Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study
Introduction: While ample evidence on improved glycemic control, weight reduction, and lowered blood pressure (BP) with sodium-glucose cotransporter type 2 inhibitors (SGLT2is) exists, real-world data on the potential benefit of SGLT2i on the diabetic population in the Middle East are lacking. The a...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Karger Publishers
2022-01-01
|
| Series: | Dubai Diabetes and Endocrinology Journal |
| Subjects: | |
| Online Access: | https://www.karger.com/Article/FullText/519871 |
| _version_ | 1818973380822433792 |
|---|---|
| author | Ahmed Hassoun Denish Kumar Dhanwal Jalal Nafach Yasmin Ajaz Asif Majid Khan Abdullah Ben Nakhi Monira AlArouj Khadija Hafidh Majdi AlNajjar Ahmed Reyas Sana Qamar Mohamed Alsayed Ahmad Bdair |
| author_facet | Ahmed Hassoun Denish Kumar Dhanwal Jalal Nafach Yasmin Ajaz Asif Majid Khan Abdullah Ben Nakhi Monira AlArouj Khadija Hafidh Majdi AlNajjar Ahmed Reyas Sana Qamar Mohamed Alsayed Ahmad Bdair |
| author_sort | Ahmed Hassoun |
| collection | DOAJ |
| description | Introduction: While ample evidence on improved glycemic control, weight reduction, and lowered blood pressure (BP) with sodium-glucose cotransporter type 2 inhibitors (SGLT2is) exists, real-world data on the potential benefit of SGLT2i on the diabetic population in the Middle East are lacking. The aim of our study was to describe the glycemic control, changes in body weight, body mass index (BMI), lipid profile, and BPs in patients receiving dapagliflozin with other antidiabetic medication. Methods: The REWARD study was a multicenter, post-authorization, prospective, open-label, noninterventional, real-world, cohort study. We enrolled 511 adult, type 2 diabetes mellitus patients on antidiabetic medications. These patients were started on dapagliflozin and followed up for 1 year to assess changes in their clinical and laboratory outcomes. Results: The mean HbA1c decreased significantly from 8.5 ± 1.6% at baseline to 7.6 ± 1.3% after 12 months (p value <0.001), with an absolute change of 0.9%. Of the study population, 41.6% of patients reached an HbA1c level less than 7% (53 mmol/mol). The systolic pressure improved (mean change = −1.9 mm Hg, p value = 0.003), yet no change in the diastolic pressure was observed. Both body weight and BMI significantly decreased by 0.7 kg and 0.2 kg/m2, respectively (p value <0.001). About 84.5% of patients were on antidyslipidemic agents, while 57.4% were on antihypertensives. Approximately 83.6% of adverse events were mild. A total of 90 hypoglycemic episodes were reported; none were severe. Conclusion: In a real-world setting, dapagliflozin in combination with other antidiabetic medications exhibited significant improvement in glycemic control, weight, BMI, and systolic BP. Additionally, it demonstrated a well-tolerated safety profile. |
| first_indexed | 2024-12-20T15:23:15Z |
| format | Article |
| id | doaj.art-059bfb4103f2495e97b4cf10defae7cc |
| institution | Directory Open Access Journal |
| issn | 2673-1797 2673-1738 |
| language | English |
| last_indexed | 2024-12-20T15:23:15Z |
| publishDate | 2022-01-01 |
| publisher | Karger Publishers |
| record_format | Article |
| series | Dubai Diabetes and Endocrinology Journal |
| spelling | doaj.art-059bfb4103f2495e97b4cf10defae7cc2022-12-21T19:35:57ZengKarger PublishersDubai Diabetes and Endocrinology Journal2673-17972673-17382022-01-0111010.1159/000519871519871Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD StudyAhmed Hassoun0Denish Kumar Dhanwal1Jalal Nafach2Yasmin Ajaz3Asif Majid Khan4Abdullah Ben Nakhi5Monira AlArouj6Khadija Hafidh7https://orcid.org/0000-0002-3632-4336Majdi AlNajjar8Ahmed Reyas9Sana Qamar10Mohamed Alsayed11Ahmad Bdair12https://orcid.org/0000-0001-7476-2401Diabetes Department, Dubai Diabetes Centre, Dubai, United Arab EmiratesDepartment of Endocrinology, Diabetes and Metabolic Disorders, NMC Specialty Hospital, Dubai, United Arab EmiratesDiabetes Department, Dubai Diabetes Centre, Dubai, United Arab EmiratesDepartment of Internal Medicine and Endocrinology, Belhoul Speciality Hospital, Dubai, United Arab EmiratesDepartment of Internal Medicine, Diabetes, and Endocrinology, Aster Medical Centre, Ras Al Khaimah, United Arab EmiratesRegulatory Affairs Department, Dasman Diabetes Institute, Kuwait, KuwaitDasman Diabetes Institute, Clinical Department, Kuwait, KuwaitInternal Medicine Diabetes Unit, Rashid Hospital Dubai, Dubai, United Arab EmiratesEndocrinology Department, Zayed Military Hospital, Abu Dhabi, United Arab