Long-term effect of rosiglitazone and/or ramipril on the incidence of diabetes

Aims/hypothesis The Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication (DREAM) trial reported that 3 years of therapy with rosiglitazone reduced the primary outcome of diabetes or death by 60%. Here we investigated whether an effect on diabetes prevention persists more than 1.5...

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Veröffentlicht in:Diabetologia 2011-03, Vol.54 (3), p.487-495
Hauptverfasser: Gerstein, H C, Mohan, V, Avezum, A, Bergenstal, R M, Chiasson, J-L, Garrido, M, MacKinnon, I, Rao, P V, Zinman, B, Jung, H, Joldersma, L, Bosch, J, Yusuf, S
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container_title Diabetologia
container_volume 54
creator Gerstein, H C
Mohan, V
Avezum, A
Bergenstal, R M
Chiasson, J-L
Garrido, M
MacKinnon, I
Rao, P V
Zinman, B
Jung, H
Joldersma, L
Bosch, J
Yusuf, S
description Aims/hypothesis The Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication (DREAM) trial reported that 3 years of therapy with rosiglitazone reduced the primary outcome of diabetes or death by 60%. Here we investigated whether an effect on diabetes prevention persists more than 1.5 years after therapy has been discontinued. Methods The DREAM On passive follow-up study was conducted at 49 of the 191 DREAM sites. Consenting participants were invited to have a repeat OGTT 1–2 years after active therapy ended. A diagnosis of diabetes at that time was based on either a fasting or 2 h plasma glucose level of ≥7.0 mmol/l or ≥11.1 mmol/l, respectively, or a confirmed diagnosis by a non-study physician. Regression to normoglycaemia was defined as a fasting and 2 h plasma glucose level of
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Here we investigated whether an effect on diabetes prevention persists more than 1.5 years after therapy has been discontinued. Methods The DREAM On passive follow-up study was conducted at 49 of the 191 DREAM sites. Consenting participants were invited to have a repeat OGTT 1–2 years after active therapy ended. A diagnosis of diabetes at that time was based on either a fasting or 2 h plasma glucose level of ≥7.0 mmol/l or ≥11.1 mmol/l, respectively, or a confirmed diagnosis by a non-study physician. Regression to normoglycaemia was defined as a fasting and 2 h plasma glucose level of &lt;6.1 mmol/l and &lt;7.8 mmol/l, respectively. Results After a median of 1.6 years after the end of the trial and 4.3 years after randomisation, rosiglitazone participants had a 39% lower incidence of the primary outcome (hazard ratio [HR] 0.61, 95% CI 0.53–0.70; p  &lt; 0.0001) and 17% more regression to normoglycaemia (95% CI 1.01–1.34; p  = 0.034). When the analysis was restricted to the passive follow-up period, a similar incidence of both the primary outcome and regression was observed in people from both treatment groups (HR 1.00, 95% CI 0.81–1.24 and HR 1.14, 95% CI 0.97–1.32, respectively). Similar effects were noted when new diabetes was analysed separately from death. Ramipril did not have any significant long-term effect. Conclusions/interpretation Time-limited exposure to rosiglitazone reduces the longer term incidence of diabetes by delaying but not reversing the underlying disease process.</description><identifier>ISSN: 0012-186X</identifier><identifier>EISSN: 1432-0428</identifier><identifier>DOI: 10.1007/s00125-010-1985-4</identifier><identifier>PMID: 21116607</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer-Verlag</publisher><subject>Aged ; Biological and medical sciences ; Diabetes ; Diabetes Mellitus - drug therapy ; Diabetes Mellitus - prevention &amp; control ; Diabetes. Impaired glucose tolerance ; Drug therapy ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. 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Here we investigated whether an effect on diabetes prevention persists more than 1.5 years after therapy has been discontinued. Methods The DREAM On passive follow-up study was conducted at 49 of the 191 DREAM sites. Consenting participants were invited to have a repeat OGTT 1–2 years after active therapy ended. A diagnosis of diabetes at that time was based on either a fasting or 2 h plasma glucose level of ≥7.0 mmol/l or ≥11.1 mmol/l, respectively, or a confirmed diagnosis by a non-study physician. Regression to normoglycaemia was defined as a fasting and 2 h plasma glucose level of &lt;6.1 mmol/l and &lt;7.8 mmol/l, respectively. Results After a median of 1.6 years after the end of the trial and 4.3 years after randomisation, rosiglitazone participants had a 39% lower incidence of the primary outcome (hazard ratio [HR] 0.61, 95% CI 0.53–0.70; p  &lt; 0.0001) and 17% more regression to normoglycaemia (95% CI 1.01–1.34; p  = 0.034). When the analysis was restricted to the passive follow-up period, a similar incidence of both the primary outcome and regression was observed in people from both treatment groups (HR 1.00, 95% CI 0.81–1.24 and HR 1.14, 95% CI 0.97–1.32, respectively). Similar effects were noted when new diabetes was analysed separately from death. Ramipril did not have any significant long-term effect. Conclusions/interpretation Time-limited exposure to rosiglitazone reduces the longer term incidence of diabetes by delaying but not reversing the underlying disease process.