NAPRO - Helps in Hip OA
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Medical News: Naproxcinod Helps in Hip OA - in Geriatrics, Pain Management from MedPage Today
L'articolo:
Naproxcinod Helps in Hip OA
Naproxcinod Helps in Hip OA
By Nancy Walsh, Staff Writer, MedPage Today
Published: December 03, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
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Treatment with the investigational anti-inflammatory naproxcinod led to significant improvements in pain and functioning among patients with hip osteoarthritis and was not associated with serious gastrointestinal or cardiovascular adverse events, a multicenter trial found.
Among patients randomized to naproxcinod, pain scores fell from a mean of 66.25 out of 100 by a least squares mean of −25.81 (95% CI −29.17 to −22.44), according to Christoph Baerwald, MD, PhD, of University Hospital in Leipzig, Germany, and colleagues.
In contrast, pain scores among patients receiving placebo changed by only −17.97 during the 13-week study (95% CI −21.27 to −14.67, P<0.0001), the investigators reported in the December issue of Arthritis & Rheumatism.Action Points
Note that this study suggests that a cyclooxygenase-inhibiting nitric oxide donator, naproxcinod, may eventuallly show promise as a less toxic replacement for naproxen in patients with hip osteoarthritis.
Naproxcinod belongs to a new class of drugs referred to as cyclooxygenase-inhibiting nitric oxide donators and was developed with the intent of minimizing the adverse effects that limit the long-term use of many nonsteroidal anti-inflammatory drugs.
The drug is metabolized to naproxen and a nitric oxide (NO)–donating moiety. It is thought that the donation of NO will modulate blood pressure and vascular tone and enhance gastrointestinal mucosal blood flow and production of mucus, thus reducing the toxicity associated with NSAIDs.
To evaluate naproxcinod's safety and efficacy, Baerwald and colleagues enrolled more than 800 patients from 105 centers in nine countries. Patients in the active treatment arms received 750 mg naproxcinod twice daily or 500 mg naproxen twice daily.
A total of 619 patients completed the study. Discontinuations because of lack of efficacy were reported by 6.2% of patients receiving naproxcinod, by 3.2% of those receiving naproxen, and by 11.5% of those on placebo, while withdrawals because of adverse events were seen in 6.8%, 9%, and 5.7% of the three groups, respectively.
Patients' mean age was 63, and two-thirds were women. Half were hypertensive, but controlled on medication.
The three primary co-endpoints were the Western Ontario and McMaster Universities Osteoarthritis Index pain and function subscales, and the patient's overall rating of disease state, using a Likert scale ranging from 1 (very poor) to 5 (very good).
The efficacy of naproxcinod was similar to that of naproxen, which showed a difference on the pain subscale from baseline of −24.31 (95% CI −28.69 to −19.93).
On the function subscale, these changes were seen from baseline:
Naproxcinod, −22.24 (95% CI −25.51 to −18.97, P<0.0001 versus placebo)
Naproxen, −21.67 (95% CI −25.97 to −17.37)
Placebo, −13.45 (95% CI −16.67 to −10.23)
Changes from baseline on patient's overall rating of disease were:
Naproxcinod, 0.86 (95% CI 0.73 to 0.99, P<0.0001 versus placebo)
Naproxen, 0.82 (95% CI 0.65 to 1)
Placebo, 0.51 (95% CI 0.38 to 0.64)
The percentage of patients who were classified as responders also were similar in the two active treatment groups, being 50.5% of those on naproxcinod and 49.4% of those on naproxen.
The most common adverse events were gastrointestinal and were seen in 15.5% of the naproxcinod group, 19.2% of the naproxen group, and 15.5% of the placebo group.
Cardiovascular events were reported in 5.3% of patients receiving naproxcinod, in 3.8% of those on naproxen, and in 3.6% of patients on placebo.
Three patients receiving naproxen had serious cardiovascular events, which were one case of worsening of hypertension, one of hypotension, and a death following surgery for an aortic hematoma.
One patient in the placebo group also developed a serious cardiovascular event, which was obstructive coronary disease.
Changes in systolic blood pressure from baseline were similar in the naproxcinod and placebo groups, differing by only −0.11 mm Hg at 13 weeks, while the difference between the naproxen and placebo groups was 2 mm Hg.
A total of 13.3% of patients receiving naproxcinod had increases of systolic blood pressure of 10 mm Hg or more, as did 15% of patients receiving placebo and 20.3% of those receiving naproxen.
"Meta-analyses and individual studies suggest that small changes in systolic [blood pressure] may translate to significant outcome differences, and this may occur quite early after the initiation of treatment," the investigators noted.
They explained that their findings suggested that the activity of the nitric oxide component of the drug "might considerably improve" the overall blood pressure effects of naproxcinod compared with other nonsteroidal anti-inflammatory drugs used by patients with osteoarthritis. The researchers cautioned that the study was not powered to demonstrate differences in blood pressure, however.
They concluded that naproxcinod "is a promising new treatment" for patients with osteoarthritis of the hip and called for further studies to assess safety and efficacy over time.
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