Pain practice : the official journal of World Institute of Pain · 2015
Effective Dose Titration of Fentanyl Sublingual Spray in Patients With Breakthrough Cancer Pain.
СтатьяНазвание и аннотация: Перевод в очереди
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Rauck Richard, Bull Janet, Parikh Neha, Dillaha Larry, Stearns Lisa
Аннотация
OBJECTIVE: To further describe effective dose titration of fentanyl sublingual spray to treat breakthrough cancer pain (BTCP) during the 26-day open-label titration phase of a phase 3, randomized, double-blind, placebo-controlled study.
METHODS: Opioid-tolerant patients with 1 to 4 episodes of BTCP per day were enrolled. For randomization into double-blind treatment, patients must have titrated to a dose (100 to 1,600 mcg) providing effective analgesia for 2 consecutive BTCP episodes. The Treatment Satisfaction Questionnaire for Medication was administered at baseline and at titration end and included a Global Satisfaction domain.
RESULTS: Of 130 patients undergoing titration, 98 (75%) achieved pain relief (median dose = 800 mcg). The most common doses that allowed for adequate pain relief were 800 mcg (24.5%) and 1,200 mcg (20.4%). Of 32 (25%) patients who withdrew from the study, only 3 (2.3%) did not achieve an effective dose. In patients attaining an effective dose, mean Global Satisfaction increased from 54.9 ± 2.1 at baseline to 75.3 ± 1.7 at the end of the titration phase. Seventy-eight patients (60%) reported ≥ 1 adverse event (AE). Thirty-three AEs (25.4%) were considered probably related to treatment, with nausea (6.2%) and somnolence (4.6%) most commonly reported.
CONCLUSIONS: In patients with BTCP, fentanyl sublingual spray can be rapidly and safely titrated to an effective dose, resulting in greater satisfaction with fentanyl sublingual spray than previous BTCP medications.
METHODS: Opioid-tolerant patients with 1 to 4 episodes of BTCP per day were enrolled. For randomization into double-blind treatment, patients must have titrated to a dose (100 to 1,600 mcg) providing effective analgesia for 2 consecutive BTCP episodes. The Treatment Satisfaction Questionnaire for Medication was administered at baseline and at titration end and included a Global Satisfaction domain.
RESULTS: Of 130 patients undergoing titration, 98 (75%) achieved pain relief (median dose = 800 mcg). The most common doses that allowed for adequate pain relief were 800 mcg (24.5%) and 1,200 mcg (20.4%). Of 32 (25%) patients who withdrew from the study, only 3 (2.3%) did not achieve an effective dose. In patients attaining an effective dose, mean Global Satisfaction increased from 54.9 ± 2.1 at baseline to 75.3 ± 1.7 at the end of the titration phase. Seventy-eight patients (60%) reported ≥ 1 adverse event (AE). Thirty-three AEs (25.4%) were considered probably related to treatment, with nausea (6.2%) and somnolence (4.6%) most commonly reported.
CONCLUSIONS: In patients with BTCP, fentanyl sublingual spray can be rapidly and safely titrated to an effective dose, resulting in greater satisfaction with fentanyl sublingual spray than previous BTCP medications.