Meta-Analysis of Randomized Trials: Efficacy and Safety of Colchicine for Secondary Prevention of Cardiovascular Disease
Bibliographic record
Abstract
Background. Colchicine has shown potential cardioprotective effects owing to its broad anti-inflammatory properties. We performed a meta-analysis to assess its safety and efficacy in secondary prevention in patients with established coronary artery disease (CAD). Methods. We searched Ovid Healthstar, MEDLINE, and Embase (inception to May 2022) for randomized controlled trials (RCTs) evaluating the cardiovascular effects of colchicine compared with placebo or usual care in patients with CAD. Study-level data on efficacy and safety outcomes were pooled using the Peto method. The primary outcome was the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke. Results. A total of 8 RCTs were included with a follow-up duration of ≥1 month, comprising a total of 12,151 patients. Compared with placebo or usual care, colchicine was associated with a significant risk reduction in the primary outcome (odds ratio (OR) 0.70, 95% CI 0.60 to 0.83, <a:math xmlns:a="http://www.w3.org/1998/Math/MathML" id="M1"><a:mi>P</a:mi><a:mo><</a:mo><a:mn>0.0001</a:mn></a:math> ; <c:math xmlns:c="http://www.w3.org/1998/Math/MathML" id="M2"><c:msup><c:mrow><c:mi>I</c:mi></c:mrow><c:mrow><c:mn>2</c:mn></c:mrow></c:msup><c:mo>=</c:mo><c:mn>52</c:mn><c:mo>%</c:mo></c:math> ). Risks of MI (OR 0.75, 95% CI 0.62 to 0.91, <e:math xmlns:e="http://www.w3.org/1998/Math/MathML" id="M3"><e:mi>P</e:mi><e:mo>=</e:mo><e:mn>0.003</e:mn></e:math> ; <g:math xmlns:g="http://www.w3.org/1998/Math/MathML" id="M4"><g:msup><g:mrow><g:mi>I</g:mi></g:mrow><g:mrow><g:mn>2</g:mn></g:mrow></g:msup><g:mo>=</g:mo><g:mn>33</g:mn><g:mo>%</g:mo></g:math> ), stroke (OR 0.47, 95% CI 0.30 to 0.74, <i:math xmlns:i="http://www.w3.org/1998/Math/MathML" id="M5"><i:mi>P</i:mi><i:mo>=</i:mo><i:mn>0.001</i:mn></i:math> ; <k:math xmlns:k="http://www.w3.org/1998/Math/MathML" id="M6"><k:msup><k:mrow><k:mi>I</k:mi></k:mrow><k:mrow><k:mn>2</k:mn></k:mrow></k:msup><k:mo>=</k:mo><k:mn>0</k:mn><k:mo>%</k:mo></k:math> ), and unplanned coronary revascularization (OR 0.67, 95% CI 0.55 to 0.82, <m:math xmlns:m="http://www.w3.org/1998/Math/MathML" id="M7"><m:mi>P</m:mi><m:mo>=</m:mo><m:mn>0.0001</m:mn></m:math> ; <o:math xmlns:o="http://www.w3.org/1998/Math/MathML" id="M8"><o:msup><o:mrow><o:mi>I</o:mi></o:mrow><o:mrow><o:mn>2</o:mn></o:mrow></o:msup><o:mo>=</o:mo><o:mn>58</o:mn><o:mo>%</o:mo></o:math> ) were all reduced in the colchicine group. Rates of CV and all-cause mortality did not differ between the two groups, but there was an increase in noncardiac deaths with colchicine (OR 1.54, 95% CI 1.10 to 2.15, <q:math xmlns:q="http://www.w3.org/1998/Math/MathML" id="M9"><q:mi>P</q:mi><q:mo>=</q:mo><q:mn>0.01</q:mn></q:math> ; <s:math xmlns:s="http://www.w3.org/1998/Math/MathML" id="M10"><s:msup><s:mrow><s:mi>I</s:mi></s:mrow><s:mrow><s:mn>2</s:mn></s:mrow></s:msup><s:mo>=</s:mo><s:mn>51</s:mn><s:mo>%</s:mo></s:math> ). The occurrence of all other adverse events was similar between the two groups, including GI reactions (OR 1.06, 95% CI 0.94 to 1.20, <u:math xmlns:u="http://www.w3.org/1998/Math/MathML" id="M11"><u:mi>P</u:mi><u:mo>=</u:mo><u:mn>0.35</u:mn></u:math> ; <w:math xmlns:w="http://www.w3.org/1998/Math/MathML" id="M12"><w:msup><w:mrow><w:mi>I</w:mi></w:mrow><w:mrow><w:mn>2</w:mn></w:mrow></w:msup><w:mo>=</w:mo><w:mn>42</w:mn><w:mo>%</w:mo></w:math> ) and infections (OR 1.04, 95% CI 0.84 to 1.28, <y:math xmlns:y="http://www.w3.org/1998/Math/MathML" id="M13"><y:mi>P</y:mi><y:mo>=</y:mo><y:mn>0.74</y:mn></y:math> ; <ab:math xmlns:ab="http://www.w3.org/1998/Math/MathML" id="M14"><ab:msup><ab:mrow><ab:mi>I</ab:mi></ab:mrow><ab:mrow><ab:mn>2</ab:mn></ab:mrow></ab:msup><ab:mo>=</ab:mo><ab:mn>53</ab:mn><ab:mo>%</ab:mo></ab:math> ). Conclusions. Colchicine therapy may reduce the risk of future cardiovascular events in patients with established CAD; however, there remains a concern about non-CV mortality. Further trials are underway that will shed light on non-CV mortality and colchicine NCT03048825, and NCT02898610.
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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 | 0.033 | 0.074 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.025 | 0.052 |
| Bibliometrics | 0.007 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".