PROSPER, 2002 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of pravastatin versus placebo in men and women aged 70-82 years with a history of, or risk factors for, vascular disease

        Z

Lancet 2002; 360:1623-30  
elderly



Studied treatment pravastatin 40mg daily
Control treatment placebo
Age (mean), yrs 75.35
Women (%) 51.7%
Total cholesterol (mmol/l) 5.7 mmol/L
LDL change, end of study (%) -34%
HDL change +5%



Patients men and women aged 70-82 years with a history of, or risk factors for, vascular disease
Group sizes2891 / 2913
Inclusion criteriamen and women aged 70–82 years; either pre-existing vascular disease (coronary, cerebral, or peripheral) or raised risk of such disease because of smoking, hypertension, or diabetes; total cholesterol between 4·0–9·0 mmol/L; triglyceride less than 6·0 mmol/L
Exclusion criteriapoor cognitive function (mini mental state examination score <24)
prior MI or CHD (%) 13.35
LDL (mmol/l) 3.8 mmol/L
HDL (mmol/l) 1.3 mmol/L
Triglycerides (mg/dl)
Diabetes(%) 10.75
BMI (kg/m2) 26.8
Stroke history 11.15
LV hypertrophy
History of hypertension (%)



Blindness double blind Inclusion period dec 1997, May 1999
Follow-up duration 3.2 years Centers multicenter
Lost to FU ND geographical localisation Ecosse, Irelande, Pays bas
Primary endpoint death, MI , stroke Design Parallel groups
PeriodeInclusiondec 1997, May 1999
HypotheseSuperiority



EndpointX1N1X0N0TE95% CI coronary events 292 2891 356 2913 0,83[0,70; 0,97] all cause deaths 298 2891 306 2913 0,98[0,83; 1,16] cardiovascular death 135 2891 157 2913 0,87[0,68; 1,10] cardiovascular events 408 2891 473 2913 0,87[0,75; 1,00] venous thromboembolism - 2891 - 2913 no data fatal stroke 22 2891 14 2913 1,58[0,81; 3,10] Haemorrhagic strokes - 2891 - 2913 no data coronary deaths 94 2891 122 2913 0,78[0,59; 1,02] stroke (fatal et non fatal) 135 2891 131 2913 1,04[0,81; 1,33] CV events (including revascularization) 454 2891 523 2913 0,87[0,76; 1,00] MI non fatal 222 2891 254 2913 0,88[0,73; 1,06] Infarctus non mortel et décès coronariens 292 2891 356 2913 0,83[0,70; 0,97] cardiac death 94 2891 122 2913 0,78[0,59; 1,02] non cardiovascular death - 2891 - 2913 no data Pancreatitis 5 2891 11 2913 0,46[0,16; 1,32] CPK >10 x ULN - 2891 - 2913 no data AST >3 x ULN - 2891 - 2913 no data ALT >3 x ULN - 2891 - 2913 no data incident diabetes 165 2510 127 2513 1,32[1,03; 1,69] Rhabdomyolyses 0 2891 0 2913 1,01[0,02; 50,80] décès par cancer 115 2891 91 2913 1,27[0,96; 1,68] Cancers mortels et non mortels - 2891 - 2913 no data Myopathies 36 2891 32 2913 1,13[0,70; 1,82] adverse events - 2891 - 2913 no data0,22,01,0

Shepherd J, Blauw GJ, Murphy MB, Bollen EL, Buckley BM, Cobbe SM, Ford I, Gaw A, Hyland M, Jukema JW, Kamper AM, Macfarlane PW, Meinders AE, Norrie J, Packard CJ, Perry IJ, Stott DJ, Sweeney BJ, Twomey C, Westendorp RG, Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360:1623-30     [PMID: 12457784]   link to pdf   add to Mendeley  



Registering number (see trial on clinicaltrials.gov)
Code Name