Efficacy and Cardiovascular Safety of Linagliptin as an Add-On to Insulin in Type 2 Diabetes : A Pooled Comprehensive Post Hoc Analysis
Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved..
OBJECTIVE: With the expanding armamentarium of noninsulin therapies for type 2 diabetes mellitus, the use of insulin with various oral agents is becoming more common. In this study, we assessed the efficacy and cardiovascular (CV) safety of the dipeptidyl peptidase-4 inhibitor linagliptin as add-on to insulin in patients with type 2 diabetes.
METHODS: In this post hoc analysis, data for patients receiving basal or basal-bolus insulin were pooled from 4 randomized, double-blind, phase 3 clinical trials of linagliptin 5 mg once daily or placebo given as add-on to background glucose-lowering treatment. Changes in glycated hemoglobin (A1C) and CV risk factors were assessed from baseline to end of trial. The primary CV endpoint was a composite of CV death, nonfatal myocardial infarction, nonfatal stroke and hospitalization due to unstable angina.
RESULTS: The number of patients receiving basal or basal-bolus insulin as background therapy was 1613 (linagliptin: n=811; placebo: n=802). The placebo-adjusted mean (SE) change from baseline in A1C was -0.41 (0.05)% (95% CI -0.50, -0.32; p<0.0001). Treatment with linagliptin provided a relative weight benefit and reduced insulin requirements without affecting blood pressure, heart rate or lipids. The incidence of hypoglycemia with linagliptin was similar to that for placebo (38.7% vs. 39.4%, respectively). The hazard ratio (HR) for the primary endpoint showed that treatment with linagliptin was not associated with an increased CV risk (HR 1.07 [95% CI 0.62, 1.85]).
CONCLUSIONS: Linagliptin, when added to ongoing insulin treatment in patients with type 2 diabetes, improves glycemic control and has a neutral impact on major adverse CV events.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2016 |
|---|---|
| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:40 |
|---|---|
| Enthalten in: |
Canadian journal of diabetes - 40(2016), 1 vom: 15. Feb., Seite 50-7 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Zinman, Bernard [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 21.10.2016 Date Revised 07.12.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.jcjd.2015.06.010 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM253759366 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM253759366 | ||
| 003 | DE-627 | ||
| 005 | 20231224170916.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231224s2016 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jcjd.2015.06.010 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0845.xml |
| 035 | |a (DE-627)NLM253759366 | ||
| 035 | |a (NLM)26474870 | ||
| 035 | |a (PII)S1499-2671(15)00536-5 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Zinman, Bernard |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and Cardiovascular Safety of Linagliptin as an Add-On to Insulin in Type 2 Diabetes |b A Pooled Comprehensive Post Hoc Analysis |
| 264 | 1 | |c 2016 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 21.10.2016 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: With the expanding armamentarium of noninsulin therapies for type 2 diabetes mellitus, the use of insulin with various oral agents is becoming more common. In this study, we assessed the efficacy and cardiovascular (CV) safety of the dipeptidyl peptidase-4 inhibitor linagliptin as add-on to insulin in patients with type 2 diabetes | ||
| 520 | |a METHODS: In this post hoc analysis, data for patients receiving basal or basal-bolus insulin were pooled from 4 randomized, double-blind, phase 3 clinical trials of linagliptin 5 mg once daily or placebo given as add-on to background glucose-lowering treatment. Changes in glycated hemoglobin (A1C) and CV risk factors were assessed from baseline to end of trial. The primary CV endpoint was a composite of CV death, nonfatal myocardial infarction, nonfatal stroke and hospitalization due to unstable angina | ||
| 520 | |a RESULTS: The number of patients receiving basal or basal-bolus insulin as background therapy was 1613 (linagliptin: n=811; placebo: n=802). The placebo-adjusted mean (SE) change from baseline in A1C was -0.41 (0.05)% (95% CI -0.50, -0.32; p<0.0001). Treatment with linagliptin provided a relative weight benefit and reduced insulin requirements without affecting blood pressure, heart rate or lipids. The incidence of hypoglycemia with linagliptin was similar to that for placebo (38.7% vs. 39.4%, respectively). The hazard ratio (HR) for the primary endpoint showed that treatment with linagliptin was not associated with an increased CV risk (HR 1.07 [95% CI 0.62, 1.85]) | ||
| 520 | |a CONCLUSIONS: Linagliptin, when added to ongoing insulin treatment in patients with type 2 diabetes, improves glycemic control and has a neutral impact on major adverse CV events | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a DPP-4 inhibitor | |
| 650 | 4 | |a cardiovascular risk | |
| 650 | 4 | |a diabète sucré de type 2 | |
| 650 | 4 | |a inhibiteur de la DPP-4 | |
| 650 | 4 | |a insulin | |
| 650 | 4 | |a insuline | |
| 650 | 4 | |a linagliptin | |
| 650 | 4 | |a linagliptine | |
| 650 | 4 | |a risque cardiovasculaire | |
| 650 | 4 | |a type 2 diabetes mellitus | |
| 650 | 7 | |a Dipeptidyl-Peptidase IV Inhibitors |2 NLM | |
| 650 | 7 | |a Glycated Hemoglobin A |2 NLM | |
| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
| 650 | 7 | |a Insulin |2 NLM | |
| 650 | 7 | |a hemoglobin A1c protein, human |2 NLM | |
| 650 | 7 | |a Linagliptin |2 NLM | |
| 650 | 7 | |a 3X29ZEJ4R2 |2 NLM | |
| 700 | 1 | |a Ahrén, Bo |e verfasserin |4 aut | |
| 700 | 1 | |a Neubacher, Dietmar |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Sanjay |e verfasserin |4 aut | |
| 700 | 1 | |a Woerle, Hans-Juergen |e verfasserin |4 aut | |
| 700 | 1 | |a Johansen, Odd Erik |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Canadian journal of diabetes |d 2008 |g 40(2016), 1 vom: 15. Feb., Seite 50-7 |w (DE-627)NLM231201249 |x 2352-3840 |7 nnns |
| 773 | 1 | 8 | |g volume:40 |g year:2016 |g number:1 |g day:15 |g month:02 |g pages:50-7 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jcjd.2015.06.010 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 40 |j 2016 |e 1 |b 15 |c 02 |h 50-7 | ||