Hair & Nails

There’s power in numbers, and why should patient advocacy be any different?

Last week, at a meeting in Philadelphia on the collection and use of clinical specimens for genetic studies, alopecia areata researcher Dr. Angela Christiano couldn’t stop praising the National Alopecia Areata Foundation, both for its financial assistance in funding her research over more than a decade, and for the group's more intrinsic aid in establishing, promoting, and populating the National Alopecia Areata Registry that provided the genetic specimens Dr. Christiano and her associates used to identify eight genes linked to the disease, study results they reported last year.

Courtesy Images from the History of Medicine Collection (NLM)

In her talk, Dr. Christiano gave some reasons why alopecia areata should have such a dynamic advocacy group. Alopecia areata, an autoimmune disorder that causes either partial or complete hair loss in otherwise healthy, young people, affects more than 5 million Americans. In addition, until recently little was know about its cause, and no evidence-based nor reliably effective treatment exists.

The genetic links that Dr. Christiano and her colleagues identified finally provide clues to what causes alopecia areata and how it might be treated. They also plan to further explore genetic links in an expanded study. Last year’s report used genetic specimens from 1,054 patients, but now the registry includes about 7,400 patients, and the researchers’ goal is to raise the total above 10,000.

The discussion at last week’s meeting made clear that patient advocacy groups can play a key role in helping researchers acquire large numbers of clinical specimens for genetic studies from patients with a variety of diseases. The Internet and social media have made patients much more informed about their conditions and have tied them into better organized networks. Alopecia areata is a disease where the payoffs from this have begun to accrue.

---Mitchel Zoler (on Twitter @mitchelzoler)

There’s power in numbers, and why should patient advocacy be any different?

Last week, at a meeting in Philadelphia on the collection and use of clinical specimens for genetic studies, alopecia areata researcher Dr. Angela Christiano couldn’t stop praising the National Alopecia Areata Foundation, both for its financial assistance in funding her research over more than a decade, and for the group's more intrinsic aid in establishing, promoting, and populating the National Alopecia Areata Registry that provided the genetic specimens Dr. Christiano and her associates used to identify eight genes linked to the disease, study results they reported last year.

Courtesy Images from the History of Medicine Collection (NLM)

In her talk, Dr. Christiano gave some reasons why alopecia areata should have such a dynamic advocacy group. Alopecia areata, an autoimmune disorder that causes either partial or complete hair loss in otherwise healthy, young people, affects more than 5 million Americans. In addition, until recently little was know about its cause, and no evidence-based nor reliably effective treatment exists.

The genetic links that Dr. Christiano and her colleagues identified finally provide clues to what causes alopecia areata and how it might be treated. They also plan to further explore genetic links in an expanded study. Last year’s report used genetic specimens from 1,054 patients, but now the registry includes about 7,400 patients, and the researchers’ goal is to raise the total above 10,000.

The discussion at last week’s meeting made clear that patient advocacy groups can play a key role in helping researchers acquire large numbers of clinical specimens for genetic studies from patients with a variety of diseases. The Internet and social media have made patients much more informed about their conditions and have tied them into better organized networks. Alopecia areata is a disease where the payoffs from this have begun to accrue.

---Mitchel Zoler (on Twitter @mitchelzoler)

There’s power in numbers, and why should patient advocacy be any different?

Last week, at a meeting in Philadelphia on the collection and use of clinical specimens for genetic studies, alopecia areata researcher Dr. Angela Christiano couldn’t stop praising the National Alopecia Areata Foundation, both for its financial assistance in funding her research over more than a decade, and for the group's more intrinsic aid in establishing, promoting, and populating the National Alopecia Areata Registry that provided the genetic specimens Dr. Christiano and her associates used to identify eight genes linked to the disease, study results they reported last year.

Courtesy Images from the History of Medicine Collection (NLM)

In her talk, Dr. Christiano gave some reasons why alopecia areata should have such a dynamic advocacy group. Alopecia areata, an autoimmune disorder that causes either partial or complete hair loss in otherwise healthy, young people, affects more than 5 million Americans. In addition, until recently little was know about its cause, and no evidence-based nor reliably effective treatment exists.

The genetic links that Dr. Christiano and her colleagues identified finally provide clues to what causes alopecia areata and how it might be treated. They also plan to further explore genetic links in an expanded study. Last year’s report used genetic specimens from 1,054 patients, but now the registry includes about 7,400 patients, and the researchers’ goal is to raise the total above 10,000.

The discussion at last week’s meeting made clear that patient advocacy groups can play a key role in helping researchers acquire large numbers of clinical specimens for genetic studies from patients with a variety of diseases. The Internet and social media have made patients much more informed about their conditions and have tied them into better organized networks. Alopecia areata is a disease where the payoffs from this have begun to accrue.

---Mitchel Zoler (on Twitter @mitchelzoler)

Dr. Richard K. Scher discussed the dangers of gel nail polish, and also gave tips to share with patients on how to have a safe experience at the nail salon at the American Academy of Dermatology's Summer Academy meeting in New York.

Patients undergoing gel nail polish application at salons expose their hands to several minutes of UV light to harden the layers of polish, said Dr. Scher of Columbia University, New York. Their hands are also soaked in acetone for up to 10 minutes to dissolve the hard to remove shellac during polish changes.

In the video below, Dr. Scher offers advice and tips for patients that frequent nail salons.

Dr. Richard K. Scher discussed the dangers of gel nail polish, and also gave tips to share with patients on how to have a safe experience at the nail salon at the American Academy of Dermatology's Summer Academy meeting in New York.

Patients undergoing gel nail polish application at salons expose their hands to several minutes of UV light to harden the layers of polish, said Dr. Scher of Columbia University, New York. Their hands are also soaked in acetone for up to 10 minutes to dissolve the hard to remove shellac during polish changes.

In the video below, Dr. Scher offers advice and tips for patients that frequent nail salons.

Dr. Richard K. Scher discussed the dangers of gel nail polish, and also gave tips to share with patients on how to have a safe experience at the nail salon at the American Academy of Dermatology's Summer Academy meeting in New York.

Patients undergoing gel nail polish application at salons expose their hands to several minutes of UV light to harden the layers of polish, said Dr. Scher of Columbia University, New York. Their hands are also soaked in acetone for up to 10 minutes to dissolve the hard to remove shellac during polish changes.

In the video below, Dr. Scher offers advice and tips for patients that frequent nail salons.

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.

The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.

The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.

Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.

All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).

By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.

At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.

The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.

Dr. Ortonne is a consultant to Galderma, the study sponsor.

SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm² or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm² or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

SEOUL, SOUTH KOREA – The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia. But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm² or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.