A new drug for the treatment of hypertension – phase I clinical trial

This phase II trial evaluated the benefit of a new drug of the aldosterone synthase inhibitors class in the treatment of high blood pressure. Different doses of this new drug were compared to a placebo, and the effects on blood pressure were reviewed.

Aldosterone is a hormone produced by the adrenal glands, and a key factor in the regulation of blood volume and pressure. Aldosterone causes salt and water to be absorbed from the kidneys back into the blood stream, and this elevates blood pressure.

Eplerenone (inspra) is a commonly used drug to reduce blood pressure that blocks the effect of aldosterone on the kidneys. LCI699 is a new drug that inhibits the production of aldosterone, and therefore belongs to a class of drugs called aldosterone synthase inhibitors.

This trial randomized 524 patients to receive LCI699 at different doses, a placebo (a substance with no therapeutic effect), or eplerenone. Both LCI699 and eplerenone showed a similar reduction in blood pressure compared to a placebo. This reduction in blood pressure was also demonstrated when a 24-hour home monitoring system was used. No difference in the rate of adverse side effects was noticed between treatment groups.

LCI699, a new aldosterone synthase inhibitor, is as effective and save as eplerenone for hypertension management. New drugs, such as LCI699, could be prescribed for patients who won't tolerate or will not respond to the standard drugs.

This trial was sponsored by Novartis Pharma AG, the developers of this new drug. It is important to note that this was an early phase trial, and additional research is needed before this new drug enters the market.