메뉴 건너뛰기




Volumn 36, Issue 8, 2014, Pages 1290-1301

The limits of evidence in drug approval and availability: A case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication

Author keywords

cilostazol; naftidrofuryl; pharmacotherapy for intermittent claudication; Pletal; Praxilene; treatment for intermittent claudication

Indexed keywords

CILOSTAZOL; CYCLIC AMP; NAFTIDROFURYL; NAFTIDROFURYL OXALATE; PENTOXIFYLLINE; TETRAZOLE DERIVATIVE; VASODILATOR AGENT;

EID: 84911976460     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2014.06.010     Document Type: Review
Times cited : (8)

References (52)
  • 1
    • 33845241195 scopus 로고    scopus 로고
    • Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)
    • L. Norgren, W.R. Hiatt, and J.A. Dormandy et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) Eur J Vasc Endovasc Surg Off J Eur Soc Vasc Surg 33 Suppl 1 2007 S1 75
    • (2007) Eur J Vasc Endovasc Surg off J Eur Soc Vasc Surg , vol.33 , Issue.SUPPL. 1 , pp. 1-75
    • Norgren, L.1    Hiatt, W.R.2    Dormandy, J.A.3
  • 2
    • 0038639693 scopus 로고    scopus 로고
    • Depressive symptoms and lower extremity functioning in men and women with peripheral arterial disease
    • M.M. McDermott, P. Greenland, and J.M. Guralnik et al. Depressive symptoms and lower extremity functioning in men and women with peripheral arterial disease J Gen Intern Med 18 2003 461 467
    • (2003) J Gen Intern Med , vol.18 , pp. 461-467
    • McDermott, M.M.1    Greenland, P.2    Guralnik, J.M.3
  • 4
    • 33644835909 scopus 로고    scopus 로고
    • Health care resources and costs for treating peripheral artery disease in a managed care population: Results from analysis of administrative claims data
    • J. Margolis, J.J. Barron, and W.D. Grochulski Health care resources and costs for treating peripheral artery disease in a managed care population: results from analysis of administrative claims data J Manag Care Pharm JMCP 11 2005 727 734
    • (2005) J Manag Care Pharm JMCP , vol.11 , pp. 727-734
    • Margolis, J.1    Barron, J.J.2    Grochulski, W.D.3
  • 5
    • 32944464483 scopus 로고    scopus 로고
    • The US experience with cilostazol in treating intermittent claudication
    • W.R. Hiatt The US experience with cilostazol in treating intermittent claudication Atheroscler Suppl 6 2005 21 31
    • (2005) Atheroscler Suppl , vol.6 , pp. 21-31
    • Hiatt, W.R.1
  • 6
    • 0033754497 scopus 로고    scopus 로고
    • A comparison of cilostazol and pentoxifylline for treating intermittent claudication
    • D.L. Dawson, B.S. Cutler, and W.R. Hiatt et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication Am J Med 109 2000 523 530
    • (2000) Am J Med , vol.109 , pp. 523-530
    • Dawson, D.L.1    Cutler, B.S.2    Hiatt, W.R.3
  • 7
    • 0034081198 scopus 로고    scopus 로고
    • Pharmacological management of intermittent claudication: A meta-analysis of randomised trials
    • D. Moher, B. Pham, M. Ausejo, A. Saenz, S. Hood, and G.G. Barber Pharmacological management of intermittent claudication: a meta-analysis of randomised trials Drugs 59 2000 1057 1070
    • (2000) Drugs , vol.59 , pp. 1057-1070
    • Moher, D.1    Pham, B.2    Ausejo, M.3    Saenz, A.4    Hood, S.5    Barber, G.G.6
  • 9
    • 0033593881 scopus 로고    scopus 로고
    • Treatment of intermittent claudication with physical training, smoking cessation, pentoxifylline, or nafronyl: A meta-analysis
    • B. Girolami, E. Bernardi, and M.H. Prins et al. Treatment of intermittent claudication with physical training, smoking cessation, pentoxifylline, or nafronyl: a meta-analysis Arch Intern Med 159 1999 337 345
    • (1999) Arch Intern Med , vol.159 , pp. 337-345
    • Girolami, B.1    Bernardi, E.2    Prins, M.H.3
  • 11
    • 84940238294 scopus 로고    scopus 로고
