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| |  Major Studies Support Safety of Calcium Channel Blockers NEW ORLEANS, Nov. 13, 1996 -- Scientists at two of the world's leading cardiovascular research centers presented major studies this week that affirm the safety of calcium channel blockers (CCBs), Pfizer said. In a major review of calcium channel blocker use among patients enrolled in the highly regarded Framingham Heart Study, researchers reported that "we found no evidence of increased mortality risk in hypertensive CCB patients." The study, presented today at American Heart Association meeting here, also showed that this finding was true whether or not patients had underlying coronary disease. Instituted by the National Heart, Lung and Blood Institute of the National Institutes of Health, the Framingham Heart Study is the longest-running scientific inquiry into the development and progression of heart disease. The Study was begun in 1948 with 5,209 male and female subjects between the ages of 30 and 60 from the Framingham, Massachusetts area. "This is a well-conducted study of CCB use by large numbers of patients during an average study period of seven years," said Roger Sachs, M.D., senior vice president, Medical Affairs, for Pfizer Inc. "These findings are particularly important because the patients were enrolled in the Framingham Heart study which has provided a wealth of findings relevant to clinical insights during the past five decades." In another major CCB safety study presented here, researchers from the Cleveland Clinic reported that records from more than 5,100 surgical patients showed no increased risk of excessive bleeding when CCBs were used. The researchers noted that these results are contrary to an earlier paper that raised questions about possible excessive bleeding based on data from only 112 patients. "The results from the Cleveland Clinic are striking because of the large number of patients examined," Dr. Sachs said. "Further, the patients in the group at greatest risk of bleeding had better outcomes when treated with CCBs compared with patients not treated with CCBs." The safety of calcium channel blockers was also affirmed by Milton Packer, M.D., of Columbia-Presbyterian Medical Center during a seminar on cardiovascular disease held this week. "The data presented against calcium channel blockers does not meet rigorous scientific standards of evidence," he said. "In fact, if the same standards of evidence were used, similar concerns could be raised for many anti-hypertensives which are known to be safe." John Flack, M.D., of the Bowman Gray School of Medicine and chairman of the session on African-American cardiovascular disease said, "Long-term control of blood pressure is essential to reducing the risks associated with hypertension. CCBs remain an important therapeutic option for hypertensive African-Americans. These well-tolerated agents are highly effective in achieving blood pressure control when used as monotherapy as well as in multi- drug therapies." Pfizer Inc. is a research-based, diversified health-care company with global operations. The company reported sales of $10 billion for 1995, and plans to spend approximately $1.7 billion on research and development this year. SIGNIFICANT CALCIUM CHANNEL BLOCKER EVENTS AND FINDINGS SINCE THE 1995 AHA MEETING 1. Analysis of data from the Framingham Heart Study: No evidence found of increased mortality risk in hypertensive CCB users; decreased mortality in CCB users with coronary heart disease. (Data being presented at the 1996 AHA annual meeting). 2. Cleveland Clinic Study of CCB use and perioperative bleeding: Case-control study of 5,157 patients found no CCB association with increased bleeding, heart attack, or death in cardiovascular surgical patients. (Data being presented at the 1996 AHA annual meeting). 3. Prospective Randomized Amlodipine Survival Evaluation (PRAISE): Multi-center study of 1,153 patients found Norvasc, the most advanced long-acting CCB, safe in patients with advanced congestive heart failure. (Published in The New England Journal of Medicine, October 10, 1996.) 4. Israeli Cohort Mortality Study of 11,575 Patients: Compared 5,843 patients taking CCBs with 5,732 who were not and found no increase in mortality among the CCB users. (Published July, 1996, in the Journal of the American College of Cardiology.) 5. Shanghai Trial of Nifedipine in the Elderly (STONE): Prospective placebo-controlled study found that patients receiving placebo had 2.4 fold greater risk of cardiovascular events than patients given the CCB Nifedipine. (Published in the October, 1996, issue of the Journal of Hypertension.) 6. Kloner presentation of world-wide data: Dr. Robert A. Kloner, of Good Samaritan Hospital, Los Angeles, presents review of safety data on 35,000 patients receiving Norvasc of Procardia XL in Pfizer-sponsored trials around the world - and finds that adverse event rate is similar to that for traditional anti-hypertensives. (Data presented at American College of Cardiology meeting, March 26, 1996, in Orlando, FL.) 7. Cancer Analysis of Israeli Cohort Study Data Base: Contrary to the findings of some much smaller studies, an analysis of the 11,575 patient Israeli data base found no association between CCB use and an increased cancer risk. 8. FDA advisory panel meeting on CCBS: An expert panel convened by the FDA found no safety issues with the long-acting CCBs and recommended strict adherence to approved uses of the short-acting agents.
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