End-of-trial inflammatory biomarkers, lipid levels, creatine kinase and markers of renal and liver function in the LoDoCo2 trial
Bibliographic record
Abstract
Abstract Background The Low-Dose Colchicine 2 (LoDoCo2) trial demonstrated that colchicine reduced major cardiovascular events in patients with chronic coronary artery disease (CAD). The effect of long-term colchicine treatment on inflammatory biomarkers and markers reflecting renal and liver function have not been investigated yet. Purpose This substudy examines levels of inflammatory biomarkers, lipid fractions, creatine kinase (CK) and markers of renal and liver function at close-out of the trial. Methods The LoDoCo2 trial randomly assigned patients with chronic CAD to colchicine 0.5 mg once daily or placebo. Blood samples were drawn during close-out visits after a median follow-up of 32.7 (interquartile range [IQR] 24.0–48.6) months. Results Assignment to colchicine was associated with lower levels of high-sensitivity C-Reactive Protein (0.94 mg/L [0.53–1.93] vs. 1.24 mg/L [0.73–2.55]; −24.2%; p<0.01) and interleukin-6 (2.70 ng/L [1.79–4.18] vs. 3.16 ng/L [2.07–4.95]; −14.9%; p<0.01), but was not associated with any differences in lipid fractions or markers of renal function. Although CK levels were higher after colchicine (123.0 U/L, [84.0–184.0] vs. 110.0 U/L, [77.0–164.0], p<0.01), the number of participants with marked elevations of CK (>5 times upper limit of normal [ULN]) was low and not different between treatment groups. Levels of alanine aminotransferase (ULN 40 U/L) and albumin (ULN 50 U/L) were higher (p<0.01) in the colchicine group compared to placebo (30.0 U/L [22.0–40.0] vs. 26.0 U/L [19.0–34.0] and 43.01 g/L±2.39 vs. 42.64 g/L±2.48, respectively). There were no differences in gamma-glutamyl transferase or bilirubin. Conclusion Long-term low-dose colchicine in patients with chronic CAD was associated with lower levels of hs-CRP and IL-6 but was not associated with clinically important differences in lipid fractions, CK, renal or liver function. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): The National Health Medical Research Council of AustraliaThe Netherlands Organization for Health Research and Development
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".