Table 3.

Effects of treatment with aliskiren and amlodipine on PRC, PRA, and BP in randomized, double-blind studies in patients with hypertension, cardiovascular disease, or diabetes

Study	Drug	N	Geometric mean % change from baseline [n]			Mean sitting SBP/DBP (mm Hg)
			PRC		PRA		Baseline	Change from baseline
Nussberger 2007 (adults with mild-to-moderate hypertension) (Nussberger et al. 2007)
Week 8	Placebo	111	−9		−11		152/NA	−5/NA
	ALI 150 mg	112	+157		−69*		151/NA	−9/NA
	ALI 300 mg	115	+246*		−71*		152/NA	−15/NA
	ALI 600 mg	113	+497*		−75*		153/NA	−16/NA
	Irbesartan 150 mg	118	+105		+109		153/NA	−13/NA
Duprez 2009 (elderly patients with systolic hypertension) (Duprez et al. 2009)
Week 12	ALI 150–300 mg	451	+246‡	[59]	−79‡	[59]	NA	−14.0*/−5.1†
	RAM 5–10 mg	439	+100	[62]	+147	[62]	NA	−11.6/−3.6
Week 36 (±HCTZ±AMLO)	ALI 150–300 mg	451	+469‡	[65]	−70‡	[65]	NA	NA
	RAM 5–10 mg	439	+173	[66]	+244	[66]	NA	NA
Andersen 2008, Andersen in press (adults with mild-to-moderate hypertension) (Andersen et al. 2008,Andersen et al. 2009)
Week 12	ALI 150–300 mg	420	ND		ND		151.3/98.8	−14.0†/−11.3†
	RAM 5–10 mg	422	ND		ND		151.5/98.9	−11.3/−9.7
Week 26 (±HCTZ)	ALI 150–300 mg	420	+224	[39]	−63	[103]	151.3/98.8	−17.9†/−13.2*
	RAM 5–10 mg	422	+145	[33]	+143	[100]	151.5/98.9	−15.2/−12.0
Oparil 2007 (adults with mild-to-moderate hypertension) (Oparil et al. 2007a)
Week 8	Placebo	459	+19	[51]	+18	[51]	154.2/100.5	−4.6/−4.1
	ALI 150 mg	437	+468	[51]	−73	[51]	154.0/100.3	−13.0/−9.0
	VAL 160 mg	455	+138	[59]	+160	[59]	154.2/100.4	−12.8/−9.7
	ALI 150 mg + VAL 160 mg	446	+912†	[60]	−44‡	[60]	152.7/100.1	−17.2‡/−12.2‡
Villamil 2007 (adults with mild-to-moderate hypertension) (Villamil et al. 2007)
Week 8	Placebo	195	+30		+1		152.7/99.3	−7.5/−6.9
	ALI 75 mg	184	+164		−54		153.2/99.4	−9.4/−8.7
	ALI 150 mg	185	+192		−65		153.4/98.8	−12.2/−8.9
	ALI 300 mg	183	+348		−58		154.4/99.3	−15.7/−10.3
	HCTZ 6.25 mg	194	+10		+4		153.4/99.3	−11.0/−9.1
	HCTZ 12.5 mg	188	+26		+45		153.4/99.1	−13.9/−10.1
	HCTZ 25 mg	176	+108		+72		154.5/99.1	−14.3/−9.4
	ALI 75 mg + HCTZ 6.25 mg	188	NA		−55		154.5/98.9	−14.3*/−10.8*
	ALI 150 mg + HCTZ 12.5 mg	186	NA		−50		154.1/99.1	−17.6*/−11.9*
	ALI 300 mg + HCTZ 25 mg	173	+1211		−62		154.6/99.3	−21.2*/−14.3*
Geiger 2009 (adults with mild-to-moderate hypertension unresponsive to HCTZ monotherapy) (Geiger et al. 2009)
Week 8	HCTZ 25 mg	152	−29	[43]	−13	[43]	154.1/99.9	−6/−6
	ALI 150–300 mg + HCTZ 25 mg	166	+490	[47]	−41	[47]	153.3/99.3	−15‡/−11‡
	VAL 160–320 mg + HCTZ 25 mg	155	+561	[42]	+509	[42]	156.7/99.9	−18‡/−14‡
	ALI 150–300 mg + VAL 160–320 mg + HCTZ 25 mg	168	+1760	[52]	+39	[52]	152.7/99.2	−22‡§/−16‡§
Drummond 2007 (mild-to-moderate hypertension in amlodipine non-responding adults) (Drummond et al. 2007)
Week 6	ALI 150 mg + AMLO 5 mg	187	NA		−74.4	[55]	150.5/95.7	−11.0/−8.5
	AMLO 5 mg	180	NA		−9.9	[48]	150.5/96.2	−5.0/−4.8
	AMLO 10 mg	178	NA		+58.0	[48]	150.8/96.5	−9.6/−8.0
Uresin 2007 (adults with mild-to-moderate hypertension + diabetes mellitus) (Uresin et al. 2007)
Week 8	ALI 300 mg	282	+139	[84]	−66	[84]	157.4/98.4	−14.7/−11.3
	RAM 10 mg	278	+72	[72]	+106	[72]	155.9/98.2	−12.0/−10.7
	ALI 300 mg + RAM 10 mg	277	+331*	[77]	−48*	[77]	156.5/98.4	−16.6¶/−12.8*
McMurray 2008 (adults with NYHA class II to class IV CHF receiving a BB + an ACEI or ARB) (McMurray et al. 2008)
Month 3	Placebo	146	−10		−9		128/76	−1.3/−0.2
	ALI 150 mg	156	+142		−77		130/78	−4.1/−2.9

Studies are sorted by order of appearance in text.

^*P<.05 vs active monotherapy comparator(s);

^†P<.01 vs active monotherapy comparator(s);

^‡P<.001 vs active monotherapy comparator(s);

^§P<.01 vs either dual therapy;

^¶P<.001 vs ramipril monotherapy.

Abbreviations: ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; ALI = aliskiren; AMLO = amlodipine; BB = beta-blocker; BP = blood pressure; CHF = congestive heart failure; DBP = diastolic blood pressure; HCTZ = hydrochlorothiazide; NA = not available; ND = not done; NYHA = New York Heart Association; PRA = plasma renin activity; PRC = plasma renin concentration; RAM = ramipril; SBP = systolic blood pressure; VAL = valsartan.