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Prexige Study Shows Significantly Less Impact on Blood Pressure,Than Ibuprofen in Osteoarthritis Patients with Controlled,Hypertension

and hip in more than 50 countries, including the European Union, Canada and Latin America.

In the US, this medicine is under review by the Food and Drug Administration (FDA) for relief of the signs and symptoms of osteoarthritis.

"Evidence from the large-scale TARGET study has shown that Prexige is associated with significantly smaller increases in blood pressure than commonly used NSAIDs," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "The new research underlines how important it is for osteoarthritis patients to have a treatment option such as Prexige."

The study presented at EULAR was a four-week, multicenter, randomized, double-blind, double-dummy, parallel group trial of 787 hypertensive osteoarthritis patients age 50 or older with ambulatory blood pressure of 140/90 mmHg or below, who were being treated with a antihypertensive medicine. A total of 741 patients completed the study, which compared Prexige 100 mg once-daily with ibuprofen 600 mg taken three times daily.

At the end of the study, patients on Prexige showed a decrease in mean ambulatory systolic blood pressure of 2.7 mmHg compared to a 2.2 mmHg increase in patients taking ibuprofen, giving an estimated difference of 5.0 mmHg between the groups (p<0.001). Mean ambulatory diastolic blood pressure decreased by 1.5 mmHg in Prexige patients compared to a 0.5 mmHg increase in those on ibuprofen, an estimated difference of 2.0 mmHg (p<0.001).

Systolic pressure represents the pressure within blood vessels when the heart contracts, while diastolic pressure is measured when the heart is at rest between beats. Both are monitored while the patient is active (or ambulatory), considered to be the most rigorous way of studying blood pressure. They are measured in millimeters of mercury or mmHg.

Results further showed Prexige and ibuprofen had similar efficacy as well as a comparable incidence of adverse events. These were mostly mild and did no
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