Effect of semaglutide in patients with type 2 diabetes and peripheral artery disease: an analysis of the STRIDE trial stratified by disease severity and age
Bibliographic record
Abstract
Abstract Introduction Peripheral artery disease (PAD) is a prevalent atherosclerotic condition in people with type 2 diabetes (T2D) which impairs perfusion in the lower limbs. Disease progression can lead to exercise-induced pain (intermittent claudication) and severe functional impairment. Disease severity at presentation, along with age, may inform prognosis for the affected limb, thereby guiding subsequent treatment strategies. Ankle-brachial index (ABI) is commonly used to screen for lower extremity PAD. In people with T2D, however, vessel incompressibility due to medial arterial calcification may result in a falsely normal or elevated ABI. The alternative toe-brachial index (TBI) is less susceptible to incompressibility artefacts from medial calcification in the digital arteries. Guidelines recommend TBI <0.7 as a diagnostic cutoff for PAD in patients with incompressible ABIs. The STRIDE trial demonstrated that semaglutide improved functional parameters, symptom status and haemodynamic measures in patients with PAD. Whether these benefits were consistent across measures of PAD severity and age is not known. Purpose To investigate whether the benefits of semaglutide in STRIDE were consistent by baseline PAD severity and age. Methods STRIDE enrolled 792 participants with PAD and T2D who were randomised to receive either once-weekly s.c. semaglutide 1.0 mg or placebo for 52 weeks. The primary and a confirmatory secondary endpoint were change in maximum walking distance (MWD) and pain-free walking distance (PFWD) on a constant load treadmill (fixed speed: 3.2 km/h and fixed inclination: 12%), respectively, at week 52. These endpoints were measured as ratio to baseline and presented as estimated treatment ratios, a ratio of the endpoints in semaglutide vs placebo groups. Analyses were stratified according to age (<65 and ≥65 years) and median TBI status (<0.52 and ≥0.52). A mixed model for repeated measures analysis, with an interaction term between the treatment and relevant subgroups adjusted for baseline of the endpoint, was performed. Results Participants had a mean (SD) age of 66.6 (9.4) years and a baseline geometric mean (CV) TBI, MWD and PFWD of 0.48 (0.4), 190.5 (0.6), and 116.2 (0.6), respectively. At Week 52, MWD ratio to baseline (geometric mean) in semaglutide vs placebo groups were 1.35 vs 1.14 in the <65-year group and 1.2 vs 1.08 in the ≥65-year group, respectively, and 1.24 vs 1.1 in the TBI <0.52 group and 1.3 vs 1.11 in the TBI ≥0.52 group. Similar trends were observed for PFWD. No significant interactions were observed with TBI or age groups for treatment effects on MWD and PFWD (Figure). Conclusions These analyses demonstrate a consistent benefit of semaglutide across different levels of lower limb perfusion deficit, as assessed by TBI recordings, in individuals with T2D and PAD. Additionally, the benefit of semaglutide persists across age groups, for functional outcomes, which are often negatively impacted by age.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| 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".