Article: 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
2021 Volume 12, Issue 7, Page(s) 1979–1992
Abstract: ... 7.7) kg/m: Conclusion: Dapagliflozin was found to be a well tolerated and effective treatment ...
Abstract | Introduction: Sodium-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. Methods: This 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. Results: A 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 Conclusion: Dapagliflozin 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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Language | English |
Publishing date | 2021-06-12 |
Publishing country | United States |
Document type | Journal Article |
ZDB-ID | 2566702-6 |
ISSN | 1869-6961 ; 1869-6953 |
ISSN (online) | 1869-6961 |
ISSN | 1869-6953 |
DOI | 10.1007/s13300-021-01092-0 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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