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| |  Large Study Indicates Safety of Calcium Antagonists TEL AVIV, Israel, August 21, 1996-- Calcium antagonist therapy is not associated with an increased risk of cancer-related mortality, including breast cancer, or all-cause mortality, according to a soon-to-be-published cohort study in 11,575 patients with chronic coronary artery disease. This conclusion -- unilaterally supported by other Israeli cohort studies -- is in sharp contrast to a recent publication (Pahor et al.) in which data were analyzed from a highly-selected subgroup of only 750 hypertensive patients. "Unlike the study by Pahor et al. -- which 'pulled out' mortality statistics for a small portion of a large elderly cohort (mean age of 78 years) -- our study presents complete data by drug usage on a significantly larger patient group," said Shimon Braun, MD, Department of Cardiology, Tel Aviv Medical Center. "These data coupled with the mortality experience in our other cohorts indicates that CCB use is unrelated to all-cause mortality or cancer mortality." The researchers examined data from 11,575 heart patients (aged 45-74 years) who were being evaluated for inclusion in an unrelated study. Approximately half the patients were taking calcium antagonists (nifedipine, verapamil or diltiazem -- all short acting) and this group was compared to non users. After adjusting for differences in baseline characteristics, there was no difference in cancer-related mortality after a mean follow-up period of 4.2 years, between the two groups, with the risk ratio for death due to cancer being 1.00 (95% CI: 0.72-1.40). The rate of breast cancer mortality was similar between CCB users- and non users -- 0.34 percent in CCB patients versus 0.29 percent in non users. This incidence rate mirrors that of the general population. Subsequent analysis of other existing databases confirm these conclusions. In 2,607 consecutive survivors of myocardial infarction, whose records were examined in parallel to the SPRINT clinical trial, mortality over the next five years was 41.1 percent in nifedipine users and 39.4 percent in non users. Over a 10-year follow up period, mortality was 58.2 percent in users and 61.5 percent in non users. After adjustment for differences in variables related to prognosis, the relative risk associated with nifedipine use was 1.08 (95% CI, 0.93-1.27) after five years and 1.01 (95% CI, 0.88-1.15) after ten years. The rates of cancer mortality over the 10-year period were 4.2 percent in nifedipine users and 5.5 percent in non users. The rate of breast cancer mortality among women in the above cohort were 1.20 percent in CCB users and 0.82 percent in non users. "The bottom line is that no matter how we looked at it -- with multivariate analysis, with numerous bivariate analyses -- there was no independent association of calcium antagonists and mortality, either from cancer or other causes," said Uri Goldbourt, Ph.D., Professor of Epidemiology, Neufeld Cardiac Research Institute, Sheba Medical Center, Tel Hashomer, Israel. A more recent analysis of 1,940 patients (Behar et al.) in the Israeli thrombolytic surveys (1992-94) found a mortality rate of 9.2 percent of CCB users as compared to 12.5 percent of non users after one year. A multivariate analysis of mortality was yielded an adjusted risk ratio of 0.92 (95% CI, 0.49 to 1.73) for all-cause mortality, associated with CCB therapy. The 11,575-patient cohort study examined data collected between Feb. 1, 1990 and Oct. 30, 1992 in 18 departments of cardiology in Israel. Mortality data were obtained from patients screened, but not chosen, for the Bezafibrate Infarction Prevention (BIP) Study, most falling outside specific serum lipids limits for inclusion. All-cause mortality results were recently published in the Journal of American College of Cardiology (Braun et al.). "These results should end the CCB 'scare' brought on by sensationalized media reports, so that appropriate patients can continue to benefit from these safe and effective drugs," said Henrietta Rechier-Reiss, MD, Neufeld Cardiac Research Institute. The study researchers include: Shimon Braun, MD, Department of Cardiology, Tel Aviv Medical Center, Tel Aviv; Valentina Boyko, MSc, Solomon Behar, MD, Henrietta Reicher-Reiss, MD, Uri Goldbourt, Ph.D. and Elieser Kaplinsky, MD, of The Neufeld Cardiac Research Institute, Tel Hashomer and The Departments of Cardiology, Epidemiology and Preventive Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
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