OBJECTIVE: To evaluate the long-term dosing, safety, and tolerability of fentanyl buccal tablet (FBT) in a large cohort of opioid-tolerant patients with chronic noncancer pain and breakthrough pain (BTP). DESIGN: Combined analysis of three double-blind, placebo-controlled, and two open-label studies. RESULTS: Of 1160 patients who received ≥1 dose of FBT, 83% achieved a successful dose, ranging from 100 to 800 μg, mostly at 600 or 800 μg. Not all of the patients included in this analysis were enrolled in long-term studies and 156 (13%) patients were still receiving ongoing treatment when their study site closed. Median treatment duration was 106.0 days. The mean FBT dose in the post-titration population (n = 946) increased from 2108 to 3132 μg/day, with ≥1 FBT dose increase in 27% of patients; most dose increases occurred during the first 6 months. The FBT daily dose as a proportion of the daily opioid dose remained fairly stable (59-65%) throughout the treatment period. Overall, 925 (80%) enrolled patients had ≥1 adverse event (AE). The most frequent AEs were nausea (21% of patients), vomiting (11%), dizziness (10%), and headache (10%). Common AEs generally occurred within 7 days of starting treatment and lasted for ≤2 days. Serious AEs occurred in 136 (12%) patients and included six deaths (none related to FBT) and 11 instances of opioid overdose (all with satisfactory resolution). AE-related discontinuations occurred in 163 (14%) patients and were similar to the common AEs. CONCLUSIONS: Despite the limitations, including the controlled clinical setting, this pooled analysis of several clinical studies provides valuable information for the long-term management of BTP with FBT. Patients require regular evaluation and, when necessary, adjustment of opioid medications to maintain adequate pain control. FBT was generally safe and well tolerated in this setting.
RCT Entities:
OBJECTIVE: To evaluate the long-term dosing, safety, and tolerability of fentanyl buccal tablet (FBT) in a large cohort of opioid-tolerant patients with chronic noncancer pain and breakthrough pain (BTP). DESIGN: Combined analysis of three double-blind, placebo-controlled, and two open-label studies. RESULTS: Of 1160 patients who received ≥1 dose of FBT, 83% achieved a successful dose, ranging from 100 to 800 μg, mostly at 600 or 800 μg. Not all of the patients included in this analysis were enrolled in long-term studies and 156 (13%) patients were still receiving ongoing treatment when their study site closed. Median treatment duration was 106.0 days. The mean FBT dose in the post-titration population (n = 946) increased from 2108 to 3132 μg/day, with ≥1 FBT dose increase in 27% of patients; most dose increases occurred during the first 6 months. The FBT daily dose as a proportion of the daily opioid dose remained fairly stable (59-65%) throughout the treatment period. Overall, 925 (80%) enrolled patients had ≥1 adverse event (AE). The most frequent AEs were nausea (21% of patients), vomiting (11%), dizziness (10%), and headache (10%). Common AEs generally occurred within 7 days of starting treatment and lasted for ≤2 days. Serious AEs occurred in 136 (12%) patients and included six deaths (none related to FBT) and 11 instances of opioid overdose (all with satisfactory resolution). AE-related discontinuations occurred in 163 (14%) patients and were similar to the common AEs. CONCLUSIONS: Despite the limitations, including the controlled clinical setting, this pooled analysis of several clinical studies provides valuable information for the long-term management of BTP with FBT. Patients require regular evaluation and, when necessary, adjustment of opioid medications to maintain adequate pain control. FBT was generally safe and well tolerated in this setting.
Authors: Harold Minkowitz; Janet Bull; R Charles Brownlow; Neha Parikh; Richard Rauck Journal: Support Care Cancer Date: 2016-01-16 Impact factor: 3.603
Authors: Jordi Guitart; Isabel Vargas; Vicente De Sanctis; Julia Ferreras; Jose Fuentes; Rafael Salazar; Juan M Vázquez; Jordi Folch; Jordi Moya; Hermann Ribera; Francisco Rodelas; Albert Tomás; María Arilla; Joan Coma; Teresa Aberasturi; Dolores Sintes; Ester Lombán Journal: Clin Drug Investig Date: 2013-09 Impact factor: 2.859
Authors: Stefan Wirz; Michael Schenk; Hannes Hofbauer; Hans-Christian Wartenberg; Marco Cascella; Kristin Kieselbach Journal: Schmerz Date: 2020-09-25 Impact factor: 1.107