Healthy Skepticism Library item: 10026

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Publication type: news

Nagle M.
Novartis' new blood pressure drug no better than the rest?
DrugResearcher.com 2007 May 9
http://www.drugresearcher.com/news/ng.asp?n=76397-novartis-hypertension-high-blood-pressure-tekturna

Full text:

A first-in-class drug developed to battle high blood pressure might not be the blockbuster success Novartis hoped for after a new study claims it is no more effective than current therapies.

Novartis’‘ Tekturna (aliskiren) was only approved two months ago, having been developed in conjunction with Speedel. The drug is designed to reduce blood pressure by directly inhibiting a protein called renin. However, a review of six large clinical trials, published in the May issue of the American Journal of Hypertension, claims that because the body secretes more renin in response to the drug, its efficacy is limited.

Novartis estimates that nearly 1bn people worldwide suffer from hypertension and the condition is uncontrolled in nearly 70 per cent of patients and so, although there are seven classes of drugs used to reduce high blood pressure, there is still a need for new therapies. When the US Food and Drug Administration (FDA) approved the drug in March this year, industry analysts predicted peak sales of over $1bn (€739m) a year.

The authors report that, in trials involving over 5000 hypertensive patients, Tekturna was no more effective than other classes of drugs that block the same renin-angiotensin system – namely converting enzyme inhibitors (CEI), angiotensin receptor blockers (ARB) or diuretics. Although Tekturna lowered blood pressure to a greater extent when combined with a CEI or an ARB or a diuretic, blood pressure control was achieved by less than 50 per cent of patients.

The authors put these results down to the fact that because the drug stimulates the kidney to secrete more renin than CEIs or ARBs do, its antihypertensive capabilities could be counteracted by large reactive increases in renin secretion; this is particularly likely at higher dosage.

“[Tekturna’s] pervasive stimulation of varying degrees of renin secretion could especially be a problem for those hypertensive patients who have hyper reactive renin systems such as patients with renovascular, advanced or malignant hypertension, all of whom were excluded from the trials,” said Jean Sealey in the article.

“Their reactive renin responses might be so great as to induce a rise in blood pressure. Until the possibility of aliskiren inducing increases in blood pressure is eliminated it seems safer, and simple and wiser to stick to the less expensive, equally effective and widely available generic drugs for treating hypertensive disorders.”