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Diabetologia. 2011 Mar;54(3):487-95. doi: 10.1007/s00125-010-1985-4. Epub 2010 Nov 30.

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

Collaborators (215)

Diaz R, Albisu J, Albisu D, Alvarez MS, Alzogoray M, Angelelli N, Ankudowicz V, Avaca H, Bello F, Bergamo S, Botto M, Busatta M, Caccavo A, Caime G, Carrillo N, Carrique A, Carrique P, Cartasegna L, Castellanos C, Centeno M, Chacon C, Cipullo M, Cismondi M, Citta L, Cristofaro PC, Crunger P, Cunero C, De Loredo L, De Loredo S, Del Pino E, Denaro R, Detzel G, Duarte C, Espinosa M, Ferrari G, Gambarte A, Garrido M, Garrido I, Giachello F, Guaymas G, Hoffman V, Insausti E, Laugle C, Lobo Marquez L, Luciardi H, Luduena Clos E, Luna M, Majul M, Maldonado N, Manuale O, Marcucci G, Martinez G, Marzetti E, Molina M, Morell Y, Navarrete S, Nieto F, Nunez M, Orce R, Pastrana M, Pelliza M, Pisaentin J, Piskorz D, Plastino M, Ramos H, Rappi S, Risolo A, Rodriguez H, Rodriguez C, Sago L, Sanchez J, Schygiel P, Sorensen P, Streitenberger P, Tommasi L, Vico M, Vizcaya Castro A, Zaidman C, Shaw J, Zimmet P, Batrouney B, Ching H, Cohen N, Colman P, Davidson M, Gunser A, Lawton M, Lynch L, Nairn J, Nankervis A, Palmer N, Smith G, Stuckey B, Sturdy G, Wagner J, Campbell G, Jones D, Jones M, Stubbs C, Bertolami M, Branco de Araujo D, Faludi A, Nakamura Y, Zatz H, Abbott C, Anand S, Anderlic T, Armstrong M, Auger D, Barnie A, Belanger A, Berard L, Bolduc H, Bonnell J, Brault S, Breen A, Chan Y, Chiasson JL, Dagenais G, Davis A, DeCurtis D, Donat D, Dufour A, Dumas R, Feig D, Gauthier S, Gourgues M, Gupta M, Hanley A, Hannah G, Harris S, Hill K, Houlden R, Hunt D, Hutchinson K, Johnson D, Kajil M, LaValle T, Leroux M, Lochnan H, Marin M, MacLean S, Mallette D, McCarthy G, McCarthy V, Mitchell J, Nyomba G, Ouellet G, Petrella R, Petrella S, Pockett S, Poisson D, Rabasa-Lhoret R, Russell L, Stevenson K, Tsigoulis M, Robert C, Vachon F, Winkler L, Woo V, Zaniol D, Zinman B, Larenas G, Raddatz Kiefer V, Roddriguez L, Toro F, Mohan V, Aravind S, Aravind SR, Ayyar V, Bantwal G, Dhope R, Gayatri R, Gopal U, Idiculla J, Jayanthi S, Kale S, Karkuzhali K, Padmalatha Devi M, Pais P, Poongothai S, Prakash S, Ramu M, Rao PV, Savitha G, Sudha S, Sujatha I, Yajnik C, Cardona E, Pascoe S, Abuomar J, Bergenstal R, Berrios Lopez L, Burgos-Calderon R, Coley L, Cushman W, Fuste P, Guzman Serrano B, Monk A, Pla A, Posada J, Santiago O, Thomas L, Walsh S, Bosch J, Desai D, Gerstein HC, Greenspan L, Haladyn JK, Joldersma L, Jung H, MacRae L, Pogue J, Santarelli L, Yusuf S.

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 <6.1 mmol/l and <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 < 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.

PMID:
21116607
[PubMed - indexed for MEDLINE]
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