A Long-Term Investigation of a New Antirheumatic Drug, Diclofenac Sodium (Voltaren)

Abstract

A long-term, non-comparative study of diclofenac sodium (Voltaren®) in patients with rheumatic diseases is described. The study was part of an international multicentre investigation in which the following three Danish hospitals participated: Fredericia Hospital, Copenhagen Municipal Hospital, and Copenhagen County Hospital, Glostrup. The trial population consisted of 17 patients, 15 of whom had rheumatoid arthritis and two an intervertebral disc syndrome. The daily dosage of diclofenac sodium employed ranged from 50 to 150 mg, adjustments being made between these limits during the trial in an attempt to achieve an optimal therapeutic effect. Of the 17 patients, 14 completed the trial with a mean treatment period of 16.1 months (range: 12-24 months). Three patients discontinued treatment prematurely, two because of unwanted effects and the third because of an acute exacerbation of her rheumatoid disease. With regard to therapeutic efficacy, the two patients with an intervertebral disc syndrome derived no benefit from the treatment. In the remaining 13 patients of the rheumatoid group, the physician considered the arthritic condition to be unchanged in six (46 %)–i.e. to be just as good as, but not better than, in response to other forms of antirheumatic therapy–and improved in seven (54%). The patients considered their arthritic condition to be unchanged in three cases (23%) and improved in ten (77%). As to functional capacity, two patients moved from a lower category to a higher one, while the others remained in the same category throughout the treatment. No significant changes in blood pressure, pulse rate, or body weight were recorded during the investigation. At no time were any abnormal laboratory values found which could have been ascribed to the treatment. On the whole, both the efficacy and the tolerability of the medication were regarded as satisfactory.