ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2021
Safety of Dapagliflozin in Patients with Type 2 Diabetes Mellitus in Saudi Arabia: A Post Authorization Safety Study.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic literature review on the burden of diabetic ketoacidosis in type 2 diabetes mellitus.Diabetes, obesity & metabolism · 2025Pooled it
- Beyond glycemic control: SGLT2 inhibitors as time-sensitive organ-protective agents in acute injury-mechanistic insights and translational implications.Frontiers in pharmacology · 2026Review
- Type 2 Diabetes Mellitus in Saudi Arabia: Prevalence, Risk Factors, and Management Strategies: A Review.Endocrine, metabolic & immune disorders drug targets · 2026Review
- Sodium-glucose cotransporter 2 inhibitor-associated severe epididymo-orchitis.BMJ case reports · 2022Article
- Efficacy and safety of empagliflozin: a "real-world" experience from Saudi Arabia.Annals of Saudi medicineReview
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Authors and funding
1 author.
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Abstract
introductionSodium-glucose co-transporter-2 (SGLT2) inhibitors moderately reduce glucose levels in type-2 diabetes mellitus (T2DM). Some cases of diabetic ketoacidosis (DKA) were reported with SGLT2 inhibitors. However, data on the long-term safety of dapagliflozin in Saudi Arabia are lacking. The present study aimed to monitor the safety of dapagliflozin in patients with T2DM and evaluate the change in HbA1c during the observation period compared to baseline.
methodsThis was a local, prospective, single-arm, non-interventional, regulatory post-marketing study. The study was conducted in Saudi Arabia from May 2017 to September 2019. Patients received either 5 or 10 mg dapagliflozin in conjunction with diet and exercise modifications to treat T2DM. The occurrence of adverse events was observed over the treatment duration and for 3 days after administering the last dose of dapagliflozin.
resultsA total of 527 patients were recruited in the study, 524 of which were eligible for the statistical analysis. About 62% were males. The median (IQR) age was 52.3 (14.8) years, while the median (IQR) body mass index was 31.6 (7.7) kg/m
conclusionDapagliflozin was found to be a well tolerated and effective treatment option for T2DM patients in Saudi Arabia. Vulvovaginal pruritus and dysuria were the most common adverse events.
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