Document Detail

Nicorandil safety in the long-term treatment of coronary heart disease.
MedLine Citation:
PMID:  7647028     Owner:  NLM     Status:  MEDLINE    
The results of an open prospective study that evaluated the long-term clinical safety of nicorandil are presented. This study included 199 patients with severe chronic stable angina treated over a 1-year period. The most often reported adverse event was headache, which was responsible for most of the study withdrawals due to clinical intolerance (9.6%). When using a progressive titration scheme, this incidence was substantially reduced to 2.7%. As with other less frequent adverse events (dizziness, gastrointestinal disorders), headaches were reported as being mild to moderate in severity, were experienced during the first days of treatment, and, if treatment was maintained, usually resolved within a few days. The incidence of adverse events was not modified when nicorandil was given in combination with a beta-blocker, a calcium antagonist, or both agents. Cardiovascular safety was satisfactory and laboratory parameters were not altered. At the end of the study, 70% of patients were maintained on nicorandil. These results are in agreement with those reported from the nicorandil safety database, which gathered 1152 patients treated by nicorandil, including those of the present study. In comparative studies of nicorandil versus beta-blockers, calcium antagonists, or nitrates, the overall incidence of adverse events was no different between the two treatment groups, although the safety profile differed according to the drug category.(ABSTRACT TRUNCATED AT 250 WORDS)
S Witchitz; J Y Darmon
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Cardiovascular drugs and therapy / sponsored by the International Society of Cardiovascular Pharmacotherapy     Volume:  9 Suppl 2     ISSN:  0920-3206     ISO Abbreviation:  Cardiovasc Drugs Ther     Publication Date:  1995 Mar 
Date Detail:
Created Date:  1995-09-28     Completed Date:  1995-09-28     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8712220     Medline TA:  Cardiovasc Drugs Ther     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  237-43     Citation Subset:  IM    
Service de Cardiologie, Hôpital Bicêtre, Le Kremlin, France.
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MeSH Terms
Adrenergic beta-Antagonists / adverse effects
Aged, 80 and over
Anti-Arrhythmia Agents / adverse effects*,  therapeutic use
Blood Pressure / drug effects
Chronic Disease
Coronary Disease / drug therapy*,  physiopathology
Drug Interactions
Heart Rate / drug effects
Long-Term Care
Middle Aged
Niacinamide / adverse effects,  analogs & derivatives*,  therapeutic use
Prospective Studies
Reg. No./Substance:
0/Adrenergic beta-Antagonists; 0/Anti-Arrhythmia Agents; 65141-46-0/Nicorandil; 98-92-0/Niacinamide

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

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