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Risk of Statin-Induced Hypertransaminasemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Rosanna Villani¹, Eliano Pio Navarese^2,3, Francesco Cavallone¹

¹C.U.R.E. (Centro per la Ricerca e la Cura delle Epatopatie), Institute of Internal Medicine, Department of Medical and Surgical Sciences, University of Foggia, Italy.

Mayo Clinic Proceedings. Innovations, Quality & Outcomes

|June 14, 2019

Abstract

Objective:

To assess the effect of statins compared with placebo on the risk of developing hypertransaminasemia.

Patients And Methods:

We performed a systematic review of electronic databases and included articles published between January 1, 1965, and April 10, 2017. Randomized clinical trials (RCTs) comparing statins vs placebo were included. Odds ratios (ORs) were pooled in random-effect meta-analyses according to established methods recommended by the Cochrane Collaboration.

Results:

Seventy-three eligible RCTs, comprising 123,051 patients, were identified. Statins associated with a significantly risk of hypertransaminasemia (OR 1.45; 95% confidence interval [CI], 1.24-1.69; P<.001). Atorvastatin showed the highest odds (OR 2.66; 95% CI, 1.74-4.06; P<.001) followed by rosuvastatin (OR 1.35; 95% CI, 1.06-1.70; P=.01) and lovastatin (OR 1.53; 95% CI, 1.03-2.28; P=.04). Pravastatin, fluvastatin, and simvastatin yielded no statistically different odds compared with placebo.

Conclusions:

A dose-dependent risk of developing hypertransaminasemia occurs in patients taking atorvastatin, rosuvastatin, and lovastatin.

Keywords:

ORs, odds ratios RCTs, randomized controlled trials

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