Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients?
Objective This study evaluated the characteristics of new users of sodium glucose co-transporter 2 inhibitors (SGLT2i) in clinical practice to assess the applicability of the findings from clinical trials (Empagliflozin, Cardiovascular Outcomes and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) tri...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-05-01
|
| Series: | BMJ Open Diabetes Research & Care |
| Online Access: | https://drc.bmj.com/content/7/1/e000742.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846121652954333184 |
|---|---|
| author | Ming-Jui Hung Edward Chia-Cheng Lai Shih-Chieh Shao Yi-Han Lin Kai-Cheng Chang Yuk-Ying Chan Yea-Huei Kao Yang |
| author_facet | Ming-Jui Hung Edward Chia-Cheng Lai Shih-Chieh Shao Yi-Han Lin Kai-Cheng Chang Yuk-Ying Chan Yea-Huei Kao Yang |
| author_sort | Ming-Jui Hung |
| collection | DOAJ |
| description | Objective This study evaluated the characteristics of new users of sodium glucose co-transporter 2 inhibitors (SGLT2i) in clinical practice to assess the applicability of the findings from clinical trials (Empagliflozin, Cardiovascular Outcomes and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial, Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 trial, Canagliflozin Cardiovascular Assessment Study (CANVAS) program and the Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes (VERTIS-CV) trial) and multinational observational studies (CVD-REAL Nordic study and CVD-REAL 2 study).Research design and methods We conducted a retrospective cohort study using the largest electronic medical records database from seven hospitals in Taiwan. We included adult patients with type 2 diabetes initiating canagliflozin, dapagliflozin and empagliflozin between 1 January 2018 and 31 August 2019. We compared the patient characteristics with SGLT2i to examine the data representativeness of clinical trials and to evaluate channeling uses between canagliflozin, dapagliflozin and empagliflozin.Results We identified a cohort of 11 650 patients newly initiating SGLT2i, 49.9% of whom received empagliflozin. However, only 18.7%, 19.2%, 50.4% and 57.3% of real-world SGLT2i new users were included in the EMPA-REG OUTCOME trial, VERTIS-CV trial, DECLARE-TIMI 58 trial and CANVAS program, respectively. Reasons for exclusion were largely reduced cardiovascular disease risks in real-world patients, namely 72.8%, 73.6% and 34.2% for EMPA-REG OUTCOME trial, VERTIS-CV trial and DECLARE-TIMI 58 trial and CANVAS program, respectively. However, hemoglobin A1c out of range accounted for the most frequent reason (25.0%) for exclusion of real-world patients from the CANVAS program. We found channeling uses in different SGLT2i, for example, more patients receiving empagliflozin (15.3%) and canagliflozin (19.6%) had poorer renal functions (eg, estimated glomerular filtration rate <60 mL/min/1.73 m2), compared with dapagliflozin (9.3%).Conclusions The findings provide clear evidence that results from current studies may be less applicable to real-world patients. Further studies are required to support the concept of real-world cardiovascular event protection through SGLT2i. |
| format | Article |
| id | doaj-art-784f8a2d02c14fe899c0183b30ecc976 |
| institution | Kabale University |
| issn | 2052-4897 |
| language | English |
| publishDate | 2019-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Diabetes Research & Care |
| spelling | doaj-art-784f8a2d02c14fe899c0183b30ecc9762024-12-15T16:30:07ZengBMJ Publishing GroupBMJ Open Diabetes Research & Care2052-48972019-05-017110.1136/bmjdrc-2019-000742Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients?Ming-Jui Hung0Edward Chia-Cheng Lai1Shih-Chieh Shao2Yi-Han Lin3Kai-Cheng Chang4Yuk-Ying Chan5Yea-Huei Kao Yang6Section of Cardiology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan2 School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwansenior pharmacist educatorDepartment of Pharmacy, Keelung Chang Gung Memorial Hospital, Keelung, TaiwanDepartment of Pharmacy, Linkou Chang Gung Memorial Hospital, Taoyuan, TaiwanDepartment of Pharmaceutical Materials Management, Chang Gung Medical Foundation, Taoyuan, TaiwanSchool of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, TaiwanObjective