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IN MANAGEMENT OF HYPERTENSION
(OPTIMIZING PATIENT ADHERENCE TO
TREATMENT)
Dr Rubin Surachno
Div.Nephrology and Hypertension.
Dr Hasan Sadikin Hospital Bandung
April 2018
COACH PIVOTALTRIAL:
Factorial Study Overview and Design
• Purpose OM
Placebo 10 mg 20 mg 40 mg
• Toassess the efficacy and
tolerability of varying doses of AML
in combination with OM compared n=162 n=161 n=161 n=162
Placeb
with each monotherapycomponent
• Pivotal study for FDAapproval of
o
• Primary endpoint n=161 n=163 n=161 n=162
AM
5 mg
L
• Mean change from baseline in
SeDBPat Week8
10 mg
• Secondary endpoint n=163 n=162 n=160 n=162
• Mean change from baseline in
SeSBPat Week8 Total N=1940
Placebo AML 5mg AML 10mg OM 20mg OM 40mg AZOR 5/20 AZOR 10/40
0 (n=160) (n=161) (n=163) (n=159) (n=160) mg (n=160) mg (n=161)
Mean Change in SeSBPFrom
–5
Baseline (mm Hg)
–10
– 5*
–15
–20 – 14†
– 15† – 16†
–25
– 20†
–30 – 24†
–35
– 30†
Mean BP baseline values were: placebo=167/102 mm Hg, AML 5 mg=163/102 mm Hg, AML 10 mg=164/102 mm Hg,
OM 20 mg=164/102 mm Hg, OM 40 mg=163/101 mm Hg, Comb. 5/20 mg=164/102 mm Hg, Comb.10/40 mg=166/102 mm Hg.
Mean SeDBP reductions were: placebo=3 mm Hg, AML 5 mg=9 mm Hg, AML 10 mg=13 mm Hg,
OM 20 mg=9 mm Hg, OM 40 mg=10 mm Hg, Comb. 5/20 mg=14 mm Hg, Comb. 10/40 mg=19 mm Hg.
*P<0.05 vs baseline. †P<0.001 vs baseline.
Chrysant SG, et al. Clin Ther. 2008;30:587–604.
COACH: SBP Reduction in a Factorial Study
of Olmesartan and Amlodipine