Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes

Abstract

In this open-label ABPM study, an OM +/- HCTZ based treatment regimen safely and significantly reduced BP in patients with hypertension and type 2 diabetes when assessed by 24-hour ABPM.

Blood pressure response with fixed-dose combination therapy

“…In three trials (protocol CS8663-402 [3], CS8663-403 [4] and CS8663-404 [5]), antihypertensive drugs were titrated sequentially in the order amlodipine, olmesartan medoxomil and HCTZ over a 12 to 20-week period. In the other two trials (protocol CS866-449 [6] and CS866-450 [7]), antihypertensive drugs were titrated sequentially in the order olmesartan followed by HCTZ. Details of the population included in the study, the duration of the trial and details of the protocol are listed in Table 1.…”

Seated Cuff Blood Pressure-Lowering Efficacy of an Olmesartan Medoxomil-Based Treatment Regimen in Patients with Type 2 Diabetes Mellitus

“…[17] The time of dosing in BENIFICIARY was in the morning hours and correlated with the SeBP measurements. [13] It may be possible that evening dose administration may affect the efficacy of treatment with an olmesartan medoxomilbased treatment algorithm. This has previously been suggested by Tofe Povedano and Garcia De La Villa, [18] who conducted a crossover design ABPM study to determine the benefits of morning versus evening dosing of olmesartan medoxomil 40 mg on ambulatory BP, nocturnal BP fall, and albuminuria in patients with type 2 diabetes and newly diagnosed hypertension.…”

“…Patients underwent a 12-week, open-label, active treatment period beginning with olmesartan medoxomil 20 mg/day following a 3-to 4-week placebo runin phase. [13] During the active treatment period, patients received olmesartan medoxomil alone or as a fixed-dose combination with hydrochlorothiazide (HCTZ) and were uptitrated if BP remained ‡120/70 mmHg according to the following schedule: olmesartan medoxomil 20 mg (weeks 1-3); olmesartan medoxomil 40 mg (weeks 4-6); olmesartan medoxomil/HCTZ 40/12.5 mg (weeks 7-9); olmesartan medoxomil/HCTZ 40/25 mg (weeks 10-12). If SeBP was <120/70 mmHg, patients entered a maintenance phase continuing on the same dosage.…”

“…[13] In the BENIFICIARY study, for the primary endpoint, the change from baseline in mean 24-hour ambulatory SBP at week 12 was 20.4 mmHg.…”

“…[8][9][10][11][12] The BENIFICIARY (BENIcar safety and efFICacy evaluatIon: An open-label, single-ARm, titration study in patients with hypertension and tYpe 2 diabetes) study assessed change from baseline in mean 24-hour ambulatory BP and achievement of ambulatory BP prespecified study targets in patients with type 2 diabetes and hypertension receiving an olmesartan medoxomil-based treatment algorithm. [13] In addition, efficacy of the olmesartan medoxomil-based therapy on SeBP levels was measured. We report herein the secondary efficacy endpoints from the BENIFICIARY study, which include the change from baseline in mean SeBP, the achievement of SeBP goals, and the distribution of SeSBP reductions.…”