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Published in: BMC Cardiovascular Disorders 1/2018

Open Access 01-12-2018 | Research article

Safety of cilostazol in peripheral artery disease: a cohort from a primary healthcare electronic database

Authors: Jordi Real, M Catalina Serna, Maria Giner-Soriano, Rosa Forés, Guillem Pera, Esther Ribes, Maite Alzamora, Josep Ramon Marsal, Antonio Heras, Rosa Morros

Published in: BMC Cardiovascular Disorders | Issue 1/2018

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Abstract

Background

Cilostazol has been associated with spontaneous reports of cardiovascular adverse events and serious bleeding. The objective of this study is to determine the relative risk of cardiovascular adverse events or haemorrhages in patients with peripheral artery disease treated with cilostazol in comparison to pentoxifylline users.

Methods

Population-based cohort study including all individuals older than 40 who initiated cilostazol or pentoxifylline during 2009–2011 in SIDIAP database. The two treatment groups were matched through propensity score (PS).

Results

Nine thousand one hundred twenty-nine patients met inclusion criteria and after PS matching, there were 2905 patients in each group. 76% of patients were men, with similar mean ages in both groups (68.8 for cilostazol and 69.4 for pentoxifylline). There were no differences in bleeding, cerebrovascular and cardiovascular events between both groups.

