Parenteral therapy with lipo-ecraprost, a lipid-based formulation of a PGE1 analog, does not alter six-month outcomes in patients with critical leg ischemia

Journal of Vascular Surgery

Volumn 43, Issue 4, 2006, Pages 752-759

  Brass, Eric P ^a,b   Anthony, Richard ^c   Dormandy, John ^d   Hiatt, William R ^e   Jiao, Jenny ^c   Nakanishi, Atsushi ^f   McNamara, Thomas ^b   Nehler, Mark ^e  

^a HARBOR UCLA MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Catalyst Pharmaceutical Research   (United States)

^d ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^e UNIVERSITY OF COLORADO   (United States)

^f Mitshubishi Pharma Corporation

Author keywords

[No Author keywords available]

Indexed keywords

ECRAPROST; LIPOPROSTAGLANDIN E1; PLACEBO; PROSTAGLANDIN E1 DERIVATIVE;

ADULT; AGED; ANKLE; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA ANALYSIS; DEATH; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; DRUG FORMULATION; DRUG MONITORING; DRUG SAFETY; FEMALE; FOLLOW UP; HEMODYNAMICS; HUMAN; HYPOTHESIS; LEG AMPUTATION; LEG ISCHEMIA; LEG REVASCULARIZATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORGANIZATION; POPULATION; POPULATION RESEARCH; POPULATION RISK; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ALPROSTADIL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG CARRIERS; FEMALE; FOLLOW-UP STUDIES; HUMANS; ILOPROST; INFUSIONS, INTRAVENOUS; INTERMITTENT CLAUDICATION; ISCHEMIA; LEG; LIMB SALVAGE; LIPIDS; MALE; MIDDLE AGED; PAIN MEASUREMENT; PERIPHERAL VASCULAR DISEASES; REFERENCE VALUES; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 33645738835     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jvs.2005.11.041     Document Type: Article

References (23)

1. Hiatt W.R. Medical treatment of peripheral arterial disease and claudication. N Engl J Med 344 (2001) 1608-1621
2. Dormandy J., Heeck L., and Vig S. Predicting which patients will develop chronic critical leg ischemia. Semin Vasc Surg 12 (1999) 138-141
3. Dormandy J., Heeck L., and Vig S. The fate of patients with critical leg ischemia. Semin Vasc Surg 12 (1999) 142-147
4. Makino H., Aoki M., Hashiya N., Yamasaki K., Hiraoka K., Shimizu H., et al. Increase in peripheral blood flow by intravenous administration of prostaglandin E1 in patients with peripheral arterial disease, accompanied by up-regulation of hepatocyte growth factor. Hypertens Res 27 (2004) 85-91
5. Salcedo R., Zhang X., Young H.A., Michael N., Wasserman K., Ma W.H., Martins-Green M., Murphy W.J., and Oppenheim J.J. Angiogenic effects of prostaglandin E2 are mediated by up-regulation of CXCR4 on human microvascular endothelial cells. Blood 102 (2003) 1966-1977
6. Mehrabi M.R., Serbecic N., Tamaddon F., Pacher R., Horvath R., Mall G., et al. Clinical benefit of prostaglandin E1-treatment of patients with ischemic heart disease: stimulation of therapeutic angiogenesis in vital and infarcted myocardium. Biomed Pharmacother 57 (2003) 173-178
7. Arosio E., Minuz P., Prior M., Zuliani V., Gaino S., De Marchi S., et al. Vascular adhesion molecule-1 and markers of platelet function before and after a treatment with iloprost or a supervised physical exercise program in patients with peripheral arterial disease. Life Sci 69 (2001) 421-433
8. Marchesi S., Pasqualini L., Lombardini R., Vaudo G., Lupattelli G., Pirro M., et al. Prostaglandin E1 improves endothelial function in critical limb ischemia. J Cardiovasc Pharmacol 41 (2003) 249-253
9. Weiss T., Fischer D., Hausmann D., and Weiss C. Endothelial function in patients with peripheral vascular disease: influence of prostaglandin E1. Prostaglandins Leukot Essent Fatty Acids 67 (2002) 277-281
10. Grant S.M., and Goa K.L. Iloprost. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in peripheral vascular disease, myocardial ischaemia and extracorporeal circulation procedures. Drugs 43 (1992) 889-924
11. Cawello W., Leonhardt A., Schweer H., Seyberth H.W., Bonn R., and Lomeli A.L. Dose proportional pharmacokinetics of alprostadil (prostaglandin E1) in healthy volunteers following intravenous infusion. Br J Clin Pharmacol 40 (1995) 273-276
12. Schellong S.M., Burchert W., Boger R.M., Creutzig A., Hundeshagen H., and Alexander K. Prostaglandin E1 in peripheral vascular disease: a PET study of muscular blood flow. Scand J Clin Lab Invest 58 (1998) 109-117
13. Trubestein G., Diehm C., Gruss J.D., and Horsch S. Prostaglandin E1 in chronic arterial disease-a multicenter study. Vasa Suppl 17 (1987) 39-43
14. Loosemore T.M., Chalmers T.C., and Dormandy J.A. A meta-analysis of randomized placebo control trials in Fontaine stages III and IV peripheral occlusive arterial disease. Int Angiol 13 (1994) 133-142
15. Treatment of limb threatening ischaemia with intravenous iloprost: a randomised double-blind placebo controlled study. U.K. Severe Limb Ischaemia Study Group. Eur J Vasc Surg 5 (1991) 511-516
16. Igarashi R., Mizushima Y., Takenaga M., Matsumoto K., Morizawa Y., and Yasuda A. A stable PGE1 prodrug for targeting delivery. J Controlled Release 20 (1992) 37-46
17. Igarashi R., Takenaga M., Takeuchi J., Kitagawa A., Matsumoto K., and Mizushima Y. Marked hypotensive and blood flow-increasing effects of a new lipo-PGE(1) (lipo-AS013) due to vascular wall targeting. J Control Release 71 (2001) 157-164
18. Belch J.J., Bell P.R., Creissen D., Dormandy J.A., Kester R.C., McCollum R.D., et al. Randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of AS-013, a prostaglandin E1 prodrug, in patients with intermittent claudication. Circulation 95 (1997) 2298-2302
19. Report on file Mitshubishi Pharma Corportion. Randomized, double-blind, placebo-controlled, phase II study evaluating the efficacy, tolerability and safety of AS-013 in patients with peripheral arterial occlusive disease Fontaine classes III or IV 2000.
20. Labs K.H., Dormandy J.A., Jaeger K.A., Stuerzebecher C., and Hiatt W.R. Trans-atlantic conference on clinical trial guidelines in PAOD (peripheral arterial occlusive disease) clinical trial methodology. Eur J Vasc Endovasc Surg 18 (1999) 253-265
21. Schwartz P.J. The autonomic nervous system and sudden death. Eur Heart J 19 Suppl F (1998) F72-F80
22. Packer M., Carver J.R., Rodeheffer R.J., Ivanhoe R.J., DiBianco R., Zeldis S.M., et al. Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. N Engl J Med 325 (1991) 1468-1475
23. The ICAI Study Group. Ischemia Cronica degli Arti Inferiori. Prostanoids for chronic critical leg ischemia. A randomized, controlled, open-label trial with prostaglandin E1. Ann Intern Med 130 (1999) 412-421