Comparative tolerability and harms of individual statins. A study-level network meta-analysis of 246,955 participants from 135 randomized, controlled trials

Naci H, Brugts J, Ades T. Comparative tolerability and harms of individual statins. A study-level network meta-analysis of 246,955 participants from 135 randomized, controlled trials. Circ Cardiovasc Qual Outcomes. 2013;6:390-399.

This meta-analysis including 246,955 subjects assessed the comparative tolerability and harms of statins via placebo-controlled and active-comparator studies.

Overall findings:  

  • Statins as a class were not associated with an increased risk of diabetes or hepatic transaminase elevations
  • No statistically detectable effect on myalgia, myopathy, rhabdomyolysis, or cancer was seen

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05 - Tolerability and Harms of Statin Therapy 

Findings relative to the effect of statins on the development of diabetes and cancer: 

  • As a class, statins were associated with a higher risk for developing diabetes (odds ratio, 1.09; 95% CI, 1.02-1.16). Rosuvastatin conferred significantly higher diabetes risk than control in placebo-controlled trials (OR, 1.16; 95% CI,1.02-1.31)
  • Evidence does not suggest an association with increased cancer risk (OR, 0.96; 95% CI, 0.91-1.02)


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06 - Statins and Diabetes Cancer Meta-Analysis

Findings relative to intensive statin therapy and adverse events:
 

  • Higher doses of some statins increase the risk of transaminase elevations, creatinine kinase elevations, and discontinuation due to adverse events.
  • Simvastatin and pravastatin at low-to-moderate doses are likely superior to other statins in terms of safety when compared head to head


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07 - Intensive Statin Therapy and Adverse Events

Findings relative to mortality and cardiovascular benefits of statins:
 

  • Clinically significant all-cause mortality benefits of statins in primary prevention were noted. At the population level, mortality and cardiovascular benefits of statin therapy greatly outweigh potential harm, even when considering the recent finding that statin therapy is associated with a modest increase in diabetes incidence.
  • Patient- and study-level data support the initiation of statin therapy in patients at increased risk for cardiovascular disease
  • However, expanding the scope of statin therapy to the wider population may have safety implications (ie, mild-to-moderate adverse events that tend to increase with treatment intensity)  
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08 - Mortality and Cardiovascular Benefits of Statins  
  

The pharmacologic agents discussed are approved for use in the United States by the U.S. Food and Drug Administration (FDA) unless otherwise noted. Consult individual prescribing information for approved uses outside of the United States. 


September 2013 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest.  

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Last Modified: 8/4/2014