Abstract | OBJECTIVE: DESIGN: This was a multicenter, double-blind, placebo-controlled study. METHODS: Ninety-five patients receiving a stable dose of beta-blockers, which was not changed for the purpose of the study, were administered either 50 mg mibefradil once daily for 2 weeks, then 100 mg once daily for 2 weeks, or matching placebo. Efficacy was evaluated by treadmill exercise tolerance testing 24 hours after dose and by diary registration of anginal episodes and nitroglycerin consumption. RESULTS: Two weeks of treatment with 50 mg mibefradil resulted in a significant increase in symptom-limited exercise duration and a significant delay in the onset of persistent 1 mm ST-segment depression (placebo-corrected treatment effect: 23.2 and 51.7 seconds, respectively). Treatment with the 100 mg dose for 2 additional weeks resulted in a larger improvement in treadmill exercise tolerance testing duration and onset of ischemia (placebo-corrected treatment effect: 52.7 and 75.8 seconds, respectively). In addition, a significant decrease in weekly anginal episodes was observed with the 100 mg dose of mibefradil compared with the effect in the placebo group (-53% vs - 12%, p = 0.037). CONCLUSIONS: The combined treatment of mibefradil and beta-blockers was well tolerated, and the overall incidence of adverse events was no different from that with beta-blockers alone. The results indicate that adding mibefradil to chronic beta-blocker treatment is associated with significant improvement in efficacy, which is not achieved at the expense of tolerability.
|
Authors | A Schneeweiss, I Kobrin, V Charlon, A Caspi, A Marmor, S Sclarovsky, L Reisin, Z Schlesinger |
Journal | American heart journal
(Am Heart J)
Vol. 135
Issue 2 Pt 1
Pg. 272-80
(Feb 1998)
ISSN: 0002-8703 [Print] United States |
PMID | 9489976
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Adrenergic beta-Antagonists
- Benzimidazoles
- Calcium Channel Blockers
- Tetrahydronaphthalenes
- Mibefradil
|
Topics |
- Adrenergic beta-Antagonists
(administration & dosage, therapeutic use)
- Angina Pectoris
(drug therapy)
- Benzimidazoles
(administration & dosage, adverse effects, therapeutic use)
- Calcium Channel Blockers
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Exercise Test
- Female
- Humans
- Male
- Mibefradil
- Middle Aged
- Tetrahydronaphthalenes
(administration & dosage, adverse effects, therapeutic use)
- Time Factors
|