Table 2.
RCTs assessing the effects of statins on cardiovascular outcomes.
| Study | Population | Intervention | Outcome | RR | NNT | Harms |
| People with type 2 diabetes mellitus | Lovastatin, pravastatin, simvastatin, atorvastatin, fluvastatin | Primary prevention: coronary artery disease death, non-fatal MI, or myocardial revascularisation procedures | Pooled CHD events: primary-prevention studies (5 RCTs); 431/5394 (8%) with statin v 535/5309 (10%) with placebo, RR 0.80, 95% CI 0.71 to 0.90 | N/A | The review gave no information on adverse effects | |
| Two RCTs of gemfibrozil (a fibrate) included (1 primary, the other secondary prevention). The review did a subgroup analysis excluding these studies | Risk reduction (includes people treated with gemfibrozil) 21%, 95% CI 11% to 30%, P less than 0.0001 | |||||
| Secondary prevention: coronary artery disease death, non-fatal MI, myocardial revascularisation procedures, stroke, and changes in blood lipid profile | Pooled CHD events: secondary-prevention studies (7 RCTs); 644/2342 (27%) with statin v 781/2330 (34%) with placebo,RR 0.79, 95% CI 0.68 to 0.93 | |||||
| Risk reduction (includes people treated with gemfibrozil) 21%, 95% CI 10% to 31%, P = 0.0005 | ||||||
| Pooled secondary-prevention studies on CHD death (3 RCTs): 43/450 (10%) with statin v 52/452 (12%) with placebo, RR 0.83, 95% CI 0.57 to 1.21 | ||||||
| Pooled secondary-prevention studies on non-fatal MI (3 RCTs): 38/450 (8%) with statin v 67/454 (15%) with placebo, RR 0.48, 95% CI 0.22 to 1.08 | ||||||
| Pooled secondary-prevention studies on myocardial revascularisation procedures (4 RCTs): 187/1138 (16%) with statin v 269/1124 (24%) with placebo, RR 0.70, 95% CI 0.59 to 0.83 | ||||||
| Pooled secondary-prevention studies on stroke (3 RCTs): 58/929 (6%) with statin v 89/936 (10%) with placebo, RR 0.66, 95% CI 0.48 to 0.90 | ||||||
| Primary prevention RCTs (people without prior CVD) in Costa systematic review | ||||||
| AFCAPS/TexCAPS | 155 people with type 2 diabetes mellitus | Lovastatin 20 mg/day | CHD events, LDL-C | CHD events: 4/84 (5%) with lovastatin v 6/71 (9%) with control; RR 0.56, 95% CI 0.17 to 1.92; | NNT 27, CI, and number of years of treatment not reported | |
| ALLHATT-LLT | 3638 people with type 2 diabetes mellitus | Pravastatin 40 mg/day | CHD events, LDL-C | CHD events: 81/1855 (4%) with statin v 88/1783 (5%) with placebo; RR 0.88, 95% CI 0.66 to 1.19 | Not reported | |
| HPS | 3982 people with type 2 diabetes mellitus | Simvastatin (dose not reported) | CHD events, LDL-C | CHD events: 276/2006 (14%) with simvastatin v 367/1976 (19%) with control; RR 0.74, 95% CI 0.64 to 0.85 | NNT 21, CI, and number of years of treatment not reported | |
| PROSPER | 396 people aged 70–82 years with type 2 diabetes mellitus | Pravastatin 40 mg/day | CHD events, LDL-C | CHD events: 32/191 (17%) with pravastatin v 28/205 (14%) with control; RR 1.23, 95% CI 0.77 to 1.95 | NNT 32, CI, and number of years of treatment not reported | |
| ASCOT-LLA | 2532 people with type 2 diabetes mellitus, hypertension, and at least 2 other CHD risk factors | Atorvastatin 10 mg/day | CHD events, LDL-C | CHD events: 38/1258 (3%) with atorvastatin v 46/1274 (4%) with control; RR 0.84, 95% CI 0.55 to 1.29 | NNT 170, CI, and number of years of treatment not reported | |
| Primary prevention RCTs (people without prior CVD) subsequent to Costa review | ||||||
| ASCOT-LAA (detailed subgroup analysis published subsequent to Costa review) | 2532 people with type 2 diabetes mellitus, hypertension, and at least 2 other CHD risk factors, but no history of previous MI or currently treated angina | Atorvastatin 10 mg/day | Total cardiovascular events and procedures: | Total cardiovascular events and procedures: HR 0.77, 95% CI 0.61 to 0.98; P = 0.036 | NNT not reported (3.3 years of treatment) | There were no significant differences in liver enzyme abnormalities between the atorvastatin and placebo groups. No cases of rhabdomyolysis were reported |
