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Prostanoids for intermittent claudication

  1. Lindsay Robertson1,*,
  2. Alina Andras2

Editorial Group: Cochrane Vascular Group

Published Online: 30 APR 2013

Assessed as up-to-date: 22 JAN 2013

DOI: 10.1002/14651858.CD000986.pub3


How to Cite

Robertson L, Andras A. Prostanoids for intermittent claudication. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD000986. DOI: 10.1002/14651858.CD000986.pub3.

Author Information

  1. 1

    The University of Edinburgh, Centre for Population Health Sciences, The Medical School, Edinburgh, UK

  2. 2

    Freeman Hospital, Department of Vascular Surgery, Newcastle upon Tyne, UK

*Lindsay Robertson, Centre for Population Health Sciences, The Medical School, The University of Edinburgh, Teviot Place, Edinburgh, EH8 9AG, UK. Lindsay.Robertson@ed.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 30 APR 2013

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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Belch 1997 {published data only}
  • Belch JJ, Bell PR, Creissen D, Dormandy JA, Kester RC, McCollum RD, 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 1997;95(9):2298-302.
Blume 1986 {published data only}
  • Blume J. Clinical efficacy of intraarterial infusion of alprostadil (PGE1) in obliterative arteriopathy of stage IIb [Klinische wirksamkeit der intraarteriellen infusionstherapie mit prostaglandin E1 im stadium IIB der arteriellen verschlusskrankheit]. Therapiewoche 1987;37(51):4819-23.
  • Blume J, Kiesewetter H, Rühlmann U. Clinical and haemorheological efficacy of i.a. PGE1 infusions in intermittent claudication. VASA - Supplementum 1987;17:32-5.
  • Blume J, Rühlmann KU, Kiesewetter H. Clinical efficacy of intra-arterial PGE1-infusion in intermittent claudication: a double-blind study. In: Sinzinger H, Rogatti W editor(s). Prostaglandin E1 in atherosclerosis. Berlin: Springer-Verlag, 1986:75-80.
Böger 1998 {published data only}
  • Böger RH, Bode-Böger SM, Thiele W, Creutzig A, Alexander K, Fröhlich JC. Restoring vascular nitric oxide formation by L-arginine improves the symptoms of intermittent claudication in patients with peripheral arterial occlusive disease. Journal of the American College of Cardiology 1998;32(5):1336-44.
Creager 2008 {published data only}
Creutzig 1988 {published data only}
  • Caspary L, Creutzig A, Radeke U, Specht S, Alexander K. Intermittent intraarterial infusion therapy with PGE1 in patients with severe claudication -- results of a randomized prospective double blind study. Biomedica Biochimica Acta 1988;47(10-11):S307-10.
  • Creutzig A, Caspary L, Alexander K. Intermittent intra-arterial prostaglandin E1 therapy of severe claudication. VASA - Supplementum 1987;17:44-6.
  • Creutzig A, Caspary L, Radeke U, Specht S, Alexander K. Intermittent intra-arterial infusion treatment of severe intermittent claudication--results of a prospective double-blind study of prostaglandin E1 versus energy-rich phosphates [Intermittierende intraarterielle Infusionsbehandlung der schweren Claudicatio intermittens - Ergebnisse einer prospektiven Doppelblindstudie Prostaglandin E1 vs. energiereiche Phosphate]. VASA - Supplementum 1988;23:133-5.
  • Creutzig A, Caspary L, Wolf U, Specht S, Alexander K. Intraarterial infusion therapy with prostaglandin E for severe intermittent claudicatio. Results of a prospective, double-blind study. Klinische Wochenschrift 1988;66:182.
Diehm 1989 {published data only}
  • Diehm C, Kühn A, Strauss R, Hübsch-Müller C, Kübler W. Effects of regular physical training in a supervised class and additional intravenous prostaglandin E1 and naftidrofuryl infusion therapy in patients with intermittent claudication - a controlled study. VASA - Supplementum 1989;28:26-30.
  • Diehm C, Stammler F, Hubsch MC, Eckstein HH. Intravenous prostaglandin E1 infusions in peripheral arterial (AVK) Stadium III - A placebo-controlled study. Zeitschrift fur Kardiologie 1987;76 Suppl 1:101.
