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Novartis' Rasilez lowers blood pressure over 1 year

Novartis AG's experimental medicine Rasilez is safe and effective in the „long-term treatment” of high blood pressure, a study presented yesterday at the World Congress of Cardiology meeting showed. The medicine, either alone or in combination with the water-retention treatment hydrochlorothiazide, effectively lowered people's blood pressure during a year-long study, researchers said. Blood pressure levels stayed lower even after patients stopped taking the medicine, the study found. Novartis expects the US Food and Drug Administration to decide whether to approve Rasilez for use against high blood pressure early in 2007. The company has so far this year asked regulators to approve four new medicines with sales potential of more than $1 billion each. In addition to Rasilez, the company is seeking approval for the blood pressure medicine Exforge and the diabetes drug Galvus. US and European regulators in Switzerland have already approved eye drug Lucentis. European Union regulators are still evaluating the application. Rasilez, developed with partner Speedel AG, would be the first new way to treat high blood pressure in more than 10 years. Heart disease, which is linked to high blood pressure, is the leading cause of death in the US and Europe. About 70% of the people with high blood pressure fail to reach target levels despite getting medication, Ameet Nathwani, head of Cardiovascular and Metabolic Clinical Development and Medical Affairs at Novartis said in an interview.

This is because many patients are prescribed only one medication when a combination of drugs is often needed to reach targets, Nathwani said. Treatment is also hampered by the fact that patients often forget or otherwise fail to take their medications because the disease doesn't have symptoms that are apparent on a day-to-day basis. This is why it's important that the blood pressure of patients who have been taking Rasilez rises only slowly after they stop, Nathwani said. „A lot of the time, people are not taking their medication and when they forget, you don't want blood pressure to go back to what it was or even higher and you also want to make sure they're still protected,” he said. „This is a chronic disease and if you lose control every time the patient forgets a pill, there are going to be important long-term consequences.” The study, led by Domenic Sica, a researcher at Virginia Commonwealth University in Richmond, Virginia, looked at 1,625 patients taking either 150 milligram or 300 milligram doses of the medicine, which is also known as aliskiren. The data is being released at the conference in Barcelona.

Blood pressure readings are given as two numbers. The first, known as the systolic blood pressure reading, represents the maximum pressure exerted when the heart contracts. The second, the diastolic blood pressure reading, represents the pressure in the arteries when the heart is at rest. The reading is given in units of millimeters of mercury, or mmHg. Measurements below 120/80 are considered normal, according to the National Institutes of Health in the US Doctors generally treat patients who have systolic blood pressure higher than 140, Nathwani said. Patients taking the highest dose of the medicine had a drop in systolic blood pressure of 18.8 mmHg on average and a drop in diastolic blood pressure of 13.3 mmHg.

The study also looked at the effect of stopping treatment by switching some patients to a placebo after 11 months. Patients taking the medicine during this „withdrawal period” maintained the reduction in blood pressure. A „gradual” rise in blood pressure was seen in those who started taking the placebo instead, the study said. Novartis' Nathwani said the company is seeking approval for the medicine to be used both alone and in combination with other drugs. Rasilez will likely be used as part of a combination and sales are likely to rise only gradually at first, he said. „Doctors go for those medicines that they've had experience with first,” he said. „It'll be the same in this case. If the other medicines don't work, then they'll try Rasilez.” He reiterated that the company expects the medicine to generate more than $1 billion in peak sales. (Bloomberg)