-The fixed-dose combination of olmesartan medoxomil and amlodipine besylate is approved for the treatment of essential hypertension in adult patients not achieving adequate blood pressure control with olmesartan or amlodipine monotherapy.
- Clinical practice guidelines recommend the use of combination therapy of first line antihypertensive agents such as calcium channel blockers, angiotensin-converting enzyme inhibitors or diuretics, in those patients who require two or more agents to achieve target blood pressure. Angiotensin receptor blockers represent an alternative in case of intolerance to angiotensin-converting enzyme inhibitors.
- Amlodipine is a calcium channel blocker that has demonstrated its efficacy in terms of morbidity and mortality, however, olmesartan, an angiotensin receptor blocker, has not been shown to reduce cardiovascular morbidity and mortality.
- There are no studies available that compare the combination olmesartan/amlodipine with other combinations of antihypertensive agents considered of choice, or with other combinations on the market.
-Efficacy of this combination formulation has been assessed in three clinical trials over placebo, olmesartan and amlodipine monotherapy. For each of the trials, the main variable was the change in blood pressure values observed from baseline (surrogate variable), with significant differences in the mean change in diastolic blood pressure with regards to this combination rather than monotherapy.
- The adverse events most frequently reported are: dizziness, headache, oedema, peripheral oedema, pitting oedema and fatigue.
- We may therefore conclude that the fixed-dose combination olmesartan/amlodipine means no therapeutic innovation and adds no advantages over other available combinations of antihypertensive agents.