  • Weiss T, Wilhelm C, Hübsch-Müller C, Hsu E, Diehm C. Does infusion therapy in trained patients with intermittent claudication have advantages? [Bringt eine Infusionstherapie bei austrainierten Patienten mit Claudicatio intermittens Vorteile?]. Vasa - Supplementum 1990;30:142-5.
Diehm 1997 {published data only}
  • Diehm C, Balzer K, Bisler H, Bulling B, Camci M, Creutzig A, et al. Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: results of a multicenter placebo-controlled double-blind trial. Journal of Vascular Surgery 1997;25(3):537-44.
Hepp 1996 {published data only}
  • Hepp W, von Bary S, Corovic D, Diehm C, Mühe E, Rudofsky G, et al. Clinical efficacy of iv prostaglandin E1 and iv pentoxifylline in patients with arterial occlusive disease of Fontaine stage IIb: A multicenter, randomized comparative study. International Journal of Angiology 1996;5(1):32-7.
  • Hepp W, von Bary S, Corovic D, Diehm C, Mühe E, Rudofsky G, et al. Intravenous prostaglandin E1 versus pentoxifylline: a randomized controlled study in patients with intermittent claudication. International Angiology 1995;14 Suppl 1:280.
  • Hepp W, von Bary S, Corovic D, Diehm C, Mühe E, Rudofsky G, et al. Randomized study comparing the clinical effectiveness of intravenous prostaglandin E1 and intravenous pentoxifylline in patients with Fontaine stage IIb arterial occlusive disease [Randomisierte Studie zum Vergleich der klinischen Wirksamkeit von i.v. Prostaglandin E1 und i.v. Pentoxifyllin bei Patienten mit arterieller Verschlußkrankheit im Stadium IIb nach Fontaine.]. VASA - supplementum 1991;33:348-9.
Lièvre 1996 {published data only}
  • Labs KH, Nehler MR, Roessner M, Jaeger KA, Hiatt WR. Reliability of treadmill testing in peripheral arterial disease: a comparison of a constant load with a graded load treadmill protocol. Vascular Medicine 1999;4(4):239-46.
  • Lievre M, Azoulay S, Lion L, Morand S, Girre JP, Boissel JP. A dose-effect study of beraprost sodium in intermittent claudication. Journal of Cardiovascular Pharmacology 1996;27(6):788-93.
Lièvre 2000 {published data only}
  • Lievre M, Morand S, Lion L, Boissel JP. Effects of beraprost sodium in intermittent claudication: results of BERCI-2, a randomized study, placebo-controlled, double-blind. Fundamentals in Clinical Pharmacology 1997;11:182.
  • Lièvre M, Morand S, Besse B, Fiessinger JN, Boissel JP, (BERCI) Research Group. Oral beraprost sodium, a prostaglandin I(2) analogue, for intermittent claudication: a double blind, randomized, multicenter controlled trial. Circulation 2000;102(4):426-31.
Luk'Janov 1995 {published data only}
  • Luk'Janov Y. Hemorheologic and hemodynamic changes after treatments with PGE versus pentoxifyllin (PF) in patients with peripheral arterial disease (PAD). International Angiology 1995;14 Suppl 1:372.
Mangiafico 2000 {published data only}
  • Mangiafico RA, Messina R, Attina T, Dell'Arte S, Giuliano L, Malatino LS. Impact of a 4-week treatment with prostaglandin E1 on health-related quality of life of patients with intermittent claudication. Angiology 2000;51(6):441-9.
Milio 2006 {published data only}
  • Milio G, Coppola G, Novo S. The effects of prostaglandin E1 in patients with intermittent claudication. Cardiovascular and Haematological Disorders Drug Targets 2006;6(2):71-6.
Mohler 2003 {published data only}
  • Mohler ER 3rd, Hiatt WR, Olin JW, Wade M, Jeffs R, Hirsch AT. Treatment of intermittent claudication with beraprost sodium, an orally active prostaglandin I2 analogue: a double-blinded, randomized, controlled trial. Journal of the American College of Cardiology 2003;41(10):1679-86.
Müller-Bühl 1987 {published data only}
  • Müller-Bühl U, Diehm C, Krais T, Zimmermann R, Mörl H, Eckstein HH. Clinical effects of intravenous iloprost in patients with intermittent claudication. European Journal of Clinical Pharmacology 1987;33(2):127-31.
Scheffler 1994 {published data only}
  • Scheffler P, de la Hamette D, Gross J, Mueller H, Schieffer H. Intensive vascular training in stage IIb of peripheral arterial occlusive disease. The additive effect of intravenous prostaglandin E1 or intravenous pentoxifylline during training. Circulation 1994;90(2):818-22.
Virgolini 1989 {published data only}
  • Virgolini I, Fitscha P, O'Grady J, Barth H, Sinzinger H. Effects of taprostene, a chemically stable prostacyclin analogue in patients with ischaemic peripheral vascular disease: a placebo controlled double-blind trial. Prostaglandins Leukotrienes and Essential Fatty Acids 1989;38(1):31-5.
Virgolini 1990 {published data only}
  • Virgolini I, Fitscha P, Linet OI, O'Grady J, Sinzinger H. A double blind placebo controlled trial of intravenous prostacyclin (PGI2) in 108 patients with ischaemic peripheral vascular disease. Prostaglandins 1990;39(6):657-64.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Acciavatti 2001 {published data only}
  • Acciavatti A, Pasine FL, Capecchi PL, Messa GL, Lazzerini PE, De Giorgi L, et al. Effects of alprostadil on blood rheology and nucleoside metabolism in patients affected with lower limb chronic ischaemia. Clinical Hemorheology and Microcirculation 2001;24(1):49-57.
Anon 2011 {published data only}
  • NCT0126392. Prostaglandin E1 in outpatients with intermittent claudication. http://clinicaltrials.gov/ct2/show/NCT01263925?term=NCT01263925&rank=1 2011.
Barradas 1989 {published data only}
  • Barradas MA, Fonseca VA, Mikhailidis DP, Dandona P. The effect of iloprost infusion on platelet function in patients with peripheral vascular disease. Journal of Drug Development 1989;2(3):147-53.
Bieron 1993 {published data only}
  • Bieron K, Grodzinska L, Kostka-Trabka E, Gryglewski RJ. Prostacyclin and molsidomine synergise in their fibrinolytic and anti-platelet actions in patients with peripheral arterial disease. Wiener Klinische Wochenschrift 1993;105(1):7-11.
Diehm 1990 {published data only}
  • Diehm C, Wilhelm C, Weiss T, Schomig A, Kubler W. Effects of an intravenous infusion treatment with prostaglandin PGE1 and naftidrofuryl in trained patients with claudicatio intermittens. Zeitschrift fur Kardiologie 1990;79 Suppl 1:89.
Esato 1995a {published data only}
  • Esato K, Yasuda K, Abe T, Hoshino S, Ishimaru S, Hori G, et al. Clinical study of TTC-909 (Prostacyclin derivative, Clinprost Incorporated in Lipid Microspheres) in patients with peripheral arterial occlusive disease: Establishment of optimal dose in multi-center double-blind comparative study. Rinsho Iyaku 1995;11(10):2083-110.
  • Esato K, Yasuda K, Abe T, Hoshino S, Ishimaru S, Hori G, et al. Clinical study of TTC-909 (Prostacyclin derivative, Clinprost Incorporated in Lipid Microspheres) in patients with peripheral arterial occlusive disease: Establishment of optimal dose in multi-center double-blind comparative study. Rinsho Iyaku 1997;13(21):5595-622.
Esato 1995b {published data only}
  • Esato K, Yasuda K, Abe T, Hoshino S, Ishimaru S, Hori G, et al. [Studies on the clinical efficacy and safety of TTC-909 in the treatment of peripheral arterial occlusive disease: a multi-center double-blind comparison with Alprostadil Incorporated in Lipid Microspheres]. Rinsho Iyaku 1995;11(10):2111-41.
Fitscha 1985 {published data only}
  • Fitscha P, Sinzinger H. Clinical effects of iloprost, a stable prostacyclin analogue in patients with peripheral vascular disease. In: Maurer PC, Becker HM, Heidrich H, Hoffmann G, Kriessmann A, Muller-Wiefel H, Pratorius C editor(s). What is New in Angiology? Trends and Controversies. Munich, West Germany: W Zuchschwerdt, 1986:537-8.
  • Fitscha P, Sinzinger H, Tiso B. Prostaglandin E1 in peripheral occlusive disease. Zeitschrift fur Kardiologie 1985;74 Suppl 5:105.
