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N Engl J Med. 2008 Jun 5;358(23):2433-46. doi: 10.1056/NEJMoa0708379.

Aliskiren combined with losartan in type 2 diabetes and nephropathy.

Collaborators (351)

Lebel M, Agharazi M, Muirhead N, House A, Rehman F, Pichette V, LeBlanc M, Bomardeaux A, Houde M, Pylypchuk G, Ahmed A, Barton J, Jolly S, Siamopoulos K, Theodorou I, Pagkalos E, Gavra M, Klitsas A, Soulis K, Pais MJ, Parreira L, Ribeiro da Cunha A, Carmo P, Gomes da Costa A, Morgado da Silva S, Carvalho D, Magalhães A, Oliveira A, Queirós J, Oguz A, Erenmemisoglu A, Seker S, Muderrisoglu C, Altinoglu E, Erenmemisoglu A, Ecder T, Yazici H, Arici M, Erenmemisoglu A, Yilmaz R, Dilek K, Erenmemisoglu A, Kahvecioglu S, Akdag I, Parving HH, Persson F, Schjødt K, Tarnow L, Svendsen OL, Christensen TM, Tanderup Petersen MB, Perrild H, Almdal T, Thorsteinsson B, Snorgård O, Juhl H, Hansen H, Henriksen J, Vind B, Østergaard O, Christiansen E, Choukroun G, El Esper N, Presne C, Aldigier J, Bataille P, Nour D, Fauvel JP, Zaoui P, Malvezzi P, Halimi JM, Lecomte P, Charpentier G, Boucherie B, Jung T, Jung N, Jordan J, Mehling H, Budziarek P, Engeli S, Haller H, Menne J, Niescken S, Herrmann A, Hellweg S, David S, Deines A, Schmieder R, Schmidt B, Schäufele T, Simon J, Oerter E, Rambausek M, Schoemig M, Stephan M, Austenat E, Grothe C, Lederer T, Al-Masry B, Blume G, Hohberg C, Butzer R, Forst T, Musholt P, Wilhelm B, Gruenerbel A, Gruenerbel M, Richter C, Santoro A, Federico M, Mandreoli M, Stalteri L, Remuzzi G, Ruggenenti P, Perticucci E, Rota S, Gesuaido L, Ktena M, Pallotta E, David S, Grasselli C, Zoccali C, Cambareri FM, Parlongo G, Balducci A, Gamerini M, Sorbo G, Fanciulli E, Freddi P, Balestra E, Quarello F, Boero R, Borsa S, Mossara C, Fabbri A, degli Esposti E, Baraccani C, Sturani A, Gentile M, Baraldi A, Federico MR, van den Meiracker A, Rutten J, Wijberga J, Kaasjager HA, Reichert LJ, Breed J, Hollander A, van Meurs P, Ciggaar F, van Hoek P, Gregoor PJ, Landewé-Cleuren S, Viergever P, Timmerman R, Verhoeven RP, Barendregt J, Lieverse R, Smit J, Radema S, van Dijk MA, van Bemmel T, Woittiez AJ, Visser F, Alegre Martin J, Aleman Llanso C, Duran Tabena M, Recio Iglesias J, Soriano Sanchez T, Comas L, Farres X, Ledesma Casteltort A, Terns M, Fernandez P, Gonzales-N F, Ortiz-Herbener F, Oliveras A, Vazquez S, Martinez Castelao A, Moreso Mateos F, Gonzalez Alvarez MT, Redon J, Casanova A, Gorriz J, Molina Vila P, Priego A, Ruilope L, Roldan C, Segura J, Campo C, Calle Pascual A, Garcia Honduvilla J, de Alvaro F, Costero Fernandez O, Garcia de Vinvera S, Goicoechea M, Luño J, Olivan J, Pizarro Nunez J, Gonzales-Serna E, Rodriguez Botaro A, Gomez P, Eady Alonso M, De Teresa Parreno L, Garcia Hermosa P, Gomez Gomez J, Fuentes Luri S, Blazquez J, Aranda P, Calvo C, Rodriguez Fernandez M, Lopez Paz J, Viberti G, Karalliedde J, Mirenda V, Gnudi L, Rees A, Roberts A, Reckless J, Robinson A, Mukhtar RY, Vora J, Joshi A, White H, Franklin J, Walker J, Sandeep T, Mukhtar A, Gray R, Heller S, Mackie A, Song SH, O'Hare J, Chittari MV, Kos K, Pierides M, Voiculescu M, Caceaune N, Iliescu L, Bobeica R, Ionescu C, Ismail G, Luca L, Tatu-Chitoiu G, Cronaciu S, Jumatate R, Zamfir D, Stefanescu M, Muntoi D, Dobreanu D, Cromos D, Dogaru G, Caldararu C, Zdrenghea D, Roman C, Malai A, Cebanu M, Ostace M, Pop D, Rosu R, Mihaila R, Mihaila R, Rezi E, Strugariu M, Deac M, Zadionchenko V, Adasheva T, Demicheva O, Antsiferov M, Koteshkova O, Sretenskaya I, Tsipuria K, Vasilieva E, Fomina I, Tarzimanova A, Vasileva A, Martsevich S, Semenova J, Serazhim A, Voronina V, Dmitrieva N, Ershova O, Kumzerov P, Borisova N, Ohapkina E, Bolshakova E, Lantsevsa O, Strezhova L, Terentieva T, Karpova I, Ostrovskaya E, Panina V, Majul C, Paez O, Puleio P, Visser M, Sinay I, Nepote M, Elbert A, Beresan H, Juncos L, Garcia N, Orias M, Barron MB, Novoa P, Wynne A, Conrow J, Rendell M, Lane J, Robertson D, Solomon R, Himot E, Schmidt S, Spisak W, Mossberg J, Graf R, Cooper R, Ouseph R, Liljenquist J, Seidner M, Culpepper R, Lester F, Wood B, Butin R, Ram V, Sachson R, Toto R, Zamora B, Busch R, Cohen K, Barreto A, Hillner K, Kopyt NP, Lipetz R, LaSalle J, Robertson J, Mageli J, Cherlin R, Snell P, Dyess E, Sapin N, Reeves M, Suchinda P, Fagan T, Parker M, Martinez D, Arakaki R, Bohannon N, Moustafa M, Chen A, Barranco E.

