New clinical data analysis confirms that the first-in-class direct renin inhibitor Rasilez (aliskiren), known as Tekturna in the US, provides significantly greater blood pressure reductions in obese patients with high blood pressure compared to the diuretic hydrochlorothiazide (HCT) alone.
The post hoc analysis presented at the European Society of Cardiology (ESC) 2008 annual congress showed that Rasilez/Tekturna 300 mg monotherapy provided reductions in mean sitting systolic blood pressure (when the heart is pumping) of -16.7 mmHg compared to -12.2 mmHg for HCT, and diastolic (when the heart is at rest) blood pressure reductions of -12.3 mmHg compared to -9.1 mmHg for HCT (p<0.001).
These findings are significant as 70 per cent of patients with high blood pressure are overweight or obese (body mass index >=30 kg/m²)4. Obese patients with high blood pressure have an increased risk of cardiovascular and kidney disease. Approximately 58 per cent of diabetes and 21 per cent of ischemic heart disease is attributable to a body mass index above 217.
"Sixty-five per cent of people with high blood pressure worldwide still do not have the condition under control and as the rate of obesity and diabetes continues to rise there is a definite need for new treatments to help bring patients to goal," said Professor Aldo Maggioni of the Italian Association of Hospital Cardiologists Research Centre, Florence, Italy. "In addition to providing effective blood pressure reductions in the general hypertensive population these data further confirm that aliskiren is effective and well tolerated in difficult to treat patients who are obese and in patients with heart failure who also have kidney disease or diabetes."
Two subgroup analyses of the ALOFT study (ALiskiren Observation of Heart Failure Treatment) were also presented. Rasilez/Tekturna, when added to standard therapy in heart failure patients with or without diabetes, provided a 25 per cent reduction in brain natriuretic peptide (BNP), an indicator of heart failure severity, from baseline compared with placebo2. Rasilez/Tekturna was well tolerated when added to standard therapy in chronic heart failure patients, including those with diabetes and kidney disease (eGFR < 60 mL/min/1.73m²).
BNP is a substance released from the heart's lower ventricles in response to increased wall tension. The level of BNP in the bloodstream increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable.
"In addition to providing powerful blood pressure reductions that last beyond 24 hours both as monotherapy and in combination, Rasilez continues to demonstrate the potential to protect organs such as the heart and kidneys," said Trevor Mundel, head of Global Development Functions at Novartis Pharma AG. "We are pleased to report that studies from the Aspire higher programme, including data from ALOFT and AVOID, have already paved the way for an enhanced European Union label for Rasilez."
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