Efficacy and safety of a stepped-care regimen using olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with moderate-to-severe hypertension: an open-label, long-term study.
BACKGROUND
Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This long-term open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ).


METHODS
Patients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5 mg/day monotherapy and who subsequently completed 16 weeks of double-blind combination treatment with olmesartan and amlodipine entered a 28-week open-label phase in which all patients initially received olmesartan/amlodipine 40/5 mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP >/=90 mmHg and >/=140 mmHg, respectively) had their doses increased in a step-wise manner to: (i) olmesartan/amlodipine 40/10 mg; (ii) olmesartan/amlodipine/HCTZ 40/10/12.5 mg; and (iii) olmesartan/amlodipine/HCTZ 40/10/25 mg.


RESULTS
In total, 692 patients entered the open-label phase (691 on olmesartan/amlodipine 40/5 mg). The majority of patients remained on olmesartan/amlodipine 40/5 mg without dose elevation, and, of these, 74.3% achieved goal BP at study completion or early termination. Additional patients achieved goal BP with each successive uptitration of therapy: in patients who finished the study on olmesartan/amlodipine 40/10 mg and olmesartan/amlodipine/HCTZ 40/10/12.5 mg, the respective proportions who reached goal BP were 59.0% and 47.1%. Overall, 66.9% of patients achieved the European guideline recommended goal BP of SBP <140 mmHg and DBP <90 mmHg for patients without diabetes mellitus, and SBP <130 mmHg and DBP <80 mmHg for patients with diabetes. Treatment was generally well tolerated, with no unexpected safety concerns.


CONCLUSIONS
A treatment algorithm based on olmesartan/amlodipine (+/- HCTZ) provides a high degree of BP control in patients with moderate-to-severe hypertension. The open-label study design suggests similar results are obtainable in clinical practice.
Volpe
Massimo
M
Specialty School of Cardiology, University of Rome 'La Sapienza', Rome, Italy. massimo.volpe@uniroma1.it
Miele
Cristina
C
Haag
Uwe
U
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004232:Diuretics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; 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; D000068557:Olmesartan Medoxomil; D017410:Practice Guidelines as Topic; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D047228:Angiotensin II Type 1 Receptor Blockers; D002121:Calcium Channel Blockers; D004232:Diuretics; D004338:Drug Combinations; D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068557:Olmesartan Medoxomil