Study title and authors:
Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis.
AB Rossebo, TR Pedersen, K Boman, P Brudi, JB Chambers, K Egstrup, E Gerdts, C Gohlke-Barwolf, I Holme, YA Kesaniemi, W Malbecq, CA Nienaber, S Ray, T Skjaerpe, K Wachtell, R Willenheimer, and SEAS Investigators
Division of Cardiology, Aker University Hospital, Trondheimsveien 235, N-0514 Oslo, Norway.
This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/18765433
This trial observed the effects of the drug Inegy (a combination of simvastatin and ezetimibe).
The trial was a 
randomizsd, double-blind trial involving 1,873 patients with mild-to-moderate, asymptomatic aortic stenosis (obstruction of blood flow across the aortic valve). The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily and were followed for 52 months.
The study found:
(a) Those taking the simvastatin/ezetimibe combination had a 4% increased risk of death compared to those taking placebo.
(b) Those taking the simvastatin/ezetimibe combination had a 21% increased risk of death from heart failure compared to those taking placebo.
(c) Those taking the simvastatin/ezetimibe combination had a 67% increased risk of death from cancer compared to those taking placebo.
(d) Those taking the simvastatin/ezetimibe combination had a 195% increased risk of death from violence or accidents compared to those taking placebo.
Professor Heinz Drexel, of the University of Innsbruck in Austria and spokesman for the European Society of Cardiology, said: "I am not sure that the efficacy is proven and I am not sure that the safety is proven. I wouldn't take the drug myself".
The trial was a randomizsd, double-blind trial involving 1,873 patients with mild-to-moderate, asymptomatic aortic stenosis (obstruction of blood flow across the aortic valve). The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily and were followed for 52 months.The study found:
(a) Those taking the simvastatin/ezetimibe combination had a 4% increased risk of death compared to those taking placebo.
(b) Those taking the simvastatin/ezetimibe combination had a 21% increased risk of death from heart failure compared to those taking placebo.
(c) Those taking the simvastatin/ezetimibe combination had a 67% increased risk of death from cancer compared to those taking placebo.
(d) Those taking the simvastatin/ezetimibe combination had a 195% increased risk of death from violence or accidents compared to those taking placebo.
Professor Heinz Drexel, of the University of Innsbruck in Austria and spokesman for the European Society of Cardiology, said: "I am not sure that the efficacy is proven and I am not sure that the safety is proven. I wouldn't take the drug myself".
In Britain, about 300,000 NHS prescriptions have been dispensed for Inegy in the last two years.
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