Background: A mometasone furoate (MF) sinus implant (1350 mcg) was evaluated in 2 randomized controlled trials (RCTs) in 400 adults with nasal polyps (NP) who were candidates for revision endoscopic sinus surgery (RESS). We conducted a pooled analysis to evaluate the efficacy of MF implant in specific subgroups of NP patients.
Methods: Pooled data from 2 RCTs for 375 patients were analyzed across prespecified subjective and objective end points through day 90.
Results: At day 90, patients receiving implants and MF nasal spray (MFNS) experienced significant improvements in nasal obstruction/congestion (NO/C) score (P = .0095), bilateral polyp grade (BPG, P = .0008), and ethmoid sinus obstruction (P < .0001) compared to control using MFNS alone. Fewer treatment than control patients remained candidates for RESS (41.0% vs 69.3%, P < .0001). All subgroups experienced significant treatment effects, except NO/C in smokers (P = .0509) and patients without altered smell (P = .1873). Subgroups without asthma and with only 1 prior ESS experienced largest treatment effect on NO/C, and those with recent surgery <24 months and BPG >5 showed largest effect on endoscopic end points and RESS. Control patients with ESS <24 months were at 7 times highest risk for RESS (P < .0001). One (0.4%) patient experienced implant-related serious adverse event (epistaxis).
Conclusion: On pooled analysis, MF implants with MFNS showed more favorable results than MFNS alone across several subjective and objective end points at day 90 and may play an important role in management of NP patients, especially those who have allergic rhinitis, expanded polyposis, altered smell, or had most recent ESS < 24 months.
Keywords: bioabsorbable; chronic sinusitis; corticosteroid; endoscopic sinus surgery; ethmoid; polyposis; sinus surgery; stent.