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

Yuri M Pozdnyakov¹; study investigators

Collaborators, Affiliations

Collaborators

study investigators:
V L Uskov, I I Gon-Charenko, T P Prasolova, V G Guseva, A S Shinkar, S M Samsonova, I V Vikhrova, S A Kuz'kina, L V Mitina, I V Timofeeva, T M Archakova, N Y Kovaleva, E A Romanova, Y V Tivon, Y N Antonova, O B Kurganova, N N Davydova, O V Klyuchantseva, Y V Popovskaya, E I Kharitonova, T N Kuzmina, K V Buzmakova, L I Kaplenko, N V Pospelova, A Y Stepanova, N A Kol-Basheva, G M Krasnova, A Y Pal'vin-Skaya, V A Toloknova, R F Bikmullina, A A Gainullina, E V Kedrina, S A Mikhailova, T A Nabiullina, A F Nizamova, A A Uskova, A E Yushkova, O V Andreeva, G V Fedotova, O L Besser-Geneva, D D Gavrilyuk, N V Ehalo, M V Zlo-Bina, E Y Zhemartseva, I A Markushina, V P Pavlovets, A A Sobolenko, I E Apanovich, N V Kireeva, I V Maksimova, T V Butz, I A Pavlova, S N Bachurina, S V Orlyachenko, T V Zaitseva, V F Beznogova, N N Litsis, A Y Novozhenina, L L Abramyan, M M Adamyan, S N Askerko, A N Bolmosov, I N Vasilieva, S I Volodova, P V Grishko, E S Zherebetskaya, N S Zemlyanaya, L N Klysh-Nikova, E I Kononchik, N A Kuznetsova, I A Kuz'minova, I V Marmurova, R Y Mikhailova, I P Mordovina, O V Nazarkina, A P Per-Epechko, N G Pivovarova, T P Potapova, D A Prokofiev, N E Proniushkina, E V Savelieva, N A Semovskikh, L D Timonenkova, V V Fomin, O A Furman, R M Tsutsieva, M V Chibrikina, I N Shoshina, P Yashchenko, T I Bocharova, O L Demya-Nenko, L B Zhukova, A Y Melnikov, I A Mer-Kulieva, E I Tyasina, N S Pakholkova, S V Rogozina, I V Chugunova, M L Brazhnik, Y V Guseva, A N Anisimova, S S Kuzeyina, R G Kulakhmetova, I S Petrova, I A Ignatyeva, T A Morozova, N V Ryb-Nikova, I I Gritsenko, O V Kondratskaya, A V Shishkin, N N Gogleva, V M Kulipanova, S V Mitrofanova, E V Parada, S Y Svistunova, T M Sergeeva, V V Kryukova, T N Suprun, E M Fedorova, O F Shnor, T N Mitroshina, T S Shemetova, L P Val'kevich, S N Varnikova, E A Ivanova, O N Shlykova, I R Guryanova, V L Zheltova, E D Bulygina, E V Gorskaya, L V Kosenko, F K Musaeva, M Y Fedorchenko, V I Harish, O M Serbarinova, Y A Yatsenya, M N Golubev, D E Kopaev, L A Miludina, L V Polischuk, O A Shilintseva, L M Krylova, M V Vasilik, D D Zotov, N B Kalishevich, L I Kachmazova, S G Kontorikova, T A Mamoshko, S A Osnovin, I O Timosh-Enko Schmalz, A N Kashina, O G Kiryanova, L E Kotova, L E Kuvshinova, I M Ulyanova, O F Shevelo, I B Kir-Eeva, L V Korohova, T I Lisunova, E V Medvedeva, T E Matvienko, S L Shovgaryan, T F Nebolsina, M A Mikusheva, N N Misharin, T O Kutaliya, V N Chernova, Y A Yanina, O V Permyakova, N N Skurikhina, L M Goldinova, T N Pri-Khodko, A G Myshyakova, E Z Akhmerova, K V Zaitseva, A A Ozerchuk, I M Polyakova, Rodionova, I D Safiullina, I N Arsentieva, O O Volkova, I N Kondrina, T E Kharlova, T L Grigorieva, K V Kurtmulaeva, O M Rogozina

Affiliation

¹ Moscow Regional Cardiology Centre, Zhukovsky, Russia. pozdn@progtech.ru.

PMID: 29779201
PMCID: PMC5986675
DOI: 10.1007/s40119-018-0110-5

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

Yuri M Pozdnyakov et al. Cardiol Ther. 2018 Jun.

. 2018 Jun;7(1):61-70.

doi: 10.1007/s40119-018-0110-5. Epub 2018 May 19.

