mometasone-furoate and Paranasal-Sinus-Diseases

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).. Randomized, double-blind, placebo-controlled, multicenter study.. Ten ear, nose, and throat clinics in Sweden.. Adult subjects with bilateral nasal polyps fulfilling the criteria for surgery who underwent FESS.. Two weeks after FESS, subjects were randomized to receive mometasone furoate nasal spray, 200 microg once daily, or placebo.. Time to relapse, defined as an increase of 1 point or more on a 0- to 6-point endoscopic polyp scale.. 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.. 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.. clinicaltrials.gov Identifier: NCT00731185.

Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Dose-Response Relationship, Drug; Double-Blind Method; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Paranasal Sinus Diseases; Postoperative Complications; Pregnadienediols; Secondary Prevention; Treatment Outcome; Young Adult

Corticosteroid-eluting stents (CESs) are increasingly used after endoscopic sinus surgery to reduce the need for revision surgery, but their use is not without risks. The objective of this study is to describe adverse events related to CESs.. Retrospective cross-sectional study.. The US Food and Drug Administration's MAUDE database (2011-2020; Manufacturer and User Facility Device Experience).. The MAUDE database was queried for reports of adverse events involving the use of CESs approved by the Food and Drug Administration, including Propel, Propel Mini, Propel Contour, and Sinuva (Intersect ENT).. There were 28 reported adverse events in total, with all events being related to the Propel family of stents and none related to Sinuva stents. Overall, 22 were categorized as patient-related adverse events and 6 as device-related events. The most common adverse event was related to postoperative infection, accounting for 39% (n = 11) of all complications. Four of these patients developed periorbital cellulitis, and 5 developed a fungal infection. The second-most common adverse event was migration of the stent, representing 21% of all complications (n = 6). Overall, 8 patients (29%) in our cohort required reintervention in the operating room, with subsequent removal of the CES.. The most commonly reported adverse events were postoperative infection, including multiple cases of fungal infection, followed by migration of the stent. An increased awareness of the complications associated with CESs can be used to better inform patients during the consenting process as well as surgeons in their surgical decision making.

Topics: Anti-Inflammatory Agents; Cross-Sectional Studies; Databases, Factual; Drug-Eluting Stents; Endoscopy; Humans; Mometasone Furoate; Paranasal Sinus Diseases; Postoperative Complications; Retrospective Studies; United States