  • Fitscha P, Tiso B, Sinzinger H. Iloprost in peripheral vascular disease - platelet function and clinical outcome. Progress in Clinical and Biological Research 1987;242:463-8.
  • Sinzinger H, Fitscha P. The effect of Iloprost on haemostasis in peripheral arterial occlusive disease [Einfluß von Iloprost auf die Hämostase bei peripherer arterieller Verschlußkrankheit (PVK)]. Vasa - Supplementum 1987;20:253-5.
  • Sinzinger H, Fitscha P, Popovic R, Krais T. Clinical and platelet effects of ZK 36374 (Iloprost) - A stable prostacyclin analogue - in peripheral vascular disease. Thrombosis and Haemostasis 1985;54(1):294, Abstract 1747.
Goya 2003 {published data only}
  • Goya K, Otsuki M, Xu X, Kasayama S. Effects of the prostaglandin I2 analogue, beraprost sodium, on vascular cells and circulating vascular cell adhesion molecule-1 level in patients with type 2 diabetes mellitus. Metabolism: Clinical and Experimental 2003;52(2):192-8.
Hay 1987 {published data only}
Ishitobi 1991 {published data only}
  • Ishitobi K, et al. Therapeutic efficacy of iloprost, a prostacyclin analogue for chronic arterial occlusion: a double-blind comparative study with PGE1. Rinsho to Kenkyu 1991;68:1836-50.
Linhart 1998 {published data only}
  • Linhart J. Prostaglandin therapy of peripheral occlusive arterial disease. Sbornik Lekarsky 1998;99(4):355-62.
Okadome-Kenchiro 1992 {published data only}
  • Okadome-Kenchiro, et al. Efficacy of lipo PGE1 in combination with an oral anti-platelet agent in chronic arterial obstruction: A multicenter comparative study. Rinsho to Kenkyu 1992;69:3655-62.
Rudofsky 1987 {published data only}
  • Rudofsky G. Intra-arterial infusion treatment with prostaglandin E1 in patients with intermittent claudication [Intraarterialle Infusionsbehandlung mit Prostaglandin E1 bei Patienten mit Claudicatio intermittens]. Wiener Klinische Wochenschrift 1988;100(14):484-8.
  • Rudofsky G, Altenhoff B, Meyer P, Lohmann A. Intra-arterial perfusion with prostaglandin E1 in patients with intermittent claudication. VASA - Supplementum 1987;17:47-51.
Rudofsky 1988 {published data only}
  • Rudofsky G. Intravenous infusion therapy using prostaglandin E1 in patients with peripheral arterial occlusive disease Stage 11b [Intravenöse PGE1-Infusionsbehandlung bei Patienten mit arterieller Verschlußkrankheit im Stadium IIb]. In: Heidrich H, Böhme H, Rogatti W editor(s). Prostaglandin E1 - Wirkungen und therapeutische Wirksamkeit. Berlin: Springer - Verlag, 1988:103-11.
Sakaguchi-Shukichi 1990 {published data only}
  • Sakaguchi-Shukichi, et al. Evaluation of the efficacy of beraprost sodium (PGI2 analogue) in chronic arterial occlusion: a double-blind comparative study with ticlopidine hydrochloride. Rinsho to Kenkyu 1990;67:575-84.
Waller 1986 {published data only}
  • Waller PC, Hay CRM, Cameron HA, Carter C, Parnell L, Greaves M, et al. Placebo controlled trial of iloprost in patients with stable intermittent claudication. British Journal of Clinical Pharmacology 1986;21:562P-3P.
Wang 2009 {published data only}
  • Wang X, Chen S, Yu F, Li H. Effect of prostaglandin E1 and traditional Chinese medicine on limb atherosclerosis obliterns. Practical Pharmacy and Clinical Remedies 2009;12(6):399-400.
Wilkinson 1988 {published data only}
  • Wilkinson D, Parkin A, Kester RC. Does iloprost benefit the patient with claudication? Results of a double-blind placebo-controlled trial. British Journal of Surgery 1989;76(12):1330-1.
  • Wilkinson D, Parkin A, Kester RC. Does iloprost benefit the patient with claudication? Results of a double-blind placebo-controlled trial. Journal of Cardiovascular Surgery 1988;29:72.
Ylitalo 1990 {published data only}
  • Ylitalo P, Kaukinen S, Reinikainen P, Salenius JP, Vapaatalo H. A randomized, double-blind, crossover comparison of iloprost with dextran in patients with peripheral arterial occlusive disease. International Journal of Clinical Pharmacology, Therapy and Toxicology 1990;28(5):197-204.

