Efficacy of aliskiren/hydrochlorothiazide single-pill combinations in aliskiren non-responders.
OBJECTIVE
To evaluate the efficacy, safety and tolerability of a single-pill combination of the direct renin inhibitor aliskiren and hydrochlorothiazide (HCT) in patients with hypertension and an inadequate BP response to aliskiren monotherapy (mean sitting diastolic BP [msDBP] > 90 and < or = 110 mmHg following 4 weeks of aliskiren 300 mg).


METHODS
In this study, 880 patients with hypertension and an inadequate BP response to aliskiren monotherapy were randomized to once-daily, double-blind treatment with a single-pill combination of aliskiren/HCT 300/25 mg or 300/12.5 mg, or aliskiren 300 mg monotherapy. At the week 8 endpoint, least-squares mean changes in mean sitting systolic/diastolic BP (msSBP/DBP) from baseline were analyzed for the intent-to-treat population.


RESULTS
Aliskiren/HCT 300/25 mg and 300/12.5 mg provided significantly greater msSBP/DBP reductions from baseline (15.9/11.0 mmHg and 13.5/10.5 mmHg, respectively) than aliskiren 300 mg alone (8.0/7.4 mmHg; both p<0.001). Rates of BP control (<140/90 mmHg) were significantly higher with aliskiren/HCT 300/25 mg (60.2%) and 300/12.5 mg (57.9%) than with aliskiren 300 mg alone (40.9%; both p<0.001). Aliskiren/HCT single-pill combination treatment showed similar tolerability to aliskiren monotherapy.


CONCLUSIONS
Aliskiren/HCT single-pill combinations provide clinically significant additional BP reductions and improved BP control rates over aliskiren alone in patients who are non-responsive to aliskiren 300 mg monotherapy.
Nickenig
Georg
G
Universitätsklinikum Bonn, Bonn, Germany. georg.nickenig@ukb.uni-bonn.de
Simanenkov
Vladimir
V
Lembo
Giuseppe
G
Rodriguez
Pablo
P
Salko
Thomas
T
Ritter
Shannon
S
Zhang
Jack
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000577:Amides / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004232:Diuretics / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004351:Drug Resistance; D023381:Endpoint Determination; D005260:Female; D005650:Fumarates / Q000627:therapeutic use*; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D000577:Amides; D000959:Antihypertensive Agents; D004232:Diuretics; D004338:Drug Combinations; D005650:Fumarates; D006852:Hydrochlorothiazide; C446481:aliskiren