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Olive oil, Mediterranean diet modify expression of atherosclerosis-related genes

March 15, 2017

It is estimated that hypertension affects 21 percent of Hispanic adults (18 years or older) in the U.S.  Additionally, the majority of patients with high blood pressure are overweight, with the condition being six times more frequent in obese people.

Results for the ethnicity subgroup analysis [Hispanic or Latino>

Additionally, in both the ethnicity and BMI subgroups of the study, the triple combination of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a greater percentage of patients reaching blood pressure goal compared with each dual combination group. The incidence of treatment-emergent events in the BMI and ethnicity subgroup analyses was comparable between groups and adverse events were mild or moderate.

TRINITY Study Design

At total of 2,492 patients with moderate to severe hypertension were enrolled into the Phase 3, multicenter, randomized, double-blind, parallel-group study, which examined the safety and efficacy of the triple combination of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg).(1,4) Patients were randomized to receive one of three dual combination therapies>

Safety & Tolerability

Across all groups, drug-related treatment adverse events (TEAEs) were reported in 25.4 percent of patients.  Most TEAEs and drug-related TEAEs were mild or moderate in severity. More discontinuations due to TEAEs occurred in the olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) (4.0 percent) versus the dual combination therapy groups (1.0 to 2.1 percent) and were due to adverse events such as dizziness and hypotension. These discontinuations can potentially be attributed to the more pronounced pharmacodynamic effect of the triple combination therapy. Peripheral edema also was a cause for discontinuation.

In addition, discontinuations for patients on triple combination therapy also included subjects who experienced an adverse event on earlier treatment (i.e. placebo or dual), prior to initiation of the triple combination regimen.

SOURCE Daiichi Sankyo