    • Cilostazol (Pletal): Risks of cardiovascular and bleeding events - Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines
    • C. Tilstone Cilostazol (Pletal): risks of cardiovascular and bleeding events - indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines Drug Saf Update 6 2013
    • (2013) Drug Saf Update , vol.6
    • Tilstone, C.1
  • 12
    • 84868659585 scopus 로고    scopus 로고
    • Systematic review of the efficacy of cilostazol, naftidrofuryl oxalate and pentoxifylline for the treatment of intermittent claudication
    • J.W. Stevens, E. Simpson, and S. Harnan et al. Systematic review of the efficacy of cilostazol, naftidrofuryl oxalate and pentoxifylline for the treatment of intermittent claudication Br J Surg 99 2012 1630 1638
    • (2012) Br J Surg , vol.99 , pp. 1630-1638
    • Stevens, J.W.1    Simpson, E.2    Harnan, S.3
  • 13
    • 84655162772 scopus 로고    scopus 로고
    • Adjunctive pharmacotherapies for intermittent claudication - NICE guidance
    • J. Shalhoub, and A.H. Davies Adjunctive pharmacotherapies for intermittent claudication - NICE guidance Heart Br Card Soc 98 2012 244 245
    • (2012) Heart Br Card Soc , vol.98 , pp. 244-245
    • Shalhoub, J.1    Davies, A.H.2
  • 14
    • 0020570295 scopus 로고
    • Studies on 2-oxoquinoline derivatives as blood platelet aggregation inhibitors. I. Alkyl 4-(2-oxo-1,2,3,4-tetrahydro-6-quinolyloxy)butyrates and related compounds
    • T. Nishi, K. Yamamoto, T. Shimizu, T. Kanbe, Y. Kimura, and K. Nakagawa Studies on 2-oxoquinoline derivatives as blood platelet aggregation inhibitors. I. Alkyl 4-(2-oxo-1,2,3,4-tetrahydro-6-quinolyloxy)butyrates and related compounds Chem Pharm Bull (Tokyo) 31 1983 798 810
    • (1983) Chem Pharm Bull (Tokyo) , vol.31 , pp. 798-810
    • Nishi, T.1    Yamamoto, K.2    Shimizu, T.3    Kanbe, T.4    Kimura, Y.5    Nakagawa, K.6
  • 15
    • 79960912304 scopus 로고    scopus 로고
    • Phosphodiesterases as targets for intermittent claudication
    • S.H. Francis, M. Conti, M.D. Houslay, Springer Berlin Heidelberg Berlin, Heidelberg. Accessed December 9, 2013
    • Y. Liu, Y. Shakur, and J. Kambayashi Phosphodiesterases as targets for intermittent claudication S.H. Francis, M. Conti, M.D. Houslay, Phosphodiesterases as drug targets Vol 204 2011 Springer Berlin Heidelberg Berlin, Heidelberg 211 236 http://www.springerlink.com/index/10.1007/978-3-642- 17969-3-9. Accessed December 9, 2013
    • (2011) Phosphodiesterases As Drug Targets , vol.204 , pp. 211-236
    • Liu, Y.1    Shakur, Y.2    Kambayashi, J.3
  • 16
    • 0033836241 scopus 로고    scopus 로고
    • Inhibition of adenosine uptake and augmentation of ischemia-induced increase of interstitial adenosine by cilostazol, an agent to treat intermittent claudication
    • Y. Liu, M. Fong, J. Cone, S. Wang, M. Yoshitake, and J. Kambayashi Inhibition of adenosine uptake and augmentation of ischemia-induced increase of interstitial adenosine by cilostazol, an agent to treat intermittent claudication J Cardiovasc Pharmacol 36 2000 351 360
    • (2000) J Cardiovasc Pharmacol , vol.36 , pp. 351-360
    • Liu, Y.1    Fong, M.2    Cone, J.3    Wang, S.4    Yoshitake, M.5    Kambayashi, J.6
  • 17
    • 1442319158 scopus 로고    scopus 로고
    • The pharmacology of cilostazol
    • K. Schrör The pharmacology of cilostazol Diabetes Obes Metab 4 Suppl 2 2002 S14 S19
    • (2002) Diabetes Obes Metab , vol.4 , Issue.SUPPL. 2
    • Schrör, K.1
  • 18
    • 0042355363 scopus 로고    scopus 로고
    • Cyclic nucleotide phosphodiesterase activity, expression, and targeting in cells of the cardiovascular system
    • D.H. Maurice Cyclic nucleotide phosphodiesterase activity, expression, and targeting in cells of the cardiovascular system Mol Pharmacol 64 2003 533 546