Conclusions

Patients treated with cilostazol were different from those treated with pentoxifylline at baseline, so they were matched through PS. We did not find differences between treatment groups in the incidence of bleeding or cardiovascular and cerebrovascular events. Cilostazol should be used with precaution in elderly polymedicated patients.
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Literature
1.
2.
go back to reference Fowkes FGR, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet Elsevier Ltd. 2013;382:1329–40. Fowkes FGR, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet Elsevier Ltd. 2013;382:1329–40.
3.
go back to reference Alzamora MT, Fores R, Baena-Diez JM, Pera G, Toran P, Sorribes M, et al. The peripheral arterial disease study (PERART/ARTPER): prevalence and risk factors in the general population. BMC Public Health. 2010;10:38.CrossRefPubMedPubMedCentral Alzamora MT, Fores R, Baena-Diez JM, Pera G, Toran P, Sorribes M, et al. The peripheral arterial disease study (PERART/ARTPER): prevalence and risk factors in the general population. BMC Public Health. 2010;10:38.CrossRefPubMedPubMedCentral
4.
go back to reference Félix-Redondo FJ, Fernández-Bergés D, Grau M, Baena-Diez JM, Mostaza JM, Vila J. Prevalencia y características clínicas de la enfermedad arterial periférica en la población general del estudio Hermex. Rev Esp Cardiol. 2012;65:726–33.CrossRefPubMed Félix-Redondo FJ, Fernández-Bergés D, Grau M, Baena-Diez JM, Mostaza JM, Vila J. Prevalencia y características clínicas de la enfermedad arterial periférica en la población general del estudio Hermex. Rev Esp Cardiol. 2012;65:726–33.CrossRefPubMed
5.
go back to reference Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: national health and nutrition examination study, 1999 to 2004. Circulation. 2011;124:17–23.CrossRefPubMedPubMedCentral Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: national health and nutrition examination study, 1999 to 2004. Circulation. 2011;124:17–23.CrossRefPubMedPubMedCentral
6.
go back to reference Fowkes FG, Murray GD, Butcher I, Heald CL, Lee RJ, Chambless LE, Folsom AR, Hirsch AT, Dramaix M, de Backer G, Wautrecht JC, Kornitzer M, Newman AB, Cushman M, Sutton-Tyrrell K, Fowkes FG, Lee AJ, Price JF, d’Agostino RB, Murabito JM, Norman PE, MM JK. Ankle brachial index combined with Framingham risk score to predict cardiovascular events and mortality: a meta-analysis. JAMA J. 2008;300:197–208.CrossRef Fowkes FG, Murray GD, Butcher I, Heald CL, Lee RJ, Chambless LE, Folsom AR, Hirsch AT, Dramaix M, de Backer G, Wautrecht JC, Kornitzer M, Newman AB, Cushman M, Sutton-Tyrrell K, Fowkes FG, Lee AJ, Price JF, d’Agostino RB, Murabito JM, Norman PE, MM JK. Ankle brachial index combined with Framingham risk score to predict cardiovascular events and mortality: a meta-analysis. JAMA J. 2008;300:197–208.CrossRef
7.
go back to reference Khan S, Cleanthis M, Smout J, Flather M, Stansby G. Life-style modification in peripheral arterial disease. Eur J Vasc Endovasc Surg. 2005;29:2–9.CrossRefPubMed Khan S, Cleanthis M, Smout J, Flather M, Stansby G. Life-style modification in peripheral arterial disease. Eur J Vasc Endovasc Surg. 2005;29:2–9.CrossRefPubMed
8.
go back to reference Leng G, Fowler B, Ernst E. Exercise for intermittent claudication. In: Leng G, editor. Cochrane database Syst. Rev. Chichester: Wiley; 2000.CrossRef Leng G, Fowler B, Ernst E. Exercise for intermittent claudication. In: Leng G, editor. Cochrane database Syst. Rev. Chichester: Wiley; 2000.CrossRef
9.
go back to reference Summary of Product Characteristics (Ficha Técnica), Elorgan. Hemovas. Sanofi-Aventis SA. 2009. p 1-30. AEMPS Summary of Product Characteristics (Ficha Técnica), Elorgan. Hemovas. Sanofi-Aventis SA. 2009. p 1-30. AEMPS
10.
go back to reference Summary of Product Characteristics, Pletal E. Otsuka Pharmaceutical Europe Ltd. Lacer SA. EMA. 2013. p. 1–11. Summary of Product Characteristics, Pletal E. Otsuka Pharmaceutical Europe Ltd. Lacer SA. EMA. 2013. p. 1–11.
12.
go back to reference European Medicines Agency. European medicines agency recommends restricting use of cilostazol-containing medicines. 2013;44:4–7. EMA/98571/2013 European Medicines Agency. European medicines agency recommends restricting use of cilostazol-containing medicines. 2013;44:4–7. EMA/98571/2013
13.
go back to reference González-Ruiz M, Cuaresma-Lasheras M, Blanco-Ramos I, Rodríguez-Dichico G, Montero-Corominas D. Cilostazol: from spontaneous reports of cardiovascular and haemorrhagic reactions to a thorough benefit-risk evaluation in Europe. A signal generation. Basic Clin Pharmacol Toxicol. 2011;109:36–36. González-Ruiz M, Cuaresma-Lasheras M, Blanco-Ramos I, Rodríguez-Dichico G, Montero-Corominas D. Cilostazol: from spontaneous reports of cardiovascular and haemorrhagic reactions to a thorough benefit-risk evaluation in Europe. A signal generation. Basic Clin Pharmacol Toxicol. 2011;109:36–36.
14.
go back to reference Castellsague J, Perez-Gutthann S, Calingaert B, Bui C, Varas-Lorenzo C, Arana A, et al. Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany. Pharmacoepidemiol. Drug Saf. 2017;26(6):615–24. Castellsague J, Perez-Gutthann S, Calingaert B, Bui C, Varas-Lorenzo C, Arana A, et al. Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany. Pharmacoepidemiol. Drug Saf. 2017;26(6):615–24.
16.
go back to reference (NICE) National Institute for Health & Clinical Excellence. Cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease | Guidance and guidelines | NICE. NICE; 2011. Available from: https://www.nice.org.uk/guidance/ta223 (NICE) National Institute for Health & Clinical Excellence. Cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease | Guidance and guidelines | NICE. NICE; 2011. Available from: https://​www.​nice.​org.​uk/​guidance/​ta223
19.
go back to reference Dawson DL, Cutler BS, Hiatt WR, Hobson RW, Martin JD, Bortey EB, et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med. 2000;109:523–30.CrossRefPubMed Dawson DL, Cutler BS, Hiatt WR, Hobson RW, Martin JD, Bortey EB, et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med. 2000;109:523–30.CrossRefPubMed
20.
go back to reference Bedenis R, Stewart M, Cleanthis M, Robless P, Mikhailidis DP, Stansby G. Cilostazol for intermittent claudication. In: Cleanthis M, editor. Cochrane database Syst. Rev. Chichester: Wiley; 2014. Bedenis R, Stewart M, Cleanthis M, Robless P, Mikhailidis DP, Stansby G. Cilostazol for intermittent claudication. In: Cleanthis M, editor. Cochrane database Syst. Rev. Chichester: Wiley; 2014.
21.
go back to reference Leeper NJ, Bauer-Mehren A, Iyer SV, LePendu P, Olson C, Shah NH, et al. Practice-based evidence: profiling the safety of Cilostazol by text-Mining of Clinical Notes. Smalheiser NR, editor. PLoS One Public Lib Sci. 2013;8:e63499.CrossRef Leeper NJ, Bauer-Mehren A, Iyer SV, LePendu P, Olson C, Shah NH, et al. Practice-based evidence: profiling the safety of Cilostazol by text-Mining of Clinical Notes. Smalheiser NR, editor. PLoS One Public Lib Sci. 2013;8:e63499.CrossRef
Metadata
Title
Safety of cilostazol in peripheral artery disease: a cohort from a primary healthcare electronic database
Authors
Jordi Real
M Catalina Serna
Maria Giner-Soriano
Rosa Forés
Guillem Pera
Esther Ribes
Maite Alzamora
Josep Ramon Marsal
Antonio Heras
Rosa Morros
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2018
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-018-0822-4

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