A Prospective Study of Pravastatin in the Elderly at Risk (PROSPER): Screening Experience and Baseline Characteristics

Ian Ford1, Gerard Jan Blauw2, Michael B Murphy3, James Shepherd1, Stuart M Cobbe1, Edward LEM Bollen2, Brendan M Buckley3, J Wouter Jukema2, Michael Hyland3, Allan Gaw1, A Margot Lagaay2, Ivan J Perry3, Peter Macfarlane1, John Norrie1, A Edo Meinders2, Brian J Sweeney3, Chris J Packard1, Rudi GJ Westendorp2, Cillian Twomey3, David J Stott1
1University of Glasgow, Scotland
2University of Leiden, The Netherlands
3University of Cork, Ireland

Tóm tắt

PROSPER was designed to investigate the benefits of treatment with pravastatin in elderly patients for whom a typical doctor might consider the prescription of statin therapy to be a realistic option. The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) is a randomised, double blind, placebo-controlled trial to test the hypothesis that treatment with pravastatin (40 mg/day) will reduce the risk of coronary heart disease death, non-fatal myocardial infarction, and fatal or non-fatal stroke in elderly men and women with pre-existing vascular disease or with significant risk of developing this condition. In Scotland, Ireland, and the Netherlands, 23,770 individuals were screened, and 5,804 subjects (2,804 men and 3,000 women), aged 70 to 82 years (average 75 years) and with baseline cholesterol 4.0–9.0 mmol/l, were randomised. Randomised subjects had similar distributions with respect to age, blood pressure, and body mass index when compared to the entire group of screenees, but had a higher prevalence of smoking, diabetes, hypertension, and a history of vascular disease. The average total cholesterol level at baseline was 5.4 mmol/l (men) and 6.0 mmol/l (women). Compared with previous prevention trials of cholesterol-lowering drugs, the PROSPER cohort is significantly older and for the first time includes a majority of women. The study, having achieved its initial goal of recruiting more than 5,500 elderly high-risk men and women, aims to complete all final subject follow-up visits in the first half of 2002 with the main results being available in the fourth quarter of 2002.

Tài liệu tham khảo

Scandinavian Simvastatin Survival Study Group: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994, 344: 1383-1389. 10.1016/S0140-6736(94)90566-5. Shepherd J, Cobbe SM, Ford I, for the West of Scotland Coronary Prevention Study Group, et al: Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. New Engl J Med. 1995, 333: 1301-1307. 10.1056/NEJM199511163332001. Sacks FM, Pfeffer MA, Moye LA, et al: The Effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. New Engl J Med. 1996, 335: 1001-1009. 10.1056/NEJM199610033351401. Long-term intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group: Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. New Engl J Med. 1998, 339: 1349-1357. 10.1056/NEJM199811053391902. Downs JR, Clearfield M, Weis S, for the AFCAPS/TexCAPS Research Group, et al: Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. JAMA. 1998, 279: 1615-1622. 10.1001/jama.279.20.1615. Shepherd J, Blauw GJ, Murphy MB, on behalf of the PROSPER Study Group, et al: The Design of a Prospective Study of Pravastatin in the Elderly at Risk (PROSPER). Am J Cardiol. 1999, 84: 1192-1197. 10.1016/S0002-9149(99)00533-0. Macfarlane PW, Latif S: Automated serial ECG comparison based on the Minnesota Code. J. Electrocardiol. 1996, 29 (Suppl): 29-34. Ashley EA, Raxwal VK, Froelicher VF: The prevalence and prognostic significance of electrocardiographic abnormalities. Current problems in Cardiology. 2000, 25: 1-72. Furberg CD, Manolio TA, Psaty BM, et al: Major electrocardiographic abnormalities in persons aged 65 years and over (Cardiovascular Health Study). Am J Cardiol. 1992, 69: 1329-1335. Freeman DJ, Norrie J, Sattar N, et al: Pravastatin and the Development of Diabetes Mellitus: Evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation. 2001, 103: 357-362.