Table II.
Clinical Trials Evaluating Dual Calcium Channel Blocker Therapy in Angina
Reference | Disease and Number of Subjects | Study Design | Monotherapy (Mean Dosage) | Dosage of Dual Therapy | Results of Dual Therapy |
Prida et al. 8 | Coronary artery spasm n=9 | R/P‐C; D‐B mono; O‐L dual, cross‐over | Diltiazem 90–360 mg/d; nifedipine 30–120 mg/d | Diltiazem 90–360 mg/d (206 mg/d); nifedipine 30–120 mg/d (61 mg/d) | Intolerable adverse effects in 33% (3/9); clinical improvement in 22% (2/9); no improvement in 44% (4/9) |
Pucci et al. 9 | Stable effort angina n=12 | D‐B/P‐C; 4 × 4 400‐mg once daily Latin‐square | Diltiazem 60 mg × 1 and felodipine 10 mg × 1 | Diltiazem 60 mg × 1 with felodipine 10 mg × 1 | Prolongation of exercise time to ischemic threshold and to peak exercise; 1 patient with hypotension |
Frishman et al. 10 | Stable effort angina n=13 | R/PL, D‐B mono; O‐L dual, cross‐over | Diltiazem 180–360 (352 mg/d) and nifedipine 30–120 mg/d (95 mg/d) | Diltiazem 180–360 (320 mg/d) and nifedipine 30–120 mg/d (52 mg/d) | Improved exercise tolerance and ↓ in angina attacks; ↑ nifedipine concentrations with dual therapy |
Toyosaki et al. 11 | Stable effort angina n=11 | R/P‐C/D‐B, cross‐over | Diltiazem 120 mg/d and nifedipine 40 mg/d | Diltiazem 120 mg/d with nifedipine 40 mg/d | ↑ exercise time; ↑ nifedipine concentrations with dual therapy |
R=randomized; P‐C=placebo‐controlled; D‐B=double‐blind; O‐L=open‐label; PL=placebo Adapted with permission from Ann Pharmacother. 1996;30:802–810. 16 |