Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study

Objective The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether glucose-lowering therapy affects this risk over time. Changes in cardiovascular risk markers were examined in patients with type 2 diabetes tr...

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Published in:Cardiovascular diabetology Vol. 14; no. 1; p. 116
Main Authors: Simó, Rafael, Guerci, Bruno, Schernthaner, Guntram, Gallwitz, Baptist, Rosas-Guzmàn, Juan, Dotta, Francesco, Festa, Andreas, Zhou, Ming, Kiljański, Jacek
Format: Journal Article
Language:English
Published: London BioMed Central 04.09.2015
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ISSN:1475-2840, 1475-2840
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Abstract Objective The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether glucose-lowering therapy affects this risk over time. Changes in cardiovascular risk markers were examined in patients with type 2 diabetes treated with exenatide twice daily (a glucagon-like peptide-1 receptor agonist) or glimepiride (a sulfonylurea) added to metformin in the EURopean EXenAtide (EUREXA) study. Research design and methods Patients with type 2 diabetes failing metformin were randomized to add-on exenatide twice daily (n = 515) or glimepiride (n = 514) until treatment failure defined by hemoglobin A1C. Anthropomorphic measures, blood pressure (BP), heart rate, lipids, and high-sensitivity C-reactive protein (hsCRP) over time were evaluated. Results Over 36 months, twice-daily exenatide was associated with improved body weight (−3.9 kg), waist circumference (−3.6 cm), systolic/diastolic BP (−2.5/−2.6 mmHg), high-density lipoprotein (HDL)-cholesterol (0.05 mmol/L), triglycerides (−0.2 mmol/L), and hsCRP (−1.7 mg/L). Heart rate did not increase (−0.3 beats/minute), and low-density lipoprotein-cholesterol (0.2 mmol/L) and total cholesterol (0.1 mmol/L) increased slightly. Between-group differences were significantly in favor of exenatide for body weight ( P  < 0.0001), waist circumference ( P  < 0.001), systolic BP ( P  < 0.001), diastolic BP ( P  = 0.023), HDL-cholesterol ( P  = 0.001), and hsCRP ( P  = 0.004). Fewer patients randomized to exenatide twice daily versus glimepiride required the addition of at least one antihypertensive (20.4 vs 26.4 %; P  = 0.026) or lipid-lowering medication (8.4 vs 12.8 %; P  = 0.025). Conclusions Add-on exenatide twice daily was associated with significant, sustained improvement in several cardiovascular risk markers in patients with type 2 diabetes versus glimepiride. Clinical trial registration: NCT00359762, http://www.ClinicalTrials.gov
AbstractList The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether glucose-lowering therapy affects this risk over time. Changes in cardiovascular risk markers were examined in patients with type 2 diabetes treated with exenatide twice daily (a glucagon-like peptide-1 receptor agonist) or glimepiride (a sulfonylurea) added to metformin in the EURopean EXenAtide (EUREXA) study.OBJECTIVEThe risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether glucose-lowering therapy affects this risk over time. Changes in cardiovascular risk markers were examined in patients with type 2 diabetes treated with exenatide twice daily (a glucagon-like peptide-1 receptor agonist) or glimepiride (a sulfonylurea) added to metformin in the EURopean EXenAtide (EUREXA) study.Patients with type 2 diabetes failing metformin were randomized to add-on exenatide twice daily (n = 515) or glimepiride (n = 514) until treatment failure defined by hemoglobin A1C. Anthropomorphic measures, blood pressure (BP), heart rate, lipids, and high-sensitivity C-reactive protein (hsCRP) over time were evaluated.RESEARCH DESIGN AND METHODSPatients with type 2 diabetes failing metformin were randomized to add-on exenatide twice daily (n = 515) or glimepiride (n = 514) until treatment failure defined by hemoglobin A1C. Anthropomorphic measures, blood pressure (BP), heart rate, lipids, and high-sensitivity