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Combination Drug Improves Adherence, Tolerability to NSAID Therapy: Presented at ACG
By Bruce Sylvester
SAN DIEGO -- October 28, 2009 -- An experimental combination pill appears to improve patients' adherence to nonsteroidal anti-inflammatory drug (NSAID) therapy among those at-risk of upper gastrointestinal symptoms, researchers said here at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting.
"Our data suggests that optimising adherence to gastrointestinal protection therapy may improve NSAID tolerability and may result in sustained use," said Jay Goldstein, MD, University of Illinois, Chicago, Illinois, in an oral presentation on October 27.
Dr. Goldstein said that treatment of chronic pain, especially for patients with arthritis, often requires long-term therapy with NSAIDs. "Patient adherence to prescribed chronic NSAID therapy can be impacted by poor upper gastrointestinal tolerability," he said.
Therefore, Dr. Goldstein and colleagues recruited patients to take the combination drug PN400, which consists of fixed-dose immediate-release esomeprazole 20 mg and enteric-coated naproxen 500 mg.
The researchers analysed efficacy and safety of PN400 in 2 phase 3 clinical studies that compared the combination pill to naproxen alone, determining how patients fared on validated measurements of illness, the Severity of Dyspepsia of Assessment, and the Overall Treatment Evaluation of Dyspepsia.
In the 2 trial 426 patients were assigned to PN400 and 426 patients were assigned to naproxen alone. Dr. Goldstein said the patients receiving the combination product experienced a significantly greater reduction in Severity of Dyspepsia Assessment pain intensity.
The decrease from baseline for those on PN400 was: -5.51 points compared with -0.15 points for those on naproxen alone (P < .001) in 1 study and -2.64 points for PN400 versus 0.09 point increase for those taking monotherapy naproxen (P = .004) in the second study.
In addition, Dr. Goldstein said patients treated with PN400 demonstrated further reductions from baseline for non-pain symptoms and achieved higher satisfaction scores.
The results on the Overall Treatment Evaluation of Dyspepsia test demonstrated similar efficacy. About 45.6% of patients taking PN400 reported positive changes after 6 months of therapy compared with 27.8% of patients on naproxen in 1 study (P < .001); in the second study, 42.9% of patients taking PN400 reported positive changes compared with 34.4% taking patients on naproxen alone.
Dr. Goldstein also said that patients taking the combination product reported fewer adverse events in both of the phase 3 studies. He found that 242 of the 391 evaluable patients on PN400 were heartburn-free at 6 months compared with 115 of 367 evaluable patients on naproxen alone (P < .001).
Funding for this study was provided by POZEN, Inc.
[Presentation title: PN400 Significantly Improves Upper Gastrointestinal Tolerability Compared With Enteric-Coated Naproxen Alone in Patients Requiring Chronic NSAID Therapy: Results From Two Prospective, Randomized, Controlled Trials. Abstract 25]
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