Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery.
OBJECTIVE
To evaluate the effect of mometasone furoate on prevention or reduction of nasal polyp relapse and worsening of symptoms after functional endoscopic sinus surgery (FESS).


METHODS
Randomized, double-blind, placebo-controlled, multicenter study.


METHODS
Ten ear, nose, and throat clinics in Sweden.


METHODS
Adult subjects with bilateral nasal polyps fulfilling the criteria for surgery who underwent FESS.


METHODS
Two weeks after FESS, subjects were randomized to receive mometasone furoate nasal spray, 200 microg once daily, or placebo.


METHODS
Time to relapse, defined as an increase of 1 point or more on a 0- to 6-point endoscopic polyp scale.


RESULTS
In the per-protocol population (n = 104), median time to relapse was 173 and 61 days for the mometasone and placebo groups, respectively (P = .007; hazard ratio [95% confidence interval], 0.72 [0.55-0.93]). In the intent-to-treat population (n = 159), median time to relapse was greater than 175 days in the mometasone group and 125 days in the placebo group (P = .049; hazard ratio, 0.79 [0.62-0.99]). The most common adverse event was epistaxis, with 6 cases reported in the mometasone group and 3 in the placebo group.


CONCLUSIONS
Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone FESS. The ability of mometasone to prevent or prolong the time to relapse among subjects undergoing FESS is important because this may prolong the time to subsequent surgery.


BACKGROUND
clinicaltrials.gov Identifier: NCT00731185.
Stjärne
Pär
P
Department of Clinical Sciences, Intervention and Technology, Division of Otorhinolaryngology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden. par.stjarne@karolinska.se
Olsson
Petter
P
Alenius
Martin
M
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004724:Endoscopy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D009298:Nasal Polyps / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D010254:Paranasal Sinus Diseases / Q000601:surgery*; D011183:Postoperative Complications; D011244:Pregnadienediols / Q000008:administration & dosage*; D055502:Secondary Prevention; D016896:Treatment Outcome; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate