Isotretinoin therapy for acne vulgaris: a re-evaluation of the need for measurements of plasma lipids and liver function tests

Abstract

A retrospective analysis of patients receiving isotretinoin for acne was performed, in order to determine the necessity for routine testing of lipid profiles and liver function tests during therapy. Data were analysed from 209 individuals, 113 (69 males, 44 females) of whom had been treated with 1 mg/kg/day, and 96 (67 males, 29 females) with 0.5 mg/kg/day. There were no significant changes in any of the tests of liver function. There were significant elevations in both plasma cholesterol and triglycerides at 8 and 16 weeks (P < 0.01) for both dose schedules, which were significant in both male and female subjects (P < 0.001). All the individuals with elevated cholesterol (> 6.5 mmol/l) at 16 weeks had elevated cholesterol at the onset of therapy. Triglyceride concentrations were elevated at 8 weeks, but there was no further increase thereafter. It was not possible to predict which subjects would become hypertriglyceridaemic from pretreatment lipid estimations. In conclusion, there appears to be little evidence to support the previously recommended regular biochemical monitoring of liver function and lipid profiles in patients who are treated with isotretinoin for 16 weeks. It would appear prudent to ensure that there is neither liver disease nor hyperlipidaemia prior to the onset of therapy, and to determine the triglyceride response to therapy on one occasion after 4 weeks' treatment. This change in patient management should result in considerable savings both in patient time and in blood collection and analysis.

Preventing and Managing the Side Effects of Isotretinoin

“…23,25 The most significant lipid elevations were observed in patients who already had elevated baseline laboratory values. 26 There was no correlation between the severity of laboratory value abnormalities and the dosage of isotretinoin. Patients who are overweight or who have increased baseline triglyceride levels are at greater risk for hypertriglyceridemia during treatment, but normal baseline triglyceride levels do not rule out the possibility of developing abnormalities.…”

A retrospective evaluation of acne patients treated with isotretinoin

“…29 In contrast, Barth et al reported no significant changes in liver function tests in a series of 200 patients treated with isotretinoin at a dose of 1 mg/kg/day. 20 In the current study, as the number of patients using Zoretanin was much lower than that of those using Roaccutane®, it was not possible to make a statistical comparison of the clinical side-effects of these two medications. However, when the proportional rates of clinical side-effects were compared, a higher rate was determined in patients using Zoretanin®.…”

“…19 Several different studies have demonstrated that there may be increases in cholesterol and triglyceride levels as a result of isotretinoin treatment. 9,18,20,21 Berstad et al applied isotretinoin at a dose of 1 mg/kg/day to 60 patients for 20 weeks and determined an increase of 17% in triglyceride levels. 22 In a study by Lestringant et al, isotretinoin at a dose of 0.2-1.6 mg/kg/day was administered to 140 patients, and a significant increase in triglyceride and cholesterol levels was reported in the sixth week.…”

“…Liver toxicity caused by retinoids has been seen at very low levels related to isotretinoin. 20 During isotretinoin treatment, there may be temporary increases in serum transaminases in approximately 20% of patients, but severe and permanent liver toxicity is lower than 1%. 26 While some studies have reported no changes in liver function tests during isotretinoin treatment, others have shown that an increase, especially in AST levels, can be determined at the end of first month.…”

“…The probability of developing liver toxicity is lower in patients with normal pre-treatment liver enzyme values. 20 In a study by Michealson et al, isotretinoin at a dose of 0.5 mg/kg/day for 3 months was administered to 90 patients and significant increases were determined in AST and ALT values. The AST value in 1 case and the ALT value in 2 cases exceeded the normal range and those abnormal AST and ALT values were stated to be rare.…”