Breakthrough Pain
Efficacy and Safety of Sublingual Fentanyl Orally Disintegrating Tablets in Patients with Breakthrough Pain: Multicentre Prospective Study.
Guitart J, Vargas I, De Sanctis V, Ferreras J, Fuentes J, Salazar R, Vázquez JM, Folch J, Moya J, Ribera H, Rodelas F, Tomás A, Arilla M, Coma J, Aberasturi T, Sintes D, Lombán E.
Source
Department of Anesthesiology, Hospital Plató, c/ Plató 21, 08006, Barcelona, Spain, jordi.guitart@hospitalplato.com.Abstract
BACKGROUND AND OBJECTIVES:
The aim of this study was to evaluate the effectiveness and safety of sublingual fentanyl oral disintegrating tablets (sublingual fentanyl ODT) for the treatment of breakthrough pain (BTP), cancer or non-cancer related, in terms of relief of pain intensity, adverse events (AEs) and patient satisfaction, and to further examine the clinical and epidemiological profile of patients with BTP in a clinical setting.METHODS:
A multicentre, prospective, open-label study was conducted in 19 pain units from Catalonia hospitals (Spain) over a 1-month period. Opioid-tolerant adult patients experiencing episodes of BTP intensity >5 on a visual analogue scale (VAS) during the 12-24 h before screening or AEs related to their previous rescue medication for BTP received sublingual fentanyl ODT in the course of routine clinical practice and completed a 30-day study period consisting of five assessment points: days 0 (baseline), 3, 7, 15 and 30. The efficacy was assessed by collecting pain intensity and pain relief data at baseline and at each assessment. AEs were recorded by investigators throughout the study during clinic visits and telephone follow-ups. For all patients, titration was begun with an initial dose of 100 μg. No more than two doses were allowed to treat an episode and patients might wait at least 4 h before treating another BTP episode with sublingual fentanyl ODT. The dose was increased by 100 μg multiples up to 400 μg as needed; and by 200 μg multiples up from 400 to 800 μg, the maximum titration step.RESULTS:
A total of 182 patients were enrolled and 177 (97.2 %) completed the study: 37 had breakthrough cancer pain (BTcP) and 145 had breakthrough non-cancer pain (BTncP). The mean pain intensity showed a statistically significant improvement at the first assessment point and at all assessments thereafter (p < 0.0001). At the end of the study, the time lag between administration and first effect of sublingual fentanyl ODT was ≤10 min in 69.0 % (60 % BTcP and 71.2 % BTncP). The number of daily BTP episodes decreased in both groups, but it was statistically significant in BTcP. 114 patients (62.64 %) experienced AEs during the study. AEs recorded included nausea, vomiting, somnolence and constipation, and seven (4.49 %) were considered severe. No death or discontinuation was considered related to AEs.CONCLUSION:
Sublingual fentanyl ODT provided rapid and consistent relief from BTP, both in cancer and non-cancer patients.It was well-tolerated and well-accepted by patients in routine clinical practice.
Clin Drug Investig. 2013 Jul 24.
Pain Med. 2013 Jul 15.
ReplyDeleteFentanyl Buccal Tablet Compared with Immediate-Release Oxycodone for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Cancer and Noncancer Pain: A Randomized, Double-Blind, Crossover Study Followed by a 12-Week Open-Label Phase to Evaluate Patient Outcomes.
Webster LR, Slevin KA, Narayana A, Earl CQ, Yang R.
Source
CRI Lifetree, Salt Lake City, Utah.
Abstract
OBJECTIVE:
Evaluate analgesic efficacy, functional benefit, and patient satisfaction with fentanyl buccal tablet vs immediate-release oxycodone for breakthrough pain (BTP).
DESIGN:
Randomized, double-blind, active-controlled crossover trial and 12-week open-label extension.
SETTING:
Forty-two U.S. sites.
PATIENTS:
Opioid-tolerant patients with predominantly chronic noncancer pain experiencing BTP.
INTERVENTION:
Patients were randomized to open-label titration periods with fentanyl buccal tablet followed by oxycodone or vice versa for BTP management. After titrating to a successful dose of both medications (single dose providing adequate analgesia without unacceptable adverse events), patients were re-randomized to treat 10 BTP episodes with one medication and 10 with the other.
OUTCOME MEASURES:
The primary efficacy measure was pain intensity (PI) difference 15 minutes postdose. Secondary measures included PI difference 5, 10, 30, 45, and 60 minutes postdose; sum of PI differences 30 and 60 minutes postdose; ≥33% and ≥50% reduction in PI; and pain relief. Questionnaires assessed functional status/satisfaction.
RESULTS:
Of 213 patients enrolled, 149 achieved a successful dose of both medications; 131 completed the double-blind phase and 112 the open-label phase. PI difference at 15 minutes (mean [standard deviation]) was greater with fentanyl buccal tablet (0.88 [1.20]) vs oxycodone (0.76 [1.13]; P < 0.001). Patients preferred fentanyl buccal tablet (47%) over oxycodone (35%); 18% had no preference. Patients and clinicians reported consistently better functional improvement and satisfaction with fentanyl buccal tablet vs short-acting opioids (P < 0.05).
CONCLUSIONS:
Fentanyl buccal tablet was associated with rapid onset of analgesia and improvements in functional status and patient satisfaction compared with immediate-release oxycodone.