C-reactive protein (hsCRP) over time were evaluated.Over 36 months, twice-daily exenatide was associated with improved body weight (-3.9 kg), waist circumference (-3.6 cm), systolic/diastolic BP (-2.5/-2.6 mmHg), high-density lipoprotein (HDL)-cholesterol (0.05 mmol/L), triglycerides (-0.2 mmol/L), and hsCRP (-1.7 mg/L). Heart rate did not increase (-0.3 beats/minute), and low-density lipoprotein-cholesterol (0.2 mmol/L) and total cholesterol (0.1 mmol/L) increased slightly. Between-group differences were significantly in favor of exenatide for body weight (P < 0.0001), waist circumference (P < 0.001), systolic BP (P < 0.001), diastolic BP (P = 0.023), HDL-cholesterol (P = 0.001), and hsCRP (P = 0.004). Fewer patients randomized to exenatide twice daily versus glimepiride required the addition of at least one antihypertensive (20.4 vs 26.4%; P = 0.026) or lipid-lowering medication (8.4 vs 12.8%; P = 0.025).RESULTSOver 36 months, twice-daily exenatide was associated with improved body weight (-3.9 kg), waist circumference (-3.6 cm), systolic/diastolic BP (-2.5/-2.6 mmHg), high-density lipoprotein (HDL)-cholesterol (0.05 mmol/L), triglycerides (-0.2 mmol/L), and hsCRP (-1.7 mg/L). Heart rate did not increase (-0.3 beats/minute), and low-density lipoprotein-cholesterol (0.2 mmol/L) and total cholesterol (0.1 mmol/L) increased slightly. Between-group differences were significantly in favor of exenatide for body weight (P < 0.0001), waist circumference (P < 0.001), systolic BP (P < 0.001), diastolic BP (P = 0.023), HDL-cholesterol (P = 0.001), and hsCRP (P = 0.004). Fewer patients randomized to exenatide twice daily versus glimepiride required the addition of at least one antihypertensive (20.4 vs 26.4%; P = 0.026) or lipid-lowering medication (8.4 vs 12.8%; P = 0.025).Add-on exenatide twice daily was associated with significant, sustained improvement in several cardiovascular risk markers in patients with type 2 diabetes versus glimepiride.CONCLUSIONSAdd-on exenatide twice daily was associated with significant, sustained improvement in several cardiovascular risk markers in patients with type 2 diabetes versus glimepiride.NCT00359762, http://www.ClinicalTrials.gov.CLINICAL TRIAL REGISTRATIONNCT00359762, http://www.ClinicalTrials.gov.
The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether glucose-lowering therapy affects this risk over time. Changes in cardiovascular risk markers were examined in patients with type 2 diabetes treated with exenatide twice daily (a glucagon-like peptide-1 receptor agonist) or glimepiride (a sulfonylurea) added to metformin in the EURopean EXenAtide (EUREXA) study. Patients with type 2 diabetes failing metformin were randomized to add-on exenatide twice daily (n = 515) or glimepiride (n = 514) until treatment failure defined by hemoglobin A1C. Anthropomorphic measures, blood pressure (BP), heart rate, lipids, and high-sensitivity C-reactive protein (hsCRP) over time were evaluated. Over 36 months, twice-daily exenatide was associated with improved body weight (-3.9 kg), waist circumference (-3.6 cm), systolic/diastolic BP (-2.5/-2.6 mmHg), high-density lipoprotein (HDL)-cholesterol (0.05 mmol/L), triglycerides (-0.2 mmol/L), and hsCRP (-1.7 mg/L). Heart rate did not increase (-0.3 beats/minute), and low-density lipoprotein-cholesterol (0.2 mmol/L) and total cholesterol (0.1 mmol/L) increased slightly. Between-group differences were significantly in favor of exenatide for body weight (P < 0.0001), waist circumference (P < 0.001), systolic BP (P < 0.001), diastolic BP (P = 0.023), HDL-cholesterol (P = 0.001), and hsCRP (P = 0.004). Fewer patients randomized to exenatide twice daily versus glimepiride required the addition of at least one antihypertensive (20.4 vs 26.4%; P = 0.026) or lipid-lowering medication (8.4 vs 12.8%; P = 0.025). Add-on exenatide twice daily was associated with significant, sustained improvement in several cardiovascular risk markers in patients with type 2 diabetes versus glimepiride. NCT00359762, http://www.ClinicalTrials.gov.
