title: Oseltamivir and inhaled zanamivir as influenza prophylaxis in Thai health workers: a randomized, double-blind, placebo-controlled safety trial over 16 weeks.
abstract: OBJECTIVE
  Long-term chemoprophylaxis using neuraminidase inhibitors may be needed during influenza epidemics but safety data are limited to several weeks. We sought to assess the tolerability of oseltamivir and zanamivir as primary prophylaxis over 16 weeks.
  
  
  METHODS
  We conducted a parallel group, double blind, 2 (active drug) :1 (placebo) randomized trial of oral oseltamivir/placebo or inhaled zanamivir/placebo over 16 weeks in healthy, Thai hospital professionals at two Bangkok hospitals. The primary endpoint was study withdrawal due to drug-related (possibly, probably, definitely) serious or adverse events (AEs) graded ≥ 2.
  
  
  RESULTS
  Recruited subjects numbered 129 oseltamivir/65 placebo and 131 zanamivir/65 placebo. A total of 102 grade ≥ 2 AEs were reported or detected in 69 subjects: 23/129 (17.8%) versus 15/65 (23.1%) (P=0.26), and 23/131 (17.6%) versus 8/65 (12.3%) (P=0.28). Intercurrent infections/fevers [26/102 (25.5%)], abnormal biochemistry [25/102 (24.5%)] and gastrointestinal symptoms [18/102 (17.6%)] were the most frequently reported AEs. There were no drug-related study withdrawals. Eight serious AEs were all due to intercurrent illnesses. Laboratory, lung function and ECG parameters were similar between drugs and placebos.
  
  
  CONCLUSIONS
  Oseltamivir and zanamivir were well tolerated in healthy hospital professionals. Both drugs can be recommended for primary influenza prophylaxis for up to 16 weeks.
authors.affiliation: Department of Preventive and Social Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Prannok Road, Bangkoknoi, Bangkok, Thailand. tanek@hotmail.com
authors.forename: T
authors.initials: T
authors.lastname: Anekthananon
authors.forename: S
authors.initials: S
authors.lastname: Pukrittayakamee
authors.forename: S
authors.initials: S
authors.lastname: Pukritayakamee
authors.forename: W
authors.initials: W
authors.lastname: Ratanasuwan
authors.forename: P
authors.initials: P
authors.lastname: Jittamala
authors.forename: P
authors.initials: P
authors.lastname: Werarak
authors.forename: P
authors.initials: P
authors.lastname: Charunwatthana
authors.forename: S
authors.initials: S
authors.lastname: Suwanagool
authors.forename: S
authors.initials: S
authors.lastname: Lawpoolsri
authors.forename: K
authors.initials: K
authors.lastname: Stepniewska
authors.forename: P
authors.initials: P
authors.lastname: Sapchookul
authors.forename: P
authors.initials: P
authors.lastname: Puthavathana
authors.forename: C
authors.initials: C
authors.lastname: Fukuda
authors.forename: N
authors.initials: N
authors.lastname: Lindegardh
authors.forename: J
authors.initials: J
authors.lastname: Tarning
authors.forename: N J
authors.initials: NJ
authors.lastname: White
authors.forename: N
authors.initials: N
authors.lastname: Day
authors.forename: W R J
authors.initials: WR
authors.lastname: Taylor
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects*; D018890:Chemoprevention / Q000009:adverse effects* / Q000379:methods; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006282:Health Personnel; D006801:Humans; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D053139:Oseltamivir / Q000008:administration & dosage / Q000009:adverse effects*; D010919:Placebos / Q000008:administration & dosage; D013785:Thailand; D055815:Young Adult; D053243:Zanamivir / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000998:Antiviral Agents; D010919:Placebos; D053139:Oseltamivir; D053243:Zanamivir