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Ernesto Zecca, from the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, and colleagues tested the non-inferiority of FST versus SCM during the first 30 minutes after administration. Patients receiving stable opioid therapy and experiencing severe pain were randomized to receive 100 µg FST (57 patients) or 5 mg SCM (56 patients). The authors assessed average pain intensity (PI) at 10, 20, and 30 minutes after administration on a 0 to 10 numerical rating scale.
The researchers found that in both groups the baseline mean PI was 7.5. At 10, 20 and 30 minutes after administration, the mean average PIs were 5.0 and 4.5 for FST and SCM, respectively; the 95 percent confidence interval of the between-group difference included the non-inferiority margin of −0.6 (−0.49; 95 percent confidence interval, −1.10 to 0.09). Receipt of a second drug dose after 30 minutes occurred more frequently in patients taking FST versus SCM (51 versus 37 percent). Both treatments were well tolerated. Most patients (93 percent) preferred the sublingual administration.
"This trial did not show non-inferiority of FST versus SCM within the chosen non-inferiority margin," the authors write. "FST provides analgesia with modest to moderate increased risk of lower efficacy compared with SCM."
Several authors disclosed financial ties to the pharmaceutical industry.
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