| Abstract | 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. |
| Authors | R Bakshi, B Darekar, C G Langdon, H Rotman
(Affiliation: Medical Department, Ciba-Geigy Ltd., Basle, Switzerland.)
|
| Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 12
Issue 7
Pg. 459-65
( 1991)
ISSN: 0300-7995 ENGLAND |
| PMID | 1778088
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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| Chemical References |
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| Topics |
- Administration, Oral
- Aged
- Aged, 80 and over
- Diclofenac
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Osteoarthritis
(drug therapy)
- Pain Measurement
(drug effects)
- Suspensions
|