</description><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Diabetes</subject><subject>Diabetes Mellitus - drug therapy</subject><subject>Diabetes Mellitus - prevention &amp; control</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Drug therapy</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. 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Impaired glucose tolerance</topic><topic>Drug therapy</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Fasting</topic><topic>Female</topic><topic>Glucose</topic><topic>Health sciences</topic><topic>Human Physiology</topic><topic>Humans</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Metabolic Diseases</topic><topic>Middle Aged</topic><topic>Plasma</topic><topic>Prevention</topic><topic>Ramipril - therapeutic use</topic><topic>Research centers</topic><topic>Thiazolidinediones - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gerstein, H C</creatorcontrib><creatorcontrib>Mohan, V</creatorcontrib><creatorcontrib>Avezum, A</creatorcontrib><creatorcontrib>Bergenstal, R M</creatorcontrib><creatorcontrib>Chiasson, J-L</creatorcontrib><creatorcontrib>Garrido, M</creatorcontrib><creatorcontrib>MacKinnon, I</creatorcontrib><creatorcontrib>Rao, P V</creatorcontrib><creatorcontrib>Zinman, B</creatorcontrib><creatorcontrib>Jung, H</creatorcontrib><creatorcontrib>Joldersma, L</creatorcontrib><creatorcontrib>Bosch, J</creatorcontrib><creatorcontrib>Yusuf, S</creatorcontrib><creatorcontrib>DREAM On (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication Ongoing Follow-up) Investigators</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetologia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gerstein, H C</au><au>Mohan, V</au><au>Avezum, A</au><au>Bergenstal, R M</au><au>Chiasson, J-L</au><au>Garrido, M</au><au>MacKinnon, I</au><au>Rao, P V</au><au>Zinman, B</au><au>Jung, H</au><au>Joldersma, L</au><au>Bosch, J</au><au>Yusuf, S</au><aucorp>DREAM On (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication Ongoing Follow-up) Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term effect of rosiglitazone and/or ramipril on the incidence of diabetes</atitle><jtitle>Diabetologia</jtitle><stitle>Diabetologia</stitle><addtitle>Diabetologia</addtitle><date>2011-03-01</date><risdate>2011</risdate><volume>54</volume><issue>3</issue><spage>487</spage><epage>495</epage><pages>487-495</pages><issn>0012-186X</issn><eissn>1432-0428</eissn><abstract>Aims/hypothesis The Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication (DREAM) trial reported that 3 years of therapy with rosiglitazone reduced the primary outcome of diabetes or death by 60%. Here we investigated whether an effect on diabetes prevention persists more than 1.5 years after therapy has been discontinued. Methods The DREAM On passive follow-up study was conducted at 49 of the 191 DREAM sites. Consenting participants were invited to have a repeat OGTT 1–2 years after active therapy ended. A diagnosis of diabetes at that time was based on either a fasting or 2 h plasma glucose level of ≥7.0 mmol/l or ≥11.1 mmol/l, respectively, or a confirmed diagnosis by a non-study physician. Regression to normoglycaemia was defined as a fasting and 2 h plasma glucose level of &lt;6.1 mmol/l and &lt;7.8 mmol/l, respectively. Results After a median of 1.6 years after the end of the trial and 4.3 years after randomisation, rosiglitazone participants had a 39% lower incidence of the primary outcome (hazard ratio [HR] 0.61, 95% CI 0.53–0.70; p  &lt; 0.0001) and 17% more regression to normoglycaemia (95% CI 1.01–1.34; p  = 0.034). When the analysis was restricted to the passive follow-up period, a similar incidence of both the primary outcome and regression was observed in people from both treatment groups (HR 1.00, 95% CI 0.81–1.24 and HR 1.14, 95% CI 0.97–1.32, respectively). Similar effects were noted when new diabetes was analysed separately from death. Ramipril did not have any significant long-term effect. Conclusions/interpretation Time-limited exposure to rosiglitazone reduces the longer term incidence of diabetes by delaying but not reversing the underlying disease process.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer-Verlag</pub><pmid>21116607</pmid><doi>10.1007/s00125-010-1985-4</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Biological and medical sciences
Diabetes
Diabetes Mellitus - drug therapy
Diabetes Mellitus - prevention & control
Diabetes. Impaired glucose tolerance
Drug therapy
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Etiopathogenesis. Screening. Investigations. Target tissue resistance
Fasting
Female
Glucose
Health sciences
Human Physiology
Humans
Hypoglycemic Agents - therapeutic use
Internal Medicine
Male
Medical research
Medical sciences
Medicine
Medicine & Public Health
Metabolic Diseases
Middle Aged
Plasma
Prevention
Ramipril - therapeutic use
Research centers
Thiazolidinediones - therapeutic use
title Long-term effect of rosiglitazone and/or ramipril on the incidence of diabetes
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