Clinical characteristics and outcomes of hospitalized patients with 2009 H1N1 influenza in a large acute care tertiary hospital, Singapore

Hsann, Yin Maw; Thang, Sue Ping; Salam, Zakir-Hussain Abdul; Yang, Yong; Lim, Vincent; Yang, Kok Soong

doi:10.1016/j.ajic.2010.11.015

Cited by 1 publication

(2 citation statements)

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“…In two zanamivir adult trials, 81,82 pneumonia reporting was based on a stricter definition of X-ray confirmation and there was also no significant treatment effect (RR 1.02, 95% CI 0.35 to 3.02; I 2 statistic = 39%). In nine zanamivir trials, 77,79,80,87,89,91,[97][98][99] pneumonia was a self-reported, investigator-mediated, unverified outcome (see Figures 8 and 9). Overall, there was no significant effect of zanamivir on mixed verified and unverified pneumonia in adult treatment (RR 0.90, 95% CI 0.58 to 1.40; I 2 statistic = 0%).…”

Section: Pneumoniamentioning

confidence: 99%

“…83,92 were excluded from the meta-analysis because one was only a synopsis 83 and one compared zanamivir to usual care and not placebo. 92 We finally included 26 zanamivir trials: 14 on treatment in adults, [71][72][73]77,[80][81][82]87,89,91,95,[97][98][99] two in children 78,84 and 10 trials in prophylaxis. 70,79,85,86,88,90,93,94,96,100 Our attempt at collecting sufficient information from regulatory files to reconstruct missing CSRs also failed because the information appeared to be insufficient for a reliable reconstruction.…”

Section: Zanamivirmentioning

confidence: 99%

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Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data

Heneghan

Onakpoya

Jones

et al. 2016

Health Technol Assess

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BackgroundNeuraminidase inhibitors (NIs) are stockpiled and recommended by public health agencies for treating and preventing seasonal and pandemic influenza. They are used clinically worldwide.ObjectivesTo (1) describe the potential benefits and harms of NIs for influenza in all age groups by reviewing all clinical study reports (CSRs) of published and unpublished randomised, placebo-controlled trials and regulatory comments; and (2) determine the effect of oseltamivir (Tamiflu®, Roche) treatment on mortality in patients with 2009A/H1N1 influenza.MethodsWe searched trial registries, electronic databases and corresponded with regulators and sponsors to identify randomised trials of NIs. We requested full CSRs and accessed regulators’ comments. We included only those trials for which we had CSRs. To examine the effects of oseltamivir on 2009A/H1N1 influenza mortality, we requested individual patient data (IPD) from corresponding authors of all included observational studies.ResultsEffect of oseltamivir and zanamivir (Relenza®, GlaxoSmithKline) in the prevention and treatment of influenza: Oseltamivir reduced the time to first alleviation of symptoms in adults by 16.8 hours [95% confidence interval (CI) 8.4 to 25.1 hours]. Zanamivir reduced the time to first alleviation of symptoms in adults by 0.60 days (95% CI 0.39 to 0.81 days). Oseltamivir reduced unverified pneumonia in adult treatment [risk difference (RD) 1.00%, 95% CI 0.22% to 1.49%]; similar findings were observed with zanamivir prophylaxis in adults (RD 0.32%, 95% CI 0.09% to 0.41%). Oseltamivir treatment of adults increased the risk of nausea (RD 3.66%, 95% CI 0.90% to 7.39%) and vomiting (RD 4.56%, 95% CI 2.39% to 7.58%). In the treatment of children, oseltamivir induced vomiting (RD 5.34%, 95% CI 1.75% to 10.29%). Both oseltamivir and zanamivir prophylaxis reduced the risk of symptomatic influenza in individuals (oseltamivir RD 3.05%, 95% CI 1.83% to 3.88%; zanamivir RD 1.98%, 95% CI 0.98% to 2.54%) and in households (oseltamivir RD 13.6%, 95% CI 9.52% to 15.47%; zanamivir RD 14.84%, 95% CI 12.18% to 16.55%). Oseltamivir increased psychiatric adverse events in the combined on- and off-treatment periods (RD 1.06%, 95% CI 0.07% to 2.76%) and the risk of headaches while on treatment (RD 3.15%, 95% CI 0.88% to 5.78%).Effect of oseltamivir on mortality in patients with 2009A/H1N1 influenza: Analysis of summary data of 30 studies as well as IPD of four studies showed evidence of time-dependent bias. After adjusting for time-dependent bias and potential confounding variables, competing risks analysis of the IPD showed insufficient evidence that oseltamivir reduced the risk of mortality (hazard ratio 1.03, 95% CI 0.64 to 1.65).ConclusionsOseltamivir and zanamivir cause small reductions in the time to first alleviation of influenza symptoms in adults. The use of oseltamivir increases the risk of nausea, vomiting, psychiatric events in adults and vomiting in children. Oseltamivir has no protective effect on mortality among patients with 2009A/H1N1 influenza. Prophylaxis with either NI may reduce symptomatic influenza in individuals and in households. The balance between benefits and harms should be considered when making decisions about use of NIs for either prophylaxis or treatment of influenza.Study registrationThis study is registered as PROSPERO CRD42012002245.FundingThe National Institute for Health Research Health Technology Assessment programme.

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