Table 3.
Fatal and nonfatal myocardial infarction in clinical trials of ARBs
| Trial | Year | Condition | Treatment arms | Total patients (N) | Follow-up (years) | Patients with MI n (%) |
|---|---|---|---|---|---|---|
| NAVIGATOR44 | 2010 | Impaired glucose tolerance + CV disease or CV risk factors | Placebo | 4675 | 5.0 | 140 (3.0) |
| Valsartan | 4631 | 138 (3.0) | ||||
| KYOTO HEART45 | 2009 | Uncontrolled hypertension | Non-ARB therapy | 1514 | 3.3 | 11 (0.7) |
| Valsartan | 1517 | 7 (0.5) | ||||
| ONTARGET42 | 2008 | Vascular disease or high-risk diabetes | Ramipril | 8576 | 4.7 | 413 (4.8) |
| Telmisartan | 8542 | 440 (5.2) | ||||
| Ramipril + telmisartan | 8502 | 438 (5.2) | ||||
| TRANSCEND43 | 2008 | ACEi intolerant + CV disease or diabetes with end-organ damage | Placebo | 2972 | 4.7 | 147 (5.0) |
| Telmisartan | 2954 | 116 (3.9) | ||||
| I-PRESERVE47 | 2008 | Heart failure + LV ejection fraction ≥45% | Placebo | 2061 | 4.1 | 54 (2.6) |
| Irbesartan | 2067 | 60 (2.9) | ||||
| PROFESS48 | 2008 | Ischemic stroke | Placebo | 10,186 | 2.5 | 169 (1.7) |
| Telmisartan | 10,146 | 168 (1.7) | ||||
| JIKEI46 | 2007 | Hypertension, coronary artery disease and/or heart failure | Non-ARB therapy | 1540 | 3.1 | 19 (1.2) |
| Valsartan | 1541 | 17 (1.1) | ||||
| E-COST41 | 2005 | Essential hypertension | Conventional therapy | 995 | 3.1 | 23 (2.8)a |
| Candesartan | 1053 | 10 (1.2)a | ||||
| VALUE29 | 2004 | Hypertension risk factors | Amlodipine | 7596 | 4.2 | 313 (4.1) |
| Valsartan | 7649 | 369 (4.8) | ||||
| SCOPE55 | 2003 | Elderly hypertension | Placebo | 2460 | 3.7 | 63 (2.6) |
| Candesartan | 2477 | 70 (2.8) | ||||
| CHARM66,67 | 2003 | Heart failure | Placebo | 3796 | 3.1 | 190 (5.0) |
| Candesartan | 3803 | 176 (4.6) | ||||
| CHARM-Added68 | 2003 | CHF + LV ejection fraction ≤40%, being treated with ACEis | Placebo | 1272 | 3.4 | 69 (5.4) |
| Candesartan | 1276 | 44 (3.4) | ||||
| CHARM Alternative69 | 2003 | ACEi intolerant, symptomatic heart failure, + LV ejection fraction ≤40% | Placebo | 1015 | 2.8 | 48 (4.7) |
| Candesartan | 1013 | 75 (7.4) | ||||
| CHARM Preserved70 | 2003 | CHF + LV ejection fraction >40% | Placebo | 1509 | 3.0 | 73 (4.8) |
| Candesartan | 1514 | 57 (3.8) | ||||
| VALIANT71,72 | 2003 | MI + heart failure and/or LV dysfunction | Captopril | 4909 | 2.1 | 559 (11.4)b |
| Valsartan | 4909 | 587 (12.0)b | ||||
| Captopril + valsartan | 4885 | 554 (11.3)b | ||||
| LIFE73 | 2002 | Hypertension + LV hypertrophy | Atenolol | 4588 | 4.8 | 188 (4.1) |
| Losartan | 4605 | 198 (4.3) | ||||
| OPTIMAAL74 | 2002 | MI | Captopril | 2733 | 2.7 | 379 (13.9) |
| Losartan | 2744 | 384 (14.0) | ||||
| IDNT75 | 2001 | Diabetic nephropathy | Placebo | 569 | 2.6 | 51 (9.0) |
| Irbesartan | 579 | 48 (8.3) | ||||
| Amlodipine | 567 | 29 (5.1) | ||||
| RENAAL76 | 2001 | Diabetic nephropathy | Placebo | 762 | 3.4 | 68 (8.9) |
| Losartan | 751 | 50 (6.7) | ||||
| ELITE II77 | 2000 | Heart failure + ejection fraction ≤40% | Captopril | 1574 | 1.5 | 28 (1.8) |
| Losartan | 1578 | 31 (2.0) |
Notes:
Percentages reported in the E-COST study are based on the intent-to-treat population (n = 815 for both treatment groups);
Number (%) of patients who had ≥1 MI; Because patients could have more than 1 MI, the number of investigator-reported MIs was 798 in the captopril group, 796 in the valsartan group, and 756 in the captopril + valsartan group.
Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; CHARM, Candesartan in Heart Failure Assessment in Reduction of Mortality; CHF, congestive heart failure; CV, cardiovascular; E-COST, Efficacy of Candesartan on Outcome in Saitama Trial; ELITE, Evaluation of Losartan in the Elderly; IDNT, Irbesartan Diabetic Nephropathy Trial; I-PRESERVE, Irbesartan in Heart Failure with Preserved Ejection Fraction; LIFE, Losartan Intervention for Endpoint Reduction in Hypertension; LV, left ventricular; MI, myocardial infarction; NAVIGATOR, Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research; ONTARGET, Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial; OPTIMAAL, Optimal Trial in Myocardial Infarction with the Angiotensin II Antagonist Losartan; PROFESS, Prevention Regimen for Effectively Avoiding Second Strokes; RENAAL, Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan; SCOPE, Study on Cognition and Prognosis in the Elderly; TRANSCEND, Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease; VALIANT, Valsartan in Acute Myocardial Infarction; VALUE, Valsartan Antihypertensive Long-Term Use Evaluation.