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). |
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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. |
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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. |