England Journal of Medicine (2011;364:2507-16).

"If and when [vemurafenib] is approved by the FDA, we will need some sort of commercially available test to assess patients [with unresectable stage IIIC or stage IV melanoma] for BRAF [mutations]," Dr. Richard D. Carvajal said in an interview after speaking at the American Academy of Dermatology’s Summer Academy meeting. "In a large, phase III trial, vemurafenib impacted survival in patients with tumors with a BRAF mutation. You’ll need to know the BRAF status to use [vemurafenib]."

Dr. Richard D. Carvajal    

In May, Genentech, a Roche subsidiary developing vemurafenib with Daiichi Sankyo subsidiary Plexxikon, announced that it had submitted a new drug approval application to the FDA.

"At my institution and at others, it’s becoming standard of care to do genotyping on these patients. We need to know how to prioritize them to experimental or standard treatments," said Dr. Carvajal, a medical oncologist specializing in melanoma and sarcomas at Memorial Sloan-Kettering Cancer Center in New York. "In the not too distant future, it will be standard to get a panel" of genotyping results, probably also including NRAS, KIT, and several other oncogenes now emerging as important players in the genetic progression of metastatic melanoma.

"As these markers become relevant for choosing treatment, they will be available in CLIA-certified tests," Dr. Carvajal said. Genotyping "should be done on all [advanced melanoma] patients; it’s just a matter of how you pay for it. The panel of genes we’ll need to look at will grow with time."

Results from genotyping studies of metastatic melanoma tumors have shown a BRAF mutation prevalence of about 43% and a NRAS mutation prevalence of about 14%, with the remaining 43% of tumors having wild type forms of both genes, Dr. Nancy E. Thomas said in a separate talk at the meeting.

The BRAF and NRAS mutations, as well as several others found with less frequency, appear mutually exclusive, so that, for example, essentially all studied tumors with BRAF mutations are wild type for NRAS, and essentially all tumors with a NRAS mutation have wild type BRAF, said Dr. Thomas, professor of dermatology at the University of North Carolina at Chapel Hill.

When vemurafenib gets U.S. marketing approval, it will also muddy the treatment algorithm for metastatic melanoma. For the time being, ipilimumab (Yervoy), an immunotherapy approved for treating advanced-stage melanoma in March 2011, is unrivaled for survival benefits as first-line therapy.

"Ipilimumab is the only FDA-approved drug [for advanced melanoma] that has demonstrated an improvement in overall survival. Right now, it’s the standard of care," Dr. Carvajal said.

But ipilimumab also has some drawbacks. The evidence base to date gives no guidance on whether ipilimumab can be targeted to certain genotypic subgroups of melanoma, and it works relatively slowly, which makes it problematic for patients with rapidly progressing disease or a large disease burden. The ipilimumab studies done so far enrolled patients regardless of their genotype status, so no information exists on whether tumors with specific gene mutations respond especially well or poorly.

"When vemurafenib is approved, the question will be how to sequence these two drugs in patients with BRAF mutations. That’s something we’re struggling with," Dr. Carvajal said.

Despite that, the success scored so far by both ipilimumab and vemurafenib represents major advances at least for certain, responsive patients, Dr. Carvajal said. "For both drugs we can see tumor shrinkage, but what we really look for is prolongation of life. A significant proportion of patients will have benefit from treatment that lasts years and years."

Dr. Carvajal said that he has been a consultant to Novartis.

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EXPERT ANALYSIS FROM THE AMERICAN ACADEMY OF DERMATOLOGY'S SUMMER ACADEMY MEETING

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Nearly Everyone Needs a Routine Vitamin D Supplement

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NEW YORK – The vast majority of children and adults should receive a routine, daily vitamin D supplement, and this recommendation applies from age 1 year all the way up to age 70 years, Dr. Henry W. Lim said at the meeting.

The only exception is a select group of people at high risk for vitamin D inadequacy who warrant initial testing to be sure they don’t need an even higher starting dosage of the vitamin, said Dr. Lim, professor and chairman of dermatology at Henry Ford Hospital in Detroit.

Photo (c) Joss/fotolia.com
     Only people at risk for vitamin D inadequacy, such as breastfed infants or people with limited sun exposure, should be tested for serum vitamin D level, according to Dr. Henry W. Lim.

Dr. Lim based his recommendations on the revised dietary reference intakes for vitamin D issued by the Institute of Medicine last November, which set a recommended dietary allowance (RDA) of 600 IU/day for ages 1-70 years.

