Merck & Co Inc announced that the US FDA has granted a new indication for Hyzaar (losartan potassium-hydrochlorothiazide tablets) for initial use in appropriate patients with severe hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients, an official release from Merck said.

"This indication provides physicians with an effective and timely treatment option for appropriate patients with severe hypertension, and provides these patients with a treatment choice that is more convenient than taking two separate tablets," said George L Bakris, director, Hypertension/Clinical Research Centre, Rush University Medical Centre in Chicago.

In the 1999-2000 National Health and Nutrition Examination Survey (NHANES), of the estimated 60 million people in the United States with high blood pressure an estimated two million people had a blood pressure reading equal to or greater than 180 mmHg systolic or equal to or greater than 110 mmHg diastolic. "Many of these people with severely elevated blood pressure may be candidates for initial therapy with Hyzaar once their physician has evaluated the benefit of starting Hyzaar against the risk of initiating combination therapy," said Dr. Bakris.

"In the clinical study supporting this new indication, we saw that more patients with severe hypertension reached their diastolic blood pressure lowering goal of less than 90 mmHg at four weeks with Hyzaar as opposed to being titrated to higher doses of Cozaar," said Dr. Bakris.

In clinical trials, treatment with Hyzaar was generally well tolerated. In the clinical study supporting this new indication, the overall side effect profile for patients with severe hypertension treated with Hyzaar as initial therapy was similar to the side effect profile in patients with severe hypertension treated with Cozaar as initial therapy. During the study period there were no reported cases of syncope in either treatment group. There were two (0.6 percent) cases and no cases of hypotension reported in the groups treated with Hyzaar and Cozaar, respectively. There were three (0.8 per cent) cases and two (1.2 per cent) cases of increased serum creatinine (> 0.5 mg/dL) in the groups treated with Hyzaar and Cozaar, respectively.