Real-world Evidence for the Antianginal Efficacy of Trimetazidine from the Russian Observational CHOICE-2 Study

Abstract

Introduction: The guidelines recommend a beta-blocker or calcium channel blocker as the first-line medication for angina, supplemented by other agents for additional symptoms. One such agent is trimetazidine (TMZ), which has been shown to reduce the frequency of anginal episodes and improve exercise performance without affecting haemodynamic parameters. However, extensive real-world evidence for its efficacy in combination with first-line therapies has been lacking. Methods: The aim of this large-scale, Russian, multicentre, 6-month, open-label, prospective observational study was to assess the effect of adding TMZ modified release 35 mg bid to background antianginal therapy in the real--world clinical setting. Results: The study included 896 patients: 54% women, aged 29-90 years (42.6% [65 years), 63% with class II angina, and receiving beta-blockers alone or in combination (93%). Add-on TMZ reduced angina frequency and

Trimetazidine and Bisoprolol to Treat Angina in Symptomatic Patients: Post Hoc Analysis From the CHOICE-2 Study

“…In our study, only 1.67% of patients discontinued TMZ [ 25 ]. The current 2019 ESC guidelines for CCS recommend that AA therapy be tailored to the patient, the patient’s preferences, comorbidities and potential drug interactions.…”

“…For the most part, this post-hoc analysis is subject to the real-world limitations associated with the open-label, observational, non-interventional design of the original CHOICE-2 study [ 25 ]. In addition, the separate analysis of the subset of patients taking bisoprolol concomitantly with TMZ was not pre-planned and no sample size calculation was conducted to determine the optimal number of patients needed to determine a statistically significant result.…”

“…The design and conduct of this observational, multicenter study have been described in detail in a previous publication on the CHOICE II study [ 25 ].…”

“…CHOICE-2 was a 6-month multicenter observational program conducted in 46 regions of the Russian Federation (ISRCTN identifier: ISRCTN65209863, protocol number IC4-06,790-013-RUS) [ 25 ]. All patients were treated with modified-release TMZ (TMZ MR) 35 mg bid in combination with a BB in addition to background hemodynamic therapy.…”

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“…Angina is also associated with an increased risk of major adverse cardiovascular event (MACE) outcomes (cardiovascular mortality, hospitalization for myocardial infarction, heart failure or stroke) 1 .…”