Statins - is liver function tests (LFT’s) monitoring required?: a scoping review
Abstract
Abstract:
Background:
Statins are among the most widely-prescribed treatments for the primary and secondary prevention of cardiovascular diseases (CVDs) around the world. Although statins have been found to be well-tolerated and adverse effects are relatively rare, the risk of hepatotoxicity and necessity for periodic laboratory follow-up in patients treated with statins remain controversial.
Objectives:
We conducted a scoping review, summarizing and appraising the current literature that assessed the frequency of clinically significant statin-induced hepatotoxicity and the need for regular LFTs monitoring following statins initiation.
Methods:
Searches of the bibliographic databases MEDLINE, EMBASE and Web of Science were conducted up to June 2020 to identify randomized controlled trials (RCTs) and observational studies (case-control and cohort) of statins use for the primary or secondary prevention of CVDs and the risk of hepatotoxicity, using pre-defined inclusion criteria. Data extraction and quality assessment were performed by the primary reviewer (AB) using standardized tools and the results were narratively synthesized and presented in tables.
Key findings:
A total of 20 eligible RCTs and observational studies, comprising 353,668 patients, fulfilled the inclusion criteria. These patients had a mean age of 57 years and 68.8% of them were males. Asymptomatic Persistent elevations of aminotransferases levels more than 3 times the upper limit of normal have been reported in a few of the patients receiving statin and was found to be 0.7% and 0.6% on one and two consecutive occasions following three months of treatment initiation, respectively. This may not differ significantly from placebo or equivalent dose of different statins. There was a clear direct dose-response relationship for lovastatin, atorvastatin and rosuvastatin. These elevations were transient and normalized through continued therapy.
Conclusion:
Given the widespread use of these drugs and very low incidence of clinically significant liver function tests abnormalities, the necessity for routine monitoring is not justified and needs to be revisited. In addition, liver enzymes should only be measured in patients who develop symptoms suggestive of statin-induced hepatotoxicity.