PMID- 23143901
OWN - NLM
STAT- MEDLINE
DCOM- 20130722
LR  - 20240329
IS  - 1460-2091 (Electronic)
IS  - 0305-7453 (Print)
IS  - 0305-7453 (Linking)
VI  - 68
IP  - 3
DP  - 2013 Mar
TI  - Oseltamivir and inhaled zanamivir as influenza prophylaxis in Thai health 
      workers: a randomized, double-blind, placebo-controlled safety trial over 16 
      weeks.
PG  - 697-707
LID - 10.1093/jac/dks418 [doi]
AB  - OBJECTIVES: 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.
FAU - Anekthananon, T
AU  - Anekthananon T
AD  - Department of Preventive and Social Medicine, Faculty of Medicine Siriraj 
      Hospital, Mahidol University, 2 Prannok Road, Bangkoknoi, Bangkok, Thailand. 
      tanek@hotmail.com
FAU - Pukrittayakamee, S
AU  - Pukrittayakamee S
FAU - Ratanasuwan, W
AU  - Ratanasuwan W
FAU - Jittamala, P
AU  - Jittamala P
FAU - Werarak, P
AU  - Werarak P
FAU - Charunwatthana, P
AU  - Charunwatthana P
FAU - Suwanagool, S
AU  - Suwanagool S
FAU - Lawpoolsri, S
AU  - Lawpoolsri S
FAU - Stepniewska, K
AU  - Stepniewska K
FAU - Sapchookul, P
AU  - Sapchookul P
FAU - Puthavathana, P
AU  - Puthavathana P
FAU - Fukuda, C
AU  - Fukuda C
FAU - Lindegardh, N
AU  - Lindegardh N
FAU - Tarning, J
AU  - Tarning J
FAU - White, N J
AU  - White NJ
FAU - Day, N
AU  - Day N
FAU - Taylor, W R J
AU  - Taylor WR
LA  - eng
GR  - WT_/Wellcome Trust/United Kingdom
GR  - 089275/WT_/Wellcome Trust/United Kingdom
GR  - 093956/WT_/Wellcome Trust/United Kingdom
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20121109
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (Antiviral Agents)
RN  - 0 (Placebos)
RN  - 20O93L6F9H (Oseltamivir)
RN  - L6O3XI777I (Zanamivir)
SB  - IM
EIN - J Antimicrob Chemother. 2013 Jul;68(7):1695. Pukritayakamee, S [corrected to 
      Pukrittayakamee, S]
MH  - Administration, Inhalation
MH  - Adult
MH  - Antiviral Agents/administration & dosage/*adverse effects
MH  - Chemoprevention/*adverse effects/methods
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - *Health Personnel
MH  - Humans
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Oseltamivir/administration & dosage/*adverse effects
MH  - Placebos/administration & dosage
MH  - Thailand
MH  - Young Adult
MH  - Zanamivir/administration & dosage/*adverse effects
PMC - PMC3566665
EDAT- 2012/11/13 06:00
MHDA- 2013/07/23 06:00
PMCR- 2020/10/20
CRDT- 2012/11/13 06:00
PHST- 2012/11/13 06:00 [entrez]
PHST- 2012/11/13 06:00 [pubmed]
PHST- 2013/07/23 06:00 [medline]
PHST- 2020/10/20 00:00 [pmc-release]
AID - dks418 [pii]
AID - 10.1093/jac/dks418 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2013 Mar;68(3):697-707. doi: 10.1093/jac/dks418. Epub 
      2012 Nov 9.