{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:02:49Z","timestamp":1791158569000,"version":"4.1.0"},"reference-count":27,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2010,3,8]],"date-time":"2010-03-08T00:00:00Z","timestamp":1268006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vasc Med"],"published-print":{"date-parts":[[2010,6]]},"abstract":"<jats:p>In patients with peripheral artery disease (PAD), statins may improve the symptoms of claudication. The Intermittent Claudication Proof of Principle (ICPOP) study tested the hypothesis that the combination of extended release niacin plus lovastatin would improve exercise performance in patients with PAD and claudication compared with a diet intervention. A phase 3 double-blind, parallel-group, multi-center, 28-week multi-national study evaluated subjects with a history of claudication who had an ankle\u2014brachial index (ABI) \u2264 0.90, a reproducible peak treadmill walking time (PWT) of 1\u201420 minutes, and a low-density lipoprotein (LDL)-cholesterol level &lt; 160 mg\/dl (&lt; 4.1 mmol\/l). Subjects were randomly assigned to low-dose niacin 1000 mg plus lovastatin 40 mg (low niacin\u2014statin), high-dose niacin 2000 mg plus lovastatin 40 mg (high niacin\u2014statin), or diet intervention (diet). The co-primary efficacy endpoint of percent change in PWT and claudication onset time (COT) at 28 weeks was assessed using a graded treadmill protocol. At completion, 385 subjects were analyzed for safety and 370 subjects were analyzed for efficacy. The primary efficacy analysis showed no statistical significance for overall treatment effect at week 28 for the co-primary endpoint of PWT and COT. The PWT component of the primary endpoint increased 26.5% on diet, 37.8% on high niacin\u2014statin ( p = 0.137) and 38.6% on low niacin\u2014statin ( p = 0.096). Flushing as the most common event leading to discontinuation and treatment was associated with increases in liver enzymes, fasting blood glucose concentration and a decrease in platelet count.<\/jats:p>","DOI":"10.1177\/1358863x09360579","type":"journal-article","created":{"date-parts":[[2010,3,9]],"date-time":"2010-03-09T00:10:37Z","timestamp":1268093437000},"page":"171-179","source":"Crossref","is-referenced-by-count":31,"title":["Effect of niacin ER\/lovastatin on claudication symptoms in patients with peripheral artery disease"],"prefix":"10.1177","volume":"15","author":[{"given":"William R","family":"Hiatt","sequence":"first","affiliation":[{"name":"Section of Vascular Medicine, Divisions of Geriatrics and Cardiology, University of Colorado Denver School of Medicine, and the Colorado Prevention Center, Denver, CO, USA,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan T","family":"Hirsch","sequence":"additional","affiliation":[{"name":"Division of Epidemiology 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