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Lancet. 2008 Oct 18;372(9647):1385-93. doi: 10.1016/S0140-6736(08)61411-7. Epub 2008 Sep 25.

Effect of candesartan on progression and regression of retinopathy in type 2 diabetes (DIRECT-Protect 2): a randomised placebo-controlled trial.

Collaborators (387)

Fox Y, George M, Svensson A, Hainer J, Klein R, Orchard T, Parving HH, Porta M, Warnold I, Agardh CD, Bilous R, Bonnici F, Charbonnel B, Cooper M, Dedov I, Gardiner R, Gomis R, Ilkova H, Katsilambros N, Kerenyi Z, Martin S, Massin P, Pirags V, Raz I, Rusavy Z, Schernthaner G, Shestakova M, Sjølie AK, Strojek K, Olofsson B, Malm A, Wissmar J, Brayshaw N, Wedel H, Wilhelmsen L, Bird A, Wedel H, Warnold I, Price G, Adler-Ekholm E, Aldington S, Dahl M, Deveney A, Karlsten E, Levins P, Lipinski H, Prenter C, Walkey H, Walters N, Cooper M, Chen R, Colman P, Davoren P, Donnelly T, d'Emden M, Jerums G, O'Brien R, Phillips P, Prins J, Roberts A, Watts G, Wilson D, Yue D, Zoungas S, Schernthaner G, Luger A, Pilger E, Prager R, Waldhäusl WK, Weitgasser R, Keymeulen B, Van Gaal L, Christov V, Hristozov K, Koeva L, Markova A, Protich M, Slavcheva A, Tankova T, Toneva A, Veleva N, Zaharieva M, Gardiner R, Babin S, Belanger A, Godin C, Joyce C, Keely E, Leiter L, Lochnan H, McManus R, Miller D, Monchesky T, Pylypchuk G, Ross S, Siegel I, Tobe S, Ur E, Woo V, Toth E, Kovacevic D, Profozic V, Rusavy Z, Andel M, Boucek P, Gregorova A, Havelkova J, Karasova J, Sjølie AK, Bek T, Hermansen K, Lervang HH, Parving HH, Rossing P, Past M, Tupits H, Podar T, Chabonnel B, Massin P, Anton B, Charpentier P, Grimaldi A, Guillausseau PJ, Kerlan V, Marechaud J, Marre M, Nocent P, Penformis A, Rodier M, Ruiz JP, Slama G, Combes ME, Gagunashvili N, Kurashvili R, Metreveli D, Martin S, Allolio B, Anderten H, Badenhoop K, Busch K, Dreyer M, Etzrodt H, Frank M, Hamann A, Hammes HP, Kempe HP, Konzok R, Mueller UA, Paschke R, Pein M, Pfeiffer A, von Reis EO, Schneider M, Schäffler A, Stuermer W, Usadel KH, Katsilambros N, Karamanos B, Melidonis A, Mygdalis I, Noutsou M, Pagalos E, Papadam A, Pappas A, Pappas S, Phenekos K, Piaditis G, Kerényi Z, Baranyai M, Bölcsvölgyi T, Dömötör E, Faludi P, Fövényi J, Koranyi L, Szöcs A, Tamás G, Tárko M, Vándorfi G, Ferriss B, McKenna J, O'Shea D, O'Sullivan S, Raz I, Adawi F, Arcavi L, Cohen J, Cohen O, Dicker D, Guttmann H, Harman-Boehm I, Herskovits T, Jaffe A, Karnieli E, Loewinger Z, Luboshitzky R, Nabriski D, Oren S, Phillip M, Ravid M, Rubinstein A, Shehadeh N, Slezak L, Stern E, Wainstein J, Yerushalmi Y, Porta M, Corgiat-Mansin L, Crepaldi G, Galluzzo A, Ghirlanda G, Invitti C, Noacco C, Piatti P, Realdi G, Saccardi F, Santeusanio F, Viviani GL, Pirags V, Jegere B, Laganovska G, Rasa I, Vinsteine I, Danileviclus J, Norkus A, Zalinkevicius R, Michel G, Wirion R, Drury P, Dunn P, Scott R, Toomath R, Strojek K, Bandurska-Stankiewicz E, Idzior-Walus B, Karnafel W, Koziol M, Krzyzagorska E, Lopatynski J, Markiewicz K, Mikolajczyk-Swatko A, Polaszwska-Muszynska M, Pynka S, Semetkowska-Jurkiewicz E, Gardete L, Gomes MJ, Sa A, Angelescu ML, Graur M, Mota M, Suciu GC, Tirgoviste CI, Veresiu AI, Dedoc I, Shestakova M, Ametov A, Bondar I, Bova E, Chizhova O, Demidova I, Dogadin S, Elpatova V, Gasparyan E, Ipatko I, Ivanova T, Jakovlevna BF, Karpova I, Khintal T, Kholopova E, Khrustalev O, Kolenko O, Korshennikov V, Kravez E, Krivolapova T, Kudriashova N, Melnichenkov G, Milovanova T, Mkrtumyan A, Morozova A, Nikiforova O, Ponomareva A, Rechkova E, Rodionova T, Shustov S, Smimova E, Suplotova L, Verbovaya N, Vladislavovich S, Vorokhobina N, Yakusevich V, Zarutskaya L, Zudaev V, Zykova T, Bonnici F, Amod A, van den Berg E, Brijkumar J, Chidi G, Distiller L, Doubell A, Fraser P, Jacovides A, Kelbe D, Kaplan H, Kok J, Lourens W, Mayet L, Moore R, Murray S, Naidoo V, Naiker P, Nortje H, Omar MA, Parker G, Philotheou A, Polakow ES, Postma A, Ramdass A, Randeree H, Robertson L, Sarvan MI, Smuts MS, Solomon E, Wellman H, Wing J, Gomis R, Albero R, Baldrich AG, Barberia Layana JJ, Peralta FG, González Albarrán O, Louis F, Sarda AN, Pinon-Selles F, Agardh CD, Adamson U, Agardh E, Alvarsson M, Lager I, Lindmark S, Nilsson A, Norberg B, Svensson M, Ilkova H, Aral Y, Ayvaz G, Baskal N, Dagdelen S, Erdogan G, Kaya A, Tanyeri F, Yilmaz C, Bilous R, Akintewe T, Anderson J, Beer S, Borthwick L, Boulton A, Collier A, Darko D, Doig J, Evans P, Gibby O, Greenwood R, Hart P, Hopkins D, Hyer S, Issa B, Jones GR, Lawrence I, Leese G, Lorrains J, Martin U, Nagi D, O'Hare JP, Page S, Patel V, Robertson D, Sampson M, Sandeman D, Walford S, Walker J, Webber J, Wiles P, Winocour P, Tesfaye S, Tooke J, Yang Y.

