A pilot study of ranolazine in patients with intermittent claudication

International Angiology

Volumn 25, Issue 4, 2006, Pages 361-369

  Ma, A ^a   Garland, W T ^b   Smith, W B ^c   Skettino, S ^d   Navarro, M T ^d   Chan, A Q ^a   Anderson, B E ^e   Cooke, John P ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b RADIANT RESEARCH   (United States)

^c New Orleans Center for Clinical Research   (United States)

^d ROCHE BIOSCIENCE   (United States)

^e PALO ALTO MEDICAL FOUNDATION RESEARCH INSTITUTE   (United States)

Author keywords

Intermittent claudication; Peripheral arterial diseases; Ranexa ; Ranolazine

Indexed keywords

DILTIAZEM; PENTOXIFYLLINE; PLACEBO; RANOLAZINE;

ADULT; AGED; ANKLE BRACHIAL INDEX; ANOREXIA; ARTERY DISEASE; ARTICLE; BRONCHITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG INDUCED HEADACHE; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; EOSINOPHILIA; EXERCISE TEST; EXERCISE TOLERANCE; FEMALE; GOUT; HUMAN; INJURY; INTERMITTENT CLAUDICATION; KINESIOTHERAPY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; ORTHOSTATIC HYPOTENSION; PHASE 2 CLINICAL TRIAL; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINITIS; SUSTAINED DRUG RELEASE; TREADMILL EXERCISE; UNSPECIFIED SIDE EFFECT;

ACETANILIDES; ADULT; AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTERMITTENT CLAUDICATION; MALE; MIDDLE AGED; PILOT PROJECTS; PIPERAZINES;

EID: 33847649923     PISSN: 03929590     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (48)