"In my opinion, testing [of serum vitamin D level] should only be done for people at high risk for vitamin D inadequacy," he said. In the group to consider for testing are breastfed infants, older adults with reduced skin synthesis of vitamin D, or people with limited sun exposure, dark skin, fat malabsorption (because vitamin D is fat soluble), or obesity.

"For the average individual [not in a high-risk group] my suggestion is to take 600 IU per day starting at age 1," Dr. Lim said in an interview. At that level, the supplement is relatively innocuous, inexpensive, and addresses the widespread vitamin D inadequacy. He did not rule out routine vitamin D supplements for children younger than 1 year, but noted that the RDA is lower.

Testing a person’s vitamin D level costs about $100, using ICD-9 code 268.9 for unspecified vitamin D deficiency. Doing that for everyone would incur a "tremendous" cost, he said. He also echoed the recent position taken by the American Academy of Dermatology that most vitamin D should come from diet and supplements, and not from sun exposure. "It is inappropriate to recommend intentional exposure to natural or artificial UV [light] for achieving an adequate vitamin D level," he said.

Dr. Henry W. Lim    

People at high risk for a low vitamin D level need testing to check whether their level falls as low as 10 ng/mL or even 5 ng/mL. With this degree of deficiency, the person might need a single 10,000-IU or even 20,000-IU dose to raise their level quickly. Daily supplements should not exceed 1,000-3,000 IU in children aged 8 years or younger and should not exceed 4,000 IU daily for those aged 9-70 years, Dr. Lim said.

Two types of vitamin D are available in supplement form, D2 and D3 (ergocalciferol and cholecalciferol, respectively). The vitamin D3 form is preferable because it is more effective at raising serum levels, it attaches better to vitamin D–binding protein, and it has a longer shelf life, Dr. Lim said.

He also reviewed the evidence documenting benefit from adequate vitamin D levels. He concurred with the IOM that the best evidence by far to support maintaining a minimum serum vitamin D level involves the vitamin’s effect on skeletal health. For other outcomes, the evidence is "inconsistent, inconclusive, and insufficient to inform nutritional requirements," Dr. Lim said.

Dr. Lim said that he has been a consultant to La Roche-Posay L’Oreal, Clinuvel, and Procter & Gamble and has been an investigator for Clinuvel.

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NEW YORK – The vast majority of children and adults should receive a routine, daily vitamin D supplement, and this recommendation applies from age 1 year all the way up to age 70 years, Dr. Henry W. Lim said at the meeting.

The only exception is a select group of people at high risk for vitamin D inadequacy who warrant initial testing to be sure they don’t need an even higher starting dosage of the vitamin, said Dr. Lim, professor and chairman of dermatology at Henry Ford Hospital in Detroit.

Photo (c) Joss/fotolia.com
     Only people at risk for vitamin D inadequacy, such as breastfed infants or people with limited sun exposure, should be tested for serum vitamin D level, according to Dr. Henry W. Lim.

Dr. Lim based his recommendations on the revised dietary reference intakes for vitamin D issued by the Institute of Medicine last November, which set a recommended dietary allowance (RDA) of 600 IU/day for ages 1-70 years.

"In my opinion, testing [of serum vitamin D level] should only be done for people at high risk for vitamin D inadequacy," he said. In the group to consider for testing are breastfed infants, older adults with reduced skin synthesis of vitamin D, or people with limited sun exposure, dark skin, fat malabsorption (because vitamin D is fat soluble), or obesity.

"For the average individual [not in a high-risk group] my suggestion is to take 600 IU per day starting at age 1," Dr. Lim said in an interview. At that level, the supplement is relatively innocuous, inexpensive, and addresses the widespread vitamin D inadequacy. He did not rule out routine vitamin D supplements for children younger than 1 year, but noted that the RDA is lower.

Testing a person’s vitamin D level costs about $100, using ICD-9 code 268.9 for unspecified vitamin D deficiency. Doing that for everyone would incur a "tremendous" cost, he said. He also echoed the recent position taken by the American Academy of Dermatology that most vitamin D should come from diet and supplements, and not from sun exposure. "It is inappropriate to recommend intentional exposure to natural or artificial UV [light] for achieving an adequate vitamin D level," he said.

Dr. Henry W. Lim    

People at high risk for a low vitamin D level need testing to check whether their level falls as low as 10 ng/mL or even 5 ng/mL. With this degree of deficiency, the person might need a single 10,000-IU or even 20,000-IU dose to raise their level quickly. Daily supplements should not exceed 1,000-3,000 IU in children aged 8 years or younger and should not exceed 4,000 IU daily for those aged 9-70 years, Dr. Lim said.

