PMID- 16490577
OWN - NLM
STAT- MEDLINE
DCOM- 20060525
LR  - 20221129
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 28
IP  - 1
DP  - 2006 Jan
TI  - Statin-related adverse events: a meta-analysis.
PG  - 26-35
AB  - BACKGROUND: The absolute frequencies of adverse events (AEs) between statins and 
      placebo are very low in clinical trials, making clinical interpretation and 
      application difficult. OBJECTIVES: This meta-analysis was intended to synthesize 
      the collective AE data observed in prospective randomized clinical trials to 
      facilitate clinical interpretation. METHODS: Using the search terms atorvastatin, 
      simvastatin,pravastatin, rosuvastatin, fluvastatin, lovastatin, prospective 
      trial, and randomized trial, the MEDLINE/EMBASE and the Cochrane Collaboration 
      databases were reviewed for prospective randomized primary and secondary 
      prevention trials of statin monotherapy. Nonrandomized uncontrolled studies and 
      those missing AE data were excluded. The Mantel-Haenszel test for fixed and 
      random effects was used to calculate odds ratios (ORs) and log ORs. RESULTS: 
      Eighteen trials including 71,108 persons, and 301,374 person-years of follow-up 
      were represented in this analysis. There were 36,062 persons receiving a statin 
      and 35,046 receiving a placebo. Statin therapy increased the risk of any AE by 
      39% (OR = 1.4; 95% CI, 1.09-1.80; P = 0.008; NNH [number needed to harm] = 197) 
      compared with placebo. Statins were associated with a 26% reduction in the risk 
      of a clinical cardiovascular event (OR = 0.74; 95% CI, 0.69-0.80; P < 0.001; 
      number needed to treat = 27). Treating 1000 patients with a statin would prevent 
      37 cardiovascular events, and 5 AEs would be observed. Serious events (creatine 
      phosphokinase >10 times the upper limit of normal or rhabdomyolysis) are 
      infrequent (NNH = 3400) and rhabdomyolysis, although serious, is rare (NNH = 
      7428). Atorvastatin was associated with the greatest risk of AEs and fluvastatin 
      with the least risk. Simvastatin, pravastatin, and lovastatin had similar odds of 
      AEs. Nonurgent AEs such as myalgia and liver function elevations were responsible 
      for approximately two thirds of AEs reported in trials. CONCLUSIONS: Statin 
      therapy was associated with greater odds of AEs compared with placebo but with 
      substantial clinical benefit. Similar rates of serious AEs were observed between 
      statin and placebo.
FAU - Silva, Matthew A
AU  - Silva MA
AD  - Massachusetts College of Pharmacy and Health Sciences, Worcester, Massachusetts 
      01608, USA. msilva@wor.mcphs.edu
FAU - Swanson, Anna C
AU  - Swanson AC
FAU - Gandhi, Pritesh J
AU  - Gandhi PJ
FAU - Tataronis, Gary R
AU  - Tataronis GR
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
SB  - IM
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects/therapeutic use
MH  - Hypercholesterolemia/*drug therapy
MH  - Incidence
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic
MH  - Rhabdomyolysis/chemically induced/epidemiology
MH  - Treatment Outcome
EDAT- 2006/02/24 09:00
MHDA- 2006/05/26 09:00
CRDT- 2006/02/24 09:00
PHST- 2005/11/13 00:00 [accepted]
PHST- 2006/02/24 09:00 [pubmed]
PHST- 2006/05/26 09:00 [medline]
PHST- 2006/02/24 09:00 [entrez]
AID - S0149-2918(06)00019-1 [pii]
AID - 10.1016/j.clinthera.2006.01.005 [doi]
PST - ppublish
SO  - Clin Ther. 2006 Jan;28(1):26-35. doi: 10.1016/j.clinthera.2006.01.005.