1. Heart Disease and Stroke Statistics - 2005 update. Dallas, TX: American Heart Association; 2005.
2. Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11): 1317-24.
3. Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S et al. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis 2004;172:95-105.
4. Kannel WB, Shurtleff D. The Framingham Study. Cigarettes and the development of intermittent claudication. Geriatrics 1973;28:61-8.
5. Creager MA. Medical management of peripheral arterial disease. Cardiol Rev 2001;9:238-45.
6. McDermott MM, Greenland P, Liu K, Guralnik JM, Celic L, Criqui MH et al. The ankle brachial index is associated with leg function and physical activity: the Walking and Leg Circulation Study. Ann Intern Med 2002;136:873-83. Erratum in: Ann Intern Med 2003;139:306. Summary for patients in: Ann Intern Med 2002;136:1-32.
7. McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC et al. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA 2001;286:1599-606.
8. Heidrich H. Frequency of non-vascular accompanying diseases in patients with peripheral arterial disease. Vasa 2004;33:155-8.
9. Aronow WS. Management of peripheral arterial disease. Cardiol Rev 2005;13:61-8.
10. Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA 1995;274:975-80.
11. Lee TM, Su SF, Hwang JJ, Tseng CD, Chen MF, Lee YT et al. Differential lipogenic effects of cilostazol and pentoxifylline in patients with intermittent claudication: potential role for interleukin-6. Atherosclerosis 2001;158:471-6.
12. Lee TM, Su SF, Tsai CH, Lee YT, Wang SS. Differential effects of cilostazol and pentoxifylline on vascular endothelial growth factor in patients with intermittent claudication. Clin Sci (Lond) 2001;101:305-11.
13. Porter JM, Cutler BS, Lee BY, Reich T, Reichle FA, Scogin JT et al. Pentoxifylline efficacy in the treatment of intermittent claudication: multicenter controlled double-blind trial with objective assessment of chronic occlusive arterial disease patients. Am Heart J 1982;104:66-72.
14. Hood SC, Moher D, Barber GG. Management of intermittent claudication with pentoxifylline: meta-analysis of randomized controlled trials. CMAJ 1996;155:1053-9.
15. De Sanctis MT, Cesarone MR, Belcaro G, Nicolaides AN, Griffin M, Incandela L et al. Treatment of intermittent claudication with pentoxifylline: a 12-month, randomized trial - walking distance and microcirculation. Angiology 2002;53 Suppl 1:S7-12.
16. Cesarone MR, Belcaro G, Nicolaides AN, Griffin M, De Sanctis MT, Incandela L et al. Treatment of severe intermittent claudication with pentoxifylline: a 40-week, controlled, randomized trial. Angiology 2002;53 Suppl 1: S1-5.
17. Strandness DE Jr, Dalman RL, Panian S, Rendell MS, Comp PC, Zhang P et al. Effect of cilostazol in patients with intermittent claudication: a randomized, double-blind, placebo-controlled study. Vasc Endovascular Surg 2002;36:83-91.
18. Mohler ER 3rd, Beebe HG, Salles-Cuhna S, Zimet R, Zhang P, Heckman J et al. Effects of cilostazol on resting ankle pressures and exercise-induced ischemia in patients with intermittent claudication. Vasc Med 2001;6:151-6.
19. Dawson DL, Cutler BS, Hiatt WR, Hobson RW 2nd, Martin JD, Bortey EB et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med 2000;109:523-30.
20. Chapman TM, Goa KL. Cilostazol: a review of its use in intermittent claudication. Am J Cardiovasc Drugs 2003;3:117-38.
21. Mohler ER, 3rd, Hiatt WR, Creager MA. Cholesterol reduction with atorvastatin improves walking distance in patients with peripheral arterial disease. Circulation 2003;108:1481-6.
22. Mondillo S, Ballo P, Barbati R, Guerrini F, Ammaturo T, Agricola E et al. Effects of simvastatin on walking performance and symptoms of intermittent claudication in hypercholesterolemic patients with peripheral vascular disease. Am J Med 2003;114:359-64.
23. Chaitman BR, Pepine CJ, Parker JO, Skopal J, Chumakova G, Kuch J et al.; Combination Assessment of Ranolazine In Stable Angina (CARISA) Investigators. Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina: a randomized controlled trial. JAMA 2004;291:309-16.
24. Chaitman BR, Skettino SL, Parker JO, Hanley P, Meluzin J, Kuch J et al.; MARISA Investigators. Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina. J Am Coll Cardiol 2004;43:1375-82.
25. Rousseau MF, Pouleur H, Cocco G, Wolff AA. Comparative efficacy of ranolazine versus atenolol for chronic angina pectoris. Am J Cardiol 2005;95:311-6.
26. Antzelevitch C, Belardinelli L, Zygmunt AC, Burashnikov A, Di Diego JM, Fish JM et al. Electrophysiological effects of ranolazine, a novel antianginal agent with antiarrhythmic properties. Circulation 2004;110:904-10.
27. Wu L, Shryock JC, Song Y, Li Y, Antzelevitch C, Belardinelli L. Antiarrhythmic effects of ranolazine in a guinea pig in vitro model of long-QT syndrome. J Pharmacol Exp Ther 2004;310:599-605.
28. Belardinelli L, Antzelevitch C, Fraser H. Inhibition of late (sustained/ persistent) sodium current: a potential drug target to reduce intracellular sodium-dependent calcium overload and its detrimental effects on cardiomyocyte function. Eur Heart J Suppl I 2004;6:I13-I17.
29. Vilin YY, Fujimoto E, Ruben PC. A single residue differentiates between human cardiac and skeletal muscle Na+ channel slow inactivation. Biophys J 2001;80:2221-30.
30. Vilin YY, Makita N, George AL, Ruben PC. Structural determinants of slow inactivation in human cardiac and skeletal muscle sodium channels. Biophys J 1999;77: 1384-93.
31. Vilin YY, Ruben PC. Slow inactivation in voltage-gated sodium channels: molecular substrates and contributions to channelopathies. Cell Biochem Biophys 2001;35: 171-90.
32. McDermott MM, Liu K, Guralnik JM, Mehta S, Criqui MH, Martin GJ et al. The ankle brachial index independently predicts walking velocity and walking endurance in peripheral arterial disease. J Am Geriatr Soc 1998;46:1355-62.
33. Jerling M, Huan BL, Leung K, Chu N, Abdallah H, Hussein Z. Studies to investigate the pharmacokinetic interactions between ranolazine and ketoconazole, diltiazem, or simvastatin during combined administration in healthy subjects. J Clin Pharmacol 2005;45:422-33.
34. Gardner AW, Skinner JS, Cantwell BW, Smith LK. Progressive vs single-stage treadmill tests for evaluation of claudication. Med Sci Sports Exerc 1991;23:402-8.
35. Imahashi K, Kusuoka H, Hashimoto K, Yoshioka J, Yamaguchi H, Nishimura T. Intracellular sodium accumulation during ischemia as the substrate for reperfusion injury. Circ Res 1999;84:1401-6.
36. Murphy E, Cross H, Steenbergen C. Sodium regulation during ischemia versus reperfusion and its role in injury. Circ Res 1999;84:1469-70.
37. Haigney MC, Lakatta EG, Stern MD, Silverman HS. Sodium channel blockade reduces hypoxic sodium loading and sodium-dependent calcium loading. Circulation 1994;90:391-9.
38. Silverman HS, Stern MD. Ionic basis of ischaemic cardiac injury: insights from cellular studies. Cardiovasc Res 1994;28:581-97.
39. Varadarajan SG, An J, Novalija E, Smart SC, Stowe DF. Changes in [Na(+)](i), compartmental [Ca(2+)], and NADH with dysfunction after global ischemia in intact hearts. Am J Physiol Heart Circ Physiol 2001;280:H280-93.
40. Bendahhou S, Cummins TR, Kula RW, Fu YH, Ptacek LJ. Impairment of slow inactivation as a common mechanism for periodic paralysis in DIIS4-S5. Neurology 2002;58:1266-72.
41. Featherstone DE, Fujimoto E, Ruben PC. A defect in skeletal muscle sodium channel deactivation exacerbates hyperexcitability in human paramyotonia congenita. J Physiol 1998; 506(Pt 3):627-38.
42. Rosenfeld J, Sloan-Brown K, George AL Jr. A novel muscle sodium channel mutation causes painful congenital myotonia. Ann Neurol 1997;42:811-4.
43. Lundgren F, Dahllof AG, Lundholm K, Schersten T, Volkmann R. Intermittent claudication: surgical reconstruction or physical training? A prospective randomized trial of treatment efficiency. Ann Surg 1989;209:346-55.
44. Larsen OA, Lassen NA. Effect of daily muscular exercise in patients with intermittent claudication. Lancet 1966;2:1093-6.
45. Hiatt WR, Regensteiner JG, Hargarten ME, Wolfel EE, Brass EP. Benefit of exercise conditioning for patients with peripheral arterial disease. Circulation 1990;81: 602-9.
46. Radack K, Wyderski RJ. Conservative management of intermittent claudication. Ann Intern Med 1990;113: 135-46.
47. Berglund B, Eklund B. Reproducibility of treadmill exercise in patients with intermittent claudication. Clin Physiol 1981;1:253-6.
48. Hiatt WR, Hirsch AT, Regensteiner JG, Brass EP. Clinical trials for claudication. Assessment of exercise performance, functional status, and clinical end points. Vascular Clinical Trialists. Circulation 1995;92:614-21.