P6272First plus recurrent CV and hospitalization events in the CArdiovascular and Renal Microvascular outcomE study with LINAgliptin (CARMELINA) in patients with type 2 diabetes and cardiorenal disease
Bibliographic record
Abstract
Abstract Background/Introduction CARMELINA was a randomized placebo-controlled clinical trial designed to demonstrate the cardiovascular (CV) safety of linagliptin in patients with type 2 diabetes (T2D) and concomitant cardiorenal disease. Despite a particularly elevated CV risk, only limited long-term evidence from randomized controlled trials for safety and efficacy of glucose lowering medications is available for this population. Purpose To characterize the effects of linagliptin on net CV disease and hospitalization burden in this population. Methods People with T2D and either i) urine albumin creatinine ratio (UACR) >30 mg/g with concomitant CV disease, or ii) estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 regardless of UACR, or eGFR ≥45–75 mL/min/1.73m2 and UACR >200 mg/g, were randomized to linagliptin 5 mg or placebo q.d. in a double-blind fashion in addition to standard of care. We assessed the effects of linagliptin versus placebo on all first plus recurrent CV events and all-cause hospitalizations using a using a negative binomial model to account for within-subject correlation. Results A total of 6979 participants were enrolled (mean age 66 years, 63% male, eGFR 54.6 ml/min/1.73m2, median UACR 162 mg/g, 59% with history of ischemic heart disease, 27% with history of heart failure (HF)) and followed for a median of 2.2 years. Adding recurrent events increased the number of events for analysis from 5.3–57.5% across CV/HF outcomes and 112.4% for hospitalizations. In analyses of first plus recurrent events, the event rate ratio (95% CI) with linagliptin versus placebo was 0.98 (0.82, 1.16; p=0.78) for 3-point MACE, 1.03 (0.79, 1.35; p=0.83) for myocardial infarction 1.03 (0.83, 1.29; p=0.77) for myocardial infarction plus revascularization, 0.89 (0.65, 1.22; p=0.48) for stroke, 0.94 (0.70, 1.27; p=0.69) for stroke plus TIA, 0.94 (0.75, 1.20; p=0.63) for hospitalized HF, 0.92 (0.77, 1.11; p=0.40) for the composite of CV death or hospitalized HF, and 0.96 (0.87, 1.06; p=0.40) for all-cause hospitalization (Figure). Conclusion Linagliptin showed similar risk of either first or recurrent CV or hospitalization events compared with placebo in patients with T2D and cardiorenal disease. These data support the CV safety of linagliptin and, considering the high volume of recurrent events, underscores the significant CV disease burden experienced by patients with T2D and cardiorenal disease Acknowledgement/Funding Boehringer Ingelheim and Eli Lilly
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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 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 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) | 0.002 | 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".