This study evaluated the characteristics of new users of sodium glucose co-transporter 2 inhibitors (SGLT2i) in clinical practice to assess the applicability of the findings from clinical trials (Empagliflozin, Cardiovascular Outcomes and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial, Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 trial, Canagliflozin Cardiovascular Assessment Study (CANVAS) program and the Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes (VERTIS-CV) trial) and multinational observational studies (CVD-REAL Nordic study and CVD-REAL 2 study).Research design and methods We conducted a retrospective cohort study using the largest electronic medical records database from seven hospitals in Taiwan. We included adult patients with type 2 diabetes initiating canagliflozin, dapagliflozin and empagliflozin between 1 January 2018 and 31 August 2019. We compared the patient characteristics with SGLT2i to examine the data representativeness of clinical trials and to evaluate channeling uses between canagliflozin, dapagliflozin and empagliflozin.Results We identified a cohort of 11 650 patients newly initiating SGLT2i, 49.9% of whom received empagliflozin. However, only 18.7%, 19.2%, 50.4% and 57.3% of real-world SGLT2i new users were included in the EMPA-REG OUTCOME trial, VERTIS-CV trial, DECLARE-TIMI 58 trial and CANVAS program, respectively. Reasons for exclusion were largely reduced cardiovascular disease risks in real-world patients, namely 72.8%, 73.6% and 34.2% for EMPA-REG OUTCOME trial, VERTIS-CV trial and DECLARE-TIMI 58 trial and CANVAS program, respectively. However, hemoglobin A1c out of range accounted for the most frequent reason (25.0%) for exclusion of real-world patients from the CANVAS program. We found channeling uses in different SGLT2i, for example, more patients receiving empagliflozin (15.3%) and canagliflozin (19.6%) had poorer renal functions (eg, estimated glomerular filtration rate <60 mL/min/1.73 m2), compared with dapagliflozin (9.3%).Conclusions The findings provide clear evidence that results from current studies may be less applicable to real-world patients. Further studies are required to support the concept of real-world cardiovascular event protection through SGLT2i.https://drc.bmj.com/content/7/1/e000742.full |
| spellingShingle | Ming-Jui Hung Edward Chia-Cheng Lai Shih-Chieh Shao Yi-Han Lin Kai-Cheng Chang Yuk-Ying Chan Yea-Huei Kao Yang Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients? BMJ Open Diabetes Research & Care |
| title | Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients? |
| title_full | Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients? |
| title_fullStr | Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients? |
| title_full_unstemmed | Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients? |
| title_short | Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients? |
| title_sort | sodium glucose co transporter 2 inhibitors and cardiovascular event protections how applicable are clinical trials and observational studies to real world patients |
| url | https://drc.bmj.com/content/7/1/e000742.full |
| work_keys_str_mv | AT mingjuihung sodiumglucosecotransporter2inhibitorsandcardiovasculareventprotectionshowapplicableareclinicaltrialsandobservationalstudiestorealworldpatients AT edwardchiachenglai sodiumglucosecotransporter2inhibitorsandcardiovasculareventprotectionshowapplicableareclinicaltrialsandobservationalstudiestorealworldpatients AT shihchiehshao sodiumglucosecotransporter2inhibitorsandcardiovasculareventprotectionshowapplicableareclinicaltrialsandobservationalstudiestorealworldpatients AT yihanlin sodiumglucosecotransporter2inhibitorsandcardiovasculareventprotectionshowapplicableareclinicaltrialsandobservationalstudiestorealworldpatients AT kaichengchang sodiumglucosecotransporter2inhibitorsandcardiovasculareventprotectionshowapplicableareclinicaltrialsandobservationalstudiestorealworldpatients AT yukyingchan sodiumglucosecotransporter2inhibitorsandcardiovasculareventprotectionshowapplicableareclinicaltrialsandobservationalstudiestorealworldpatients AT yeahueikaoyang sodiumglucosecotransporter2inhibitorsandcardiovasculareventprotectionshowapplicableareclinicaltrialsandobservationalstudiestorealworldpatients |