Ford Ian, Blauw Gerard Jan, Murphy Michael B, Shepherd James, Cobbe Stuart M, Bollen Edward LEM, Buckley Brendan M, Jukema J Wouter, Hyland Michael, Gaw Allan, Lagaay A Margot, Perry Ivan J, Macfarlane Peter, Norrie John, Meinders A Edo, Sweeney Brian J, Packard Chris J, Westendorp Rudi GJ, Twomey Cillian, Stott David J
University of Glasgow, Scotland.
Curr Control Trials Cardiovasc Med. 2002 May 20;3(1):8. doi: 10.1186/1468-6708-3-8.
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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
“普伐他汀在老年患者中的前瞻性研究(PROSPER)”旨在调查普伐他汀治疗对老年患者的益处,这类老年患者是典型医生可能认为他汀类药物治疗处方是一个现实选择的人群。
“普伐他汀在高危老年患者中的前瞻性研究(PROSPER)”是一项随机、双盲、安慰剂对照试验,以检验以下假设:普伐他汀(40毫克/天)治疗将降低患有既往血管疾病或有发生该疾病显著风险的老年男性和女性的冠心病死亡、非致死性心肌梗死以及致死性或非致死性中风的风险。
在苏格兰、爱尔兰和荷兰,对23770人进行了筛查,5804名受试者(2804名男性和3000名女性),年龄在70至82岁(平均75岁),基线胆固醇水平为4.0 - 9.0毫摩尔/升,被随机分组。与整个筛查人群相比,随机分组的受试者在年龄、血压和体重指数方面分布相似,但吸烟、糖尿病、高血压和血管疾病史的患病率更高。基线时的平均总胆固醇水平男性为5.4毫摩尔/升,女性为6.0毫摩尔/升。
与以往降胆固醇药物的预防试验相比,PROSPER队列的年龄显著更大,并且首次纳入了大多数女性。该研究已实现招募5500多名老年高危男性和女性的初始目标,并计划在2002年上半年完成所有受试者的最终随访,主要结果将于2002年第四季度公布。