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Diltiazem and Reinfarction in Patients with Non-Q-Wave Myocardial Infarction

List of authors.
  • Robert S. Gibson, M.D.,
  • William E. Boden, M.D.,
  • Pierre Theroux, M.D.,
  • Hans D. Strauss, M.D.,
  • Craig M. Pratt, M.D.,
  • Mihai Gheorghiade, M.D.,
  • Robert J. Capone, M.D.,
  • Michael H. Crawford, M.D.,
  • Robert C. Schlant, M.D.,
  • Robert E. Kleiger, M.D.,
  • Phillip M. Young, Pharm.D.,
  • Kenneth Schechtman, Ph.D.,
  • M. Benjamin Perryman, Ph.D.,
  • Robert Roberts, M.D.,
  • and the Diltiazem Reinfarction Study Group

Abstract

We performed a multicenter, double-blind, randomized study to evaluate the effect of diltiazem on reinfarction after a non-Q-wave myocardial infarction. Nine centers enrolled 576 patients: 287 received diltiazem (90 mg every six hours) and 289 received placebo. Treatment was initiated 24 to 72 hours after the onset of infarction and continued for up to 14 days. The primary end point, reinfarction, was defined as an abnormal reelevation of MB creatine kinase in plasma within 14 days.

Reinfarction occurred in 27 patients in the placebo group (9.3 percent) and in 15 in the diltiazem group (5.2 percent) — a 51.2 percent reduction in cumulative life-table incidence (P = 0.0297; 90 percent confidence interval, 7 to 67 percent). Diltiazem reduced the frequency of refractory postinfarction angina (a secondary end point) by 49.7 percent (P = 0.0345; 90 percent confidence interval, 6 to 73 percent). Mortality was similar in the two groups (3.1 and 3.8 percent, respectively, in the placebo and diltiazem groups), but adverse drug reactions (most of which were mild) were more common in the diltiazem group. Nevertheless, the drug was well tolerated, despite concurrent treatment with beta-blockers in 61 percent of the patients.

We conclude that diltiazem was effective in preventing early reinfarction and severe angina after non-Q-wave infarction and that it was also safe and generally well tolerated. (N Engl J Med 1986; 315:423–9.)

Funding and Disclosures

Address reprint requests to Dr. Gibson at Box 468, Medical Center, University of Virginia, Charlottesville, VA 22908.

The members of the Diltiazem Reinfarction Study Group were as follows: Project Principal Investigator: Robert Roberts. Policy Board: Chairman — Bertram Pitt, Curt Furberg and Sidney Goldstein. End-Point Verification Committee: Chairman — Robert Roberts, William Boden, Robert Gibson. Benjamin Perryman, and Philip Young. Creatine Kinase Core Laboratory: Director — Benjamin Perryman, Rebecca Montgomery, Robert Roberts, and Rand Sacry. Biostatistics Committee: Chairman — Kenneth Schechtman, Kerry Lee and Michael Rubison. Electrocardiographic Committee: Co-chairmen — Robert Kleiger and William Boden. Robert Capone, Robert Gibson, and David Schwartz. Data Coordinating Center: Chairman — Michael Rubison, Mary Collins, Douglas Moore, and Phillip Young. Auditing Committee: Chairman — Phillip Young. Barbara Geiger and Kelvin Gipson. Writing Committee: Chairman — Robert Gibson, William Boden, Robert Capone, Michael Crawford, Mihai Gheorghiade, Robert Kleiger, Craig Pratt, Robert Roberts, Robert Schlant, Hans Strauss, and Pierre Theroux. The participating centers and their principal investigators, coinvestigators, and coordinators were University of Virginia — Robert Gibson and Mihai Gheorghiade, George Beller and Donald Lilly, and Ann Cooper and Carolyn St. Clair; Brown University — William Boden and Robert Capone, Tom Marantz and Robert McGhee, and Ginny Rich, Diane Hardink, Kathy Alberti, and Judy Doherty; Montreal Heart Institute — Pierre Theroux, Martial Bourassa and Xavier Bosch, and Marilyn Hache; Toronto Western Hospital — Hans Strauss, Susan Lenkei-Kerwin, and Sally Veldman; Baylor College of Medicine — Craig Pratt, James Young and Alfredo Montero, and Pat Carlson; University of Texas Health Science Center, San Antonio — Michael Crawford, Robert O'Rourke, and Gemma Kennedy; Emory University — Robert Schlant, Daniel Arensberg, and Velma Jeffries; Washington University — Robert Kleiger, David Schwartz, and Jeanne Gallo and Jane Humphrey; and University of California, Los Angeles — Prediman Shah, Devendra Amin, and Sharon Hulse.

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