title: Baseline characteristics in the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).
abstract: BACKGROUND
  Patients with type 2 diabetes are at enhanced risk for macro- and microvascular complications. Albuminuria and/or reduced kidney function further enhances the vascular risk. We initiated the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). Aliskiren, a novel direct renin inhibitor, which lowers plasma renin activity, may thereby provide greater cardio-renal protection compared with angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) alone.
  
  
  METHODS
  ALTITUDE is a randomized, double-blind, placebo-controlled study in high risk type 2 diabetic patients receiving aliskiren 300 mg once daily or placebo added to recommended cardio-renal protective treatment including ACEi or ARB, but not both. The number of patients randomized was 8606.
  
  
  RESULTS
  Baseline characteristics (median, IQR) are: age 65 (58, 72) years, male 68%, BMI 29.1 (25.7, 32.2) kg/m(2), cardiovascular disease 47.9%, blood pressure 134.7 (126, 150)/74.3 (67, 81) mmHg, HbA(1c) 7.5 (6.6, 8.6)%, LDL-cholesterol 2.4 (1.9, 3.0) mmol/L, haemoglobin 130 (119, 143) g/L, serum creatinine 115 (91, 137) µmol/L, eGFR 51.7 (42, 65) ml/min per 1.73 m(2), geometric mean UACR 198.9 (52, 2886) mg/g and frequency of micro/macroalbuminuria 25.7% and 58.2%. ALTITUDE is an event-driven trial to continue until 1628 patients experience a primary cardiovascular-renal event.
  
  
  CONCLUSIONS
  ALTITUDE will determine the potential cardio-renal benefit and safety of aliskiren in combination with ACEi or ARB in high risk patients with type 2 diabetes.
authors.affiliation: Department of Medical Endocrinology, Rigshospitalet, University of Copenhagen, Denmark. hhparving@dadlnet.dk
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Parving
authors.forename: Barry M
authors.initials: BM
authors.lastname: Brenner
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
authors.forename: Dick
authors.initials: D
authors.lastname: de Zeeuw
authors.forename: Steven M
authors.initials: SM
authors.lastname: Haffner
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
authors.forename: Nish
authors.initials: N
authors.lastname: Chaturvedi
authors.forename: Frederik
authors.initials: F
authors.lastname: Persson
authors.forename: Maria
authors.initials: M
authors.lastname: Nicolaides
authors.forename: Alexia
authors.initials: A
authors.lastname: Richard
authors.forename: Zhihua
authors.initials: Z
authors.lastname: Xiang
authors.forename: Juergen
authors.initials: J
authors.lastname: Armbrecht
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
mesh_terms: D000368:Aged; D000419:Albuminuria / Q000150:complications / Q000188:drug therapy; D000577:Amides / Q000494:pharmacology / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000150:complications / Q000188:drug therapy; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D023381:Endpoint Determination; D005260:Female; D005650:Fumarates / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009206:Myocardium / Q000473:pathology*
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D005650:Fumarates; C446481:aliskiren