Side effects of low-dose colchicine in chronic coronary syndromes, the LoDoCo2 trial
Bibliographic record
Abstract
Abstract Background Recent trials have demonstrated that low-dose colchicine can reduce the risk of cardiovascular events in patients with coronary artery disease.(1) However, discontinuation rates of trial medication ranged from 10.1% to 25.9%, potentially reducing its effectiveness.(2,3) The role of side effects in this remains unclear. Purpose To evaluate the incidence and type of side effects that led to premature discontinuation of trial medication in participants with chronic coronary syndromes in the Low-Dose Colchicine 2 (LoDoCo2) trial. Methods We evaluated the incidence of side effects leading to discontinuation of trial medication in the LoDoCo2 trial, which consisted of a 30-day run-in phase during which all participants received colchicine 0.5 mg once daily, followed by randomization to colchicine or placebo. Side effects of colchicine were evaluated at the end of the run-in phase (early side effects, within 30 days) and during the randomization phase (late side effects, median follow-up: 29.5 months). Cumulative incidences of side effects are presented using Kaplan-Meier curves and compared by treatment arm using Cox proportional hazards modelling. Results Trial medication was discontinued by 997 of 6519 (15.3%) participants during the run-in phase, of whom 618 (9.5%) participants reported early side effects. After randomization, 273 (10.0%) participants in the colchicine group and 281 (10.3%) participants in the placebo group discontinued trial medication. Among those who stopped trial medication, 114 participants in the colchicine group reported side effects (4.2%, 1.6 events per 100 person-years), compared to 120 participants in the placebo group (4.4%, 1.7 events per 100 person-years, hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.73–1.22). Gastrointestinal upset and myalgia were the most common side effects (2.0% and 1.2% in the colchicine group and 1.7% and 1.6% in the placebo group, respectively), with no differences between treatment groups. Female sex was independently associated with an increased risk of both early- and late side effects, irrespective of treatment allocation. Statin use was independently associated with lower rates of late side effects, with no difference between colchicine and placebo. Conclusion After the open-label run-in phase, the incidence of late side effects in participants with chronic coronary syndromes did not differ between patients randomized to low-dose colchicine or placebo.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot 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.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".