Objective The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether glucose-lowering therapy affects this risk over time. Changes in cardiovascular risk markers were examined in patients with type 2 diabetes treated with exenatide twice daily (a glucagon-like peptide-1 receptor agonist) or glimepiride (a sulfonylurea) added to metformin in the EURopean EXenAtide (EUREXA) study. Research design and methods Patients with type 2 diabetes failing metformin were randomized to add-on exenatide twice daily (n = 515) or glimepiride (n = 514) until treatment failure defined by hemoglobin A1C. Anthropomorphic measures, blood pressure (BP), heart rate, lipids, and high-sensitivity C-reactive protein (hsCRP) over time were evaluated. Results Over 36 months, twice-daily exenatide was associated with improved body weight (−3.9 kg), waist circumference (−3.6 cm), systolic/diastolic BP (−2.5/−2.6 mmHg), high-density lipoprotein (HDL)-cholesterol (0.05 mmol/L), triglycerides (−0.2 mmol/L), and hsCRP (−1.7 mg/L). Heart rate did not increase (−0.3 beats/minute), and low-density lipoprotein-cholesterol (0.2 mmol/L) and total cholesterol (0.1 mmol/L) increased slightly. Between-group differences were significantly in favor of exenatide for body weight ( P  < 0.0001), waist circumference ( P  < 0.001), systolic BP ( P  < 0.001), diastolic BP ( P  = 0.023), HDL-cholesterol ( P  = 0.001), and hsCRP ( P  = 0.004). Fewer patients randomized to exenatide twice daily versus glimepiride required the addition of at least one antihypertensive (20.4 vs 26.4 %; P  = 0.026) or lipid-lowering medication (8.4 vs 12.8 %; P  = 0.025). Conclusions Add-on exenatide twice daily was associated with significant, sustained improvement in several cardiovascular risk markers in patients with type 2 diabetes versus glimepiride. Clinical trial registration: NCT00359762, http://www.ClinicalTrials.gov
ArticleNumber 116
Author Gallwitz, Baptist
Rosas-Guzmàn, Juan
Kiljański, Jacek
Festa, Andreas
Dotta, Francesco
Zhou, Ming
Guerci, Bruno
Schernthaner, Guntram
Simó, Rafael
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  surname: Simó
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  organization: CIREDEM, Carlos III Health Institute, Diabetes Research and Metabolism Unit, Institut de Recerca Hospital Universitari Vall d’Hebron
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  givenname: Bruno
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  organization: Diabetologie, Maladies Metaboliques and Nutrition, Hôpital Brabois, CHU de Nancy, et CIC Inserm
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  givenname: Guntram
  surname: Schernthaner
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  surname: Rosas-Guzmàn
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  organization: Diabetes Unit, Policlinico Le Scotte, University of Siena
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  fullname: Festa, Andreas
  organization: Eli Lilly and Company, Eli Lilly Regional Operations Ges.m.b.H
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  fullname: Kiljański, Jacek
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Issue 1
Keywords Type 2 diabetes
Exenatide twice daily
High-sensitivity C-reactive protein
GLP-1 receptor agonist
Cardiovascular risk
Language English
License Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Snippet Objective The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether...
The risk of cardiovascular morbidity and mortality is significantly increased in patients with diabetes; thus, it is important to determine whether...
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StartPage 116
SubjectTerms Aged
Angiology
Biomarkers - blood
Blood Glucose - drug effects
Blood Glucose - metabolism
Blood Pressure - drug effects
C-Reactive Protein - metabolism
Cardiology
Cardiovascular Diseases - blood
Cardiovascular Diseases - diagnosis
Cardiovascular Diseases - etiology
Cardiovascular Diseases - physiopathology
Cardiovascular Diseases - prevention & control
Diabetes
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - diagnosis
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - physiopathology
Drug Administration Schedule
Drug Therapy, Combination
Europe
Exenatide
Female
Glycated Hemoglobin - metabolism
Heart Rate - drug effects
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Incretins - administration & dosage
Incretins - adverse effects
Lipids - blood
Male
Medicine
Medicine & Public Health
Metformin - administration & dosage
Middle Aged
Original Investigation
Peptides - administration & dosage
Peptides - adverse effects
Risk Factors
Sulfonylurea Compounds - administration & dosage
Sulfonylurea Compounds - adverse effects
Time Factors
Treatment Outcome
Venoms - administration & dosage
Venoms - adverse effects
Title Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study
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https://www.ncbi.nlm.nih.gov/pubmed/26338040
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https://pubmed.ncbi.nlm.nih.gov/PMC4558893
Volume 14
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