Laboratory Monitoring During Isotretinoin Therapy for Acne

Abstract

IMPORTANCE Oral isotretinoin has been associated with several adverse effects, but evidence-based estimates of laboratory changes during isotretinoin therapy in large patient samples are limited. OBJECTIVE To develop estimates of the laboratory changes that occur during isotretinoin therapy for acne using extant data and meta-analytic methods. DATA SOURCES A comprehensive search strategy using Ovid/MEDLINE, EMBASE, and gray literature was conducted (1960-August 1, 2013) to identify all relevant studies of isotretinoin use in acne vulgaris. Terms related to acne treatment, isotretinoin, and diagnostic procedures were searched with all available synonyms. STUDY SELECTION Inclusion criteria consisted of clinical trials using oral isotretinoin, doses of 40 mg/d or more, duration of at least 4 weeks, patients aged 9 to 35 years with acne vulgaris, and 10 or more participants. Studies from all countries published in any language were included. Exclusion criteria were use of modified isotretinoin products, isotretinoin therapy for conditions other than acne vulgaris, and concomitant acne therapy. The initial search yielded 342 records; 116 of these were screened for full-text examination. DATA EXTRACTION AND SYNTHESIS Two authors independently reviewed the publications to determine eligibility, and disagreements were resolved by a third author. Generated weighted means and 99% CIs were calculated using the reported means (SDs or SEs). A random effects model was created, and statistical heterogeneity was quantified. Data were analyzed from August 25, 2014, to December 4, 2015. MAIN OUTCOMES AND MEASURES Laboratory values for lipid levels, hepatic function, and complete blood cell count were evaluated. RESULTS Data from 61 of the 116 studies were evaluated; 26 studies (1574 patients) were included in the meta-analysis. The mean (99% CI) values during treatment (nonbaseline) for triglycerides was 119.98 mg/dL (98.58-141.39 mg/dL); for total cholesterol, 184.74 mg/dL (178.17-191.31 mg/dL); for low-density lipoprotein cholesterol, 109.23 mg/dL (103.68-114.79 mg/dL); for high-density lipoprotein cholesterol, 42.80 mg/dL (39.84-45.76 mg/dL

Not every patient needs a triglyceride check, but all can get pancreatitis: a systematic review and clinical characterization of isotretinoin-associated pancreatitis

“…Another serious complication is pancreatitis, which may be idiosyncratic, and thus not preventable or predictable, or due to elevated triglycerides. Elevated triglyceride levels are noted in practically all patients on isotretinoin, but may either not cross the threshold of abnormality or may be a marker of elevated arteriosclerosis risk rather than a cause . We agree with other authors that for the brief periods of therapy that are typical for acne, this is likely not relevant, except as a prognostic marker …”

“…The prevention of pancreatitis due to hypertriglyceridaemia is the primary reason for monitoring triglycerides in patients on isotretinoin. Recent reviews have looked at triglycerides in patients with acne and found that they are usually not highly elevated . However, it may still make sense to monitor patients extensively, if monitoring avoids an extremely rare catastrophic event.…”

Efficacy and adverse events of oral isotretinoin for acne: a systematic review

“…One meta‐analysis was conducted in 1999 on isotretinoin effectiveness; however, this study considered single‐arm studies without comparators, did not evaluate treatment based on lesion counts, did not consider study quality or risk of bias and did not report adverse events. Systematic reviews have been published on isotretinoin adverse events such as psychiatric outcomes, laboratory abnormalities and inflammatory bowel disease; however, these were either not focused on randomized controlled trial evidence and thus are prone to confounding by indication, or did not concurrently consider the effect of isotretinoin. Therefore, given the prevalence of acne and broad use of isotretinoin, a review focusing on the highest quality of evidence on treatment efficacy and adverse events is well justified.…”

Wie viele Laborkontrollen unter systemischen Retinoiden?

“…Eine anonyme Umfrage an mehr als 2.300 Dermatologen während eines Kongresses bestätigte sehr große individuelle Unterschiede bei den Laborkontrollen [2]. Deshalb hat eine Autorengruppe um Kirby (Hershey, Pennsylvania) diese systematische Übersichtsarbeit mit der Frage nach Laborabweichungen von Triglyzeriden/Cholesterin sowie AST (= GOT) und ALT (= GPT) unter einer Isotretinointherapie erstellt [3]. …”