| Cardiovascular mortality, non-fatal MI, unstable angina, chronic stable angina, life-threatening arrhythmias, non-fatal heart failure, non-fatal stroke, PAD, retinal vascular thrombosis, revascularisation procedures, transient ischaemic attacks, and reversible ischaemic neurological deficits | Effects with different baseline cholesterol levels less than 5 mmol/L: HR 0.71, 95% CI 0.44 to 1.18 Effects with different baseline cholesterol levels 5.0 to less than 6.0 mmol/L: HR 0.74, 95% CI 0.52 to 1.05 Effects with different baseline cholesterol levels at least 6.0 mmol/L: HR 0.84, 95% CI 0.54 to 1.31 | |||||
| CARDS | 2838 people with type 2 diabetes, without CVD, aged 40–75 years, primary prevention About 15% of people in each group had microalbuminuria, 2% had macroalbuminuria. Mean duration of diabetes 7.90 ± 6.33 years in placebo. Mean HbA1c 7.87 ± 1.42% in atorvastatin group and 7.81 ± 1.39% in placebo group | Atorvastatin 10 mg once daily | Fatal and non-fatal MI, unstable angina, resuscitated cardiac arrest, coronary revascularisation, and fatal and non-fatal stroke | Cardiovascular events over 3.9 years: 83/1428 (6%) with atorvastatin v 127/1410 (9%) with placebo; HR 0.63, 95% CI 0.48 to 0.83; P = 0.001 In people with a baseline LDL-C less than 3.1 mmol/L (less than 120 mg/dL): HR 0.63, 95% CI 0.42 to 0.94 | NNT 32/3.9 years, CI not reported | Serious adverse events overall did not differ between treatment groups (myalgia: 61/1428 [4%] with atorvastatin v 72/1410 [5%] with placebo; creatine kinase rise at least 10 times upper limit of normal: 0.1% with atorvastatin v 0.7% with placebo; AST rise at least 3 times upper limit of normal: 1% in both groups; aspartate aminotransferase rise at least 3 times the upper limit of normal: 0.4% with atorvastatin v 0.3% with placebo) |
| Secondary prevention RCTs (people with CVD) in Costa systematic review | ||||||
| 4S | 483 people with type 2 diabetes mellitus and heart disease | Simvastatin (dose not reported) | CHD events, LDL-C | CHD events: 59/251 (24%) with simvastatin v 87/232 (38%) with control; RR 0.63, 95% CI 0.47 to 0.83 | ||
| CARE | 586 people with type 2 diabetes mellitus, MI, or angina | Pravastatin 40 mg/day | CHD events, LDL-C | CHD events: 81/282 (29%) with pravastatin v 112/304 (39%) with control; RR 0.78, 95% CI 0.62 to 0.99 | ||
| HPS | 1981 people with type 2 diabetes mellitus | Simvastatin 40 mg/day | CHD events, LDL-C | CHD events: 325/972 (33%) with simvastatin v 381/1009 (38%) with control; RR 0.89, 95% CI 0.79 to 1.00 | ||
| LIPID | 1077 people with type 2 diabetes mellitus and heart disease | Pravastatin 40 mg/day | CHD events, LDL-C | CHD events: 106/542 (20%) with pravastatin v 125/535 (23%) with control; RR 0.84, 95% CI 0.67 to 1.05 | ||
| LIPS | 202 people with type 2 diabetes mellitus and previous percutaneous coronary intervention | Fluvastatin 80 mg/day | CHD events, LDL-C | CHD events: 26/120 (22%) with fluvastatin v 31/82 (38%) with control; RR 0.57, 95% CI 0.37 to 0.89 | ||
| PostCABG | 116 people with type 2 diabetes mellitus and previous CABG | Lovastatin, cholestyramine (doses not reported) | CHD events, LDL-C | CHD events: 9/63 (14%) with lovastatin v 14/53 (26%) with control; RR 0.54, 95% CI 0.25 to 1.15 | ||
| PROSPER | 227 people with type 2 diabetes mellitus | Pravastatin 40 mg/day | CHD events, LDL-C | CHD events: 38/112 (34%) with pravastatin v 31/115 (27%) with control; RR 1.26, 95% CI 0.85 to 1.87 | ||
4S, Scandinavian Simvastatin Survival Study; AFCAPS, Air Force Coronary Atherosclerosis Prevention Study; ALLHATT, Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial; ASCOT, Anglo-Scandinavian Cardiac Outcome Trial; AST, alanine transaminase CABG, coronary artery bypass grafting; CARDS, Collaborative Atorvastatin (Lipitor™) and Diabetes Study; CARE, Cholesterol And Recurrent Events; C HPS, Heart Protection Study; LDL-C, low-density lipoprotein cholesterol; LIPID, Long-term Intervention with Pravastatin in Ischemic Disease; LIPS, Lescol Intervention Prevention Study; MRC/BHS, Medical Research Council/British Hypertension Society; PAD, peripheral arterial disease; TexCAPS, Texas Coronary Atherosclerosis Prevention Study; PostCABG, Post Coronary Artery Bypass; PROSPER, PROspective Study of Pravastatin in the Elderly at Risk; Texas Coronary Atherosclerosis Prevention Study.