EmiratesInternal Medicine Department, Prime Medical Center, Dubai, United Arab EmiratesMedical Affairs Department, AstraZeneca Gulf, Dubai, United Arab EmiratesMedical Affairs Department, AstraZeneca Gulf, Dubai, United Arab EmiratesMedical Affairs Department, AstraZeneca Gulf, Dubai, United Arab EmiratesIntroduction: While ample evidence on improved glycemic control, weight reduction, and lowered blood pressure (BP) with sodium-glucose cotransporter type 2 inhibitors (SGLT2is) exists, real-world data on the potential benefit of SGLT2i on the diabetic population in the Middle East are lacking. The aim of our study was to describe the glycemic control, changes in body weight, body mass index (BMI), lipid profile, and BPs in patients receiving dapagliflozin with other antidiabetic medication. Methods: The REWARD study was a multicenter, post-authorization, prospective, open-label, noninterventional, real-world, cohort study. We enrolled 511 adult, type 2 diabetes mellitus patients on antidiabetic medications. These patients were started on dapagliflozin and followed up for 1 year to assess changes in their clinical and laboratory outcomes. Results: The mean HbA1c decreased significantly from 8.5 ± 1.6% at baseline to 7.6 ± 1.3% after 12 months (p value <0.001), with an absolute change of 0.9%. Of the study population, 41.6% of patients reached an HbA1c level less than 7% (53 mmol/mol). The systolic pressure improved (mean change = −1.9 mm Hg, p value = 0.003), yet no change in the diastolic pressure was observed. Both body weight and BMI significantly decreased by 0.7 kg and 0.2 kg/m2, respectively (p value <0.001). About 84.5% of patients were on antidyslipidemic agents, while 57.4% were on antihypertensives. Approximately 83.6% of adverse events were mild. A total of 90 hypoglycemic episodes were reported; none were severe. Conclusion: In a real-world setting, dapagliflozin in combination with other antidiabetic medications exhibited significant improvement in glycemic control, weight, BMI, and systolic BP. Additionally, it demonstrated a well-tolerated safety profile.https://www.karger.com/Article/FullText/519871dapagliflozinsodium-glucose cotransporter type 2sodium-glucose cotransporter type 2 inhibitorsdiabetes mellitustype 2 diabetes mellitustype 2 diabetes |
| spellingShingle | Ahmed Hassoun Denish Kumar Dhanwal Jalal Nafach Yasmin Ajaz Asif Majid Khan Abdullah Ben Nakhi Monira AlArouj Khadija Hafidh Majdi AlNajjar Ahmed Reyas Sana Qamar Mohamed Alsayed Ahmad Bdair Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study Dubai Diabetes and Endocrinology Journal dapagliflozin sodium-glucose cotransporter type 2 sodium-glucose cotransporter type 2 inhibitors diabetes mellitus type 2 diabetes mellitus type 2 diabetes |
| title | Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study |
| title_full | Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study |
| title_fullStr | Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study |
| title_full_unstemmed | Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study |
| title_short | Real-World Assessment of Efficacy and Safety Parameters for Dapagliflozin in Management of Type 2 Diabetes Mellitus: REWARD Study |
| title_sort | real world assessment of efficacy and safety parameters for dapagliflozin in management of type 2 diabetes mellitus reward study |
| topic | dapagliflozin sodium-glucose cotransporter type 2 sodium-glucose cotransporter type 2 inhibitors diabetes mellitus type 2 diabetes mellitus type 2 diabetes |
| url | https://www.karger.com/Article/FullText/519871 |
| work_keys_str_mv | AT ahmedhassoun realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT denishkumardhanwal realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT jalalnafach realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT yasminajaz realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT asifmajidkhan realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT abdullahbennakhi realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT moniraalarouj realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT khadijahafidh realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT majdialnajjar realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT ahmedreyas realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT sanaqamar realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT mohamedalsayed realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy AT ahmadbdair realworldassessmentofefficacyandsafetyparametersfordapagliflozininmanagementoftype2diabetesmellitusrewardstudy |