Evaluating the Clinical Effectiveness and Safety of Semaglutide in Individuals with Uncontrolled Type 2 Diabetes. Real-World Evidence from Saudi Arabia: The Observational, Multicenter, 15-Month EVOLUTION Study

被引:6
作者
Alsheikh, Abdulrahman [1 ,2 ]
Alshehri, Ali [3 ]
Alzahrani, Saad [3 ]
Jammah, Anwar A. [4 ,5 ]
Alqahtani, Fahad [6 ]
Alotaibi, Metib [5 ,7 ]
Aldahash, Raed [7 ,8 ]
Alhozali, Amani M. [1 ,9 ]
Alsabaan, Fahad [10 ]
Almehthel, Mohammed [3 ]
Aljuhani, Naser [11 ]
Aldabeis, Ali [10 ]
Alamri, Moneer [12 ]
Maghawry, Waleed [13 ]
Alzaman, Naweed [14 ,15 ]
Alshaikh, Alshaima [16 ]
M. Alnozha, Omar [14 ,17 ]
Issak, Emad R. [18 ]
Alsifri, Saud [19 ]
机构
[1] King Abdulaziz Univ Hosp, Jeddah, Saudi Arabia
[2] Dr Suliman Fakeeh Hosp, Jeddah, Saudi Arabia
[3] King Fahad Med City, Riyadh, Saudi Arabia
[4] King Saud Univ Med City, Riyadh, Saudi Arabia
[5] Alhammadi Hosp, Riyadh, Saudi Arabia
[6] Tadawi Med Ctr, Abha, Saudi Arabia
[7] Dr Suliman Alhabeeb Hosp, Riyadh, Saudi Arabia
[8] King Abdallah Med City, Natl Guard, Riyadh, Saudi Arabia
[9] Int Med Ctr, Jeddah, Saudi Arabia
[10] Secur Forces Hosp, Riyadh, Saudi Arabia
[11] East Jeddah Hosp, Jeddah, Saudi Arabia
[12] Southern Armed Forces Hosp, Khamis Mushait, Saudi Arabia
[13] Alnahda Polyclin, Jeddah, Saudi Arabia
[14] Taibah Univ, Coll Med, Dept Med, Madinah, Saudi Arabia
[15] Madina Med Ctr, Madinah, Saudi Arabia
[16] King Abdallah Med City, Natl Guard, Jeddah, Saudi Arabia
[17] Saudi German Hosp, Madinah, Saudi Arabia
[18] Ain Shams Univ, Dept Internal Med, Cairo, Egypt
[19] Alhada Armed Forces Hosp, Taif, Saudi Arabia
关键词
Semaglutide; Type; 2; diabetes; HbA1c; Hypoglycemia; Weight reduction; ONCE-WEEKLY SEMAGLUTIDE; OPEN-LABEL; PHASE; 3A; ADD-ON; EFFICACY; METFORMIN; 56-WEEK;
D O I
10.1007/s13300-023-01516-z
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction: This study aimed to assess the safety and effectiveness of semaglutide, administered either by weekly subcutaneous (SC) injection or orally, in real-life practice in Saudi Arabia in individuals with type 2 diabetes mellitus (T2DM).Methods: A retrospective chart review study was conducted at 18 Saudi Arabia centers. An accredited centralized institutional review board approved the study. Medical records were included for individuals of any age >= 18 years with uncontrolled T2DM. The primary outcome measure was the laboratory glycated hemoglobin (HbA1c) level. Secondary measures included fasting blood glucose (FBG), weight, and hypoglycemia. All variables were checked after 6 and 12 months of semaglutide initiation.Results: The analysis of this study included 1223 patients with uncontrolled T2DM (HbA1c > 7%). The mean (SD) baseline HbA1c was 10.02% (1.17). HbA1c was reduced by an average of 3.02% (0.84) and 3.17% (0.84) at 6 and 12 months, respectively. Results of a repeated measure analysis of variance (ANOVA) indicated significant differences in HbA1c (p value < 0.001). HbA1c levels at 6 and 12 months were significantly lower, 7.00% (0.70) and 6.85% (0.69), than at baseline, 10.02% (1.17). About 193 patients (56.4%) of the 295 patients having HbA1c < 9% achieved HbA1c of 5.7% or less. The frequency of hypoglycemia events was 4.60 (1.10) in the 3 months before semaglutide was initiated. The frequency of hypoglycemia events in the last 3 months was 2.30 (0.80) events and 0.80 (0.50) events at 6-month and 12-month follow-up visits, respectively.The percent reduction in body mass index (BMI) was an average of 13.07% (1.53) and 19.89% (4.07) at 6 and 12 months, respectively. Lipid profile and blood pressure were improved at 6 and 12 months.Conclusion: Semaglutide, administered either by SC injection or orally, provided substantial glycemic and weight-loss benefits in adults with T2DM.
引用
收藏
页码:473 / 485
页数:13
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