Document Detail


Pioglitazone and the risk of cardiovascular events in patients with Type 2 diabetes receiving concomitant treatment with nitrates, renin-angiotensin system blockers, or insulin: results from the PROactive study (PROactive 20).
MedLine Citation:
PMID:  20923486     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Patients with Type 2 diabetes mellitus (T2DM) are often treated with multiple glucose-lowering and cardiovascular agents. The concomitant use of nitrates, renin-angiotensin system (RAS) blockers, or insulin has been linked to a potential increase in myocardial ischemic risk with rosiglitazone. The PROactive database provides an opportunity to investigate the effects of these medications on the potential macrovascular benefits reported with pioglitazone.
METHODS: The PROactive study was a randomized double-blind prospective trial that evaluated mortality and cardiovascular morbidity in 5238 patients with T2DM and macrovascular disease. Patients received pioglitazone or placebo in addition to their baseline glucose-lowering and cardiovascular medications. The effect of pioglitazone on composite endpoints was evaluated, including all-cause death, myocardial infarction (MI), and stroke, as well as safety events of edema and serious heart failure, in subgroups using nitrates, RAS blockers, or insulin at baseline.
RESULTS: The risk of all-cause death, MI, and stroke for pioglitazone versus placebo was similar regardless of the baseline use of nitrates, RAS blockers, or insulin, with hazard ratios ranging from 0.81 to 0.87. Similar results were obtained for the other composite endpoints analyzed. There were no significant interactions between baseline medication subgroups and treatment. The increased risk of edema and serious heart failure was consistent across the baseline medication subgroups.
CONCLUSIONS: This post hoc analysis did not reveal an increased risk of macrovascular events with pioglitazone in patients receiving nitrates, RAS blockers, or insulin. Rather, all patients realized the same trend towards benefit with pioglitazone, and adverse events of edema and heart failure were predictable.
Authors:
Erland Erdmann; Robert Spanheimer; Bernard Charbonnel;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of diabetes     Volume:  2     ISSN:  1753-0407     ISO Abbreviation:  J Diabetes     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-10-06     Completed Date:  2011-02-02     Revised Date:  2011-03-28    
Medline Journal Info:
Nlm Unique ID:  101504326     Medline TA:  J Diabetes     Country:  Australia    
Other Details:
Languages:  eng     Pagination:  212-20     Citation Subset:  IM    
Copyright Information:
© 2010 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Blackwell Publishing Asia Pty Ltd.
Affiliation:
Medizinische Klinik III der Universität zu Köln, Köln, Germany. erland.erdmann@uni-koeln.de
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MeSH Terms
Descriptor/Qualifier:
Age of Onset
Aged
Angiotensin-Converting Enzyme Inhibitors / adverse effects,  therapeutic use
Diabetes Mellitus, Type 2 / complications,  drug therapy*,  mortality
Diabetic Angiopathies / drug therapy,  epidemiology*,  mortality
Edema / drug therapy,  epidemiology
Female
Heart Failure / drug therapy,  epidemiology
Humans
Hypoglycemic Agents / adverse effects,  therapeutic use*
Insulin / adverse effects,  therapeutic use
Male
Middle Aged
Multicenter Studies as Topic
Myocardial Ischemia / chemically induced*,  epidemiology
Nitrates / adverse effects,  therapeutic use
Thiazolidinediones / adverse effects,  therapeutic use*
Chemical
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; 0/Hypoglycemic Agents; 0/Nitrates; 0/Thiazolidinediones; 11061-68-0/Insulin; 111025-46-8/pioglitazone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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