The efficacy and tolerability of a new dispersible formulation of
diclofenac were evaluated in a randomized, double-blind, placebo-controlled, multi-centre study in patients aged 60 to 80 years suffering from
osteoarthritis. A total of 314 elderly patients with a mean age of 68.9 years received either 50 mg
diclofenac dispersible or placebo 3-times daily for a period of 4 weeks, with
paracetamol being allowed as rescue
analgesic for both treatment groups. The study consisted of a baseline evaluation and two follow-up visits after 14 and 28 days of treatment. The following clinical parameters were assessed:
pain at rest, on movement and on local pressure; global severity of
pain; effect of
pain on daily activity; duration of stiffness after immobility; rescue
analgesic consumption; overall opinion of the investigator on efficacy; and occurrence of adverse events. At either one or both post-treatment assessments,
diclofenac dispersible was found to be significantly superior to placebo for almost all measures of efficacy (p less than or equal to 0.05). Thirty (14.4%) patients out of 208 assessed in the
diclofenac group reported adverse events compared to 18 (17%) out of 106 who received placebo;
therapy was discontinued prematurely due to poor tolerability in 4.8% and 5.7% of patients, respectively. The adverse events were predominantly related to the gastro-intestinal system and were mostly mild to moderate in severity. The results of this 4-week study thus demonstrate that
diclofenac dispersible is not only effective in treating
osteoarthritis in the elderly but also has an acceptable tolerability profile in a patient population which is especially vulnerable to adverse effects induced by non-steroidal anti-inflammatory drugs.