Effectiveness and tolerability of trimetazidine 80mg once daily in patients with chronic coronary syndrome: the V-GOOD observational study
Authors: Wolff Gowdak L , Dourado P , Precoma D , Dusilek C , Silva F , Yugar-Toledo J , Pena F , Gomes D , Cestario E , Guimaraes Jr O , Hoffmann Filho C , Almeida C , Brito F , Martins G , Ferreira V 
Published: November 2023

Background

Trimetazidine (TMZ) has shown anti-ischemic and anti-anginal effects by shifting the production of ATP from free fatty acid to glucose oxidation. Few clinical studies have looked at the effectiveness and tolerability of a new presentation of TMZ (80mg once daily) in real-world practice.

Purpose

The V-GOOD study was conducted in routine clinical practice to evaluate the effect of adding TMZ 80mg OD to treat patients with angina or angina equivalents despite treatment with background anti-anginal therapies.

Methods

This multicenter, prospective, observational study recruited symptomatic adult outpatients with a confirmed diagnosis of stable angina to whom physicians had decided to prescribe TMZ 80mg OD in 70 health facilities across Brazil from October 2021 to June 2022. Data on the number of angina attacks, the prevalence of angina-free patients, severity of angina (CCS class), impairment in daily activities, treatment adherence, tolerability, and physician and patient satisfaction were collected at baseline (V1) and at 1-month (V2) and 3-month (V3) follow-up visits. Patients with known hypersensitivity to TMZ, Parkinson's disease, related movement disorders, and severe or moderate renal impairment were excluded.

Results

1,029 patients (57.9% women) with a mean age of 66.8±10.3 years were included, and 959 (93.2%) completed all three planned visits. Diabetes (53.7%), dyslipidemia (85.1%), and hypertension (85.1%) were the most frequent cardiovascular risk factors; 55.7% of patients had angina CCS class II and 25.1% class III. At V1, the mean number of angina attacks per week was 5.1±3.7 despite anti-anginal therapy, including beta-blockers (82%), CCBs (23%), and nitrates (22%). Following the addition of TMZ 80 OD, it decreased to 3.4±3.3 attacks per week at V2 and 3.5±6.4 at V3 (P&lt;.001). The prevalence of angina-free patients increased from 15.4% (V1) to 73% at V3 (P&lt;.001); accordingly, there was a significant decrease in the proportion of patients with limiting angina (CCS 3 or 4) from 27.3% (V1) to 8.7% (V3) (P&lt;.001). The assessment of impairment in daily activities by a visual scale (ranging from 0 to 10) showed a significant improvement from V1 (5.1±2.2) to V3 (2.1±2.2) (P&lt;.001). Patient adherence to the anti-anginal treatment was excellent, with only 4.4% of patients reporting forgetting to take the drug. The incidence of any adverse event was 2.1% on V3, with 1.1% attributed to the drug. In the end, satisfaction with treatment was classified as satisfactory/very satisfactory by 97.1% of patients and 91.0% of doctors.

Conclusion

The study confirms that the new formulation of TMZ 80mg OD when added to anti-anginal therapy in patients with symptomatic chronic coronary syndrome effectively reduced the angina frequency and severity, improved functional class, yielded a significant proportion of patients free of angina, decreased physical limitation, and it was well tolerated.