Two types of vitamin D are available in supplement form, D2 and D3 (ergocalciferol and cholecalciferol, respectively). The vitamin D3 form is preferable because it is more effective at raising serum levels, it attaches better to vitamin D–binding protein, and it has a longer shelf life, Dr. Lim said.

He also reviewed the evidence documenting benefit from adequate vitamin D levels. He concurred with the IOM that the best evidence by far to support maintaining a minimum serum vitamin D level involves the vitamin’s effect on skeletal health. For other outcomes, the evidence is "inconsistent, inconclusive, and insufficient to inform nutritional requirements," Dr. Lim said.

Dr. Lim said that he has been a consultant to La Roche-Posay L’Oreal, Clinuvel, and Procter & Gamble and has been an investigator for Clinuvel.

NEW YORK – The vast majority of children and adults should receive a routine, daily vitamin D supplement, and this recommendation applies from age 1 year all the way up to age 70 years, Dr. Henry W. Lim said at the meeting.

The only exception is a select group of people at high risk for vitamin D inadequacy who warrant initial testing to be sure they don’t need an even higher starting dosage of the vitamin, said Dr. Lim, professor and chairman of dermatology at Henry Ford Hospital in Detroit.

Photo (c) Joss/fotolia.com
     Only people at risk for vitamin D inadequacy, such as breastfed infants or people with limited sun exposure, should be tested for serum vitamin D level, according to Dr. Henry W. Lim.

Dr. Lim based his recommendations on the revised dietary reference intakes for vitamin D issued by the Institute of Medicine last November, which set a recommended dietary allowance (RDA) of 600 IU/day for ages 1-70 years.

"In my opinion, testing [of serum vitamin D level] should only be done for people at high risk for vitamin D inadequacy," he said. In the group to consider for testing are breastfed infants, older adults with reduced skin synthesis of vitamin D, or people with limited sun exposure, dark skin, fat malabsorption (because vitamin D is fat soluble), or obesity.

"For the average individual [not in a high-risk group] my suggestion is to take 600 IU per day starting at age 1," Dr. Lim said in an interview. At that level, the supplement is relatively innocuous, inexpensive, and addresses the widespread vitamin D inadequacy. He did not rule out routine vitamin D supplements for children younger than 1 year, but noted that the RDA is lower.

Testing a person’s vitamin D level costs about $100, using ICD-9 code 268.9 for unspecified vitamin D deficiency. Doing that for everyone would incur a "tremendous" cost, he said. He also echoed the recent position taken by the American Academy of Dermatology that most vitamin D should come from diet and supplements, and not from sun exposure. "It is inappropriate to recommend intentional exposure to natural or artificial UV [light] for achieving an adequate vitamin D level," he said.

Dr. Henry W. Lim    

People at high risk for a low vitamin D level need testing to check whether their level falls as low as 10 ng/mL or even 5 ng/mL. With this degree of deficiency, the person might need a single 10,000-IU or even 20,000-IU dose to raise their level quickly. Daily supplements should not exceed 1,000-3,000 IU in children aged 8 years or younger and should not exceed 4,000 IU daily for those aged 9-70 years, Dr. Lim said.

Two types of vitamin D are available in supplement form, D2 and D3 (ergocalciferol and cholecalciferol, respectively). The vitamin D3 form is preferable because it is more effective at raising serum levels, it attaches better to vitamin D–binding protein, and it has a longer shelf life, Dr. Lim said.

He also reviewed the evidence documenting benefit from adequate vitamin D levels. He concurred with the IOM that the best evidence by far to support maintaining a minimum serum vitamin D level involves the vitamin’s effect on skeletal health. For other outcomes, the evidence is "inconsistent, inconclusive, and insufficient to inform nutritional requirements," Dr. Lim said.

Dr. Lim said that he has been a consultant to La Roche-Posay L’Oreal, Clinuvel, and Procter & Gamble and has been an investigator for Clinuvel.

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AAD: Nearly Everyone Needs a Routine Vitamin D Supplement

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AAD: Nearly Everyone Needs a Routine Vitamin D Supplement

NEW YORK – The vast majority of children and adults should receive a routine, daily vitamin D supplement, and this recommendation applies from age 1 year all the way up to age 70 years, Dr. Henry W. Lim said at the American Academy of Dermatology's Summer Academy meeting.

The only exception is a select group of people at high risk for vitamin D inadequacy who warrant initial testing to be sure they don’t need an even higher starting dosage of the vitamin, said Dr. Lim, professor and chairman of dermatology at Henry Ford Hospital in Detroit.

