title: Safety Profile of the Use of Iodopovidone for Pleurodesis in Patients with Malignant Pleural Effusion.
abstract: BACKGROUND
  Iodopovidone is an alternative agent used to promote pleurodesis in patients with malignant pleural effusion (MPE). However, safety is a concern, and many authors still reject its use.
  
  
  OBJECTIVE
  Our main objective is to describe the occurrence of common and severe adverse events after pleurodesis with two different doses of iodopovidone in patients with MPE. Our secondary objective is to evaluate dose dependency, efficacy, quality of life, and systemic inflammation.
  
  
  METHODS
  We conducted a double-blind, randomized clinical trial including patients with recurrent MPE. Patients underwent chest tube insertion and were randomized into two groups according to the doses of iodopovidone: group 1 received 1% iodopovidone, and group 2 received 2% iodopovidone. During follow-up, adverse events, inflammatory markers, quality of life, and imaging exams were systematically evaluated and registered.
  
  
  RESULTS
  Sixty patients were analyzed (55 females, 5 males, median age 55.9 years). Overall, 227 adverse events possibly related to pleurodesis were registered, including 47 serious adverse events (in 34 patients). Pleuritic pain and hypertensive peaks were the most frequently observed serious adverse events (11 and 10 episodes, respectively). Grade 3/4 metabolic events such as hyponatremia and an increase in alkaline phosphatase, AST and ALT levels were also common. C-reactive protein (CRP) levels increased substantially and peaked 48 h after pleurodesis. No difference was observed between groups with regard to adverse events, CRP levels, efficacy, or quality of life.
  
  
  CONCLUSIONS
  Adverse events after iodopovidone pleurodesis in patients with MPE are common and similar in the two doses studied.
authors.affiliation: Thoracic Surgery Division, Hospital Aristides Maltez, Salvador, Brazil.
authors.forename: José Dias
authors.initials: JD
authors.lastname: Andrade Neto
authors.forename: Ricardo Mingarini
authors.initials: RM
authors.lastname: Terra
authors.forename: Rodrigo Maia
authors.initials: RM
authors.lastname: Teixeira
authors.forename: Sylvana Vianna
authors.initials: SV
authors.lastname: Pereira
authors.forename: Paulo Manuel
authors.initials: PM
authors.lastname: Pego-Fernandes
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D015505:Chest Tubes; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D016066:Pleural Effusion, Malignant / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality; D018700:Pleurodesis / Q000295:instrumentation / Q000379:methods*; D011206:Povidone-Iodine / Q000008:administration & dosage*; D013902:Radiography, Thoracic; D012008:Recurrence; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D011206:Povidone-Iodine