Effective systolic blood pressure reduction with olmesartan medoxomil/amlodipine combination therapy: post hoc analysis of data from a randomized, double-blind, parallel-group, multicentre study.
OBJECTIVE
Systolic blood pressure (SBP) strongly predicts cardiovascular risk and is an important factor to evaluate in studies of antihypertensive treatments. A recent randomized controlled study has shown that the angiotensin II type 1 receptor antagonist (angiotensin receptor blocker [ARB]) olmesartan medoxomil (hereafter olmesartan) combined with the calcium channel antagonist (calcium channel blocker) amlodipine can control SBP in a majority of patients with moderate-to-severe hypertension. The aim of this report is to present results from a post hoc analysis of this study to further evaluate the effects of this combination on SBP.


METHODS
A post hoc analysis of changes in seated SBP (SeSBP) levels in patients treated with olmesartan 40 mg plus amlodipine 5 or 10 mg was carried out to investigate the distribution of SeSBP changes produced by this combination. Patients who reached the end of the 52-week study were categorized by size of SeSBP reduction from baseline as follows: </=15 mmHg; >15 to </=30 mmHg; >30 to </=45 mmHg and >45 mmHg.


RESULTS
In 578 patients who received olmesartan/amlodipine 40 mg/5 mg or 40 mg/10 mg and completed the study, the mean SeSBP reduction from baseline was 31.18 mmHg, and the proportions of patients with SeSBP reductions </=15 mmHg, >15 to </=30 mmHg, >30 to </=45 mmHg and >45 mmHg were 12.8%, 36.0%, 35.3% and 15.9%, respectively. In patients who received olmesartan/amlodipine 40 mg/10 mg, the proportion of patients in the </=15 mmHg group was smaller (12.2%) and in the >45 mmHg group was larger (21.6%). Moreover, patients in the >45 mmHg category showed the greatest reduction in SeSBP from baseline (53.5 mmHg for olmesartan/amlodipine 40 mg/10 mg recipients). Categorical analysis of patients treated with olmesartan/amlodipine 40 mg/10 mg in a separate, factorial study showed similar results: SeSBP reductions of </=15 mmHg; >15 to </=30 mmHg; >30 to </=45 mmHg and >45 mmHg were seen in 17%, 34%, 36% and 14% of patients, respectively.


CONCLUSIONS
Treatment with a combination based upon olmesartan 40 mg plus amlodipine 5 or 10 mg effectively reduces elevated SeSBP, particularly in patients with high levels of SeSBP.
Assistance Publique-Hôpitaux de Paris, Avicenne Hospital and University Paris XIII, Bobigny, France. jean-jacques.mourad@avc.aphp.fr
Jean-Jacques
JJ
Mourad
Sylvain
S
Le Jeune
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017311:Amlodipine / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D000068557:Olmesartan Medoxomil; D016032:Randomized Controlled Trials as Topic; D013777:Tetrazoles / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D007093:Imidazoles; D013777:Tetrazoles; D017311:Amlodipine; D000068557:Olmesartan Medoxomil