EAST HANOVER, N.J., June 15, 2007 /PRNewswire/ -- Patients with osteoarthritis who also have controlled hypertension experienced a slight decrease in average daily blood pressure when treated with the investigational selective COX-2 inhibitor lumiracoxib compared to a slight increase in those taking ibuprofen, a commonly-used non-steroidal anti-inflammatory drug (NSAID).
These new results, presented today at the Annual European Congress of Rheumatology (EULAR) in Barcelona, are important because around 40% of patients with osteoarthritis also have high blood pressure (or hypertension).
While this study did not assess long-term cardiovascular outcomes, independent research shows that even small elevations in blood pressure can contribute to an increased risk of cardiovascular events. Osteoarthritis is the most common form of arthritis affecting 21 million Americans.
"NSAIDs, including some COX-2s, have been associated with raised blood pressure, and this effect may be in part responsible for the increased risk of cardiovascular disease associated with this class of medications," said Tom MacDonald, Ph.D., Professor of Clinical Pharmacology at the Hypertension Research Centre at Ninewells Hospital & Medical School in Dundee, Scotland. "These data indicate that lumiracoxib may have less impact on blood pressure than the most commonly used NSAID ibuprofen."
In the US, lumiracoxib 100 mg once-daily 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 lumiracoxib is associated with significantly smaller increases in blood pressure than commonly used NSAIDs," said James Shannon, MD, Global Head of Development at Nov artis Pharma AG. "The new research underlines how important it is for osteoarthritis patients to have a treatment option such as lumiracoxib."
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, and who were being treated with an antihypertensive medicine. A total of 741 patients completed the study, which compared lumiracoxib 100 mg once-daily with ibuprofen 600 mg taken three times daily.
At the end of the study, patients on lumiracoxib 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 lumiracoxib 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 lumiracoxib and ibuprofen had similar efficacy as well as a comparable incidence of adverse events. These were mostly mild and did not indicate treatment-limiting toxicity. The most common adverse event in both treatment groups was upper abdominal pain, which occurred in less than 2% of patients.
Lumiracoxib has a different chemical structure from other COX-2 inhibitors. It is the only one that does not contain a sulphur molecule, which has been associated with sulphur-related skin reactions in some patients. Lumiracoxib also has a plasma half-life of approxi 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).
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 be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that lumiracoxib will be approved for sale in the US or any other additional markets, or for any additional indications. Neither can there be any guarantee that lumiracoxib will reach any particular level of sales. In particular, management's expectations regarding lumiracoxib could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the public debate and regulatory activity regarding COX-2 inhibitors like lumiracoxib; unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; government, industry, and general public pricing pressures; competition in general; Novartis' ability to obtain or maintain patent or other proprietary intellectual property protection; as well as other risk factors discussed in Novartis AG's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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