| Efficacy and safety of controlled-release isosorbide-5-mononitrate in Japanese patients with stable effort angina pectoris. | |
| | |
MedLine Citation:
|
PMID: 17106140 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
A new controlled-release isosorbide-5-mononitrate (CR-ISMN) preparation has been developed to meet the requirement for a low nitrate concentration interval in order to avoid nitrate tolerance. We conducted a randomized, double-blind, placebo-controlled study in 31 Japanese patients with stable effort angina pectoris to investigate the efficacy and safety of CR-ISMN. Patients were randomly assigned to either CR-ISMN (40 mg once daily) or placebo groups for 2 weeks after two consecutive symptom-limited treadmill exercise tests using the Bruce protocol to ascertain the reproducibility of exercise tolerance during the placebo run-in period. Exercise tests were repeated at 5, 12, and 24 hours after administration on the final day. No significant difference in exercise time to moderate angina was identified between the CR-ISMN and placebo groups at 5, 12, or 24 hours after administration. However, the changes in exercise were prolonged at 5 hours but not shortened at 24 hours in the CR-ISMN group. The results of subgroup analysis suggested that the concomitant use of insulin might lead to confounding results. Although headache was the most frequent adverse effect in the CR-ISMN group, all symptoms were mild and at self-limiting levels. The plasma concentrations of CR-ISMN maintained therapeutic levels at 5 and 12 hours, and gradually decreased to less than the minimum therapeutic concentration (100 ng/mL) at 24 hours after administration. This study demonstrates that CR-ISMN improves exercise tolerance during the daytime and is well-tolerated in Japanese patients with stable effort angina pectoris without increasing the number of serious adverse effects. |
| | |
Authors:
|
Kazunori Shimada; Satoshi Sunayama; Kaoru Nakazato; Hiroyuki Satoh; Yoshiki Kusama; Kiyoshi Kawakubo; Hiroyuki Daida |
Publication Detail:
|
Type: Journal Article; Randomized Controlled Trial |
Journal Detail:
|
Title: International heart journal Volume: 47 ISSN: 1349-2365 ISO Abbreviation: - Publication Date: 2006 Sep |
Date Detail:
|
Created Date: 2006-11-19 Completed Date: 2007-10-19 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 101244240 Medline TA: Int Heart J Country: Japan |
Other Details:
|
Languages: eng Pagination: 695-705 Citation Subset: IM |
Affiliation:
|
Department of Cardiovascular Medicine, Juntendo University School of Medicine, Tokyo, Japan. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Aged Angina Pectoris / drug therapy*, physiopathology Delayed-Action Preparations Double-Blind Method Drug Tolerance Exercise Test Exercise Tolerance Female Humans Isosorbide Dinitrate / administration & dosage, analogs & derivatives*, blood Male Middle Aged Reproducibility of Results Treatment Outcome Vasodilator Agents / administration & dosage*, blood |
| Chemical | |
Reg. No./Substance:
|
0/Delayed-Action Preparations; 0/Vasodilator Agents; 16051-77-7/isosorbide-5-mononitrate; 87-33-2/Isosorbide Dinitrate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Impact of histological plaque characteristics on intravascular ultrasound parameters at culprit lesi...
Next Document: Late angiographic stent thrombosis in a drug-eluting stent that occurred 20 months after premature d...