ArticleDrug safety2014
Safety profile of dapagliflozin for type 2 diabetes: pooled analysis of clinical studies for overall safety and rare events.
Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 1 of them a synthesis that pooled it.
What it found
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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
49 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systematic Review of Literature Examining Bacterial Urinary Tract Infections in Diabetes.Journal of diabetes research · 2022Pooled it
- Dapagliflozin as an oral antihyperglycemic agent in the management of diabetes mellitus in patients with liver cirrhosis.World journal of experimental medicine · 2024Trial
- Long-term (52-week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT-2 study.Diabetes, obesity & metabolism · 2021Trial
- Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study.Diabetes, obesity & metabolism · 2018Trial
- Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin.Diabetes, obesity & metabolism · 2018 · on this mapTrial
- Dapagliflozin once daily plus exenatide once weekly in obese adults without diabetes: Sustained reductions in body weight, glycaemia and blood pressure over 1 year.Diabetes, obesity & metabolism · 2017 · on this mapTrial
- Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials.Journal of diabetes investigation · 2016Trial
- Trial
- Brazilian guidelines for the management of osteoporosis in diabetes mellitus.Diabetology & metabolic syndrome · 2025Review
- Role of sodium-glucose cotransporter 2 inhibitors in liver diseases.World journal of experimental medicine · 2025Review
- Exploring Dapagliflozin's Influence on Autophagic Flux in Mania-like Behaviour: Insights from the LKB1/AMPK/LC3 Pathway in a Mouse Model.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2025Article
- Insightful Perspectives on Sodium-glucose Co-transporter 2 Inhibitors: Navigating Safety Updates and Beyond.Current drug research reviews · 2025Review
- Antidiabetic Agents and Bone Quality: A Focus on Glycation End Products and Incretin Pathway Modulations.Journal of bone metabolism · 2024Article
- Acute Kidney Injury and Electrolyte Imbalances Caused by Dapagliflozin Short-Term Use.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Article
- Benefits and risks of drug combination therapy for diabetes mellitus and its complications: a comprehensive review.Frontiers in endocrinology · 2023Review
- New Therapeutic Horizons in Chronic Kidney Disease: The Role of SGLT2 Inhibitors in Clinical Practice.Drugs · 2022Article
- Renal outcomes with sodium-glucose cotransporters 2 inhibitors.Frontiers in endocrinology · 2022Review
- Safety of Dapagliflozin in Patients with Type 2 Diabetes Mellitus in Saudi Arabia: A Post Authorization Safety Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021Article
- The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus.Diabetologia · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDapagliflozin reduces hyperglycaemia in patients with type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion.
objectivesThis study determined the overall safety profile of dapagliflozin in T2DM.
methodsSafety of dapagliflozin in pooled analyses of phase IIb/III studies was evaluated. Patients received comparator or dapagliflozin as monotherapy, add-on to antidiabetic therapy, or as initial combination with metformin. Proportions of patients with adverse events (AEs) and prespecified parameters related to previous clinical observations and dapagliflozin's action were assessed. The principal analysis used data from 12 placebo-controlled studies. Rare events were assessed across phase IIb/III studies, including special populations, comparator-controlled trials and ongoing long-term extensions.
resultsIn placebo-controlled studies, hypoglycaemia was more common with dapagliflozin (11.8 %) than placebo (7.0 %), with imbalance driven by add-on of dapagliflozin to sulfonylurea or insulin. Urinary tract infections (4.8 vs 3.7 %), vulvovaginitis/balanitis and related infections (5.1 vs 0.9 %), and non-serious volume-related events (0.8 vs 0.4 %) occurred more often with dapagliflozin than placebo. No substantial AEs were seen on electrolytes or renal function. Pyelonephritis was rare and balanced among treatments; there were no imbalances in fractures or liver test elevations. Overall incidence of malignancies was balanced between groups. The incidence rate ratios of malignancy in certain organ systems were slightly lower for dapagliflozin (renal tract, female reproductive) and in others were slightly lower for control (breast, prostate, bladder). Most AEs associated with dapagliflozin were mild/moderate and related to the mechanism of action.
conclusionDapagliflozin has a favourable and predictable tolerability profile, with reported events related to its mechanism of action.
Indexed as
Identifiers
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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.