Abstract
A multicenter, double-blind study was performed to compare the efficacy and safety of the calcium antagonists, amlodipine and diltiazem controlled release (CR), in patients with stable angina pectoris. One hundred and thirty-two patients were randomized to receive either amlodipine (5–10 mg) once daily or diltiazem CR (90–120 mg) twice daily for 8 weeks. A standard bicycle exercise tolerance test was used for the primary efficacy assessment. The median time to 1 mm ST-segment depression and time to onset of chest pain were increased by 16% (P < 0.0001) and 13% (P < 0.0001) with amlodipine, and by 16% (P < 0.0001) and 7% (P = 0.009) with diltiazem CR, respectively. Amlodipine, but not diltiazem CR, also produced a significant improvement in the median time to end of exercise of 5% (P < 0.0002), although the between-treatment difference for this parameter was not statistically significant. The number of angina attacks and nitroglycerin (NTG) tablet consumption were similar with both agents. Amlodipine was withdrawn in 3% and diltiazem CR in 9% of patients due to adverse events. The adverse events were reported by 15% of patients on amlodipine and 26% of those on diltiazem CR. The results from this study demonstrate that both drugs have a comparable therapeutic effect and possibly that amlodipine was better tolerated in patients with stable angina. Furthermore, amlodipine has the advantage of once-daily dosing and so may also be beneficial in ensuring good patient compliance.
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Perondi R, Saino A, Zanchetti A, Mancia G. Coronary vascular reactivity and calcium antagonist therapy in patients with angina. J Cardiovasc Pharmacol 1994;24(Suppl. A): S30–S36.
Murdoch D, Heel RC. Amlodipine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cardiovascular disease. Drugs 1991;41:478–505.
Haria M, Wagstaff AJ. Amlodipine. A reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease. Drugs 1995;50:560–586.
Brorson L, Arvill A, Löfdahl P, et al. Conventional and controlled release diltiazem. Bioavailability in healthy volunteers and anti-anginal effects in combination with metoprolol in stable angina pectoris. Eur J Clin Pharmacol 1994; 47:75–79.
Opie LH, Singh BN. Calcium channel antagonists (slow channel blockers). In: Opie LH, ed. Drugs for the Heart, 4th ed. Philadelphia: W.B. Saunders, 1997:50–82.
Chaffman M, Brogden RN. Diltiazem: A review of its pharmacologic properties and therapeutic efficacy. Drugs 1985; 29:387–454.
Singh BN. Silent myocardial ischemia: Historical development of the concept and scope of the clinical problem. In: Singh BN, ed. Silent Myocardial Ischemia and Angina. Prevalence, Prognostic, and Therapeutic Significance. New York: Pergamon Press, 1988:3–15.
EC Note for Guidance: Good Clinical Practice for Trials on Medicinal Products in the European Community: The Rules Governing Medicinal products in the European Community. Vol. 3, Addendum July 1999, ISBN 92-826-0421-7.
Bernink PJLM, de Weerd P, ten Cate FJ, Remme WJ, Barth J, Enthoven R, and co-investigators. An 8-week double-blind study of amlodipine and diltiazem in patients with stable exertional angina pectoris. J Cardiovasc Pharmacol 1991;17(Suppl. 1):S53–S56.
Canale C, Terrachini V, Masperone MA, Caponnetto S. Open comparative study to assess the efficacy and safety of two calcium antagonists: Amlodipine and diltiazem in the treatment of symptomatic myocardial ischaemia. J Cardiovasc Pharmacol 1991;17(Suppl. 1):S57–S60.
Mulcahy D, Purcell H, Sparrow J, Cunningham D, Wright C, Fox KM. Effects of amlodipine versus diltiazem on morning peak in myocardial ischemic activity in angina pectoris. Am J Cardiol 1993;72:1203–1206.
Deanfield JE, Detry J-MRG, Lichtlen PR, Magnani B, Sellier P, Thaulow E. Amlodipine reduces transient myocardial ischemia in patients with coronary artery disease: Double-blind Circadian Anti-ischemia Program in Europe (CAPE Trial). J Am Coll Cardiol 1994;24:1460–1467.
Gaffney M, Taylor C, Cusenza E. Harmonic regression analysis of the effect of drug treatment on the diurnal rhythm of blood pressure and angina. Stat Med 1993;12: 129–142.
Kubota K, Pearce GL, Inman WHW. Vasodilation-related adverse events in diltiazem and dihydropyridine calcium antagonists studied by prescription-event monitoring. Eur J Clin Pharmacol 1995;48:1–7.
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van Kesteren, H., Withagen, A. A Comparative Study of Once-Daily Amlodipine versus Twice-Daily Diltiazem Controlled Release (CR) in the Treatment of Stable Angina Pectoris. Cardiovasc Drugs Ther 12 (Suppl 3), 233–237 (1998). https://doi.org/10.1023/A:1007726109850
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DOI: https://doi.org/10.1023/A:1007726109850