Photo (c) Joss/fotolia.com
     Only people at risk for vitamin D inadequacy should be tested for serum vitamin D level, according to Dr. Henry W. Lim.

Dr. Lim based his recommendations on the revised dietary reference intakes for vitamin D issued by the Institute of Medicine last November, which set a recommended dietary allowance (RDA) of 600 IU/day for ages 1-70 years.

"In my opinion, testing [of serum vitamin D level] should only be done for people at high risk for vitamin D inadequacy," he said. In the group to consider for testing are breastfed infants, older adults with reduced skin synthesis of vitamin D, or people with limited sun exposure, dark skin, fat malabsorption (because vitamin D is fat soluble), or obesity.

Dr. Henry W. Lim    

"For the average individual [not in a high-risk group] my suggestion is to take 600 IU per day starting at age 1," Dr. Lim said in an interview. At that level, the supplement is relatively innocuous, inexpensive, and addresses the widespread vitamin D inadequacy. He did not rule out routine vitamin D supplements for children younger than 1 year, but noted that the RDA is lower.

Testing a person's vitamin D level costs about $100, using ICD-9 code 268.9 for unspecified vitamin D deficiency. Doing that for everyone would incur a "tremendous" cost, he said. He also echoed the recent position taken by the American Academy of Dermatology that most vitamin D should come from diet and supplements, and not from sun exposure. "It is inappropriate to recommend intentional exposure to natural or artificial UV [light] for achieving an adequate vitamin D level," he said.

People at high risk for a low vitamin D level need testing to check whether their level falls as low as 10 ng/mL or even 5 ng/mL. With this degree of deficiency, the person might need a single 10,000-IU or even 20,000-IU dose to raise their level quickly. Daily supplements should not exceed 1,000-3,000 IU in children aged 8 years or younger and should not exceed 4,000 IU daily for those aged 9-70 years, Dr. Lim said.

Two types of vitamin D are available in supplement form, D2 and D3 (ergocalciferol and cholecalciferol, respectively). The vitamin D3 form is preferable because it is more effective at raising serum levels, it attaches better to vitamin D–binding protein, and it has a longer shelf life, Dr. Lim said.

He also reviewed the evidence documenting benefit from adequate vitamin D levels. He concurred with the IOM that the best evidence by far to support maintaining a minimum serum vitamin D level involves the vitamin's effect on skeletal health. For other outcomes, the evidence is "inconsistent, inconclusive, and insufficient to inform nutritional requirements," Dr. Lim said.

Dr. Lim said that he has been a consultant to La Roche-Posay L'Oreal, Clinuvel, and Procter & Gamble and has been an investigator for Clinuvel.

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NEW YORK – The vast majority of children and adults should receive a routine, daily vitamin D supplement, and this recommendation applies from age 1 year all the way up to age 70 years, Dr. Henry W. Lim said at the American Academy of Dermatology's Summer Academy meeting.

The only exception is a select group of people at high risk for vitamin D inadequacy who warrant initial testing to be sure they don’t need an even higher starting dosage of the vitamin, said Dr. Lim, professor and chairman of dermatology at Henry Ford Hospital in Detroit.

Photo (c) Joss/fotolia.com
     Only people at risk for vitamin D inadequacy should be tested for serum vitamin D level, according to Dr. Henry W. Lim.

Dr. Lim based his recommendations on the revised dietary reference intakes for vitamin D issued by the Institute of Medicine last November, which set a recommended dietary allowance (RDA) of 600 IU/day for ages 1-70 years.

"In my opinion, testing [of serum vitamin D level] should only be done for people at high risk for vitamin D inadequacy," he said. In the group to consider for testing are breastfed infants, older adults with reduced skin synthesis of vitamin D, or people with limited sun exposure, dark skin, fat malabsorption (because vitamin D is fat soluble), or obesity.

Dr. Henry W. Lim    

"For the average individual [not in a high-risk group] my suggestion is to take 600 IU per day starting at age 1," Dr. Lim said in an interview. At that level, the supplement is relatively innocuous, inexpensive, and addresses the widespread vitamin D inadequacy. He did not rule out routine vitamin D supplements for children younger than 1 year, but noted that the RDA is lower.

Testing a person's vitamin D level costs about $100, using ICD-9 code 268.9 for unspecified vitamin D deficiency. Doing that for everyone would incur a "tremendous" cost, he said. He also echoed the recent position taken by the American Academy of Dermatology that most vitamin D should come from diet and supplements, and not from sun exposure. "It is inappropriate to recommend intentional exposure to natural or artificial UV [light] for achieving an adequate vitamin D level," he said.

