Document Detail

The novel phosphodiesterase inhibitor NM-702 improves claudication-limited exercise performance in patients with peripheral arterial disease.
MedLine Citation:
PMID:  17174195     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The current study tested the hypothesis that NM-702 improves treadmill exercise performance in peripheral arterial disease patients with claudication-limited exercise performance. BACKGROUND: Patients with claudication experience significant disability, owing to their exercise limitation. Therapeutic options to improve exercise performance in these patients are limited. NM-702 is a novel drug that inhibits phosphodiesterase as well as thromboxane A2 synthase. METHODS: This study was a randomized, multi-center, placebo-controlled, double-blind trial. Patients were randomized to receive 24 weeks of twice-daily treatment with either placebo (intent to treat population, n = 130), 4 mg NM-702 (n = 126), or 8 mg NM-702 (n = 130). RESULTS: After 24 weeks of treatment, 8 mg NM-702 was associated with a statistically significant increased peak walking time on a graded treadmill as compared with placebo (p = 0.004). Peak walking time after 24 weeks was increased by 17.1 +/- 49.0% in the placebo arm, 22.1 +/- 60.1% in the 4-mg NM-702 arm, and 28.1 +/- 50.5% in the 8-mg NM-702 arm. NM-702 at the 8-mg dose for 24 weeks was associated with statistically significant improvements in the treadmill claudication onset time as compared with placebo. In addition, as compared with placebo, NM-702 improved the physical component and physical functioning scores of the Medical Outcomes Study 36-Item Short Form and the walking distance and stair climbing domains of the Walking Impairment Questionnaire. NM-702 was generally well tolerated, but adverse events typical of vasodilators were common. CONCLUSIONS: NM-702 used for 24 weeks by patients with claudication was associated with improvements in laboratory- and ambulatory-based exercise performance.
Eric P Brass; Richard Anthony; Frederick R Cobb; Isao Koda; Jenny Jiao; William R Hiatt
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-11-28
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  48     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2006 Dec 
Date Detail:
Created Date:  2006-12-18     Completed Date:  2007-01-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2539-45     Citation Subset:  AIM; IM    
Department of Medicine, Harbor-UCLA Medical Center, Torrance, California 90502, USA.
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MeSH Terms
Aged, 80 and over
Double-Blind Method
Exercise Test
Exercise Tolerance / drug effects*
Intermittent Claudication / drug therapy*,  etiology
Middle Aged
Peripheral Vascular Diseases / complications,  drug therapy*
Phosphodiesterase Inhibitors / therapeutic use*
Pyridazines / therapeutic use*
Reg. No./Substance:
0/4-bromo-6-(3-(4-chlorophenyl)propoxy)-5-(3-pyridylmethylamino)-3(2H)-pyridazinone hydrochloride; 0/Phosphodiesterase Inhibitors; 0/Pyridazines

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