english.prescrire.org > Spotlight > Archives : 2012 > Arterial hypertension: don’t expose patients to the adverse effects of aliskiren

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Arterial hypertension: don’t expose patients to the adverse effects of aliskiren

In the absence of proven efficacy based on robust clinical criteria, and given the risk of severe adverse effects, the use of aliskiren to treat arterial hypertension cannot be justified.

The marketing authorisation for aliskiren, an antihypertensive drug, relies on surrogate endpoints, i.e. blood pressure levels, and not on robust clinical outcomes, such as the reduction of cardiovascular events. Its adverse effects profile is no more favourable than that of other antihypertensive drugs with similar action mechanisms (angiotensin-converting enzyme inhibitors (also called ACE inhibitors) and angiotensin II receptor blockers).

This profile has become all the more worrying since the interruption, at the end of December 2011, of a clinical trial comparing aliskiren with placebo, following an excessive number of sometimes fatal adverse events, such as cardiovascular disorders and renal failure. Furthermore, this trial did not demonstrate aliskiren’s superiority over placebo.

The European Medicines Agency (EMA) is currently reassessing aliskiren’s harm-benefit balance.

In practice, given aliskiren’s uncertain harm-benefit balance, it is better not to prescribe it for hypertension, either alone or in combination, but rather to rely on hypertensives whose efficacy in reducing cardiovascular events has been proven.

©Prescrire 1 July 2012

"Aliskiren: negative trial data" Prescrire Int 2012; 21 (129): 176. (Pdf, subscribers only).
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