Document Detail

Safety of long-acting dihydropyridine calcium channel blockers in hypertensive patients.
MedLine Citation:
PMID:  9591899     Owner:  NLM     Status:  MEDLINE    
Issues raised recently concerning the safety of calcium channel blockers (CCBs) prompted an analysis of the occurrence of cardiovascular events and death in the Pfizer Inc. hypertension clinical trial databases for amlodipine (Norvasc) and nifedipine in the gastrointestinal therapeutic system (GITS) formulation (Procardia XL). Prospectively defined analyses of data from comparative and noncomparative trials of amlodipine and nifedipine GITS were conducted. Outcome measures included cardiovascular and noncardiovascular deaths, and adverse cardiovascular events including new/worsened angina, myocardial infarction (MI), serious arrhythmia, stroke, congestive heart failure, and bleeding. Among all amlodipine-treated patients (n = 32,920), the incidence rates for all-cause death, MI, and new/worsened angina were 3.0, 3.3, and 1.6/1,000 patient-years of exposure, respectively. Among those in comparative trials alone (n = 4,126), the all-cause death rate was 4.1/1,000 patient-years, which was comparable to that of other non-CCB agents and significantly less than that of other CCBs (23.8/1,000 patient-years, p = 0.015), although the difference in rates represents only 2 deaths. Among all nifedipine-GITS-treated patients (n = 2,645), the rate of all-cause death was 4.1/1,000 patient-years, of MI 6.5/1,000 patient-years, and of new/ worsened angina 5.7/1,000 patient-years. The incidence rates for MI and other cardiac events were low in these hypertension trials, and did not differ among treatment groups in either the amlodipine or nifedipine GITS comparative analyses. In the clinical trial databases analyzed, there is no signal suggesting excessive risk of death or cardiovascular events for hypertensive patients treated with amlodipine or nifedipine GITS.
R A Kloner; G W Vetrovec; B J Materson; M Levenstein
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Publication Detail:
Type:  Comparative Study; Journal Article; Meta-Analysis    
Journal Detail:
Title:  The American journal of cardiology     Volume:  81     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  1998 Jan 
Date Detail:
Created Date:  1998-06-02     Completed Date:  1998-06-02     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  163-9     Citation Subset:  AIM; IM    
Heart Institute, Good Samaritan Hospital and the University of Southern California, Los Angeles 90017, USA.
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MeSH Terms
Amlodipine / adverse effects*,  therapeutic use
Calcium Channel Blockers / adverse effects*,  therapeutic use
Cause of Death
Cerebrovascular Disorders / chemically induced,  epidemiology
Clinical Trials as Topic
Delayed-Action Preparations
Follow-Up Studies
Heart Failure / chemically induced,  epidemiology
Hemorrhage / chemically induced,  epidemiology
Hypertension / drug therapy*,  mortality
Middle Aged
Myocardial Infarction / chemically induced,  epidemiology
Nifedipine / adverse effects*,  therapeutic use
Prospective Studies
Survival Rate
Treatment Outcome
United States / epidemiology
Reg. No./Substance:
0/Calcium Channel Blockers; 0/Delayed-Action Preparations; 21829-25-4/Nifedipine; 88150-42-9/Amlodipine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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