A phase II dose-ranging study of the phosphodiesterase inhibitor K-134 in patients with peripheral artery disease and claudication

Journal of Vascular Surgery

Volumn 55, Issue 2, 2012, Pages

  Brass, Eric P ^a   Cooper, Leslie T ^b   Morgan, Roger E ^c   Hiatt, William R ^d  

^a HARBOR UCLA MEDICAL CENTER   (United States)

^b MAYO CLINIC   (United States)

^c Kowa Research Institute   (United States)

^d UNIVERSITY OF COLORADO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CILOSTAZOL; K 134; PHOSPHODIESTERASE INHIBITOR; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CLAUDICATION; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEART DISEASE; HEART PALPITATION; HUMAN; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; NAUSEA; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHASE 2 CLINICAL TRIAL; POSITIONAL DIZZINESS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINUS TACHYCARDIA; TREADMILL EXERCISE; TREATMENT DURATION; VOMITING;

EID: 84856098414     PISSN: 07415214     EISSN: 10976809     Source Type: Journal    
DOI: 10.1016/j.jvs.2011.09.004     Document Type: Article

References (17)

1. W.R. Hiatt Medical treatment of peripheral arterial disease and claudication N Engl J Med 344 2001 1608 1621 (Pubitemid 32479915)
2. M.M. McDermott, P. Greenland, K. Liu, J.M. Guralnik, L. Celic, M.H. Criqui The ankle brachial index is associated with leg function and physical activity: the Walking and Leg Circulation Study Ann Intern Med 136 2002 873 883 (Pubitemid 34625699)
3. L. Norgren, W.R. Hiatt, J.A. Dormandy, M.R. Nehler, K.A. Harris, F.G. Fowkes Inter-Society Consensus for the Management of peripheral Arterial Disease (TASC II) Eur J Vasc Endovasc Surg 33 Suppl 1 2007 S1 S75
4. E.M. Sorkin, A. Markham Cilostazol Drugs Aging 14 1999 63 71 discussion: 72-3 (Pubitemid 29050247)
5. P.D. Thompson, R. Zimet, W.P. Forbes, P. Zhang Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication Am J Cardiol 90 2002 1314 1319 (Pubitemid 35449476)
6. R.L. Pande, W.R. Hiatt, P. Zhang, N. Hittel, M.A. Creager, M. McDermott A pooled analysis of the durability and predictors of treatment response of cilostazol in patients with intermittent claudication Vasc Med 15 2010 181 188
7. E.P. Brass, R. Anthony, F.R. Cobb, I. Koda, J. Jiao, W.R. Hiatt The novel phosphodiesterase inhibitor NM-702 improves claudication-limited exercise performance in patients with peripheral arterial disease J Am Coll Cardiol 48 2006 2539 2545 (Pubitemid 44881218)
8. V. Lakics, E.H. Karran, F.G. Boess Quantitative comparison of phosphodiesterase mRNA distribution in human brain and peripheral tissues Neuropharmacology 59 2010 367 374
9. R.J. Lewis, J.T. Connor, J.R. Teerlink, J.R. Murphy, L.T. Cooper, W.R. Hiatt Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication Trials 12 2011 134
10. A.W. Gardner, J.S. Skinner, B.W. Cantwell, L.K. Smith Progressive vs single-stage treadmill tests for evaluation of claudication Med Sci Sports Exerc 23 1991 402 408
11. E.P. Brass, J. Jiao, W. Hiatt Optimal assessment of baseline treadmill walking performance in claudication clinical trials Vasc Med 12 2007 97 103
12. M.M. McDermott, D.R. Kerwin, K. Liu, G.J. Martin, E. O'Brien, H. Kaplan Prevalence and significance of unrecognized lower extremity peripheral arterial disease in general medicine practice (*) J Gen Intern Med 16 2001 384 390 (Pubitemid 34205656)
13. W.R. Hiatt, J.G. Regensteiner, M.A. Creager, A.T. Hirsch, J.P. Cooke, J.W. Olin Propionyl-L-carnitine improves exercise performance and functional status in patients with claudication Am J Med 110 2001 616 622 (Pubitemid 32510688)
14. L.L. Craft, J.M. Guralnik, L. Ferrucci, K. Liu, L. Tian, M.H. Criqui Physical activity during daily life and circulating biomarker levels in patients with peripheral arterial disease Am J Cardiol 102 2008 1263 1268
15. M.M. McDermott, L. Ferrucci, K. Liu, M.H. Criqui, P. Greenland, D. Green D-dimer and inflammatory markers as predictors of functional decline in men and women with and without peripheral arterial disease J Am Geriatr Soc 53 2005 1688 1696 (Pubitemid 43109931)
16. R.G. Depalma, V.W. Hayes, B.K. Chow, G. Shamayeva, P.E. May, L.R. Zacharski Ferritin levels, inflammatory biomarkers, and mortality in peripheral arterial disease: a substudy of the iron (Fe) and Atherosclerosis Study (FeAST) Trial J Vasc Surg 51 2010 1498 1503
17. N.E. Duran, I. Duran, E. Grel, S. Gndz, G. Gl, M. Biteker Coronary artery disease in patients with peripheral artery disease Heart Lung 39 2010 116 120