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. 2016 Sep 5;2016(9):CD009571. doi: 10.1002/14651858.CD009571.pub2

Cowell 2005.

Methods Randomised, double‐blind, placebo‐controlled trial.
Participants 155 participants were randomised (older than 18 years of age, mean of age = 68 years) with calcific aortic stenosis, an aortic jet velocity of at least 2.5 m per second and aortic valve calcification measured by Doppler Echocardiography. Participants were followed between 7 and 36 months (median of 25 months).
Baseline Characteristics of Participants:
Men = 68% (atorvastatin group) and 72% (placebo group).
Tricuspid Aortic Valve = 96% (atorvastatin group) and 97% (placebo group).
Bicuspid Aortic Valve = 4% (atorvastatin group) and 3% (placebo group).
Peak Pressure Gradient, mean (± SD) mmHg = 47.8 (± 17.4) (atorvastatin group) and 49.5 (± 19.5) (placebo group).
Aortic Valve Area, mean (± SD) cm² = 1.03 (± 0.40) (atorvastatin group) and 1.02 (± 0.41) (placebo group).
Aortic Jet Velocity, mean (± SD) m/s = 3.39 (± 0.62) (atorvastatin group) and 3.45 (± 0.67) (placebo group).
Most of the participants had hypertension and used aspirin.
Current Smoker = 27% (atorvastatin group) and 28% (placebo group).
Coronary heart disease = 23% (atorvastatin group) and 26% (placebo group).
β‐blocker use = 27% (atorvastatin group) and 34% (placebo group).
LDL value (± SD) = 137 mg/dL (± 34) (atorvastatin group) and 133 mg/dL (± 30) (placebo group).
Interventions Atorvastatin 80 mg daily (n = 77) or matching placebo (n = 78).
Outcomes Primary Outcome: Progression of aortic valve stenosis by changes in aortic jet velocity on doppler echocardiography and progression of valvular calcification by computer tomography.
Secondary Outcome: Aortic valve replacement, death from any cause, death from cardiovascular causes, hospitalisation for severe aortic valve, hospitalisation for any cause and hospitalisation for cardiovascular causes.
Notes The study drug was provided by Pfizer, which has no access to the rest of the data.The authors received support from Pfizer.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Atorvastatin and placebo groups were randomised using a minimisation technique with a dedicated, locked computer program (Edinburgh University).
Allocation concealment (selection bias) Low risk Numbered containers were used.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk There was no information to say that the investigators were blinded to evaluate the data.The paper just mentioned what each author did in the study.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The number of missing values was well‐balanced between groups.
Selective reporting (reporting bias) Low risk Study protocol is available and well‐described.
Other bias High risk The study drug was provided by Pfizer, which had no access to the rest of the data.The authors received support from Pfizer.