Key result
Single-pill olmesartan/amlodipine reduces SBP by ~22 mmHg in uncontrolled hypertension.
Why the study?
Switching to single-pill combinations can improve medication adherence, but the blood pressure-lowering effect of switching to olmesartan medoxomil and amlodipine besylate after non-response to amlodipine monotherapy required evaluation.
Does a single-pill combination of olmesartan 20 mg and amlodipine 5 mg reduce blood pressure in hypertensive patients unresponsive to amlodipine 5 mg monotherapy?
Does a single-pill combination of olmesartan 20 mg and amlodipine 5 mg reduce blood pressure in hypertensive patients unresponsive to amlodipine 5 mg monotherapy?
Absolute Event Rate: 131% vs 153%
p-value: p=<0.001
Switching to a single-pill combination of olmesartan 20 mg and amlodipine 5 mg significantly reduces blood pressure and improves arterial stiffness in patients with hypertension uncontrolled by amlodipine 5 mg monotherapy.
May support SPC addition after amlodipine failure; leaves open need for RCTs on outcomes before practice change.
Background: As combination therapy, switching to single-pill combination (SPC) medication after a short period of monotherapy is helpful because reducing pill numbers can improve patients' adherence to medications. This study was aimed to assess the effect of the single-pill combination (SPC) of olmesartan medoxomil 20 mg and amlodipine besylate 5mg (OLM 20 mg/AML 5 mg) on blood pressure (BP) reduction in hypertensive patients who did not respond to amlodipine besylate 5 mg (AML 5 mg) monotherapy for 4 weeks. Methods: This study was a prospective, open-label, multi-center, non-comparative study. Patients whose BP was not got the target BP (≥140 mmHg and if diabetic patients ≥130 mmHg) after 4 weeks treatment with AML 5 mg, were enrolled. AML 5 mg was switched to the SPC (OLM 20 mg/AML 5 mg) treatment for 8 weeks. The primary effectiveness endpoint was the reduction of seated systolic blood pressure (SeSBP) after SPC (OLM 20 mg/AML 5 mg) treatment for 8 weeks. The changes of brachial-ankle pulse wave velocity (baPWV), central BP (CBP), and augmentation index (AIx@75) were evaluated also. Results: Forty-seven patients were enrolled (mean age = 52±9 years, 36 men). After the SPC treatment for 8 weeks, SeSBP was reduced from 153±9 mmHg to 131±18 mmHg and seated diastolic BP (SeDBP) from 95±8 mmHg to 81±11 mmHg (p<0.001 and p<0.001, respectively). The reduction of SeSBP/SeDBP were 22 mmHg and 14 mmHg, respectively. The target goal BP achievement rate was 74.5%, and baPWV, CBP, and AIx@75 were improved. Conclusion: SPC (OLM 20 mg/AML 5 mg) treatment for 8 weeks was effective in reducing BP, achieving target BP goal, and also improving arterial stiffness in uncontrolled hypertensive patients with AML 5 mg monotherapy.
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Byong-Kyu Kim (2023) studied Uncontrolled hypertension (n=47). Olmesartan medoxomil and amlodipine besylate single-pill combination vs. Baseline (amlodipine 5 mg monotherapy) was evaluated on Reduction of seated systolic blood pressure (SeSBP) at 8 weeks (p=<0.001). An 8-week treatment with a single-pill combination of olmesartan 20 mg and amlodipine 5 mg significantly reduced seated systolic blood pressure by 22 mmHg (p<0.001) in patients with uncontrolled hypertension.
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