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Adding the new calcium antagonist mibefradil to patients receiving long-term beta-blocker therapy results in improved antianginal and antiischemic efficacy.

AbstractOBJECTIVE:
The objective of this study was to evaluate the efficacy, tolerability, and safety of mibefradil, a new selective T-type calcium channel blocker, in patients with chronic stable angina pectoris receiving concomitant beta-blocker therapy.
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.
AuthorsA Schneeweiss, I Kobrin, V Charlon, A Caspi, A Marmor, S Sclarovsky, L Reisin, Z Schlesinger
JournalAmerican heart journal (Am Heart J) Vol. 135 Issue 2 Pt 1 Pg. 272-80 (Feb 1998) ISSN: 0002-8703 [Print] United States
PMID9489976 (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

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