    • (2003) Mol Pharmacol , vol.64 , pp. 533-546
    • Maurice, D.H.1
  • 19
    • 0035979669 scopus 로고    scopus 로고
    • Endothelium-dependent relaxation by cilostazol, a phosphodiesteras III inhibitor, on rat thoracic aorta
    • T. Nakamura, H. Houchi, and A. Minami et al. Endothelium-dependent relaxation by cilostazol, a phosphodiesteras III inhibitor, on rat thoracic aorta Life Sci 69 2001 1709 1715
    • (2001) Life Sci , vol.69 , pp. 1709-1715
    • Nakamura, T.1    Houchi, H.2    Minami, A.3
  • 20
    • 9844267305 scopus 로고    scopus 로고
    • Cilostazol, a cAMP phosphodiesterase inhibitor, attenuates the production of monocyte chemoattractant protein-1 in response to tumor necrosis factor-alpha in vascular endothelial cells
    • Y. Nishio, A. Kashiwagi, and N. Takahara et al. Cilostazol, a cAMP phosphodiesterase inhibitor, attenuates the production of monocyte chemoattractant protein-1 in response to tumor necrosis factor-alpha in vascular endothelial cells Horm Metab Res Horm- Stoffwechselforschung Horm Métabolisme 29 1997 491 495
    • (1997) Horm Metab Res Horm- Stoffwechselforschung Horm Métabolisme , vol.29 , pp. 491-495
    • Nishio, Y.1    Kashiwagi, A.2    Takahara, N.3
  • 21
    • 0033503548 scopus 로고    scopus 로고
    • Cilostazol pharmacokinetics after single and multiple oral doses in healthy males and patients with intermittent claudication resulting from peripheral arterial disease
    • S.L. Bramer, W.P. Forbes, and S. Mallikaarjun Cilostazol pharmacokinetics after single and multiple oral doses in healthy males and patients with intermittent claudication resulting from peripheral arterial disease Clin Pharmacokinet 37 Suppl 2 1999 1 11
    • (1999) Clin Pharmacokinet , vol.37 , Issue.SUPPL. 2 , pp. 1-11
    • Bramer, S.L.1    Forbes, W.P.2    Mallikaarjun, S.3
  • 22
    • 28544438424 scopus 로고    scopus 로고
    • Naftidrofuryl: A review of its use in the treatment of intermittent claudication
    • D.R. Goldsmith, and K. Wellington Naftidrofuryl: a review of its use in the treatment of intermittent claudication Drugs Aging 22 2005 967 977
    • (2005) Drugs Aging , vol.22 , pp. 967-977
    • Goldsmith, D.R.1    Wellington, K.2
  • 23
    • 84877778606 scopus 로고    scopus 로고
    • Spectrophotometric, spectrofluorimetric and voltammetric analyses of naftidrofuryl oxalate in its tablets
    • S.M. Sabry, T.S. Belal, M.H. Barary, and M.E.A. Ibrahim Spectrophotometric, spectrofluorimetric and voltammetric analyses of naftidrofuryl oxalate in its tablets Int J Biomed Sci IJBS 5 2009 283 292
    • (2009) Int J Biomed Sci IJBS , vol.5 , pp. 283-292
    • Sabry, S.M.1    Belal, T.S.2    Barary, M.H.3    Ibrahim, M.E.A.4
  • 24
    • 0028281062 scopus 로고
    • Serotonin, 5-HT2 receptors, and their blockade by naftidrofuryl: A targeted therapy of vascular diseases
    • N.F. Wiernsperger Serotonin, 5-HT2 receptors, and their blockade by naftidrofuryl: a targeted therapy of vascular diseases J Cardiovasc Pharmacol 23 Suppl 3 1994 S37 S43
    • (1994) J Cardiovasc Pharmacol , vol.23 , Issue.SUPPL. 3
    • Wiernsperger, N.F.1
  • 25
    • 0025652344 scopus 로고
    • The effect of naftidrofuryl, a 5-HT2 antagonist, on collateral vascular responses to serotonin and to platelet activation
    • N.K. Hollenberg, and Q. Nie The effect of naftidrofuryl, a 5-HT2 antagonist, on collateral vascular responses to serotonin and to platelet activation J Cardiovasc Pharmacol 16 Suppl 3 1990 S36 S39
    • (1990) J Cardiovasc Pharmacol , vol.16 , Issue.SUPPL. 3
    • Hollenberg, N.K.1    Nie, Q.2
  • 26
    • 0025563074 scopus 로고
    • The role of serotonin in thrombogenesis
    • F. De Clerck The role of serotonin in thrombogenesis Clin Physiol Biochem 8 Suppl 3 1990 40 49
