TITLE

Double-Blind Study of Papaverine Hydrochloride on the Efficacy in the Treatment of Intermittent Claudication

AUTHOR(S)
Seino, Yoshihiko; Rose, Harold B.; Kanazawa, Masakuni; Vyden, John K.; Wall, Francis J.
PUB. DATE
April 1983
SOURCE
Angiology;Apr1983, Vol. 34 Issue 4, p257
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
A double-blind, placebo-controlled, parallel groups study design was utilized to evaluate the efficacy and the safety of papaverine HCL (PA, 300-1,500 mg/day) in the treatment of intermittent claudication. The study was in two phases: Phase 1-6 weeks duration with treadmill claudication tests and doppler ankle/brachial pressure studies every 2 weeks to establish disease stability; Phase 11-12 weeks double-blind evaluation of PA versus placebo (PL) with treadmill claudication tests and doppler ankle/brachial pressure studies every 4 weeks. Intermittent claudication was documented by symptoms, history and objective evidence of decreased blood supply to the lower extremities: decreased resting and post-exercise ankle/brachial pressure indices (A/B Pr), diminished segmental pulse-volumes and physical findings. Data were collected to determine the distance to initial pain (IP), rapidly increasing pain (RIP) and absolute claudication (AC) during treadmill tests and also the changes in resting and post-exercise A/B Pr. In 20 patients who completed this study, the distance to RIP was increased 43% by PA and decreased 2% by PL (p=0.012). PA increased the distance to AC by 29%, but was decreased by 1% in PL (p=0.039). The A/B Pr studies showed significant less decrease in 1 minute and 2.5 minutes post exercise A/B Pr at 12 weeks in PA patients as compared to those in PL patients. Compared to PL, significantly greater increases in the key measurements of exercise performance and less decreases in post exercise A/B Pr were developed by the peripheral vasodilator, papaverine HCL. These results indicate that papaverine HCL is a safe and useful adjunct in the medial treatment of peripheral arterial insufficiency.
ACCESSION #
16391357

 

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