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Effectiveness and tolerability of trimetazidine 80mg once daily in patients with chronic coronary syndrome: the V-GOOD observational study

2023· article· en· W4388601108 on OpenAlexaboutno aff
L Wolff Gowdak, Priscila Leocádia Rosa Dourado, Dalton Bertolim Précoma, Cesar Dusilek, F Silva, Juan Carlos Yugar‐Toledo, D. Gomes, Elizabeth Do Esp Cestario, Octavio Guimaraes, C Hoffmann Filho, Cícero Almeida, Gustavo Celestino Martins, Vı́tor F. Ferreira

Bibliographic record

VenueEuropean Heart Journal · 2023
Typearticle
Languageen
FieldMedicine
TopicAntiplatelet Therapy and Cardiovascular Diseases
Canadian institutionsnot available
FundersServier
KeywordsMedicineTolerabilityAnginaTrimetazidineInternal medicineObservational studyDyslipidemiaCanadian Cardiovascular SocietyAcute coronary syndromeDiabetes mellitusPhysical therapyAdverse effectDiseaseMyocardial infarction

Abstract

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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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.003
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.005
Threshold uncertainty score0.010

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0010.000
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.043
GPT teacher head0.290
Teacher spread0.248 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations0
Published2023
Admission routes1
Has abstractyes

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