Transdermal fentanyl was released in Germany in 1995. From October 1996 to
February 1998 transdermal treatment was documented for 1005 patients (506 m
en and 499 women with a mean age of 60 years, range 20-92 years) with chron
ic pain in an open survey including 290 physicians from hospitals and gener
al practitioners throughout Germany. Most patients suffered from cancer pai
n and only 11 patients had chronic pain from non-malignant disease. Physici
ans were asked to complete a questionnaire for patients treated with transd
ermal fentanyl on initiation of therapy (day 0), and days 3, 6, 18, 30 ther
eafter, followed by monthly follow-up intervals. Patients were asked to com
plete a pain diary. Transdermal therapy was documented from day 0 for 824 p
atients, while 181 patients had been treated with transdermal fentanyl befo
re admission in the survey. Most of the other 824 patients had been treated
with other step 3 opioids (55% of the patients) or step 2 opioids (23%) be
fore conversion to transdermal fentanyl, whereas 8% had been treated only w
ith non-opioids and 14% had received analgesics only as required or not at
ail before initiation of transdermal therapy. The most important reasons fo
r switching to transdermal opioid therapy were insufficient pain relief wit
h the previous medication followed by a variety of gastrointestinal symptom
s impeding oral analgesic therapy, Initial fentanyl doses ranged from 0.6 t
o 9.6 mg/day (25 to 400 mug/h) with a median of 1.2 mg/day (50 mug/h). Medi
an doses slowly increased throughout the observation period to 2.4 mg/day (
100 mug/h) after 4 months of treatment. Most patients continued transdermal
therapy until the time of death (47% of patients). Other reasons for disco
ntinuation were inadequate pain relief (10%), pain relief with other analge
sic regimens (10%), other symptoms than pain (5%), rejection of transdermal
therapy by the patient (6%) or miscellaneous (16%). Adverse events were do
cumented as the reason for discontinuation of transdermal therapy in 49 pat
ients (5%). Dyspnoea was documented for seven patients as the reason for di
scontinuation. One of these patients. as well as another patient with an ep
isode of apnoea, had to be treated with artificial respiration for several
hours, but both patients recovered without sequelae. Transdermal therapy wi
th fentanyl was safe and efficient in this national survey.
Transdermal fentanyl can be recommended for treatment of moderate to severe
cancer pain and probably may even be used as a first-line drug on step 3 o
f the World Health Organization recommendations in selected patient groups.