Authors

Yuri M Pozdnyakov¹; study investigators

Collaborators

study investigators:
V L Uskov, I I Gon-Charenko, T P Prasolova, V G Guseva, A S Shinkar, S M Samsonova, I V Vikhrova, S A Kuz'kina, L V Mitina, I V Timofeeva, T M Archakova, N Y Kovaleva, E A Romanova, Y V Tivon, Y N Antonova, O B Kurganova, N N Davydova, O V Klyuchantseva, Y V Popovskaya, E I Kharitonova, T N Kuzmina, K V Buzmakova, L I Kaplenko, N V Pospelova, A Y Stepanova, N A Kol-Basheva, G M Krasnova, A Y Pal'vin-Skaya, V A Toloknova, R F Bikmullina, A A Gainullina, E V Kedrina, S A Mikhailova, T A Nabiullina, A F Nizamova, A A Uskova, A E Yushkova, O V Andreeva, G V Fedotova, O L Besser-Geneva, D D Gavrilyuk, N V Ehalo, M V Zlo-Bina, E Y Zhemartseva, I A Markushina, V P Pavlovets, A A Sobolenko, I E Apanovich, N V Kireeva, I V Maksimova, T V Butz, I A Pavlova, S N Bachurina, S V Orlyachenko, T V Zaitseva, V F Beznogova, N N Litsis, A Y Novozhenina, L L Abramyan, M M Adamyan, S N Askerko, A N Bolmosov, I N Vasilieva, S I Volodova, P V Grishko, E S Zherebetskaya, N S Zemlyanaya, L N Klysh-Nikova, E I Kononchik, N A Kuznetsova, I A Kuz'minova, I V Marmurova, R Y Mikhailova, I P Mordovina, O V Nazarkina, A P Per-Epechko, N G Pivovarova, T P Potapova, D A Prokofiev, N E Proniushkina, E V Savelieva, N A Semovskikh, L D Timonenkova, V V Fomin, O A Furman, R M Tsutsieva, M V Chibrikina, I N Shoshina, P Yashchenko, T I Bocharova, O L Demya-Nenko, L B Zhukova, A Y Melnikov, I A Mer-Kulieva, E I Tyasina, N S Pakholkova, S V Rogozina, I V Chugunova, M L Brazhnik, Y V Guseva, A N Anisimova, S S Kuzeyina, R G Kulakhmetova, I S Petrova, I A Ignatyeva, T A Morozova, N V Ryb-Nikova, I I Gritsenko, O V Kondratskaya, A V Shishkin, N N Gogleva, V M Kulipanova, S V Mitrofanova, E V Parada, S Y Svistunova, T M Sergeeva, V V Kryukova, T N Suprun, E M Fedorova, O F Shnor, T N Mitroshina, T S Shemetova, L P Val'kevich, S N Varnikova, E A Ivanova, O N Shlykova, I R Guryanova, V L Zheltova, E D Bulygina, E V Gorskaya, L V Kosenko, F K Musaeva, M Y Fedorchenko, V I Harish, O M Serbarinova, Y A Yatsenya, M N Golubev, D E Kopaev, L A Miludina, L V Polischuk, O A Shilintseva, L M Krylova, M V Vasilik, D D Zotov, N B Kalishevich, L I Kachmazova, S G Kontorikova, T A Mamoshko, S A Osnovin, I O Timosh-Enko Schmalz, A N Kashina, O G Kiryanova, L E Kotova, L E Kuvshinova, I M Ulyanova, O F Shevelo, I B Kir-Eeva, L V Korohova, T I Lisunova, E V Medvedeva, T E Matvienko, S L Shovgaryan, T F Nebolsina, M A Mikusheva, N N Misharin, T O Kutaliya, V N Chernova, Y A Yanina, O V Permyakova, N N Skurikhina, L M Goldinova, T N Pri-Khodko, A G Myshyakova, E Z Akhmerova, K V Zaitseva, A A Ozerchuk, I M Polyakova, Rodionova, I D Safiullina, I N Arsentieva, O O Volkova, I N Kondrina, T E Kharlova, T L Grigorieva, K V Kurtmulaeva, O M Rogozina

Affiliation

¹ Moscow Regional Cardiology Centre, Zhukovsky, Russia. pozdn@progtech.ru.

PMID: 29779201
PMCID: PMC5986675
DOI: 10.1007/s40119-018-0110-5

Abstract

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 available for this article.

Keywords: Formulation; Randomized clinical trial; Safety; Stable angina; Trimetazidine.

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References

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

Collaborators

Affiliation

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

Authors

Collaborators

Affiliation

Abstract

References

LinkOut - more resources

Full Text Sources

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