Randomized placebo-controlled trial of amlodipine in vasospastic angina. Amlodipine Study 160 Group

Division of Cardiology, University of Miami, Florida 33101.

OBJECTIVES. This study was designed to assess the efficacy and safety of amlodipine, a long-acting calcium channel blocker, in patients with vasospastic angina. BACKGROUND. Previous studies have established the value of short-acting calcium channel blockers in the treatment of coronary spasm. METHODS. Fifty-two patients with well documented vasospastic angina were entered into the present study. After a single-blind placebo run-in period, patients were randomized (in a double-blind protocol) to receive either amlodipine (10 mg) or placebo every morning for 4 weeks. Twenty-four patients received amlodipine and 28 received placebo. All patients were given diaries in which to record both the frequency, severity, duration and circumstances of anginal episodes and their intake of sublingual nitroglycerin tablets. RESULTS. The rate of anginal episodes decreased significantly (p = 0.009) with amlodipine treatment compared with placebo and the intake of nitroglycerin tablets showed a similar trend. Peripheral edema was the only adverse event seen more frequently in amlodipine-treated patients. No patient was withdrawn from the double-blind phase of the study because of an adverse event. Patients who completed the double-blind phase as responders to amlodipine or as nonresponders to placebo were offered the option of receiving amlodipine in a long-term, open label extension phase. During the extension, the daily dose of amlodipine was adjusted to 5 or 15 mg if needed and the rate of both anginal episodes and nitroglycerin tablet consumption showed statistically significant decreases between baseline and final assessment. CONCLUSION. This study suggests that amlodipine given once daily is efficacious and safe in the treatment of vasospastic angina.

This article has been cited by other articles:

				K. Wakabayashi, H. Suzuki, Y. Honda, D. Wakatsuki, K. Kawachi, K. Ota, S. Koba, N. Shimizu, F. Asano, T. Sato, et al. Provoked Coronary Spasm Predicts Adverse Outcome in Patients With Acute Myocardial Infarction: A Novel Predictor of Prognosis After Acute Myocardial Infarction J. Am. Coll. Cardiol., August 12, 2008; 52(7): 518 - 522. [Abstract] [Full Text] [PDF]

				J. L. Anderson, C. D. Adams, E. M. Antman, C. R. Bridges, R. M. Califf, D. E. Casey Jr, W. E. Chavey II, F. M. Fesmire, J. S. Hochman, T. N. Levin, et al. ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine J. Am. Coll. Cardiol., August 14, 2007; 50(7): e1 - e157. [Full Text] [PDF]

				J. L. Anderson, C. D. Adams, E. M. Antman, C. R. Bridges, R. M. Califf, D. E. Casey Jr, W. E. Chavey II, F. M. Fesmire, J. S. Hochman, T. N. Levin, et al. ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine J. Am. Coll. Cardiol., August 14, 2007; 50(7): 652 - 726. [Full Text] [PDF]

				P. K. Mishra Variations in presentation and various options in management of variant angina. Eur. J. Cardiothorac. Surg., May 1, 2006; 29(5): 748 - 759. [Abstract] [Full Text] [PDF]

				T Azeem, D Adlam, and A Gershlick Failure of intravascular ultrasound to identify the site of recurrent focal coronary spasm during stenting Heart, June 1, 2004; 90(6): e33 - e33. [Abstract] [Full Text] [PDF]

				E. Braunwald, E. M. Antman, J. W. Beasley, R. M. Califf, M. D. Cheitlin, J. S. Hochman, R. H. Jones, D. Kereiakes, J. Kupersmith, T. N. Levin, et al. ACC/AHA guidelines for the management of patients with unstable angina and non-st-segment elevation myocardial infarction: A report of the american college of cardiology/ american heart association task force on practice guidelines (committee on the management of patients with unstable angina) J. Am. Coll. Cardiol., September 1, 2000; 36(3): 970 - 1062. [Full Text] [PDF]

				B. Jorgensen, S. Simonsen, K. Endresen, K. Forfang, K. Vatne, J. Hansen, J. Webb, C. Buller, G. Goulet, J. Erikssen, et al. Restenosis and clinical outcome in patients treated with amlodipine after angioplasty: results from the coronary AngioPlasty Amlodipine REStenosis Study (CAPARES) J. Am. Coll. Cardiol., March 1, 2000; 35(3): 592 - 599. [Abstract] [Full Text] [PDF]

				R. J. Gibbons, K. Chatterjee, J. Daley, J. S. Douglas, S. D. Fihn, J. M. Gardin, M. A. Grunwald, D. Levy, B. W. Lytle, R. A. O'Rourke, et al. ACC/AHA/ACP-ASIM guidelines for the management of patients with chronic stable angina: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients With Chronic Stable Angina) J. Am. Coll. Cardiol., June 1, 1999; 33(7): 2092 - 2197. [Full Text] [PDF]

				G Y H Lip, K K Ray, and M F Shiu Coronary spasm in acute myocardial infarction Heart, August 1, 1998; 80(2): 197 - 199. [Abstract] [Full Text]