People at high risk for a low vitamin D level need testing to check whether their level falls as low as 10 ng/mL or even 5 ng/mL. With this degree of deficiency, the person might need a single 10,000-IU or even 20,000-IU dose to raise their level quickly. Daily supplements should not exceed 1,000-3,000 IU in children aged 8 years or younger and should not exceed 4,000 IU daily for those aged 9-70 years, Dr. Lim said.

Two types of vitamin D are available in supplement form, D2 and D3 (ergocalciferol and cholecalciferol, respectively). The vitamin D3 form is preferable because it is more effective at raising serum levels, it attaches better to vitamin D–binding protein, and it has a longer shelf life, Dr. Lim said.

He also reviewed the evidence documenting benefit from adequate vitamin D levels. He concurred with the IOM that the best evidence by far to support maintaining a minimum serum vitamin D level involves the vitamin's effect on skeletal health. For other outcomes, the evidence is "inconsistent, inconclusive, and insufficient to inform nutritional requirements," Dr. Lim said.

Dr. Lim said that he has been a consultant to La Roche-Posay L'Oreal, Clinuvel, and Procter & Gamble and has been an investigator for Clinuvel.

NEW YORK – The vast majority of children and adults should receive a routine, daily vitamin D supplement, and this recommendation applies from age 1 year all the way up to age 70 years, Dr. Henry W. Lim said at the American Academy of Dermatology's Summer Academy meeting.

The only exception is a select group of people at high risk for vitamin D inadequacy who warrant initial testing to be sure they don’t need an even higher starting dosage of the vitamin, said Dr. Lim, professor and chairman of dermatology at Henry Ford Hospital in Detroit.

Photo (c) Joss/fotolia.com
     Only people at risk for vitamin D inadequacy should be tested for serum vitamin D level, according to Dr. Henry W. Lim.

Dr. Lim based his recommendations on the revised dietary reference intakes for vitamin D issued by the Institute of Medicine last November, which set a recommended dietary allowance (RDA) of 600 IU/day for ages 1-70 years.

"In my opinion, testing [of serum vitamin D level] should only be done for people at high risk for vitamin D inadequacy," he said. In the group to consider for testing are breastfed infants, older adults with reduced skin synthesis of vitamin D, or people with limited sun exposure, dark skin, fat malabsorption (because vitamin D is fat soluble), or obesity.

Dr. Henry W. Lim    

"For the average individual [not in a high-risk group] my suggestion is to take 600 IU per day starting at age 1," Dr. Lim said in an interview. At that level, the supplement is relatively innocuous, inexpensive, and addresses the widespread vitamin D inadequacy. He did not rule out routine vitamin D supplements for children younger than 1 year, but noted that the RDA is lower.

Testing a person's vitamin D level costs about $100, using ICD-9 code 268.9 for unspecified vitamin D deficiency. Doing that for everyone would incur a "tremendous" cost, he said. He also echoed the recent position taken by the American Academy of Dermatology that most vitamin D should come from diet and supplements, and not from sun exposure. "It is inappropriate to recommend intentional exposure to natural or artificial UV [light] for achieving an adequate vitamin D level," he said.

People at high risk for a low vitamin D level need testing to check whether their level falls as low as 10 ng/mL or even 5 ng/mL. With this degree of deficiency, the person might need a single 10,000-IU or even 20,000-IU dose to raise their level quickly. Daily supplements should not exceed 1,000-3,000 IU in children aged 8 years or younger and should not exceed 4,000 IU daily for those aged 9-70 years, Dr. Lim said.

Two types of vitamin D are available in supplement form, D2 and D3 (ergocalciferol and cholecalciferol, respectively). The vitamin D3 form is preferable because it is more effective at raising serum levels, it attaches better to vitamin D–binding protein, and it has a longer shelf life, Dr. Lim said.

He also reviewed the evidence documenting benefit from adequate vitamin D levels. He concurred with the IOM that the best evidence by far to support maintaining a minimum serum vitamin D level involves the vitamin's effect on skeletal health. For other outcomes, the evidence is "inconsistent, inconclusive, and insufficient to inform nutritional requirements," Dr. Lim said.

Dr. Lim said that he has been a consultant to La Roche-Posay L'Oreal, Clinuvel, and Procter & Gamble and has been an investigator for Clinuvel.

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EXPERT ANALYSIS FROM THE AMERICAN ACADEMY OF DERMATOLOGY'S SUMMER ACADEMY MEETING

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