Table 1.
Characteristics of Large-scale Randomized Controlled Trials
| Trial | Dates | N | Treatment Arm (mg/d) |
Control Arm (mg/d) |
Double- Blinded |
Baseline LDL-C*† |
ΔLDLBaseline -Final† |
ΔLDLControl- Treatment† |
Cumulative CHD Incidence-Controls |
F/U mo |
|---|---|---|---|---|---|---|---|---|---|---|
| 4S | 1988–1994 | 4,444 | Simvastatin 20‡ | Placebo | + | 188 | 66 (35%) | 68 (36%) | 27.3% (5.1%/y) | 65 |
| WOSCOPS | 1989–1995 | 6,595 | Pravastatin 40 | Placebo | + | 192 | 50 (26% ) | 50 (26%) | 7.9% (1.6%/y) | 59 |
| CARE | 1989–1996 | 4,159 | Pravastatin 40 | Placebo | + | 139 | 42 (30%) | 42 (30%) | 13.2% (2.4%/y) | 60 |
| LIPID | 1990–1997 | 9,014 | Pravastatin 40 | Placebo | + | 150 | 38 (25%) | 38 (25%) | 15.9% (2.6%/y) | 73 |
| AFCAPS/ TexCAPS |
1990–1997 | 6,605 | Lovastatin 20‡ | Placebo | + | 150 | 35 (23%) | 41 (26%) | 3.1% (0.6%/y) | 62 |
| GISSI-P | 1993–1996 | 4,271 | Pravastatin 20‡ | Usual Care | 0 | 152 | 23 (15%) | 18 (12%) | 3.9% (2.0%/y) | 23 |
| HPS | 1994–2001 | 20,536 | Simvastatin 40 | Placebo | + | 131 | 54 (41%) | 38 (32%) | 11.8% (2.4%/y) | 60 |
| ALLHAT- LLT |
1994–2002 | 10,355 | Pravastatin 40 | Usual Care | 0 | 146 | 42 (29%) | 17 (14%) | 10.4% (2.2%/y) | 58 |
| PROSPER | 1997–2001 | 5,804 | Pravastatin 40 | Placebo | + | 147 | 50 (34%) | 50 (34%) | 12.2% (3.8%/y) | 38 |
| ASCOT- LLA |
1998–2002 | 10,305 | Atorvastatin 10 | Placebo | + | 132 | 42 (32%) | 37 (29%) | 3.0% (0.9%/y) | 40 |
| GREACE | 1998–2001 | 1,600 | Atorvastatin10‡ | Usual Care | 0 | 179 | 83 (46%) | 72 (43%) | 11.2% (3.7%/y) | 36 |
| CARDS | 1997–2003 | 2,838 | Atorvastatin10 | Placebo | + | 117 | 36 (31%) | 39 (32%) | 5.5% (1.4%/y) | 47 |
| TNT | 1998–2005 | 10,001 | Atorvastatin 80 | Atorvastatin10 | + | 152 | 75 (49%) | 24 (24%) | 8.3% (1.7%/y) | 59 |
| IDEAL | 1999–2005 | 8,888 | Atorvastatin 80 | Simvastatin 20–40 |
0 | 122 | 42 (34%) | 20 (20%) | 23.8% (5.0%/y) | 58 |
| SPARCL | 1998–2005 | 4,731 | Atorvastatin 80 | Placebo | + | 133 | 60 (45%) | 56 (43%) | 5.1% (1.0%/y) | 59 |
| MEGA | 1994–2004 | 7,832 | Pravastatin 10‡ + Diet |
Diet/Usual Care |
0 | 157 | 29 (18%) | 23 (15%) | 1.1% (0.2%/y) | 64 |
| ASPEN | 1996–2003 | 2,410 | Atorvastatin 10 | Placebo | + | 114 | 34 (30%) | 34 (30%) | 4.0% (1.0%/y) | 48 |
| CORONA | 2003–2007 | 5,001 | Rosuvastatin 10 | Placebo | + | 137 | 61 (45%) | 62 (45%) | 6.0% (2.2%/y) | 33 |
| JUPITER | 2003–2008 | 17,802 | Rosuvastatin 20 | Placebo | + | 108 | 53 (49%) | 54 (50%) | 0.8% (0.4%/y) | 23 |
| SEARCH | NA | 12,064 | Simvastatin 80 | Simvastatin 20 | + | 97 | 11 (11%) | 11 (11%) | 13.4% (2.0%/y) | 80 |
All means except for LIPID, where median is reported.
in mg/dL (percent reduction, i.e., %ΔLDLBaseline-Final and %ΔLDLControl-Rx).
With upward titration of dose as indicated.
AFCAPS/TexCAPS = Air Force/Texas Coronary Atherosclerosis Prevention Study; ALLHAT-LLT = Antihypertensive and Lipid Lowering Treatment to prevent Heart Attack Trial – Lipid Lowering Trial; ASCOT-LLA = Anglo-Scandinavian Cardiac Outcomes Trial – Lipid Lowering Arm (ASCOT-LLA); ASPEN = Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus; CARDS = Collaborative AtoRvastatin Diabetes Study; CARE = Cholesterol and Recurrent Events; CHD = Coronary Heart Disease; CORONA = Controlled Rosuvastatin Multinational Trial in Heart Failure; F/U = Follow Up; GISSI-P = Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico – Prevenzione; GREACE = GREek Atorvastatin and Coronary-heart-disease Evaluation; HPS = Heart Protection Study; IDEAL = Incremental Decrease in End Points through Aggressive Lipid Lowering; JUPITER = Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; LDL-C = Low-density Lipoprotein Cholesterol; LIPID = Long-term Intervention with Pravastatin in Ischaemic Disease; MEGA = Management of Elevated cholesterol in the primary prevention Group of Adult Japanese; mg/d = milligrams per day; mo = months; NA = Not available; PROSPER = PROspective Study of Pravastatin in the Elderly at Risk; 4S = Scandinavian Simvastatin Survival Study; SEARCH = Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine; SPARCL = Stroke Prevention by Aggressive Reduction in Cholesterol Levels; TNT = Treating to New Targets; WOSCOPS = West Of SCOtland COronary Prevention Study