Abstract

BACKGROUND:

Diabetic nephropathy is the leading cause of end-stage renal disease in developed countries. We evaluated the renoprotective effects of dual blockade of the renin-angiotensin-aldosterone system by adding treatment with aliskiren, an oral direct renin inhibitor, to treatment with the maximal recommended dose of losartan (100 mg daily) and optimal antihypertensive therapy in patients who had hypertension and type 2 diabetes with nephropathy.

METHODS:

We enrolled 599 patients in this multinational, randomized, double-blind study. After a 3-month, open-label, run-in period during which patients received 100 mg of losartan daily, patients were randomly assigned to receive 6 months of treatment with aliskiren (150 mg daily for 3 months, followed by an increase in dosage to 300 mg daily for another 3 months) or placebo, in addition to losartan. The primary outcome was a reduction in the ratio of albumin to creatinine, as measured in an early-morning urine sample, at 6 months.

RESULTS:

The baseline characteristics of the two groups were similar. Treatment with 300 mg of aliskiren daily, as compared with placebo, reduced the mean urinary albumin-to-creatinine ratio by 20% (95% confidence interval, 9 to 30; P<0.001), with a reduction of 50% or more in 24.7% of the patients who received aliskiren as compared with 12.5% of those who received placebo (P<0.001). A small difference in blood pressure was seen between the treatment groups by the end of the study period (systolic, 2 mm Hg lower [P=0.07] and diastolic, 1 mm Hg lower [P=0.08] in the aliskiren group). The total numbers of adverse and serious adverse events were similar in the groups.

CONCLUSIONS:

Aliskiren may have renoprotective effects that are independent of its blood-pressure-lowering effect in patients with hypertension, type 2 diabetes, and nephropathy who are receiving the recommended renoprotective treatment. (ClinicalTrials.gov number, NCT00097955 [ClinicalTrials.gov].).

Copyright 2008 Massachusetts Medical Society.

PMID:
18525041
[PubMed - indexed for MEDLINE]
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