Efficacy of Olmesartan/Amlodipine combination therapy in reducing BP in hypertensive patients not controlled by amlodipine alone

Clinical trials in hypertension have repeatedly shown that adequate blood pressure (BP) control is important for the prevention of cardiovascular morbidity and mortality. However, most patients do not achieve target BP levels, and the majority of them require combination therapy with two or more drugs in order to obtain an adequate BP reduction.

Single-pill combinations of Calcium Channel Blockers (CCBs) and Angiotensin II receptor Blockers (ARBs) have been reported to be widely used, well tolerated and effective treatments for controlling BP. One advantage of these combinations, as compared with a Calcium Channel Blockers (CCBs) and Angiotensin-Converting Enzyme Inhibitor (ACE-I), is that Angiotensin II receptor Blockers (ARBs) have been shown to be as effective as Angiotensin-Converting Enzyme Inhibitor (ACE-Is), but better tolerated.

Take Home Message:

An adequate level of BP control throughout the 24-h dosing period is important in the treatment of hypertensive patients, because BP levels evaluated by ambulatory BP monitoring (ABPM) have consistently been shown to provide valuable information on cardiovascular risk, independently from clinic BP levels.

In particular, BP assessed during the night time and in the morning is closely related to the rate of cardiovascular events, and its adequate control may be important in reducing the risk of such events.

Furthermore, studies have shown that BP variability is an important CV risk factor, which correlates with target organ damage in a manner that is independent of mean BP values.

Treatments that reduce BP in a smooth and consistent manner to give reduced variability over 24 h and effective BP control during the early morning period may thus provide optimal protection against the BP-related risk of cardiovascular complications.

In conclusion, the combination of olmesartan medoxomil and amlodipine is safe and effective in achieving and maintaining good BP control over 24 h in patients with moderate-to-severe hypertension not controlled with amlodipine 5 mg monotherapy. In these patients, the combination of olmesartan and amlodipine not only reduced mean 24-h BP but also guaranteed a homogeneous distribution of BP reduction throughout the 24-h period,

The safety and tolerability of olmesartan/amlodipine combination therapy in the primary analysis of this study have been previously reported and shown to be consistent with that of an ARB and a CCB.

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Ambulatory blood pressure monitoring (ABPM) involves measuring blood pressure (BP) at regular intervals (usually every 20–30 minutes) over a 24 hour period while patients undergo normal daily activities, including sleep.

Ambulatory blood pressure monitoring is accomplished with a special device that consists of a blood pressure cuff that is worn on patients arm and is attached to a small recording device that patients wear on their belt.

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Abstract

Objectives:

The aim of this ABPM analysis was to evaluate whether and by how much an olmesartan/amlodipine combination at different doses may control BP over 24 h, and whether it might achieve a smooth BP reduction over the day and night, in patients with moderate-to-severe hypertension not adequately controlled with amlodipine monotherapy.

This preplanned analysis investigated the efficacy of the olmesartan/amlodipine combination at different doses on 24-h blood pressure (BP) control, as well as assessed trough estimation of trough-to-peak ratio (TPR) and smoothness index (SI).

Method:

Ambulatory BP monitoring was performed in patients with moderate-to-severe hypertension whose BP was inadequately controlled after 8 weeks’ treatment with amlodipine 5 mg.

Patients were randomized to continue with amlodipine 5 mg or to receive olmesartan/amlodipine 10/5, 20/5 or 40/5 mg for 8 weeks (Period II). Patients not achieving BP control were uptitrated to a more powerful regimen for another 8 weeks (Period III).

Results:

During Period II, each olmesartan/amlodipine combination reduced 24-h systolic and diastolic BP (SBP/DBP), as well as morning and early morning SBP/DBP, significantly more than amlodipine 5 mg. TPRs were higher in each olmesartan/amlodipine group than with amlodipine 5 mg, and SI values showed dose-related increases; olmesartan/amlodipine 40/5 mg produced a significantly higher SI for SBP and DBP (1.55 and 1.33, respectively) than amlodipine 5 mg (0.96 and 0.77, respectively).

During Period III, uptitrated patients showed further BP reductions, which were largest in those on olmesartan/amlodipine 40/10 mg. SI values increased in uptitrated patients and were highest with olmesartan/amlodipine 40/10 mg (SBP 1.62/DBP 1.41).

Conclusions:

The olmesartan/amlodipine combination effectively reduces BP over 24 h, including the morning hours, in a dose-related manner. Compared with amlodipine alone, the olmesartan/amlodipine combination has better 24-h coverage (TPR) and a dose-related improvement in BP lowering homogeneity (SI).

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