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Risk and Timing of Isotretinoin-Related Abnormalities on Lab Tests
abstract
This abstract is available on the publisher's site.
Access this abstract nowINTRODUCTION
Uncertainty surrounds the optimal routine laboratory monitoring in acne patients treated with isotretinoin.
OBJECTIVE
Our aim was to evaluate the risk of mild and severe laboratory abnormalities in patients with acne starting isotretinoin versus oral antibiotic treatment.
METHODS
A global population-based retrospective cohort study assigned two groups of patients with acne-prescribed isotretinoin (n = 79,012) and oral antibiotics (n = 79,012). Comprehensive propensity-score matching was conducted.
RESULTS
Compared to acne patients treated with oral antibiotics, those under isotretinoin demonstrated an increased risk of grade ≥3 hypertriglyceridemia (hazard ratio [HR], 7.85; 95% confidence interval [CI], 5.58-11.05; P < 0.001) and grade ≥3 elevated aspartate transaminase (AST) levels (HR, 1.45; 95% CI, 1.13-1.85; P = 0.003) within the initial 3 months of treatment. The absolute risk of these abnormalities among isotretinoin initiators was 0.4% and 0.2%, respectively. The risk difference of these findings was clinically marginal: 3 and 1 additional cases per 1,000 patients starting isotretinoin, respectively. There was no significant risk of grade ≥3 impairment in cholesterol, alanine transaminase, gamma-glutamyl transferase, or creatinine levels under isotretinoin. Most laboratory abnormalities were documented 1-3 months after drug initiation in time-stratified analysis.
CONCLUSION
Isotretinoin is associated with a clinically marginal increased risk of severe hypertriglyceridemia and hypertransaminasemia. Routine blood testing should be performed 1-3 months after commencing therapy.
Additional Info
Disclosure statements are available on the authors' profiles:
Risk and timing of isotretinoin-related laboratory disturbances: a population-based study
Int. J. Dermatol 2024 May 03;[EPub Ahead of Print], S Emtenani, M Abdelghaffar, RJ Ludwig, E Schmidt, K KridinFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Oral isotretinoin is easily the most effective agent that we have available to treat acne. The potential risks of the drug are widely misrepresented and misunderstood, which leads to unwarranted fear and avoidance of this highly effective gold-standard medication. However, over the last decade, some of the potential risks of isotretinoin, including depression, delayed wound healing, and inflammatory bowel disease have been called into question. We have had several studies over the past few years that specifically looked at the frequency and timing of laboratory investigations in patients receiving isotretinoin. These studies consistently recommend a simplified laboratory evaluation and fewer blood draws.
This large global population-based study assessed laboratory parameter abnormalities in 79,012 patients with acne initiating treatment with isotretinoin versus 79,012 patients initiating oral antibiotics. Consistent with data from prior studies, the most common laboratory abnormality associated with isotretinoin was hypertriglyceridemia. Severe hypertriglyceridemia (triglyceride levels ≥500 mg/dL) was reported in only 0.4% of the patients on isotretinoin. The only other severe-grade laboratory abnormality that was significantly higher in patients on isotretinoin than in those on antibiotics, was aspartate transaminase levels (AST). Severe-grade elevations of AST levels were observed in only 0.2% of the patients on isotretinoin. There were no significant severe-grade elevations in alanine transaminase, gamma-glutamyl transferase, or creatinine levels in patients on isotretinoin versus those on antibiotics. It is notable that there were no severe elevations in cholesterol levels, and, in my opinion, there is no reason to monitor cholesterol levels at all. Most of the laboratory abnormalities were observed in the first 3 months of treatment.
In summary, severe-grade laboratory abnormalities during isotretinoin treatment are quite rare, and their clinical significance is unclear. For example, do triglyceride levels more than 500 mg/dL necessarily portend a negative outcome during a course of isotretinoin? Most cases of hypertriglyceridemia-induced pancreatitis occur when triglyceride levels are higher than 1000 mg/dL. Aside from acute pancreatitis, the risks of short-term elevation of triglyceride levels during a typical course of isotretinoin are likely quite low.
At this point, I order laboratory testing at baseline and after 2 months of treatment with isotretinoin. I check triglyceride, AST, and alanine transaminase levels and, of course, a pregnancy test when appropriate. I do not check the cholesterol level, complete blood count, absolute neutrophil count, or creatinine level. I do not do any additional laboratory tests unless an abnormality is observed or other risk factors are present. I am pleased to see another study that affirms this minimalist approach.