Baseline characteristics of patients with type 2 diabetes mellitus initiating dapagliflozin in Saudi Arabia: Results from postauthorization safety study

Abstract

Context: There are limited reports in the literature regarding treatment with dapagliflozin in actual clinical settings in Saudi Arabia. Aims: The primary objective is to examine the safety profile of dapagliflozin in uncontrolled patients with type 2 diabetes mellitus (T2DM) in Saudi Arabia. In this brief report, we describe the baseline characteristics of patients initiating dapagliflozin in Saudi Arabia. Settings and Design: Prospective regulatory postmarketing study that was conducted in governmental and private hospitals in Riyadh and Jeddah, Saudi Arabia. Subjects and Methods: Five hundred T2DM patients initiating dapagliflozin at the decision of the treating physician as indicated by the Saudi Food and drug authority. Statistical Analysis Used: Data were statistically described in terms of frequencies and percentages for categorical variables. Mean, standard deviations (SD), minimum and maximum were used to describe the numerical variables. Results: At baseline, a total of 503 patients (female 38.8%, male 61.2%, and mean [SD] age 50.9 [10.1] years) were eligible for the analysis. Their mean body mass index was 32.8 (6.5) kg/m2. The mean duration of diabetes was 8.9 (8.3) years. Comorbidities were reported in 62% of our eligible population: 50.5% with hyperlipidemia and 39.6% with hypertension. Mean HbA1c at baseline was 8.6 (1.6) %, mean fasting blood glucose was 183.2 (70.1) mg/dL, and mean postprandial blood glucose was 237.8 (94.1) mg/dL. Conclusion: Recruited patients were matching our eligibility criteria and were representing average diabetic patients in the local community.

Keywords

• dapagliflozin
• hba1c
• pass
• patients' characteristics
• saudi arabia