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New article re: low dose accutane

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Journal of the American Academy of Dermatology

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Low-dose isotretinoin is effective for treating acne vulgaris

March 22, 2006

ST LOUIS (MD Consult) - Low-dose isotretinoin (0.3-0.4 mg/kg/d) is effective in treating acne vulgaris and causes fewer adverse effects than do standard dosages, according to the April Journal of the American Academy of Dermatology.

In an open-label trial, Dr Boaz Amichai and colleagues of Huzot Clinic of Clalit Health Services in Ashkelon, Israel, and other institutions prospectively studied 638 patients with moderate papulopustular acne. Patients were given 0.3 to 0.4 mg/kg/d of isotretinoin for 6 months, which is lower than the standard dosage of 0.5 to 1.0 mg/kg/d.

At the end of therapy, complete or almost complete remission of acne was obtained in 94.8% of the younger patients (12-20 years old) and in 92.6% of the older patients (21-35 years old). These success rates were similar to those reported for patients taking standard-dose therapy. However, <5% of the current patients had abnormal serum lipid levels or abnormal liver enzyme levels, whereas these adverse effects occur in up to 35% and 10%, respectively, of patients receiving standard therapy.

Thus, while the authors recommend standard dosages for patients with severe acne, they suggest lower dosages can be effective and are better tolerated in patients with moderate acne.

J Am Acad Dermatol. 2006;54:644-646.

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It doesn't really mean anything if they don't tell us what the remission rates are in the years following treatment. Sure, low dose will usually clear you by the end of the course, but the effects don't seem to last as long as the higher dose courses.

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I just thought I'd post it. It looks interesting. Here is the 4 year follow-up info:

At the end of the treatment phase, good results were observed in 94.8% of the patients aged 12 to 20 years, and in 92.6% of the patients aged 21 to 35 years. Failure of the treatment occurred in 5.2% and 7.4% of the two groups, respectively. Twenty-one patients dropped out of the study because of lack of compliance, and another patient discontinued participation because of a laboratory side effect. During the 4-year follow-up period, relapses of the acne occurred in 3.9% of the patients aged 12 to 20 years and in 5.9% of the patients aged 21 to 35 years. Elevated serum lipid levels (up to 20% higher than the upper limit of normal value) were found in 4.2% of the patients and abnormal (<twice the upper limit of normal values) liver tests were observed in 4.8%.

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Thanks for posting the study. It reaffirms what FDA says re Roche's application for approval of a new formulation of Accutane:

The current recommended dosage range for AC for the treatment of severe recalcitrant

nodular acne is 0.5 to 2.0 mg/kg/day given with food in two divided doses. The

dosage of AC used in the clinical trial in this application was 1 mg/kg with food.

According to the Sponsor, it is likely that patients who received AC in the

therapeutic study had approximately 240% higher exposure to isotretinoin than

the subjects who received NF. Since therapeutic equivalence was demonstrated

in the adequately powered total trial population, it would appear that the currently

recommended dosing range for Accutane® may be too high. This is of

considerable clinical importance because many of the side effects of isotretinoin

are dose-dependent. Even those that would appear to be “non-serious� (e.g.

mucocutaneous effects, transient moderate hypertriglyceridemia) can lead to

treatment discontinuation for patients who might otherwise greatly benefit by

completing a course. Available dose-ranging studies for Accutane® do not

definitively establish that even the lower end of the currently labeled dosage is

the minimum effective dose.

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