Safety of long-acting dihydropyridine calcium channel blockers in hypertensive patients

Robert A. Kloner, George W. Vetrovec, Barry J Materson, Marcia Levenstein

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

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 far 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 far 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 law 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.

Original languageEnglish
Pages (from-to)163-169
Number of pages7
JournalAmerican Journal of Cardiology
Volume81
Issue number2
DOIs
StatePublished - Jan 15 1998
Externally publishedYes

Fingerprint

Calcium Channel Blockers
Amlodipine
Nifedipine
Safety
Myocardial Infarction
Cause of Death
Therapeutics
Clinical Trials
Databases
Hypertension
1,4-dihydropyridine
Incidence
Cardiac Arrhythmias
Heart Failure
Stroke
Outcome Assessment (Health Care)
Hemorrhage
Mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Safety of long-acting dihydropyridine calcium channel blockers in hypertensive patients. / Kloner, Robert A.; Vetrovec, George W.; Materson, Barry J; Levenstein, Marcia.

In: American Journal of Cardiology, Vol. 81, No. 2, 15.01.1998, p. 163-169.

Research output: Contribution to journalArticle

Kloner, Robert A. ; Vetrovec, George W. ; Materson, Barry J ; Levenstein, Marcia. / Safety of long-acting dihydropyridine calcium channel blockers in hypertensive patients. In: American Journal of Cardiology. 1998 ; Vol. 81, No. 2. pp. 163-169.
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