    • (1990) Clin Physiol Biochem , vol.8 , Issue.SUPPL. 3 , pp. 40-49
    • De Clerck, F.1
  • 27
    • 0029919411 scopus 로고    scopus 로고
    • Adhesion of platelets to surface-bound fibrinogen under flow
    • T.N. Zaidi, L.V. McIntire, D.H. Farrell, and P. Thiagarajan Adhesion of platelets to surface-bound fibrinogen under flow Blood 88 1996 2967 2972
    • (1996) Blood , vol.88 , pp. 2967-2972
    • Zaidi, T.N.1    McIntire, L.V.2    Farrell, D.H.3    Thiagarajan, P.4
  • 28
    • 0033861550 scopus 로고    scopus 로고
    • Effect of naftidrofuryl on platelet aggregation in plasma from aspirin treated patients: An in vitro study
    • C. Le Dévéhat, T. Khodabandehlou, and M. Mosnier Effect of naftidrofuryl on platelet aggregation in plasma from aspirin treated patients: an in vitro study Clin Hemorheol Microcirc 22 2000 197 204
    • (2000) Clin Hemorheol Microcirc , vol.22 , pp. 197-204
    • Le Dévéhat, C.1    Khodabandehlou, T.2    Mosnier, M.3
  • 29
    • 0025613452 scopus 로고
    • Effects of naftidrofuryl on the contraction and proliferation of cultured myocytes evoked by serotonin
    • P. Bodin, and P. Travo Effects of naftidrofuryl on the contraction and proliferation of cultured myocytes evoked by serotonin J Cardiovasc Pharmacol 16 Suppl 3 1990 S25 S28
    • (1990) J Cardiovasc Pharmacol , vol.16 , Issue.SUPPL. 3
    • Bodin, P.1    Travo, P.2
  • 30
    • 0031721280 scopus 로고    scopus 로고
    • Influence of age on the pharmacokinetics of naftidrofuryl after single oral administration in elderly versus young healthy volunteers
    • T. Hulot, S. Gamand, T. Dupain, P. Ahtoy, and M. Bromet Influence of age on the pharmacokinetics of naftidrofuryl after single oral administration in elderly versus young healthy volunteers Arzneimittelforschung 48 1998 900 904
    • (1998) Arzneimittelforschung , vol.48 , pp. 900-904
    • Hulot, T.1    Gamand, S.2    Dupain, T.3    Ahtoy, P.4    Bromet, M.5
  • 31
    • 84878145117 scopus 로고    scopus 로고
    • Predictors of walking capacity in peripheral arterial disease patients
    • B.Q. Farah, J.P. Souza Barbosa, A. dos, and G.G. Cucato et al. Predictors of walking capacity in peripheral arterial disease patients Clin São Paulo Braz 68 2013 537 541
    • (2013) Clin São Paulo Braz , vol.68 , pp. 537-541
    • Farah, B.Q.1    Souza Barbosa, J.P.2    Dos, A.3    Cucato, G.G.4
  • 32
    • 0025900968 scopus 로고
    • Progressive vs single-stage treadmill tests for evaluation of claudication
    • A.W. Gardner, J.S. Skinner, B.W. Cantwell, and L.K. Smith Progressive vs single-stage treadmill tests for evaluation of claudication Med Sci Sports Exerc 23 1991 402 408
    • (1991) Med Sci Sports Exerc , vol.23 , pp. 402-408
    • Gardner, A.W.1    Skinner, J.S.2    Cantwell, B.W.3    Smith, L.K.4
  • 33
    • 66249147909 scopus 로고    scopus 로고
    • Pharmacologic therapy for intermittent claudication
    • P.P. Dobesh, Z.A. Stacy, and E.L. Persson Pharmacologic therapy for intermittent claudication Pharmacotherapy 29 2009 526 553
    • (2009) Pharmacotherapy , vol.29 , pp. 526-553
    • Dobesh, P.P.1    Stacy, Z.A.2    Persson, E.L.3
  • 34
    • 0031745532 scopus 로고    scopus 로고
    • Measurement of walking endurance and walking velocity with questionnaire: Validation of the walking impairment questionnaire in men and women with peripheral arterial disease
    • M.M. McDermott, K. Liu, J.M. Guralnik, G.J. Martin, M.H. Criqui, and P. Greenland Measurement of walking endurance and walking velocity with questionnaire: validation of the walking impairment questionnaire in men and women with peripheral arterial disease J Vasc Surg 28 1998 1072 1081
    • (1998) J Vasc Surg , vol.28 , pp. 1072-1081
    • McDermott, M.M.1    Liu, K.2    Guralnik, J.M.3    Martin, G.J.4    Criqui, M.H.5    Greenland, P.6
