Transdermal fentanyl for the treatment of pain caused by osteoarthritis of the

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Transdermal fentanyl for the treatment of pain caused by

osteoarthritis of the knee or hip, an open, multicentre study

Xavier Le Loet , Karel Pavelka and Ute Richarz

BMC Musculoskeletal Disorders 2005, 6:31 doi:10.1186/1471-2474-6-31

Published 15 June 2005

Abstract (provisional)

Background

This study was designed to evaluate the utility of transdermal

fentanyl (TDF, Durogesic®) for the treatment of pain due to

osteoarthritis (OA) of the knee or hip, which was not adequately

controlled by non-opioid analgesics or weak opioids. The second part

of the trial, investigating TDF in patients with rheumatoid arthritis

(RA) is reported separately.

Methods

Current analgesia was optimised during a 1-week run-in. Patients then

received 28 days treatment with TDF starting at 25mg/hr, with the

option to increase the dose until adequate pain control was achieved.

Metoclopramide was taken during the first week and then as needed.

Results

Of the 159 patients recruited, 75 with OA knee and 44 with OA hip

completed the treatment phase, 30 knee and 18 hip patients entered

the one-week taper-off phase. The most frequently used maximum dose

of TDF was 25ug/hr. The number of patients with adequate pain control

increased during the run-in period from 4% to 27%, and further

increased during TDF treatment to 88% on day 28. From baseline to

endpoint, there were significant reductions in pain (p<0.001) and

improvements in functioning (p<0.001) and physical (p<0.001) and

mental (p<0.05) health. Scores for 'pain right now' decreased

significantly within 24 hours of starting TDF treatment. TDF was

assessed favourably and 84 percent of patients would recommend it for

OA-related pain. Nausea and vomiting were the most common adverse

events (reported by 32 percent and 26 percent of patients

respectively), despite prophylaxis with metoclopramide, which showed

limited efficacy in this setting.

Conclusions

TDF significantly increased pain control, and improved functioning

and quality of life. Metoclopramide appeared to be of limited value

in preventing nausea and vomiting; more effective anti-emetic

treatment may enable more people to benefit from strong opioids such

as TDF. This study suggests that four weeks is a reasonable period to

test the benefit of adding TDF to improve pain control in OA patients

and that discontinuing therapy in cases of limited benefit creates no

major obstacles.