title: Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study.
abstract: BACKGROUND
  Long-term use of systemic glucocorticoid therapy has been associated with hypothalamic-pituitary-adrenal axis suppression and other systemic adverse events. This pharmacokinetic study evaluated the systemic safety and performance of a bioabsorbable sinus implant that gradually releases 1350 μg of mometasone furoate directly to the sinus mucosa.
  
  
  METHODS
  A prospective, single-center study treating 5 adult patients with recurrent polyposis after bilateral total ethmoidectomy. Each patient received 2 steroid-releasing implants in-office under local/topical anesthesia. Plasma concentrations of mometasone furoate and cortisol were determined before placement and through 30-day follow-up, which also included endoscopic grading and patient-reported outcomes.
  
  
  RESULTS
  Five patients (mean age 46.2 ± 9.2 standard deviation [SD] years; 60% male) underwent successful placement in all 10 ethmoid sinuses. There were no serious adverse events. The plasma concentrations of mometasone furoate were generally below the lower limit of quantification (LLOQ) of the assay (30 pg/mL). Cortisol concentrations at follow-up ranged from 3.9 to 5.7 mg/dL compared to 4.7 mg/dL at baseline. At 1 month, there was a significant improvement in bilateral polyp grade (p = 0.037), nasal obstruction score (p = 0.002), and 22-item Sino-Nasal Outcome Test (SNOT-22) (p = 0.010) compared to baseline.
  
  
  CONCLUSIONS
  The reported 100% placement success, negligible systemic exposure to mometasone furoate released over time, lack of adrenal suppression, and the absence of serious adverse events suggest that the implant provides a valid and safe option for the in-office treatment of recurrent polyposis. Randomized, controlled, blinded clinical studies are underway to provide further evidence of safety and efficacy.
authors.affiliation: Sacramento Ear, Nose and Throat, Roseville, CA.
authors.forename: Randall
authors.initials: R
authors.lastname: Ow
authors.forename: Eli
authors.initials: E
authors.lastname: Groppo
authors.forename: Donald
authors.initials: D
authors.lastname: Clutter
authors.forename: Anna K
authors.initials: AK
authors.lastname: Gawlicka
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D004343:Drug Implants; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D009298:Nasal Polyps / Q000188:drug therapy / Q000378:metabolism*; D010256:Paranasal Sinuses / Q000601:surgery; D011244:Pregnadienediols / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011446:Prospective Studies; D053719:Tandem Mass Spectrometry; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D004343:Drug Implants; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D006854:Hydrocortisone
keywords: bioabsorbable; chronic rhinosinusitis; corticosteroid; cortisol; drug-eluting; endoscopic sinus surgery; localized drug delivery; mometasone furoate; nasal polyps