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

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.

SUBMITTER: Villani R

PROVIDER: S-EPMC6544559 | biostudies-other | 2019 Jun

REPOSITORIES: biostudies-other

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

Villani Rosanna R Navarese Eliano Pio EP Cavallone Francesco F Kubica Jacek J Bellanti Francesco F Facciorusso Antonio A Vendemiale Gianluigi G Serviddio Gaetano G

Mayo Clinic proceedings. Innovations, quality & outcomes 20190505 2

<h4>Objective</h4>To assess the effect of statins compared with placebo on the risk of developing hypertransaminasemia.<h4>Patients and methods</h4>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.<h4> ...[more]

PMID: 31193835

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Project description:BackgroundThe effects of perioperative statin therapy on clinical outcome after cardiac or non-cardiac surgery are controversial. We aimed to assess the association between perioperative statin therapy and postoperative outcome.MethodsElectronic databases were searched up to May 1, 2018, for randomized controlled trials of perioperative statin therapy versus placebo or no treatment in adult cardiac or non-cardiac surgery. Postoperative outcomes were: myocardial infarction, stroke, acute kidney injury (AKI), and mortality. We calculated risk ratio (RR) or odds ratio (OR) and 95% confidence interval (CI) using fixed-effects meta-analyses. We performed meta-regression and subgroup analyses to assess the possible influence of statin therapy regimen on clinical outcomes and trial sequential analysis to evaluate the risk of random errors and futility.ResultsWe included data from 35 RCTs involving 8200 patients. Perioperative statin therapy was associated with lower incidence of postoperative myocardial infarction in non-cardiac surgery (OR?=?0.44 [95% CI 0.30-0.64], p?<?0.0001), but not in cardiac surgery (OR?=?0.93 [95% CI 0.70-1.24], p?=?0.61) (psubgroup?=?0.002). Higher incidence of AKI was present in cardiac surgery patients receiving perioperative statins (RR?=?1.15 [95% CI 1.00-1.31], p?=?0.05), nonetheless not in non-cardiac surgery (RR?=?1.52 [95% CI 0.71-3.26], p?=?0.28) (psubgroup?=?0.47). No difference in postoperative stroke and mortality was present in either cardiac or non-cardiac surgery. However, low risk of bias trials performed in cardiac surgery showed a higher mortality with statins versus placebo (OR?=?3.71 [95% CI 1.03-13.34], p?=?0.04). Subgroup and meta-regression analyses failed to find possible relationships between length of statin regimens and clinical outcomes. Trial sequential analysis suggested no firm conclusions on the topic.ConclusionsPerioperative statins appear to be protective against postoperative myocardial infarction in non-cardiac surgery and associated with higher AKI in cardiac surgery. Possible positive or even negative effects on mortality could not be excluded and merits further investigations. Currently, no randomized evidence supports the systematic administration of statins in surgical patients.

Project description:In 2012, the United States Food and Drug Administration (FDA) issued a warning regarding potential adverse effects of HMG-CoA reductase inhibitors (statins) on cognition, based on the Adverse Events Reporting System and a review of the medical literature. We aimed to synthesize randomized clinical trial (RCTs) evidence on the association between statin therapy and cognitive outcomes.We searched MEDLINE, EMBASE, and Cochrane CENTRAL through December 2012, and reviewed published systematic reviews of statin treatment. We sought RCTs that compared statin treatment versus placebo or standard care, and reported at least one cognitive outcome (frequency of adverse cognitive events or measurements using standard neuropsychological cognitive test scores). Studies reporting sufficient information to calculate effect sizes were included in meta-analyses. Standardized and unstandardized mean differences were calculated for continuous outcomes for global cognition and for pre-specified cognitive domains. The main outcome was change in cognition measured by neuropsychological tests; an outcome of secondary interest was the frequency of adverse cognitive events observed during follow-up.We identified 25 RCTs (all placebo-controlled) reporting cognitive outcomes in 46,836 subjects, of which 23 RCTs reported cognitive test results in 29,012 participants. Adverse cognitive outcomes attributable to statins were rarely reported in trials involving cognitively normal or impaired subjects. Furthermore, meta-analysis of cognitive test data (14 studies; 27,643 participants) failed to show significant adverse effects of statins on all tests of cognition in either cognitively normal subjects (standardized mean difference 0.01, 95% confidence interval, CI, -0.01 to 0.03, p?=?0.42) or Alzheimer's disease subjects (standardized mean difference -0.05, 95% CI -0.19 to 0.10, p?=?0.38).Statin therapy was not associated with cognitive impairment in RCTs. These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition.

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

Publications

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

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