Journal
EUROPEAN HEART JOURNAL
Volume 35, Issue 14, Pages 895-902Publisher
OXFORD UNIV PRESS
DOI: 10.1093/eurheartj/eht384
Keywords
Pentaerithrityl tetranitrate; Chronic stable angina; Total exercise duration; Organic nitrate
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The organic nitrate pentaerithrityl tetranitrate (PETN) has been shown to have ancillary properties that prevent the development of tolerance and endothelial dysfunction. This randomized, double-blind, placebo-controlled, multicentre study (CLEOPATRA study) was designed to investigate the anti-ischaemic efficacy of PETN 80 mg b.i.d. (morning and mid-day) over placebo in patients with chronic stable angina pectoris. A total of 655 patients were evaluated in the intention-to-treat population, randomized to PETN (80 mg b.i.d., n 328) or placebo (n 327) and completed the study. Patients underwent treadmill exercise tests at randomization, after 6 and 12 weeks of treatment. Treatment with PETN over 12 weeks did not modify the primary endpoint total exercise duration (TED, P 0.423). In a pre-specified sub-analysis of patients with reduced exercise capacity (TED at baseline 9 min, n 257), PETN appeared more effective than placebo treatment (P 0.054). Superiority of PETN over placebo was evident in patients who were symptomatic at low exercise levels (n 120; P 0.017). Pentaerithrityl tetranitrate 80 mg b.i.d. was well tolerated, and the overall safety profile was comparable with placebo. Although providing no additional benefit in unselected patients with known coronary artery disease, PETN therapy, administered in addition to modern anti-ischaemic therapy, could increase exercise tolerance in symptomatic patients with reduced exercise capacity.
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