References to studies awaiting assessment

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Nakagawa 1998 {published data only}
  • Nakagawa T, Sanke T, Anaguchi R, Konami T, Useda K, Bessho H, et al. The prophylactic effect of beraprost on development of atherosclerosis in non-insulin dependent diabetes mellitus patients. Journal of the Japan Diabetes Society 1998;41(11):989-94.

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Valerio 2012 {published data only}
  • Valerio A, Gussoni G, Anastasio L, Mazzuca S, Bitti G, Cardinale A, et al. Effect of Iloprost on pain-free walking distance and clinical outcomes in patients with IIb-stage peripheral artery disease non-eligible for surgery. The FADOI - 2bPILOT study. Italian Journal of Medicine 2012;6:143.
  • Valerio A, Gussoni G, Fontanella A, Anastasio L, Bitti G, DiSalvo M, et al. Clinical improvement in patients treated with iloprost at iib-stage peripheral arterial disease. The multicenter randomized fadoi-2bpilot study. Blood Transfusion 2012;10:s49-50.

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
ATC 2002
  • Antithrombotic Trialist's Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324(7329):71-86.
Beard 2000
Coffman 1991
Davis 2005
  • Davis M. Critical limb ischemia, ulcers and gangrene. The Royal Free Hospital Vascular Unit 2005.
De Backer 2000
  • De Backer TL, Vander Stichele RH, Bogaert MG. Buflomedil for intermittent claudication. Cochrane Database of Systematic Reviews 2000, Issue 2. [DOI: 10.1002/14651858.CD000988]
de la Haye 1992
  • de la Haye R, Diehm C, Blume J, Breddin K, Gerlach H, Rettig K, et al. An epidemiologic study of the value and limits of physical therapy/exercise therapy in Fontaine stage II arterial occlusive disease [Eine epidemiologische Untersuchung zur Einsetzbarkeit und zu den Grenzen der physikalischen Therapie / Bewegungstherapie bei der arteriellen Verschlußkrankheit im Stadium II nach Fontaine]. VASA - Supplementum 1992;38:1-40.
Dormandy 1999
  • Dormandy J, Heeck L, Vig S. The natural history of claudication: risk of life and limb. Seminars in Vascular Surgery 1999;12(2):123-37.
Dormandy 2000
  • Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Concensus (TASC). Journal of Vascular Surgery 2000;31(1 Pt 2):S1-S296.
Ernst 1993
Ernst 1994
Frampton 1995
  • Frampton JE, Brogden RN. Pentoxifylline (oxpentifylline). A review of its therapeutic efficacy in the management of peripheral vascular and cerebrovascular disorders. Drugs and Aging 1995;7(6):480-503.
Grant 1992
  • Grant SM, Goa KL. Iloprost. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in peripheral vascular disease, myocardial ischaemia and extracorporeal circulation procedures. Drugs 1992;43(6):889-924.
Heidrich 1992
  • Heidrich H, Allenberg J, Cachovan M, Creutzig A, Diehm C, Gruss J, et al. Guidelines for therapeutic studies on peripheral arterial occlusive disease in Fontaine stages II-IV. German Society of Angiology. VASA 1992;21(4):333-43.
Hiatt 2001
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Inglis 2012
  • Inglis SC,  Lewsey JD,  Chandler D,  Byrne DS,  Lowe GD,  MacIntyre K,  Peripheral Artery Disease Project Advisory Group. Sex-specific time trends in first admission to hospital for peripheral artery disease in Scotland 1991-2007. British Journal of Surgery 2012;99(5):680-7.
Leng 1993
  • Leng GC, Fowkes FGR. The epidemiology of peripheral arterial disease. Vascular Medicine Review 1993;4(1):5-18.
Leng 2000
  • Leng GC, Fowler B, Ernst E. Exercise for intermittent claudication. Cochrane Database of Systematic Reviews 2000, Issue 2. [DOI: 10.1002/14651858.CD000990]
Matsuo 1998
  • Matsuo H. Preliminary evaluation of AS-O13 (prodrug of prostaglandin E1) administration for chronic peripheral arterial occlusive disease. International Journal of Angiology 1998;7(1):22-4.
Pell 1995
RevMan 2011 [Computer program]
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.1. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2011.
Ruffolo 2010
Salhiyyah 2012
Scheffler 1991
  • Scheffler P, Hamette D, Leipnitz G, Groß J. Effects of intravenous PGE1 on blood flow and microcirculation. In: Diehm C, Sinzinger H, Rogatti W editor(s). Prostaglandin E1. New aspects on pharmacology, metabolism, and clinical efficacy. 5th International symposium on prostaglandins and cardiovascular systems. Berlin: Springer, 1991:91-100.
The Scottish Health Survey 2010
  • Bromley C, Given L, Scottish Centre for Social Research. The Scottish Health Survey 2010 - Volume 1: Main Report. http://www.scotland.gov.uk/Publications/2011/09/27084018/0 (accessed 12 December 2012).
Van den Brande 1998
  • Van den Brande P, Maurel A. A placebo-controlled study of the effects of intravenous Buflomedil on foot skin microcirculation in patients with severe intermittent claudication. Angiology 1998;49(2):105-14.
Verstraete 1994
  • Verstraete M. Prostaglandins in critical limb ischemia. Vascular Medicine Review 1994;5(2):93-5.

References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Reiter 2003