The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1018 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-07-01

Brief Summary

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Thirty years ago, Dzau and Braunwald introduced the concept of a continuum of cardiovascular diseases and defined them as a series of events caused by numerous related and unrelated risk factors, thus developing to end-stage heart disease through many pathophysiological pathways and processes. Owing to treatment concept changes and the urgency of investigating T2D combined with CHF, SUs are being re-evaluated, of which glimepiride is undoubtedly the most promising.

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Detailed Description

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Since the first sulfonylurea (SU; tolbutamide) was commercially launched in Germany in 1956, SUs, as the oldest oral hypoglycemic drugs, have been developed for three generations and are commonly used for patients with T2D. In 2008, the US Food and Drug Administration and European Drug Administration required cardiovascular safety certification for all hypoglycemic drugs, resulting in increased related clinical trials. Currently, data on the relationship between SUs and cardiovascular outcomes are limited, and the cardiovascular effects remain controversial in observational studies. Third-generation SUs, such as glimepiride, are widely used for treating T2D because of their definite hypoglycemic efficacy, relatively low risk of hypoglycemia, convenient daily use, and low price. Glimepiride has good cardiovascular safety according to randomized controlled trials (RCTs). The proportion of SUs used in patients with heart failure is as high as 60.4%. Although some studies have shown that SUs are neutral in terms of hospitalization rates and adverse cardiovascular events in patients with CHF, no standard RCT of glimepiride has been conducted to study its effect on the prognosis of patients with T2D and confirmed CHF. Glimepiride inhibits soluble epoxide hydrolase (sEH), thus reducing epoxyeicosatrienoic acid (EET) degradation . Increased EET production exerts protective effects on the heart, indicating the potential cardiovascular effect of glimepiride.

This retrospective cohort study aimed to evaluate the effects of glimepiride on the clinical outcomes of patients with T2D and CHF and provide theoretical evidence for the clinical application of glimepiride in these patients.

Conditions

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Chronic Heart Failure Type 2 Diabetes Cardiovascular Mortality Cohort Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glimepiride group

509 patients aged \>18 years with T2D and CHF had continuous glimepiride use (1-4 mg/day).

Glimepiride

Intervention Type DRUG

Glimepiride 1-4 mg/day

Non-glimepiride group

509 patients aged \>18 years with T2D and CHF had no glimepiride use.

No interventions assigned to this group

Interventions

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Glimepiride

Glimepiride 1-4 mg/day

Intervention Type DRUG

Other Intervention Names

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Amaryl

Eligibility Criteria

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Inclusion Criteria

* Chronic heart failure (\>6 months duration, according to 2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure)
* Reduced ejection fraction defined as LVEF \< 50%
* N-terminal pro-brain natriuretic peptide (NT-proBNP) level: \>125 pg/mL
* NYHA-class II/III/IV with stable symptoms for at least the past 3 months
* Type 2 diabetes (according to the Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022)

Exclusion Criteria

* Those who did not meet the diagnostic criteria
* Lacked echocardiographic and NT-proBNP data
* Used sulfonylureas other than glimepiride were excluded

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No