Efficacy of amlodipine/olmesartan medoxomil ± HCTZ in obese patients uncontrolled on antihypertensive monotherapy.
OBJECTIVE
BP-CRUSH (Blood Pressure Control in All Subgroups With Hypertension) was a phase IV, prospective, open-label, multicenter, single-arm, dose-titration study (N = 999). The present subgroup analysis reports the efficacy/safety of up to 20 weeks of treatment with amlodipine (AML)/olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) in obese and non-obese patients with hypertension uncontrolled on antihypertensive monotherapy.


METHODS
Eligible obese (body mass index ≥30 kg/m(2); n = 505) and non-obese (<30 kg/m(2); n = 494) patients were switched to AML/OM 5/20 mg and uptitrated at 4-week intervals to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 mg + HCTZ 12.5 mg, and AML/OM 10/40 mg + HCTZ 25 mg. Uptitration to higher doses of AML/OM was permitted if mean seated systolic BP (SeSBP) was ≥120 mmHg, or mean seated diastolic BP (SeDBP) was ≥70 mmHg. HCTZ was added if mean SeSBP was ≥125 mmHg, or mean SeDBP was ≥75 mmHg.


BACKGROUND
ClinicalTrials.gov identifier: NCT00791258


METHODS
The primary efficacy endpoint was the cumulative proportion of patients achieving SeSBP <140 mmHg (<130 mmHg for patients with diabetes mellitus) at 12 weeks. Secondary endpoints included seated cuff BP (SeBP) goal rates, ambulatory BP target rates, and mean change from baseline in SeBP and ambulatory BP at weeks 12 and 20.


RESULTS
At 12 weeks, 71.6% of obese patients (80.2% non-obese) achieved the primary endpoint of cumulative SeSBP <140 mmHg (<130 mmHg for patients with diabetes). The cumulative SeBP goal of <140/90 mmHg (<130/80 mmHg if diabetes) was achieved by 64.8% and 81.2% of obese patients by weeks 12 and 20, respectively (vs. 77.9% and 88.5% of non-obese patients, respectively). Treatment was well-tolerated, with 26.1% of obese patients (24.9% non-obese) experiencing drug-related treatment-emergent adverse events (TEAEs). There were no serious drug-related TEAEs.


CONCLUSIONS
An AML/OM ± HCTZ treatment regimen provided effective and safe BP control in obese patients with hypertension uncontrolled on monotherapy.
The Methodist Hospital Research Institute, Houston, TX 77030, USA. wahsueh@tmhs.org
Willa A
WA
Hsueh
Ali
A
Shojaee
Jen-Fue
JF
Maa
Joel M
JM
Neutel
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000627:therapeutic use*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications*; D000068557:Olmesartan Medoxomil; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*
D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068557:Olmesartan Medoxomil