title: Efficacy of amlodipine/olmesartan ± hydrochlorothiazide in patients uncontrolled on prior calcium channel blocker or angiotensin II receptor blocker monotherapy.
abstract: BACKGROUND
  While monotherapy is often recommended as initial treatment, most patients require dose escalation and add-on agents to achieve their blood pressure (BP) goal. This secondary analysis evaluated the efficacy and safety of initiating patients on a regimen of fixed-dose amlodipine (AML)/olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) who were uncontrolled on prior monotherapy with a calcium channel blocker (CCB) or angiotensin II receptor blocker (ARB).
  
  
  METHODS
  Patients uncontrolled on prior monotherapy with CCB or ARB therapy were initiated on AML/OM 5/20 mg and up-titrated every 4 weeks to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 + HCTZ 12.5 mg, and AML/OM 10/40 + HCTZ 25 mg. Patients were up-titrated to a higher AML/OM dose if mean seated cuff BP (SeBP) was ≥120/70 mmHg, and up-titrated to any HCTZ dose if mean SeBP was ≥125/75 mmHg. The primary efficacy endpoint was the cumulative proportion of patients achieving a seated cuff systolic BP (SeSBP) goal of <140 mmHg (<130 mmHg for patients with diabetes) after 12 weeks. Secondary endpoints included mean change from baseline in SeBP and ambulatory BP, ambulatory BP target achievement, and safety.
  
  
  RESULTS
  For the prior CCB (n = 118; baseline SeBP: 153.4/91.5 mmHg) and ARB (n = 237; 154.6/92.6 mmHg) groups, SeSBP goal achievement after 12 weeks was 72.7% and 76.9%, respectively. Mean changes (± SE) from baseline in SeBP were dose proportional for prior CCB and ARB patients, ranging from -9.9 (± 1.25)/-5.8 (± 0.83) mmHg and -13.9 (± 0.79)/-7.6 (± 0.47) mmHg at the AML/OM 5/20 mg dose, respectively, to -21.8 (± 1.68)/-11.6 (±.12) mmHg and -26.2 (± 1.31)/-15.0 (± 0.86) mmHg at the AML/OM 10/40 mg + HCTZ 25 mg dose (P < 0.0001 for all).
  
  
  CONCLUSIONS
  An AML/OM-based titration regimen was efficacious in achieving BP goal in patients uncontrolled on prior monotherapy with a CCB or ARB.
authors: Department of Clinical Pharmacology, Orange County Research Center, Tustin, CA 92780, USA. jmneutel@aol.com
authors: Joel
authors: J
authors: Neutel
authors: Ali
authors: A
authors: Shojaee
authors: Jen-Fue
authors: JF
authors: Maa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005006:Ethnicity; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; C437965:olmesartan