Table 1.
Clinical studies utilizing nifedipine
| Reference | n | Patients | Treatment (mg) | Mean duration (years) | Primary endpoint | Outcome |
|---|---|---|---|---|---|---|
| Gong et al29 (STONE) | 1632 | 60–79 y/o with SBP ≥ 160 or DBP ≥ 96 | nif 10–30 bida vs placebo | 2.5 | Combined CV events (stroke, HF, MI, severe arrhythmia, and sudden death) | 62% risk reduction in combined CV events; (p = 0.0001) |
| Yui et al31 (JMIC-B) | 1650 | ≤75 y/o with HTN and CAD | nif 10–20 bidb,c vs enal 5–10 daily or imid 5–10 daily or lis 10–20 daily |
3 | Overall incidence of cardiac events (cardiac death/sudden death, MI, hospitalization for angina pectoris or HF, serious arrhythmia, and coronary interventions | No significant difference between nif and ACE-I groups; p = 0.75 |
| Brown et al39 (INSIGHT) | 6321 | 55–80 y/o with HTN and 1 additional risk factord | nif 30–60 dailye vs co-amil 25–50/2.5–5 daily |
4 | CV death, MI, heart failure, and death | No significant difference between nif and co-amil group; p = 0.35 |
| Poole-Wilson et al41 (ACTION) | 3825 | ≥35 y/o with stable angina pectoris for ≥1 month and CAD | nif 30–60 daily vs placebo | 5 | CV event-free survival defined as death from any cause, acute MI, refractory angina, new overt heart failure, debilitating stroke, and peripheral revascularization | No significant difference between nif and placebo; p = 0.54 |
Additional therapy (if needed) included captopril 20 to 50 mg/day and/or dihydrochlorothiazide 25 mg/day to get BP to goal (<160/90).
Additional therapy (if needed) included doxazosin, bunazosin or prazosin to get BP to goal (<150/90).
Additional therapy (if needed) included long-acting or short-acting nitrates and/or beta-blockers if angina persisted on monotherapy.
Risk factors included hyperlipidemia, smoker, family history of MI in parent or sibling <50 y/o, left ventricular hypertrophy, coronary heart disease, left ventricular strain, peripheral vascular disease, or proteinuria.
Additional therapy (if needed) included atenolol 25 mg daily or enalapril 5 mg daily to get BP to goal (<140/90).
Abbreviations: nif, nifedipine; enal, enalapril; imid, imidapril; lis, lisinopril; co-amil, co-amilozide (hydrochlorothiazide/amiloride); CV, cardiovascular; HF, heart failure; MI, myocardial infarction; HTN, hypertension; CAD, coronary artery disease; ACE-I, angiotensin converting enzyme inhibitor, bid, twice daily; y/o, years of age.