Author information

  • 1Department of Ophthalmology, Odense University Hospital, Odense, Denmark.

Abstract

BACKGROUND:

Diabetic retinopathy remains a leading cause of visual loss in people of working age. We examined whether candesartan treatment could slow the progression and, secondly, induce regression of retinopathy in people with type 2 diabetes.

METHODS:

We did a randomised, double-blind, parallel-group, placebo-controlled trial in 309 centres worldwide. We recruited normoalbuminuric, normotensive, or treated hypertensive people with type 2 diabetes with mild to moderately severe retinopathy and assigned them to candesartan 16 mg once a day or placebo. After a month, the dose was doubled to 32 mg once per day. Investigators and patients were unaware of the treatment allocation status. Progression of retinopathy was the primary endpoint, and regression was a secondary endpoint. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00252694.

FINDINGS:

1905 participants (aged 37-75 years) were randomised to candesartan (n=951) or placebo (n=954). 161 (17%) patients in the candesartan group and 182 (19%) in the placebo group had progression of retinopathy by three steps or more on the Early Treatment Diabetic Retinopathy Study scale. The risk of progression of retinopathy was non-significantly reduced by 13% in patients on candesartan compared with those on placebo (hazard ratio [HR] 0.87, 95% CI 0.70-1.08, p=0.20). Regression on active treatment was increased by 34% (1.34, 1.08-1.68, p=0.009). HRs were not attenuated by adjustment for baseline risk factors or changes in blood pressure during the trial. An overall change towards less severe retinopathy by the end of the trial was observed in the candesartan group (odds 1.17, 95% CI 1.05-1.30, p=0.003). Adverse events did not differ between the treatment groups.

INTERPRETATION:

Treatment with candesartan in type 2 diabetic patients with mild to moderate retinopathy might induce improvement of retinopathy.

Comment in

PMID:
18823658
[PubMed - indexed for MEDLINE]
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