  • 35
    • 0000491118 scopus 로고
    • Evaluation of walking impairment by questionnaire in patients with peripheral arterial disease
    • J. Regensteiner, J. Steiner, R. Panzer, and W. Hiatt Evaluation of walking impairment by questionnaire in patients with peripheral arterial disease J Vasc Med Biol 2 1990 142 152
    • (1990) J Vasc Med Biol , vol.2 , pp. 142-152
    • Regensteiner, J.1    Steiner, J.2    Panzer, R.3    Hiatt, W.4
  • 37
    • 33748954122 scopus 로고    scopus 로고
    • Lack of relationship between gait parameters and physical function in peripheral arterial disease
    • S.A. Scherer, W.R. Hiatt, and J.G. Regensteiner Lack of relationship between gait parameters and physical function in peripheral arterial disease J Vasc Surg 44 2006 782 788
    • (2006) J Vasc Surg , vol.44 , pp. 782-788
    • Scherer, S.A.1    Hiatt, W.R.2    Regensteiner, J.G.3
  • 38
    • 0002904243 scopus 로고    scopus 로고
    • Management of peripheral arterial disease (PAD)
    • J.A. Dormandy, and R.B. Rutherford Management of peripheral arterial disease (PAD) J Vasc Surg 31 2000 S1 S296
    • (2000) J Vasc Surg , vol.31
    • Dormandy, J.A.1    Rutherford, R.B.2
  • 39
    • 85059107309 scopus 로고    scopus 로고
    • Outcome assessment of intermittent claudication in clinical practice
    • Outcome assessment of intermittent claudication in clinical practice. J Vasc Surg. 2000;31:S74-S77.
    • (2000) J Vasc Surg , vol.31
  • 41
    • 84940287042 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research Accessed May 15, 2013
    • Center for Drug Evaluation and Research. New Drug Application for Pletal (cilostazol) Tablet. 1999. Available at: http://www.accessdata.fda.gov/ drugsatfda-docs/nda/99/20863.cfm. Accessed May 15, 2013.
    • (1999) New Drug Application for Pletal (Cilostazol) Tablet
  • 42
    • 0037114872 scopus 로고    scopus 로고
    • Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication
    • P.D. Thompson, R. Zimet, W.P. Forbes, and 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
    • (2002) Am J Cardiol , vol.90 , pp. 1314-1319
    • Thompson, P.D.1    Zimet, R.2    Forbes, W.P.3    Zhang, P.4
  • 43
    • 4344685960 scopus 로고    scopus 로고
    • Drug treatment of intermittent claudication
    • D. Jacoby, and E.R. Mohler 3rd Drug treatment of intermittent claudication Drugs 64 2004 1657 1670
    • (2004) Drugs , vol.64 , pp. 1657-1670
    • Jacoby, D.1    Mohler III, E.R.2
  • 44
    • 76349123100 scopus 로고    scopus 로고
    • Springer London. Accessed December 22, 2013
    • A.H. Davies, and C.M. Brophy Vascular surgery 2006 Springer London http://site.ebrary.com/id/10228787. Accessed December 22, 2013
    • (2006) Vascular Surgery
    • Davies, A.H.1    Brophy, C.M.2
  • 48
    • 2442482962 scopus 로고    scopus 로고
    • Key factors in the rising cost of new drug discovery and development
    • M. Dickson, and J.P. Gagnon Key factors in the rising cost of new drug discovery and development Nat Rev Drug Discov 3 2004 417 429
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 417-429
    • Dickson, M.1    Gagnon, J.P.2
  • 49
    • 78049521348 scopus 로고    scopus 로고
    • Using Market-Exclusivity Incentives to Promote Pharmaceutical Innovation
    • A.S. Kesselheim Using Market-Exclusivity Incentives to Promote Pharmaceutical Innovation N Engl J Med 363 2010 1855 1862
    • (2010) N Engl J Med , vol.363 , pp. 1855-1862
    • Kesselheim, A.S.1
  • 51
    • 33746872608 scopus 로고    scopus 로고
    • A proposal for radical changes in the drug-approval process
    • A.J.J. Wood A proposal for radical changes in the drug-approval process N Engl J Med 355 2006 618 623
    • (2006) N Engl J Med , vol.355 , pp. 618-623
    • Wood, A.J.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.