Trimetazidine Modified Release in the Treatment of Stable Angina

TRIUMPH Study

Vladimir I. Makolkin; Konstantin K. Osadchiy

Disclosures

Clin Drug Invest. 2004;24(12):731-738. 

In This Article

Abstract and Introduction

Objective: To assess the clinical efficacy, safety and effects on quality of life of trimetazidine modified release (MR) in patients with stable angina.
Methods: This large, open-label, uncontrolled study was conducted in 906 patients with stable angina in the Russian Federation. Patients were treated for 8?weeks with trimetazidine MR (35mg tablet, twice a day) in addition to their conventional therapy.
Results: Overall 846 patients (516 men and 330 women) aged 58.7 ± 9 years completed the study. During the 8-week treatment period the number of angina attacks per week decreased continuously and significantly from 11.2 ± 0.4 to 3.6 ± 0.2 (p < 0.0001). Concurrently, the number of short-acting nitrate tablets taken per week decreased from 11.9 ± 0.8 to 3.4 ± 0.2 (p < 0.0001). Patients' quality of life, assessed on the Seattle Angina Questionnaire, showed a significant improvement (p < 0.0001) for all five items evaluated: physical limitation increased from 50.7 ± 0.7 to 61.0 ± 0.6, angina stability improved from 57.6 ± 0.9 to 92.5 ± 0.7, angina frequency extended from 33.3 ± 0.7 to 55.6 ± 0.8, treatment satisfaction increased from 62.3 ± 0.7 to 77.4 ± 0.5, and disease perception improved from 36.7 ± 0.6 to 55.5 ± 0.7. Adverse events were reported in 2.4% of patients (22/906) during the 8?weeks of treatment. No serious adverse events were reported.
Conclusion: The results of this study suggest an improvement in clinical efficacy and in quality of life and a good tolerance of trimetazidine MR administered at a dose of 35mg twice a day for 8 weeks in patients with stable angina.

Cardiovascular diseases, in particular ischaemic heart disease (IHD) or coronary artery disease (CAD), are one of the leading causes of death worldwide;[1,2] they are now particularly common in developed countries.

The main aim of the treatment of stable angina is to improve the prognosis by preventing myocardial infarction and death. The pharmacological treatment of stable angina according to the latest European Cardiology Society Guidelines includes three groups of well known antianginal agents with a haemodynamic mode of action (long-term nitrates, ß-blockers and calcium antagonists) and also drugs?with a metabolic mechanism of action, i.e. trimetazidine.[3,4]

Trimetazidine was first marketed in 1978 and is currently registered in almost 100 countries worldwide, including in the Russian Federation, under the trade name Preductal™ (Servier, France).2 The efficacy and safety of trimetazidine in the treatment of patients with coronary heart disease and stable angina has been demonstrated in a number of randomised, controlled clinical trials.[5] Trimetazidine is effective in monotherapy and in combination with haemodynamic agents.[6,7,8,9,10,11,12,13] Long-term treatment with trimetazidine significantly improves patients' clinical condition (reducing the number of angina attacks and supplementary nitroglycerin intake), increases exercise tolerance, improves the results of exercise tests, and restores patients' quality of life.[6,7,8,9,10,11,12,13] Trimetazidine is a metabolic antianginal and anti-ischaemic agent that has been shown to preserve energy balance.[14,15]

New modified-release formulations of drugs represent a major advantage in the pharmacological treatment of diseases. They are more convenient for the patient and significantly improve patient compliance. They may, eventually, determine treatment results, as they maintain their efficacy even at minimal concentrations, at the end of the dosing interval.

The modified-release (MR) formulation of trimetazidine, which is now available to physicians, maintains all the properties of trimetazidine.[14,15] It has been developed to maintain a prolonged coverage in patients with ischaemic heart disease by providing sustained antianginal and anti-ischaemic efficacy round-the-clock. The ability of trimetazidine to protect the myocardium against ischaemic damage in the early morning is of particular importance for patients with coronary artery disease, since the frequency of acute ischaemic episodes may significantly increase at the time of awakening. Trimetazidine MR 35mg offers the advantage of a twice-daily dosage, which is more convenient for the patient and may improve his/her compliance.

The aim of this large study was to assess the efficacy, safety and effect on quality of life of the modified-release formulation of trimetazidine at a dose of one tablet twice a day in patients with stable angina.

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