title: Efficacy and tolerability of the single-pill combination of aliskiren 300 mg/amlodipine 10 mg in hypertensive patients not controlled by olmesartan 40 mg/amlodipine 10 mg.
abstract: OBJECTIVE
  We aimed to investigate whether the single pill combination (SPC) of aliskiren 300 mg and amlodipine 10 mg (ALIS 300/AMLO 10) improves blood pressure (BP) reduction in hypertensive patients not adequately controlled by the SPC olmesartan 40 mg and amlodipine 10 mg (OLM 40/AMLO 10).
  
  
  METHODS
  Open-label, non-randomized single-arm study. Patients with stage 2 hypertension were titrated to the SPC OLM 40/AMLO 10 (4-week Phase 1). If hypertension was not controlled they were switched to the SPC ALIS 300/AMLO 10 (4-week Phase 2). In the optional 4-week study extension hydrochlorothiazide (HCT) 12.5 mg was added. EudraCT 2009-016693-33.
  
  
  RESULTS
  In the 342 patients treated, OLM 40/AMLO 10 reduced systolic BP (SBP)/diastolic BP (DBP) by 24.5/14.5 mmHg by end of Phase 1. Those 187 patients with uncontrolled hypertension at the end of Phase 1 switched to ALIS 300/AMLO 10 experienced a further SBP reduction of 5.1 mmHg (95% confidence interval [CI] 3.7 to 6.5, p < 0.0001) and a DBP reduction of 4.8 mmHg (95% CI 3.8 to 5.8; p < 0.0001) in Phase 2. DBP or SBP responder rates were achieved by 51.3% or 44.4%, respectively, SBP and DBP normalization by 36.4%. In 65 patients whose BP was not controlled in Phase 2, SPC ALIS 300/AMLO 10/HCT 12.5 mg decreased SBP/DBP by further 8.1/6.7 mmHg (p < 0.0001 each). No deaths or serious adverse events were noted. Significant adverse events leading to study discontinuation were reported in 2.6% (Phase 1), 2.7% (Phase 2), and 0% (extension). Limitations included the open-label, single-arm non-randomized design, and the relatively short duration.
  
  
  CONCLUSIONS
  In this switch study reflecting clinical practice, patients with moderate hypertension not controlled by the SPC OLM 40/AMLO 10 achieved a clinically and statistically significant reduction of blood pressure from the SPC ALIS 300/AMLO 10 and the optional addition of HCT. All drug combinations were well tolerated.
authors: Department of Internal Medicine, Klinikum Pirna GmbH, Pirna, Germany. christoph.axthelm@klinikum-pirna.de
authors: Christoph
authors: C
authors: Axthelm
authors: Christian
authors: C
authors: Sieder
authors: Franziska
authors: F
authors: Meister
authors: Edelgard
authors: E
authors: Kaiser
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000577:Amides / Q000008:administration & dosage* / Q000009:adverse effects*; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D004351:Drug Resistance / Q000187:drug effects; D057915:Drug Substitution; D005260:Female; D005650:Fumarates / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D013607:Tablets / Q000008:administration & dosage / Q000009:adverse effects; D013777:Tetrazoles / Q000008:administration & dosage*; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D004338:Drug Combinations; D005650:Fumarates; D007093:Imidazoles; D013607:Tablets; D013777:Tetrazoles; D017311:Amlodipine; C446481:aliskiren; C437965:olmesartan