title: Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index.
abstract: OBJECTIVE
  Blood pressure (BP) reduction in hypertensive patients is more difficult to achieve in the elderly or in the presence of comorbidities. We aimed to investigate the efficacy of the single-pill combination (SPC) aliskiren/amlodipine in hypertensive elderly patients, patients with high body mass index (BMI), with at least one metabolic risk factor, and/or type 2 diabetes mellitus (DM).
  
  
  METHODS
  In an open-label non-randomized study, patients not adequately controlled by previous treatment with the SPC olmesarten 40/amlodipine 10 (phase 1) were switched to the SPC aliskiren 300/amlodipine 10 (phase 2). The present post-hoc analysis investigated BP reduction in phase 2 in the named subgroups. The EudraCT identifier was 2009-016693-33, ClinicalTrials.gov identifier NCT01113047.
  
  
  RESULTS
  Of the 187 patients not adequately controlled in phase 1 and thus treated with the SPC aliskiren 300/amlodipine 10 in phase 2, 69 were of advanced age (≥65 years), 74 or 89 were overweight or obese (BMI 25.0-29.9 kg/m(2) or ≥30 kg/m(2), respectively), 91 had metabolic risk factors (without DM) and 41 had DM. At the beginning of phase 2, depending on the subgroup, baseline SBP was 168-169 mmHg and DBP 103-104 mmHg. After 4 weeks of treatment with aliskiren 300/amlodipine 10, SBP/DBP was lowered by -5.1/-4.8 mmHg in the total cohort, by -5.5/-5.1 mmHg in elderly patients, by -6.7/-5.5 in overweight and by -4.2/-4.5 mmHg in obese patients, by -6.4/-4.7 mmHg in patients with metabolic risk factors without DM, and by -3.3/-5.0 mmHg in DM patients. Limitations include low sample size, limited treatment duration and the fact that the post-hoc defined groups were not mutually exclusive.
  
  
  CONCLUSIONS
  In this study reflecting clinical practice, the aliskiren/amlodipine combination achieved effective BP reduction in elderly patients or with metabolic comorbidities, including DM that might be more difficult to treat. This consistent BP lowering pattern facilitates everyday care of patients who receive aliskiren/amlodipine.
authors.affiliation: Cardiologicum, PirnaGermany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Axthelm
authors.affiliation: Clinical and Regulatory Affairs, Novartis Pharma GmbH, NuernbergGermany.
authors.forename: Christian
authors.initials: C
authors.lastname: Sieder
authors.affiliation: Clinical and Regulatory Affairs, Novartis Pharma GmbH, NuernbergGermany.
authors.forename: Franziska
authors.initials: F
authors.lastname: Meister
authors.affiliation: Institut für Klinische Pharmakologie, Technische Universität DresdenGermany.
authors.forename: David
authors.initials: D
authors.lastname: Pittrow
authors.affiliation: Clinical and Regulatory Affairs, Novartis Pharma GmbH, NuernbergGermany.
authors.forename: Edelgard
authors.initials: E
authors.lastname: Kaiser
keywords: Aliskiren; Amlodipine; Arterial hypertension; Combination therapy; Diabetes mellitus; Elderly; Metabolic risk factors; Olmesartan