ReviewDiabetes care2013
Interpreting adverse signals in diabetes drug development programs.
Review in Diabetes care, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed.
- Suppression of Postprandial Blood Glucose Fluctuations by a Low-Carbohydrate, High-Protein, and High-Omega-3 Diet via Inhibition of Gluconeogenesis.International journal of molecular sciences · 2018Article
- Pharmacology and therapeutic implications of current drugs for type 2 diabetes mellitus.Nature reviews. Endocrinology · 2016Review
- Diabetes Drugs and Cardiovascular Safety.Endocrinology and metabolism (Seoul, Korea) · 2016Review
- Causal inference methods to assess safety upper bounds in randomized trials with noncompliance.Clinical trials (London, England) · 2015Article
- Dipeptidyl-peptidase-4 inhibitors and pancreatic cancer: a cohort study.Diabetes, obesity & metabolism · 2014Article
- Pathophysiological and pharmacological rationale for the use of exenatide once weekly in patients with type 2 diabetes.Advances in therapy · 2014Review
- Comparative effectiveness of oral diabetes drug combinations in reducing glycosylated hemoglobin.Journal of comparative effectiveness research · 2014Article
- Signals and noise in drug safety analyses: the incretin therapy debate provides the rationale for revamping epidemiologic pharmacovigilance.Diabetes care · 2013Article
- Cardiovascular outcomes and safety with antidiabetic drugs.International journal of health sciencesReview
- Mapping Global Research on Adverse Effects of GLP-1 Receptor Agonists (2006-2025): A Scopus-Based Bibliometric and Thematic Analysis.Inquiry : a journal of medical care organization, provision and financingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Detection and interpretation of adverse signals during preclinical and clinical stages of drug development inform the benefit-risk assessment that determines suitability for use in real-world situations. This review considers some recent signals associated with diabetes therapies, illustrating the difficulties in ascribing causality and evaluating absolute risk, predictability, prevention, and containment. Individual clinical trials are necessarily restricted for patient selection, number, and duration; they can introduce allocation and ascertainment bias and they often rely on biomarkers to estimate long-term clinical outcomes. In diabetes, the risk perspective is inevitably confounded by emergent comorbid conditions and potential interactions that limit therapeutic choice, hence the need for new therapies and better use of existing therapies to address the consequences of protracted glucotoxicity. However, for some therapies, the adverse effects may take several years to emerge, and it is evident that faint initial signals under trial conditions cannot be expected to foretell all eventualities. Thus, as information and experience accumulate with time, it should be accepted that benefit-risk deliberations will be refined, and adjustments to prescribing indications may become appropriate.
Indexed as
Identifiers
What Socratic 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 Socratic graph.