Last Updated: 2008-07-04 9:33:22 -0400 (Reuters Health)

NEW YORK (Reuters Health) - The synergistic drug candidate CRx-102, which combines dipyridamole with low dose prednisolone, is a safe and effective treatment for reducing pain in patients with hand osteoarthritis, according to a report in the June 19th issue of the Annals of the Rheumatic Diseases.

The findings support preclinical research suggesting that each component drug is more effective when combined rather than given alone, lead author Dr. T. K. Kvien, from Diakonhjemmet Hospital in Oslo, Norway, and colleagues state. "Dipyridamole selectively amplifies prednisolone's anti-inflammatory and immunomodulatory effects without replicating steroid side effect," they explain.

In the study, 83 patients with hand osteoarthritis were randomized to receive CRx-102 or placebo daily for 6 weeks. To be eligible for the study, the patients were required to have at least one swollen and tender joint and have a pain score of at least 30 mm on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) visual analogue pain scale.

The average patient age was 60 years and 93% of the subjects were female, the report indicates.

At 42-day follow-up, the investigators found that CRx-102 was significantly better than placebo at reducing pain. The changes on the AUSCAN pain scale were -14.2 with CRx-102 and -4.0 with placebo (p = 0.02)

The drug was generally well tolerated, although 52% of patients experienced a headache compared with just 15% of those given placebo.

"This placebo-controlled phase 2 study suggests that the (dipyridamole/prednisolone) combination is effective in patients with hand osteoarthritis. Follow-up studies should be initiated to compare the clinical effects of CRx-102 versus the individual components in hand osteoarthritis and other rheumatic joint diseases," the investigators conclude.

Ann Rheum Dis 2008;67:942-948.