Safety of Dapagliflozin in Patients with Type 2 Diabetes Mellitus in Saudi Arabia: A Post Authorization Safety Study.

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

SUBMITTER: Alguwaihes AM 

PROVIDER: S-EPMC8266941 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature