Effectiveness and tolerability of trimetazidine 80mg once daily in patients with chronic coronary syndrome: the V-GOOD observational study
Notice bibliographique
Résumé
Abstract 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<.001). The prevalence of angina-free patients increased from 15.4% (V1) to 73% at V3 (P<.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<.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<.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.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».