Cargando…

Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris

INTRODUCTION: Trimetazidine (TMZ) is an anti-ischemic metabolic agent that has been shown to be efficacious in angina treatment, both in monotherapy and in combination. A new formulation of TMZ modified-release (MR) 80 mg was developed, which is to be taken once daily (od), instead of twice daily (b...

Descripción completa

Detalles Bibliográficos
Autor principal: Pozdnyakov, Yuri M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5986675/
https://www.ncbi.nlm.nih.gov/pubmed/29779201
http://dx.doi.org/10.1007/s40119-018-0110-5
_version_ 1783328963315105792
author Pozdnyakov, Yuri M.
author_facet Pozdnyakov, Yuri M.
author_sort Pozdnyakov, Yuri M.
collection PubMed
description INTRODUCTION: Trimetazidine (TMZ) is an anti-ischemic metabolic agent that has been shown to be efficacious in angina treatment, both in monotherapy and in combination. A new formulation of TMZ modified-release (MR) 80 mg was developed, which is to be taken once daily (od), instead of twice daily (bid) for the currently available TMZ MR 35 mg, with the aim of simplifying the medication regimen. METHODS: The present study was an international, multicenter, randomized, double-blind, parallel-group phase III study with a 12-week treatment period. The safety of TMZ MR 80 mg once daily was assessed compared to TMZ MR 35 mg twice daily, in patients previously treated successfully by the latter. Emergent adverse events (EAEs), biological parameters, vital signs, 12-lead resting ECG (electrocardiogram) and Canadian Cardiovascular Society (CCS) classification were recorded. RESULTS: One-hundred and sixty-five patients previously diagnosed with stable angina pectoris on treatment were randomized to receive either TMZ MR 80 mg od or TMZ MR 35 mg bid. In the TMZ MR 80 mg group, fewer patients had ≥ 1 EAE (17.1 vs. 22.9% in the TMZ MR 35 mg group). Serious EAEs were reported by three patients in each group. No EAE required dose modification, withdrawal, or temporary interruption of study treatments. Vital signs, 12-lead ECG, and laboratory parameters did not change. No worsening in CCS classes was observed with either treatment. CONCLUSIONS: TMZ MR 80 mg od and TMZ MR 35 mg bid have similar safety profiles. This new once-daily formulation could improve patient compliance with therapy, thereby enhancing clinical benefit. TRIAL REGISTRATION: ISRCTN registry, ISRCTN 84362208. FUNDING: Institut de Recherches Internationales Servier and Servier, Moscow, Russian Federation. PLAIN LANGUAGE SUMMARY: Plain language summary available for this article. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40119-018-0110-5) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5986675
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-59866752018-06-13 Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris Pozdnyakov, Yuri M. Cardiol Ther Original Research INTRODUCTION: Trimetazidine (TMZ) is an anti-ischemic metabolic agent that has been shown to be efficacious in angina treatment, both in monotherapy and in combination. A new formulation of TMZ modified-release (MR) 80 mg was developed, which is to be taken once daily (od), instead of twice daily (bid) for the currently available TMZ MR 35 mg, with the aim of simplifying the medication regimen. METHODS: The present study was an international, multicenter, randomized, double-blind, parallel-group phase III study with a 12-week treatment period. The safety of TMZ MR 80 mg once daily was assessed compared to TMZ MR 35 mg twice daily, in patients previously treated successfully by the latter. Emergent adverse events (EAEs), biological parameters, vital signs, 12-lead resting ECG (electrocardiogram) and Canadian Cardiovascular Society (CCS) classification were recorded. RESULTS: One-hundred and sixty-five patients previously diagnosed with stable angina pectoris on treatment were randomized to receive either TMZ MR 80 mg od or TMZ MR 35 mg bid. In the TMZ MR 80 mg group, fewer patients had ≥ 1 EAE (17.1 vs. 22.9% in the TMZ MR 35 mg group). Serious EAEs were reported by three patients in each group. No EAE required dose modification, withdrawal, or temporary interruption of study treatments. Vital signs, 12-lead ECG, and laboratory parameters did not change. No worsening in CCS classes was observed with either treatment. CONCLUSIONS: TMZ MR 80 mg od and TMZ MR 35 mg bid have similar safety profiles. This new once-daily formulation could improve patient compliance with therapy, thereby enhancing clinical benefit. TRIAL REGISTRATION: ISRCTN registry, ISRCTN 84362208. FUNDING: Institut de Recherches Internationales Servier and Servier, Moscow, Russian Federation. PLAIN LANGUAGE SUMMARY: Plain language summary available for this article. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40119-018-0110-5) contains supplementary material, which is available to authorized users. Springer Healthcare 2018-05-19 2018-06 /pmc/articles/PMC5986675/ /pubmed/29779201 http://dx.doi.org/10.1007/s40119-018-0110-5 Text en © The Author(s) 2018 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Pozdnyakov, Yuri M.
Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris
title Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris
title_full Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris
title_fullStr Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris
title_full_unstemmed Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris
title_short Clinical Acceptability Of Trimetazidine Modified-Release 80 mg Once Daily Versus Trimetazidine Modified-Release 35 mg Twice Daily In Stable Angina Pectoris
title_sort clinical acceptability of trimetazidine modified-release 80 mg once daily versus trimetazidine modified-release 35 mg twice daily in stable angina pectoris
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5986675/
https://www.ncbi.nlm.nih.gov/pubmed/29779201
http://dx.doi.org/10.1007/s40119-018-0110-5
work_keys_str_mv AT pozdnyakovyurim clinicalacceptabilityoftrimetazidinemodifiedrelease80mgoncedailyversustrimetazidinemodifiedrelease35mgtwicedailyinstableanginapectoris
AT clinicalacceptabilityoftrimetazidinemodifiedrelease80mgoncedailyversustrimetazidinemodifiedrelease35mgtwicedailyinstableanginapectoris