Table 2: Clinical Trial Data on the Efficacy of Aliskiren/HCTZ in Reducing BP

Reference Patients, n (ITT) Treatment and Daily Dose (mg) Change in SBP from Baseline at Endpoint (mm Hg) Change in DBP from Baseline at Endpoint (mm Hg) Responder Rate (%) BP Control Rate at Endpoint (%)

Villamil (2007) [21] 192 Placebo -7.5 -6.9 45.8 28.1
183 Aliskiren 75 -9.4 -8.7±0.59a 51.9 (29.0
183 Aliskiren 150 -12.2b -8.9±0.59a 51.9 to
180 Aliskiren 300 -15.7c -10.3±0.60c 63.9b c 46.7)
194 HCTZ 6.25 -11.0a -9.1±0.58a 53.6 (32.5
188 HCTZ 12.5 -13.9c -10.1±0.59c 60.6a to
173 HCTZ 25 -14.3c -9.4±0.61a 59.0a 37.8)
187 Aliskiren/HCTZ 75/6.25 -14.3 ±0.93c,d -10.8c,d 61.5a a
189 Aliskiren/HCTZ 75/12.5 -15.6c -11.1c 63.5b a
186 Aliskiren/HCTZ 75/25 -17.3c,d -11.5c,d 70.4c,d a,d (37.4
173 Aliskiren/HCTZ 150/6.25 -15.3c -10.4±0.59c 58.4a a to
184 Aliskiren/HCTZ 150/12.5 -17.6c,d -11.9c,d 69.6c a,d 59.5)
187 Aliskiren/HCTZ 150/25 -19.5c,d -12.7c,d 71.1c,d a,d
180 Aliskiren/HCTZ 300/12.5 -19.8c,d -13.9c,d 80.6c,d a,d
173 Aliskiren/HCTZ 300/25 -21.2±0.97c,d -14.3±0.61c,d 76.9c,d a,d

Jordan(2007) [22] 117 HCTZ 25 -8.6±1.00 -7.9±0.73 59.0 34.2
113 Aliskiren/HCTZ 300/25 -15.8±1.01e -11.9±0.74e 73.5f 56.6g
117 Irbesartan/HCTZ 300/25 -15.4±1.00h -11.3±0.72h 70.9h 54.7h
122 Amlodipine/HCTZ 10/25 -13.6±0.98h -10.3±0.71h 68.0h 45.1i

Nickenig (2008) [20] 296 Aliskiren 300 -8.0±0.9 -7.4±0.5 62.2 40.9
292 Aliskiren/HCTZ 300/12.5 -13.5±0.9j -10.5±0.5j 73.3k 57.9j
284 Aliskiren/HCTZ 300/25 -15.9±0.9j -11.0±0.6j 77.1j 60.2j

Blumenstein (2009) [23] 244 HCTZ 25 mg -7.1±0.7 -4.8±0.4 47.1 25.8
242 Aliskiren/HCTZ 150/25 -12.9±0.7l -8.5±0.4l 67.4l 48.8l
232 Aliskiren/HCTZ 300/25 -16.7±0.7l,m -10.7±0.4l,n 78.5l 58.2l,o

Geiger (2009) [24] 151 HCTZ 25 -6±1.12 -6±0.70 NR 20.53
164 Aliskiren/HCTZ 300/25 -15 ±1.08l -11±0.67l NR 40.85l
154 Valsartan/HCTZ 320/25 -18 ±1.12l -14±0.70l NR 48.70l
168 Aliskiren/Valsartan/HCTZ 300/320/25 -22±1.07l,p,q -16±0.67l,p,q NR 66.67l,p,q

Changes in blood pressure are presented as the least-squares mean changes (with ± SEM, whenever provided by the authors).
a P < 0.05,
b P < 0.001,
c P ≤ 0.0001 vs placebo;
d P < 0.05 vs each component monotherapy;
e P < 0.0001 vs HCTZ 25 mg;
f P < 0.05 vs HCTZ 25 mg;
g P = 0.0005 vs HCTZ 25 mg;
h P > 0.05 vs aliskiren/HCTZ 300/25 mg;
i P = 0.052 vs aliskiren/HCTZ 300/25 mg;
j P < 0.001 vs aliskiren 300 mg;
k P = 0.002 vs aliskiren 300 mg;
l P < 0.001 vs HCTZ 25 mg;
m P = 0.009 vs aliskiren/HCTZ 150/25 mg;
n P < 0.001 vs aliskiren/HCTZ 150/25 mg;
o P = 0.033 vs aliskiren/HCTZ 150/25 mg;
p P < 0.001 vs aliskiren/HCTZ 300/25 mg;
q P < 0.01 vs valsartan/HCTZ 320/25 mg;
r P < 0.001 vs valsartan/HCTZ 320/25 mg.
BP – Blood pressure; DBP – Diastolic blood pressure; HCTZ – Hydrochlorothiazide; ITT – Intention-to-treat analysis; NR – Not reported; SBP – Systolic blood pressure.