***
TOLERABILITY AND SAFETY OF INTRANASAL FENTANYL TREATMENT FOR BREAKTHROUGH PAIN IN PATIENTS WITH CANCER: FOUR-MONTH FOLLOW-UP
S. Kaasa, C. Marchesini, Z. Kaczmarek, A. Oronska, H. Kress, T. Nolte
Purpose of the study: To confirm the long-term tolerability and safety of treatment with intranasal fentanyl titrated to doses of 50, 100, and 200 mcg, for the treatment of breakthrough pain in patients with cancer, during an open-label follow-up safety period.
***
Methods: This was a randomised double-blind, placebo-controlled, cross-over, multicentre trial involving 120 adult in/out patients with cancer, receiving stable, chronic opioid therapy and experiencing ‡3 BTP episodes per week and £4 per day. Patients were titrated to an effective dose (providing pain relief within 10 min) of 50, 100, or 200 mcg of intranasal fentanyl per administration. Subsequently, they received their successful treatment dose of intranasal fentanyl (in a randomised, double blinded sequence), for six of eight breakthrough pain episodes (maximum four per day), and placebo for one breakthrough pain episode each of episodes 1–4 and 5–8, respectively. Rescue analgesic after 20 minutes of treatment was permitted for patients with no or inadequate pain relief. Patients were monitored for safety for 4 months after inclusion of the last patient in the trial.
***
Results: In 108 patients, the mean number of days of exposure was 106.4. Sixty-five patients experienced adverse events (AEs) during this period: 52 had serious AEs, 42 died and 44 patients discontinued trial due to AEs, mainly due to progression of malignant neoplasm and unrelated to study medication.
Only five patients experienced AEs considered to be related to trial drug (4.6% of all patients): five had nausea; four had constipation; two experienced vomiting, and one had epistaxis, all of which were graded mild or moderate, and one patient experienced severe dysgeusia (taste disturbance) who discontinued participation in the trial.
***
Conclusions: All doses of intranasal fentanyl were shown to be safe and well tolerated. The majority of those AEs considered related to study drug were mild to moderate, and most reported AEs were considered to be related to progression of patients’ underlying disease.
Referências: Annals of Oncology 19 (Supplement 8): viii254–viii258, 2008
Nenhum comentário:
Postar um comentário