(Circulation. 1995;92:1326-1331.)
© 1995 American Heart Association, Inc.
Articles |
Nifedipine
Dose-Related Increase in Mortality in Patients With Coronary Heart Disease
From the Department of Public Health Sciences, Bowman Gray School of Medicine, Winston-Salem, NC (C.D.F., J.V.M.), and the Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle (B.M.P.).
Correspondence to Dr Curt D. Furberg, Department of Public Health Sciences, Bowman Gray School of Medicine, Winston-Salem, NC 27157-1063.
Background The purpose of this study was to assess the effect of the dose of nifedipine, a dihydropyridine calcium antagonist, on the increased risk of mortality seen in the randomized secondary-prevention trials and to review the mechanisms by which this adverse effect might occur.
Methods and Results We restricted the dose-response meta-analysis to the 16 randomized secondary-prevention trials of nifedipine for which mortality data were available. Recent trials of any calcium antagonist and formulation were also reviewed for information about the possible mechanisms of action that might increase mortality. Overall, the use of nifedipine was associated with a significant adverse effect on total mortality (risk ratio, 1.16, with a 95% CI of 1.01 to 1.33). This summary estimate fails to draw attention to an important dose-response relationship. For daily doses of 30 to 50, 60, and 80 mg, the risk ratios for total mortality were 1.06 (95% CI, 0.89 to 1.27), 1.18 (95% CI, 0.93 to 1.50), and 2.83 (95% CI, 1.35 to 5.93), respectively. In a formal test of dose response, the high doses of nifedipine were significantly associated with increased mortality (P=.01). While the mechanism of this adverse effect is not known, there are several plausible explanations, including the established proischemic effect, negative inotropic effects, marked hypotension, recently reported prohemorrhagic effects attributed to antiplatelet and vasodilatory actions of calcium antagonists, and possibly proarrhythmic effects.
Conclusions In patients with coronary disease, the use of short-acting nifedipine in moderate to high doses causes an increase in total mortality. Other calcium antagonists may have similar adverse effects, in particular those of the dihydropyridine type. Long-term safety data are lacking for most calcium antagonists.
Key Words: coronary disease • dihydropyridine • nifedipine • meta-analysis • mortality
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W. B. Stason, C. H. Schmid, D. Niedzwiecki, G. W. Whiting, J.-F. Caubet, D. Cory, D. Luo, S. D. Ross, and T. C. Chalmers Safety of Nifedipine in Angina Pectoris : A Meta-Analysis Hypertension, January 1, 1999; 33(1): 24 - 31. [Abstract] [Full Text] [PDF]
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A. J.J. Wood, C. M. Stein, and R. Woosley Making Medicines Safer -- The Need for an Independent Drug Safety Board N. Engl. J. Med., December 17, 1998; 339(25): 1851 - 1854. [Full Text]
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K. P. Alexander, E. D. Peterson, C. B. Granger, A. C. Casas, F. Van de Werf, P. W. Armstrong, A. Guerci, E. J. Topol, R. M. Califf, and for the GUSTO-IIB Investigators Potential impact of evidence-based medicine in acute coronary syndromes: insights from GUSTO-IIb J. Am. Coll. Cardiol., December 1, 1998; 32(7): 2023 - 2030. [Abstract] [Full Text] [PDF]
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M. F. Rossier, E. A. Ertel, M. B. Vallotton, and A. M. Capponi Inhibitory Action of Mibefradil on Calcium Signaling and Aldosterone Synthesis in Bovine Adrenal Glomerulosa Cells J. Pharmacol. Exp. Ther., December 1, 1998; 287(3): 824 - 831. [Abstract] [Full Text]
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 L. D. Ramunno, T. A. Dodds, and N. D. Traven Cooperative Cardiovascular Project (CCP) Quality Improvement in Maine, New Hampshire, and Vermont Eval Health Prof, December 1, 1998; 21(4): 442 - 460. [Abstract] [PDF]
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C. J. Pepine, E. Handberg-Thurmond, R. G. Marks, M. Conlon, R. Cooper-Dehoff, P. Volkers, P. Zellig, and for The INVEST Investigators Rationale and design of the International Verapamil SR/Trandolapril Study (INVEST): an Internet-based randomized trial in coronary artery disease patients with hypertension J. Am. Coll. Cardiol., November 1, 1998; 32(5): 1228 - 1237. [Abstract] [Full Text] [PDF]
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V. M. Abascal, M. G. Larson, J. C. Evans, A. T. Blohm, K. Poli, and D. Levy Calcium Antagonists and Mortality Risk in Men and Women With Hypertension in the Framingham Heart Study Arch Intern Med, September 28, 1998; 158(17): 1882 - 1886. [Abstract] [Full Text]
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M. Nordlander, M. Pfaffendorf, and H. B. van Wezel Calcium Antagonists for Perioperative Blood Pressure Control Seminars in Cardiothoracic and Vascular Anesthesia, September 1, 1998; 2(3): 231 - 242. [Abstract] [PDF]
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J. A. Staessen, L. Thijs, R. H. Fagard, W. H. Birkenhager, G. Arabidze, S. Babeanu, B. Gil-Extremera, C. J. Bulpitt, C. Davidson, P. W. de Leeuw, et al. Calcium Channel Blockade and Cardiovascular Prognosis in the European Trial on Isolated Systolic Hypertension Hypertension, September 1, 1998; 32(3): 410 - 416. [Abstract] [Full Text] [PDF]
