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

mately four hours and in this study showed similar efficacy in a once-daily dose compared to ibuprofen given three times a day.

The clinical trial database for lumiracoxib comprises approximately 40,000 patients, making it one of the largest bodies of evidence for any drug in its class. This includes the results of TARGET (Therapeutic Arthritis Research and Gastrointestinal Trial) involving more than 18,000 patients. Results of this trial showed lumiracoxib also significantly reduced the incidence of upper gastrointestinal complications by 79% in patients not taking aspirin compared to ibuprofen and naproxen.

In TARGET, serious adverse events were reported in 6% of patients receiving lumiracoxib, the same rate seen in patients receiving ibuprofen or naproxen. Adverse events requiring study discontinuation occurred in 16% of lumiracoxib patients and 18% of NSAID patients.

The most frequently occurring gastrointestinal (GI) events were dyspepsia (25% of lumiracoxib patients compared with 26% of NSAID patients) and upper abdominal pain (10% vs. 13%). All other GI events occurred in less than 10% of patients in both groups. In an analysis of cardiovascular outcomes in TARGET, the incidence of events -- defined as non-fatal and silent myocardial infarction, stroke, or cardiovascular death -- was low and comparable in both groups. At one year, there were 59 events in the group of patients taking lumiracoxib (0.65%) and 50 events in the group taking NSAIDs (0.55%, p=0.5074).

Disclaimer

The foregoing press release contains forward-looking statements such as "can," "may," or similar expressions, or by express or implied discussions regarding potential future regulatory filings or approvals or potential future sales of lumiracoxib. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with lumiracoxib to
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