12-month post-trial follow-up of participants in the Australian arm of the second low-dose colchicine trial
Bibliographic record
Abstract
Abstract Background In the Australian arm of the LoDoCo2 trial, colchicine 0.5mg daily compared with placebo markedly reduced the risk of cardiovascular (CV) events in patients with chronic coronary disease (2.0 vs 3.9 events per 100 person years, HR 0.51; 95% CI 0.39–0.67). The purpose of this analysis was to explore CV and non-CV outcomes in the Australian cohort out to one year after cessation of trial medication. Methods Information was collected on all potential CV events and non-CV deaths as well as a range of other co-morbidities. All CV events were blindly adjudicated. The analysis examined the primary outcome (a composite of CV death, myocardial infarction, ischemic stroke, and unscheduled revascularization) and non-CV deaths by initial randomized treatment from the beginning of the trial up until one year after cessation of trial medication. A landmark analysis was then used to examine these outcomes from the date of last contact during the trial until one year after cessation of trial medication. Results The clinical status was confirmed in 1819/1824 (99.7%) participants who were alive at the end of the trial, and in 100% of those participants still taking trial medication at the end of the trial. During post-trial follow up, 515 patients (28.2%) were taking non-study colchicine, including 278 (30.5%) originally randomized to colchicine and 237 (25.9%) randomized to placebo. Over the entire follow-up period that included the 12-month period after the trial medication was ceased, the effect of prior exposure to colchicine on the primary CV outcome was still evident (2.2 vs 3.8 events per 100 person years, HR 0.58; 95% CI 0.45–0.74), however no post-trial CV benefit were apparent in the landmark analysis (3.3 vs 3.4 events per 100 person years, HR 0.97; 95% CI 0.56–0.1.69). Over the entire course of follow-up the incidence of new cancer (7.9% vs 7.2% RR 0.91; 95% CI 0.66–1.25) and non-CV death (0.9 vs 0.6 events per 100 person years, HR 1.44; 95% CI 0.92–2.27) was no different in the treatment groups. Conclusion Although the CV benefits of colchicine treatment that emerged during the trial were still evident in the year after stopping study treatment, no additional CV benefit accrued after it was ceased. These data suggest that colchicine should be continued long-term to maximize its CV benefits. Funding Acknowledgement Type of funding sources: None.
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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 | 0.004 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 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".