Key result
In Korean patients with moderate hypertension not controlled with dual therapy, switching to triple fixed-dose combination therapy significantly reduced mean seated diastolic blood pressure compared to continuing dual therapy (-9.50 vs -4.23 mmHg, p<0.0001).
Why the study?
Does triple fixed-dose combination therapy with olmesartan, amlodipine, and hydrochlorothiazide improve blood pressure reduction in patients with hypertension uncontrolled on dual therapy?
RCT (n=338)
Double-blind
Randomized
Yes
Does triple fixed-dose combination therapy with olmesartan, amlodipine, and hydrochlorothiazide improve blood pressure reduction in patients with hypertension uncontrolled on dual therapy?
Absolute Event Rate: -9.5% vs -4.23%
p-value: p=<0.0001
Triple combination therapy with olmesartan, amlodipine, and hydrochlorothiazide provides superior blood pressure reduction compared to continuing dual therapy in patients with uncontrolled moderate hypertension.
Supports switching to triple FDC in moderate hypertension uncontrolled on dual therapy; extends RCT evidence for this olmesartan/amlodipine/HCTZ regimen.
BACKGROUND: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5). METHODS: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP >140/90 mmHg or msSBP/msDBP >130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period. RESULTS: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p < 0.0001 vs. baseline; p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated. CONCLUSION: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).
No takes yet. Share an insight, caveat, or question.
Sohn et al. (2015) conducted an RCT in Moderate hypertension not controlled with dual fixed-dose combination therapy (n=338). Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (OM/AML/HCTZ) vs. Olmesartan medoxomil and hydrochlorothiazide (OM/HCTZ) 20/12.5 mg once daily was evaluated on Change in mean seated diastolic blood pressure (msDBP) from randomization to the end of the 8-week double-blind treatment period (p=<0.0001). In Korean patients with moderate hypertension not controlled with dual therapy, switching to triple fixed-dose combination therapy significantly reduced mean seated diastolic blood pressure compared to continuing dual therapy (-9.50 vs -4.23 mmHg, p<0.0001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: