ADVANTAGE OF FIXED DOSE COMBINATION

IN MANAGEMENT OF HYPERTENSION
(OPTIMIZING PATIENT ADHERENCE TO
TREATMENT)

Dr Rubin Surachno
Div.Nephrology and Hypertension.
Dr Hasan Sadikin Hospital Bandung
April 2018
 COACH PIVOTAL TRIAL:
Factorial Study Overview and Design
• Purpose OM
Placebo 10 mg 20 mg 40 mg
• To assess the efficacy and
tolerability of varying doses of AML
in combination with OM compared n=162 n=161 n=161 n=162

Placebo
with each monotherapy component
• Pivotal study for FDA approval of

AML
• Primary endpoint n=161 n=163 n=161 n=162

5 mg
• Mean change from baseline in
SeDBP at Week 8

10 mg
• Secondary endpoint n=163 n=162 n=160 n=162
• Mean change from baseline in
SeSBP at Week 8 Total N=1940

AML=amlodipine; OM=olmesartan medoxomil; SeDBP=seated DBP; SeSBP=seated SBP.

Chrysant SG, et al. Clin Ther. 2008;30:587–604.
 COACH: Dual-Therapy Provided
BP Reductions Over AML Monotherapy
Mean SBP Reductions at Week 8 in the Overall Population

Placebo AML 5 mg AML 10 mg OM 20 mg OM 40 mg 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 SeSBP From

–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

Chrysant et al. Clinic Ther 2008;30(4):587–604

Mean Reduction in SBP at Weeks 2, 4, 6 and
8 with Olmesartan Combinations

Chrysant et al. Clinic Ther 2008;30(4):587–604

BP Reduction of Olmesartan-Amlodipine Combination
in Challenging Patients: Elderly

Chrysant et al. J Hum Hypertens 2010;24:730-738

BP Reduction of Olmesartan-Amlodipine Combination
in Challenging Patients: Type 2 DIABETES

Chrysant et al. J Hum Hypertens 2010;24:730-738

BP Reduction of Olmesartan-Amlodipine
Combination in Challenging Patients: Obesity

Chrysant et al. J Hum Hypertens 2010;24:730-738

Adding Amlodipine Increases the
Control Rates

Volpe et al. Clin Drug Invest 2009;29:11–25

Thank You