Table.
Baseline characteristics and eligibility criteria of participating trials
| Number of patients | Treatment comparison (mg per day) | Median follow–up in survivors (years)* | Baseline LDL-C (mmol/L) | LDL-C difference at 1 year (mmol/L) | Women (%) | Diabetes (%) | Prior CHD (%) | Other vascular disease (%)† | No prior vascular disease (%)‡ | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| More versus less statin | |||||||||||
| PROVE–IT | 4162 | A80 vs P40 | 2·1 | 2·62§ | −0·65 | 911 (22%) | 734 (18%) | 4162 (100%) | 328 (8%) | 0 | |
| A to Z | 4497 | S40 then S80 vs placebo then S20 | 2·0 | 2·09§ | −0·30 | 1100 (24%) | 1059 (24%) | 4497 (100%) | 479 (11%) | 0 | |
| TNT | 10 001 | A80 vs A10 | 5·0 | 2·52 | −0·62 | 1902 (19%) | 1501 (15%) | 10 001 (100%) | 1537 (15%) | 0 | |
| IDEAL | 8888 | A40–80 vs S20–40 | 4·8 | 2·64§ | −0·55 | 1702 (19%) | 1069 (12%) | 8888 (100%) | 971 (11%) | 0 | |
| SEARCH | 12 064 | S80 vs S20 | 7·0 | 2·50 | −0·39 | 2052 (17%) | 1267 (11%) | 12 064 (100%) | 1062 (9%) | 0 | |
| Subtotal (5 trials) | 39 612 | NA | 5·1‖ | 2·53‖ | −0·51‖ | 7667 (19%) | 5630 (14%) | 39 612 (100%) | 4377 (11%) | 0 | |
| Statin versus control | |||||||||||
| SSSS | 4444 | S20–40 vs placebo | 5·4 | 4·88 | −1·77 | 827 (19%) | 202 (5%) | 4444 (100%) | 126 (3%) | 0 | |
| WOSCOPS | 6595 | P40 vs placebo | 4·8 | 4·96 | −1·07 | 0 | 76 (1%) | 338 (5%) | 193 (3%) | 6096 (92%) | |
| CARE | 4159 | P40 vs placebo | 5·0 | 3·58 | −1·03 | 576 (14%) | 586 (14%) | 4159 (100%) | 0 | 0 | |
| Post–CABG | 1351 | L40–80 vs L2·5–5 | 4·3 | 4·02 | −1·07 | 102 (8%) | 116 (9%) | 1351 (100%) | 37 (3%) | 0 | |
| AFCAPS/TexCAPS | 6605 | L20–40 vs placebo | 5·2 | 3·89 | −0·94 | 997 (15%) | 155 (2%) | 10 (<1%) | 9 (<1%) | 6586 (>99%) | |
| LIPID | 9014 | P40 vs placebo | 6·0 | 3·88 | −1·03 | 1516 (17%) | 782 (9%) | 9014 (100%) | 905 (10%) | 0 | |
| GISSI–P | 4271 | P20 vs no treatment | 2·0 | 3·92 | −0·35 | 587 (14%) | 582 (14%) | 4271 (100%) | 179 (4%) | 0 | |
| LIPS | 1677 | F80 vs placebo | 3·9 | 3·42 | −0·92 | 271 (16%) | 202 (12%) | 1677 (100%) | 142 (8%) | 0 | |
| HPS | 20 536 | S40 vs placebo | 5·4 | 3·38 | −1·29 | 5082 (25%) | 5963 (29%) | 13 386 (65%) | 8865 (43%) | 3161 (15%) | |
| PROSPER | 5804 | P40 vs placebo | 3·3 | 3·79 | −1·04 | 3000 (52%) | 623 (11%) | 1881 (32%) | 1026 (18%) | 3254 (56%) | |
| ALLHAT–LLT | 10 355 | P40 vs usual care | 4·9 | 3·76 | −0·54 | 5051 (49%) | 3638 (35%) | 1188 (11%) | 1788 (17%) | 8037 (78%) | |
| ASCOT–LLA | 10 305 | A10 vs placebo | 3·3 | 3·44 | −1·07 | 1942 (19%) | 2527 (25%) | 15 (<1%) | 1435 (14%) | 8860 (86%) | |
| ALERT | 2102 | F40 vs placebo | 5·5 | 4·14 | −0·84 | 715 (34%) | 396 (19%) | 400 (19%) | 241 (11%) | 1702 (81%) | |
| CARDS | 2838 | A10 vs placebo | 4·1 | 3·03 | −1·14 | 909 (32%) | 2838 (100%) | 9 (<1%) | 97 (3%) | 2738 (96%) | |
| ALLIANCE** | 2442 | A10–80 vs usual care | 4·7 | 3·80 | −1·16 | 434 (18%) | 540 (22%) | 2442 (100%) | 162 (7%) | 0 | |
| 4D** | 1255 | A20 vs placebo | 4·0 | 3·25 | −0·89 | 578 (46%) | 1255 (100%) | 630 (50%) | 666 (53%) | 344 (27%) | |
| ASPEN** | 2410 | A10 vs placebo | 4·0 | 2·93 | −0·99 | 811 (34%) | 2410 (100%) | 578 (24%) | 302 (13%) | 1663 (69%) | |
