See the published version of this article at Cardiovascular Diabetology.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Original investigation
Metabolic Syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: A post hoc analyses of the EMPA-REG OUTCOME trial
João Pedro Ferreira
Université de Lorraine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2304-6138
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Cardiovascular Diabetology.
Background: Patients with type 2 diabetes (T2D) and metabolic syndrome (MetS) are at greater cardiovascular risk than those with T2D without MetS. In the current report we aim to study the characteristics, cardio-renal outcomes and the effect of empagliflozin in patients with MetS enrolled in the EMPA-REG OUTCOME trial.
Methods: A total of 7020 patients with T2D and atherosclerotic cardiovascular disease were treated with empagliflozin (10mg or 25mg) or placebo for a median of 3.1 years. The World Health Organization MetS criteria could be determined for 6985 (99.5%) patients. We assessed the association between baseline MetS and multiple cardio-renal endpoints using Cox regression models, and we studied the change in the individual component over time of the MetS using mixed effect models.
Results: MetS at baseline was present in 5740 (82%) patients; these were more often white and had more often albuminuria and heart failure, had lower eGFR and HDL-cholesterol, and higher blood pressure, body mass index, waist circumference, and triglycerides. In the placebo group, patients with MetS had a higher risk of all outcomes including cardiovascular death: HR=1.73 (95%CI=1.01-2.98), heart failure hospitalization: HR=2.64 (95%CI=1.22, 5.72), and new or worsening nephropathy: HR=3.11 (95%CI=2.17-4.46). The beneficial effect of empagliflozin was consistent on all cardio-renal outcomes regardless of presence of MetS.
Conclusions: A large proportion of the EMPA-REG OUTCOME population fulfills the criteria for MetS. Those with MetS had increased risk of adverse cardio-renal outcomes. Compared with placebo, empagliflozin improved cardio-renal outcomes in patients with and without MetS.
Keywords
type 2 diabetes mellitus, metabolic syndrome, empagliflozin, treatment effect, cardiovascular disease
Figure 1
Figure 1
Figure 2
Figure 2
Figure 3
Figure 3
Figure 4
Figure 4
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 19 Nov, 2020
No comments provided
Editorial decision: Minor Revision
On 26 Sep, 2020
Review #5 received
Received 12 Sep, 2020
Review #4 received
Received 12 Sep, 2020
Review #2 received
Received 12 Sep, 2020
Review #3 received
Received 04 Sep, 2020
Reviewers invited
Invitations sent on 04 Sep, 2020
Reviewer #1 agreed
On 04 Sep, 2020
Reviewer #2 agreed
On 04 Sep, 2020
Reviewer #3 agreed
On 04 Sep, 2020
Reviewer #4 agreed
On 04 Sep, 2020
Reviewer #5 agreed
On 04 Sep, 2020
Reviewer #6 agreed
On 04 Sep, 2020
Review #1 received
Received 04 Sep, 2020
Editor assigned
On 03 Sep, 2020
Editor invited
On 02 Sep, 2020
Submission checks complete
On 30 Aug, 2020
First submitted
On 24 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Learn more about our company.
This preprint is under consideration at Cardiovascular Diabetology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Original investigation
Metabolic Syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: A post hoc analyses of the EMPA-REG OUTCOME trial
João Pedro Ferreira
Université de Lorraine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2304-6138
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 19 Nov, 2020
No comments provided
Editorial decision: Minor Revision
On 26 Sep, 2020
Review #5 received
Received 12 Sep, 2020
Review #4 received
Received 12 Sep, 2020
Review #2 received
Received 12 Sep, 2020
Review #3 received
Received 04 Sep, 2020
Reviewers invited
Invitations sent on 04 Sep, 2020
Reviewer #1 agreed
On 04 Sep, 2020
Reviewer #2 agreed
On 04 Sep, 2020
Reviewer #3 agreed
On 04 Sep, 2020
Reviewer #4 agreed
On 04 Sep, 2020
Reviewer #5 agreed
On 04 Sep, 2020
Reviewer #6 agreed
On 04 Sep, 2020
Review #1 received
Received 04 Sep, 2020
Editor assigned
On 03 Sep, 2020
Editor invited
On 02 Sep, 2020
Submission checks complete
On 30 Aug, 2020
First submitted
On 24 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Cardiovascular Diabetology.
Background: Patients with type 2 diabetes (T2D) and metabolic syndrome (MetS) are at greater cardiovascular risk than those with T2D without MetS. In the current report we aim to study the characteristics, cardio-renal outcomes and the effect of empagliflozin in patients with MetS enrolled in the EMPA-REG OUTCOME trial.
Methods: A total of 7020 patients with T2D and atherosclerotic cardiovascular disease were treated with empagliflozin (10mg or 25mg) or placebo for a median of 3.1 years. The World Health Organization MetS criteria could be determined for 6985 (99.5%) patients. We assessed the association between baseline MetS and multiple cardio-renal endpoints using Cox regression models, and we studied the change in the individual component over time of the MetS using mixed effect models.
Results: MetS at baseline was present in 5740 (82%) patients; these were more often white and had more often albuminuria and heart failure, had lower eGFR and HDL-cholesterol, and higher blood pressure, body mass index, waist circumference, and triglycerides. In the placebo group, patients with MetS had a higher risk of all outcomes including cardiovascular death: HR=1.73 (95%CI=1.01-2.98), heart failure hospitalization: HR=2.64 (95%CI=1.22, 5.72), and new or worsening nephropathy: HR=3.11 (95%CI=2.17-4.46). The beneficial effect of empagliflozin was consistent on all cardio-renal outcomes regardless of presence of MetS.
Conclusions: A large proportion of the EMPA-REG OUTCOME population fulfills the criteria for MetS. Those with MetS had increased risk of adverse cardio-renal outcomes. Compared with placebo, empagliflozin improved cardio-renal outcomes in patients with and without MetS.
Figure 1
Figure 1
Figure 2
Figure 2
Figure 3
Figure 3
Figure 4
Figure 4