ReviewIndian heart journal
Cardiovascular outcome trials for anti-diabetes medication: A holy grail of drug development?
Review in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- The Timeline of the Association Between Diabetes and Cardiovascular Diseases: A Narrative Review.Journal of clinical medicine · 2025Review
- Methodology of clinical trials on sodium-glucose cotransporter 2 inhibitors registered on ClinicalTrials.gov: a cross-sectional study.BMC medical research methodology · 2024Article
- Cardiorenal Syndrome in Type 2 Diabetes Mellitus - Rational Use of Sodium-glucose Cotransporter-2 Inhibitors.European endocrinology · 2020Review
- Cardiovascular safety outcomes of once-weekly GLP-1 receptor agonists in people with type 2 diabetes.Journal of clinical pharmacy and therapeutics · 2020Review
- Diabetic Gastroparesis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Article
- Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From aDiabetes care · 2018 · on this mapArticle
- Follow the LEADER-Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results Trial.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016Article
- Modern sulphonylureas and cardiovascular adverse effects: Will CAROLINA put an end to the controversy?Indian heart journalReview
- Unravelling the utility of modern sulfonylureas from cardiovascular outcome trials and landmark trials: expert opinion from an international panel.Indian heart journalReview
- Salutogenesis in Type 2 Diabetes Care: A Biopsychosocial Perspective.Indian journal of endocrinology and metabolismArticle
- Glycemic equipoise.Indian journal of endocrinology and metabolismArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Since the time questions arose on cardiovascular safety of Rosiglitazone, FDA has suggested guidelines on conduct of studies on anti-diabetic drugs so as to prove that the cardiovascular risk is acceptable. Based on the cardiovascular risks of pre-approval clinical trials, guidelines have been made to conduct cardiovascular safety outcome trials (CVSOTs) prior to the drug approval or after the drug has been approved. Unlike the trials comparing the efficacy of antidiabetic agents, the CVSOTs examine the cardiovascular safety of a drug in comparison to standard of care. These trials are expensive aspects of drug development and are associated with various technical and operational challenges. More cost effective models of assessing cardiovascular safety like use of biomarkers, electronic medical records, pragmatic and factorial designs can be adopted. This article critically looks at the antidiabetic drug approval from a cardiovascular perspective by asking a few questions and arriving at answers.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.