| MEGA**†† | 8214 | P10–20 vs usual care | 5·0 | 4·05 | −0·67 | 5547 (68%) | 1686 (21%) | 42 (<1%) | 53 (<1%) | 8119 (99%) | |
| JUPITER** | 17 802 | R20 vs placebo | 2·0 | 2·70 | −1·09 | 6801 (38%) | 76 (<1%) | 0 | 0 | 17 802 (100%) | |
| GISSI–HF** | 4574 | R10 vs placebo | 4·2 | 3·06 | −0·92 | 1032 (23%) | 1196 (26%) | 1797 (39%) | 4574 (100%) | 0 | |
| AURORA** | 2773 | R10 vs placebo | 4·6 | 2·58 | −0·99 | 1050 (38%) | 731 (26%) | 659 (24%) | 743 (27%) | 1663 (60%) | |
| Subtotal (21 trials) | 129 526 | NA | 4·8‖ | 3·70‖ | −1·07‖ | 37 828 (29%) | 26 580 (21%) | 48 291 (37%) | 21 543 (17%) | 70 025 (54%) | |
| Total (26 trials) | 169 138 | NA | 4·9‖ | NA | NA | 45 495 (27%) | 32 210 (19%) | 87 903 (52%) | 25 920 (15%) | 70 025 (41%) | |
LDL-C=LDL-cholesterol. CHD=coronary heart disease. PROVE-IT=Pravastatin or Atorvastatin Evaluation and Infection Therapy.24 A=atorvastatin. P=pravastatin. A to Z=Aggrastat to Zocor.23 S=simvastatin. TNT=Treating to New Targets.26 IDEAL=Incremental Decrease in End Points Through Aggressive Lipid Lowering Study Group.25 SEARCH=Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine.27 SSSS=Scandinavian Simvastatin Survival Study.2 WOSCOPS=West of Scotland Coronary Prevention Study.3 CARE=Cholesterol And Recurrent Events.4 Post-CABG=Post-Coronary Artery Bypass Graft.5 L=lovastatin. AFCAPS/TexCAPS=Air Force/Texas Coronary Atherosclerosis Prevention Study.6 LIPID=Long–term Intervention with Pravastatin in Ischaemic Disease.7 GISSI–P=Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico.8 LIPS=Lescol Intervention Prevention Study.9 F=fluvastatin. HPS=Heart Protection Study.10 PROSPER=PROspective Study of Pravastatin in the Elderly at Risk.11 ALLHAT-LLT=Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.12 ASCOT-LLA=Anglo-Scandinavian Cardiac Outcomes Trial–Lipid Lowering Arm.13 ALERT=Assessment of Lescol in Renal Transplantation.14 CARDS=Collaborative Atorvastatin Diabetes Study.15 ALLIANCE=Aggressive Lipid-Lowering Initiation Abates New Cardiac Events.39 4D=Die Deutsche Diabetes Dialyse Studie.29 ASPEN=Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus.40 MEGA=Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group.37 JUPITER=Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin study group.38 R=rosuvastatin. GISSI-HF=Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza cardiac.31 AURORA=A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events.30
Estimated with standard Kaplan-Meier methods, with patients censored at their date of death.
History of intracerebral bleed, transient ischaemic attack, ischaemic stroke, unknown stroke, peripheral artery disease, or heart failure (if known).
No known history of CHD or other vascular disease.
These three trials did not have active run–in periods; the values shown are the estimated on-treatment LDL cholesterol levels in the standard statin group.
Median follow–up, baseline LDL-C, and LDL-C difference at 1 year weighted by trial–specific variances of observed logrank (o–e) for major vascular events.
Additional statin versus control trials included in this second cycle of analyses.
Includes 382 randomised patients who were excluded from the original publication.37