| Autor: |
Althobaiti FM; Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia.; Department of Endocrine and Diabetes, Armed Forces Hospital, Southern Region, Khamis Mushait 61961, Saudi Arabia.; Saudi Toxicology Society, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia., Alsanosi SM; Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia.; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow G12 8QQ, UK., Falemban AH; Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia.; Saudi Toxicology Society, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia., Alzahrani AR; Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia.; Saudi Toxicology Society, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia., Fataha SA; Department of Endocrine and Diabetes, Armed Forces Hospital, Southern Region, Khamis Mushait 61961, Saudi Arabia., Salih SO; Department of Endocrine and Diabetes, Armed Forces Hospital, Southern Region, Khamis Mushait 61961, Saudi Arabia., Alrumaih AM; Ministry of Defence, Riyadh 11159, Saudi Arabia., Alotaibi KN; Ministry of Defence, Riyadh 11159, Saudi Arabia., Althobaiti HM; King Faisal Medical City, Taif 26514, Saudi Arabia., Al-Ghamdi SS; Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia.; Saudi Toxicology Society, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia., Ayoub N; Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia.; Saudi Toxicology Society, Umm Al-Qura University (UQU), Makkah 21955, Saudi Arabia.; Department of Pharmacognosy, Faculty of Pharmacy, Ain-Shams University, Cairo 11566, Egypt. |
| Abstrakt: |
The Saudi Food and Drug Authority (SFDA) approved sodium-glucose cotransporter-2 (SGLT2) inhibitors in 2018. The efficacy and safety of empagliflozin (EMPA) have been confirmed in the U.S., Europe, and Japan for patients with type 2 diabetes mellitus (T2DM); however, analogous evidence is lacking for Saudi T2DM patients. Therefore, the current study aimed to assess the efficacy and safety of EMPA in Saudi patients (n = 256) with T2DM. This is a 12-week prospective, open-label, observational study. Adult Saudi patients with T2DM who had not been treated with EMPA before enrolment were eligible. The exclusion criteria included T2DM patients less than 18 years of age, adults with type one diabetes, pregnant women, paediatric population. The results related to efficacy included a significant decrease in haemoglobin A1c (HbA1c) (adjusted mean difference −0.93% [95% confidence interval (CI) −0.32, −1.54]), significant improvements in fasting plasma glucose (FPG) (−2.28 mmol/L [95% CI −2.81, −1.75]), and a reduction in body weight (−0.874 kg [95% CI −4.36, −6.10]) following the administration of 25 mg of EMPA once daily as an add-on to ongoing antidiabetic therapy after 12 weeks. The primary safety endpoints were the change in the mean blood pressure (BP) values, which indicated significantly reduced systolic and diastolic BP (−3.85 mmHg [95% CI −6.81, −0.88] and −0.06 mmHg [95% CI −0.81, −0.88], respectively) and pulse rate (−1.18 [95% CI −0.79, −3.15]). In addition, kidney function was improved, with a significant reduction in the urine albumin/creatinine ratio (UACR) (−1.76 mg/g [95% CI −1.07, −34.25]) and a significant increase in the estimated glomerular filtration rate (eGFR) (3.54 mL/min/1.73 m2 [95% CI 2.78, 9.87]). Furthermore, EMPA reduced aminotransferases (ALT) in a pattern (reduction in ALT > AST). The adjusted mean difference in the change in ALT was −2.36 U/L [95% CI −1.031, −3.69], while it was −1.26 U/L [95% CI −0.3811, −2.357] for AST and −1.98 U/L [95% CI −0.44, −3.49] for GGT. Moreover, in the EMPA group, serum high-density lipoprotein (HDL) significantly increased (0.29 mmol/L [95% CI 0.74, 0.15]), whereas a nonsignificant increase was seen in low-density lipoprotein (LDL) (0.01 mmol/L [95% CI 0.19, 0.18]) along with a significant reduction in plasma triglyceride (TG) levels (−0.43 mmol/L [95% CI −0.31, −1.17]). Empagliflozin once daily is an efficacious and tolerable strategy for treating Saudi patients with insufficiently controlled T2DM as an add-on to ongoing antidiabetic therapy. |
