Patients with moderate to severe
pain were treated with
buprenorphine patches in one of 3 concentrations: 35 micrograms/h, 52.5 micrograms/h and 70 micrograms/h (= 0.8 mg/d, 1.2 mg/d and 1.6 mg/d respectively). The aim of this review was to assess the efficacy and tolerability of this transdermal system (
TDS) in patients with
chronic pain. A total of 445 patients were included in 3 double-blinded studies. The dosage titration with
buprenorphine patches followed pretreatment with
buprenorphine sublingual
tablets, higher doses of weak
opioids (level 2 substances), low dose
morphine (level 3) or other
analgesics. Patients with chronic tumour or non-tumour
pain were recruited for these studies and treated with
buprenorphine patches or placebo for 6 to 15 days. All patients were offered, in addition,
buprenorphine sublingual
tablets to be taken as required for supplementary
pain relief.
Pain intensity,
analgesia, consumption of
buprenorphine sublingual
tablets and sleep duration were all assessed. All patients in the double-blinded studies were between the ages of 22 and 88. 249 patients suffered from tumour
pain and 196 patients suffered from non-tumour
pain. To examine long-term efficacy and tolerability of the transdermal system, treatment was expanded, if the patients were interested in participating in an open-label-study. In all 3 studies, the number of patients with moderate, severe and very severe
pain increased in the placebo-patch treated group, while the patients in the
buprenorphine transdermal system treated group had a greater incidence of mild or no
pain. A further benefit in the
buprenorphine transdermal system treated group was evidenced by a great number of patients with a daily sleep duration of more than 6 hours compared to the placebo group--an
indicator of greater well-being. The systemic side-effects were typically
opioid in nature and rare and usually only mild. Of particular note was the very low incidence of
constipation in only 5.3% of cases. Dermatological reactions to the patches were only rarely encountered. The dermatological reactions consisted mainly of
erythema and
pruritus with a mild to moderate extent. Half the cases of
erythema and more than on third of the cases of
pruritus were spontaneously reversible. More than half the patients (53.7%) in the double blind studies wished to continued treatment with
buprenorphine transdermal system. These results demonstrate that
buprenorphine patches achieved a very good
analgesic effect in all 3 studies and that in particular with respect to the quality of life of the patient these patches offer an exceptional alternative to other conventional
therapies.