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M. T. Donohoe Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses Arch Intern Med, August 10, 1998; 158(15): 1596 - 1608. [Abstract] [Full Text]
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K. Sakata, M. Shirotani, H. Yoshida, and C. Kurata Comparison of effects of enalapril and nitrendipine on cardiac sympathetic nervous system in essential hypertension J. Am. Coll. Cardiol., August 1, 1998; 32(2): 438 - 443. [Abstract] [Full Text] [PDF]
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W. J. Burman, R. R. Reves, and D. L. Cohn The Case for Conservative Management of Early HIV Disease JAMA, July 1, 1998; 280(1): 93 - 95. [Full Text] [PDF]
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X. Zhang and D. Fedida Potassium Channel–Blocking Actions of Nifedipine: A Cause for Morbidity at High Doses? Circulation, May 26, 1998; 97(20): 2098 - 2098. [Full Text]
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P. A. Kaufmann, J. Frielingsdorf, L. Mandinov, C. Seiler, R. Hug, and O. M. Hess Reversal of Abnormal Coronary Vasomotion by Calcium Antagonists in Patients With Hypercholesterolemia Circulation, April 14, 1998; 97(14): 1348 - 1354. [Abstract] [Full Text] [PDF]
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H. Krum, R. J. Viskoper, Y. Lacourciere, M. Budde, V. Charlon, and The Bosentan Hypertension Investigators The Effect of an Endothelin-Receptor Antagonist, Bosentan, on Blood Pressure in Patients with Essential Hypertension N. Engl. J. Med., March 19, 1998; 338(12): 784 - 791. [Abstract] [Full Text] [PDF]
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R. O. Estacio, B. W. Jeffers, W. R. Hiatt, S. L. Biggerstaff, N. Gifford, and R. W. Schrier The Effect of Nisoldipine as Compared with Enalapril on Cardiovascular Outcomes in Patients with Non-Insulin-Dependent Diabetes and Hypertension N. Engl. J. Med., March 5, 1998; 338(10): 645 - 652. [Abstract] [Full Text] [PDF]
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J. A. Cutler Calcium-Channel Blockers for Hypertension -- Uncertainty Continues N. Engl. J. Med., March 5, 1998; 338(10): 679 - 681. [Full Text]
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S. Richard, F. Leclercq, S. Lemaire, C. Piot, and J. Nargeot Ca2+ currents in compensated hypertrophy and heart failure Cardiovasc Res, February 1, 1998; 37(2): 300 - 311. [Abstract] [Full Text] [PDF]
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H. T. Stelfox, G. Chua, K. O'Rourke, and A. S. Detsky Conflict of Interest in the Debate over Calcium-Channel Antagonists N. Engl. J. Med., January 8, 1998; 338(2): 101 - 106. [Abstract] [Full Text] [PDF]
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T. Yamazaki, I. Komuro, Y. Zou, S. Kudoh, I. Shiojima, T. Mizuno, Y. Hiroi, R. Nagai, and Y. Yazaki Efficient Inhibition of the Development of Cardiac Remodeling by a Long-Acting Calcium Antagonist Amlodipine Hypertension, January 1, 1998; 31(1): 32 - 38. [Abstract] [Full Text]
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G. F. Mitchell, L. A. Moye, E. Braunwald, J.-L. Rouleau, V. Bernstein, E. M. Geltman, G. C. Flaker, M. A. Pfeffer, and f. t. S. Investigators Sphygmomanometrically Determined Pulse Pressure Is a Powerful Independent Predictor of Recurrent Events After Myocardial Infarction in Patients With Impaired Left Ventricular Function Circulation, December 16, 1997; 96(12): 4254 - 4260. [Abstract] [Full Text]
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The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Arch Intern Med, November 24, 1997; 157(21): 2413 - 2446. [Abstract] [PDF]
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K. Geurian and D. Lipschitz Successful Management of Refractory Hypertension With Dual Calcium Channel Blocker Therapy: Case Presentation Arch Fam Med, September 1, 1997; 6(5): 503 - 505. [Abstract] [PDF]
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W. B. Stason, C. H. Schmid, D. Niedzwiecki, G. W. Whiting, D. Luo, S. D. Ross, and T. C. Chalmers Safety of Nifedipine in Patients With Hypertension : A Meta-Analysis Hypertension, July 1, 1997; 30(1): 7 - 14. [Abstract] [Full Text]
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W. B. Stason, C. H. Schmid, D. Niedzwiecki, G. W. Whiting, D. Luo, S. D. Ross, and T. C. Chalmers Safety of Nifedipine in Patients With Hypertension : A Meta-Analysis Hypertension, July 1, 1997; 30 (1): 7 - 14. [Abstract] [Full Text]
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K. Ishikawa, S. Nakai, T. Takenaka, K. Kanamasa, J. Hama, I. Ogawa, T. Yamamoto, M. Oyaizu, A. Kimura, K. Yamamoto, et al. Short-Acting Nifedipine and Diltiazem Do Not Reduce the Incidence of Cardiac Events in Patients With Healed Myocardial Infarction Circulation, May 20, 1997; 95(10): 2368 - 2373. [Abstract] [Full Text]
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J. H. Olsen, H. T. Sorensen, S. Friis, J. K. McLaughlin, F. H. Steffensen, G. L. Nielsen, M. Andersen, J. F. Fraumeni Jr, and J. Olsen Cancer Risk in Users of Calcium Channel Blockers Hypertension, May 1, 1997; 29(5): 1091 - 1094. [Abstract] [Full Text]
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R. A. Deyo, B. M. Psaty, G. Simon, E. H. Wagner, and G. S. Omenn The Messenger under Attack -- Intimidation of Researchers by Special-Interest Groups N. Engl. J. Med., April 17, 1997; 336(16): 1176 - 1180. [Full Text]
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