Document Detail


Cardiovascular effects of tadalafil.
MedLine Citation:
PMID:  14609622     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
To determine the effects of tadalafil on the cardiovascular system, safety assessments were performed on a database of >4000 subjects who received tadalafil in >60 clinical pharmacology, phase 2, phase 3, and open-label studies. In healthy subjects, tadalafil resulted in small changes in blood pressure, which are not believed to be clinically relevant. Daily administration of tadalafil 20 mg for 26 weeks in healthy male subjects or patients with mild erectile dysfunction resulted in blood pressure changes similar to those observed after placebo administration. In patients with coronary artery disease (CAD), tadalafil administration before nitrate administration resulted in small decreases in blood pressure. The resulting mean maximal change in standing systolic blood pressure (SBP) after coadministration of sublingual nitroglycerin in patients with chronic stable angina was -36 mm Hg for tadalafil 5 mg, -31 mm Hg for tadalafil 10 mg, and -28 mm Hg for placebo. In addition, a larger number of men had a standing SBP <85 mm Hg after coadministration of sublingual nitroglycerin and tadalafil 5 mg (p <0.001 vs placebo) or tadalafil 10 mg (p <0.01 vs placebo) compared with coadministration with placebo. In patients with chronic stable angina taking doses of isosorbide mononitrate on a long-term basis, the mean maximal change in standing SBP was -23 mm Hg for placebo, -23 mm Hg for tadalafil 5 mg, and -26 mm Hg for tadalafil 10 mg. In a study of older subjects (>or=55 years of age) with no overt evidence of CAD, the resulting mean maximal change in standing SBP after coadministration of sublingual nitroglycerin was -25 mm Hg for tadalafil 10 mg, -29 mm Hg for sildenafil 50 mg, and -25 mm Hg for placebo. Cardiac mortality rates in tadalafil studies are consistent with the expected rate in this male population. Across all studies, the incidence rate of myocardial infarction was low in tadalafil-treated patients (0.43 per 100 patient-years) compared with patients who received placebo (0.6 per 100 patient-years), and the incidence rate was comparable to that observed in the age-standardized male population (0.60 per 100 patient-years). The incidence rate of presumed thrombotic strokes in tadalafil studies (0.27 per 100 patient-years) is comparable to the expected rate in this patient population. The data presented herein suggest that tadalafil can be safely used by healthy subjects and by patients with cardiovascular diseases. As with sildenafil, the use of tadalafil is contraindicated in patients receiving nitrate therapy because of the potential for significant hypotensive effects.
Authors:
Robert A Kloner; Malcolm Mitchell; Jeffrey T Emmick
Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  The American journal of cardiology     Volume:  92     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2003 Nov 
Date Detail:
Created Date:  2003-11-11     Completed Date:  2003-12-16     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:  37M-46M     Citation Subset:  AIM; IM    
Affiliation:
Division of Cardiovascular Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA. rkloner@goodsam.org
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MeSH Terms
Descriptor/Qualifier:
3',5'-Cyclic-GMP Phosphodiesterases / antagonists & inhibitors*
Carbolines / pharmacology*
Cardiovascular Diseases / complications,  drug therapy
Cardiovascular System / drug effects*
Drug Interactions
Erectile Dysfunction / complications,  drug therapy*
Hemodynamics / drug effects
Humans
Male
Nitric Oxide Donors / pharmacology
Phosphodiesterase Inhibitors / pharmacology*
Chemical
Reg. No./Substance:
0/Carbolines; 0/Nitric Oxide Donors; 0/Phosphodiesterase Inhibitors; 0/tadalafil; EC 3.1.4.35/3',5'-Cyclic-GMP Phosphodiesterases

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


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