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Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group.

Abstract

BACKGROUND

Use of some antiviral drugs for influenza infection is limited by potential rapid emergence of resistance. We studied the efficacy and safety of oseltamivir, the oral prodrug of the neuraminidase inhibitor GS4071, in adults with naturally acquired laboratory-confirmed influenza.

METHODS

We did a randomised controlled trial of 726 previously healthy non-immunised adults with febrile influenza-like illness of up to 36 h duration. Patients were assigned oral oseltamivir 75 mg (n=243), oseltamivir 150 mg (n=245), or placebo (n=238) twice daily for 5 days. We assessed recovery by questionnaire and temperature recordings. The primary endpoint was time to resolution of illness in influenza-infected patients.

FINDINGS

475 (66%) patients had confirmed infection. Duration of illness was significantly shorter by 29 h (25% reduction, median duration 87.4 h [95% CI 73.3-104.7], p=0.02) with oseltamivir 75 mg and by 35 h (30%, 81.8 h [68.2-100.0], p=0.01) with oseltamivir 150 mg than with placebo (116.5 h [101.5-137.8]). The effect of oseltamivir was apparent within 24 h of the start of treatment. In patients treated within 24 h of symptom onset, symptoms were alleviated 43 h (37% reduction) and 47 h (40%) earlier with oseltamivir 75 mg and 150 mg, respectively, compared with placebo (75 mg 74.5 h [68.2-98.0], p=0.02; 150 mg 70.7 h [54.0-89.4], p=0.01; placebo 117.5 h [103.0-143.8]). Oseltamivir was associated with lower [corrected] symptom scores, less viral shedding, and improved health, activity, and sleep quality, and was well tolerated.

INTERPRETATION

Oseltamivir was effective and well tolerated in the treatment of natural influenza infection in adults. The efficacy, tolerability, and ease of administration warrant further investigation in children, elderly patients, and at-risk patients.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Infectious Disease Unit, Leicester Royal Infirmary, UK.

    , , , , , , ,

    Source

    Lancet (London, England) 355:9218 2000 May 27 pg 1845-50

    MeSH

    Acetamides
    Administration, Oral
    Adult
    Antiviral Agents
    Double-Blind Method
    Drug Administration Schedule
    Enzyme Inhibitors
    Female
    Humans
    Influenza, Human
    Male
    Neuraminidase
    Oseltamivir
    Prodrugs
    Severity of Illness Index
    Surveys and Questionnaires

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    10866439

    Citation

    Nicholson, K G., et al. "Efficacy and Safety of Oseltamivir in Treatment of Acute Influenza: a Randomised Controlled Trial. Neuraminidase Inhibitor Flu Treatment Investigator Group." Lancet (London, England), vol. 355, no. 9218, 2000, pp. 1845-50.
    Nicholson KG, Aoki FY, Osterhaus AD, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet. 2000;355(9218):1845-50.
    Nicholson, K. G., Aoki, F. Y., Osterhaus, A. D., Trottier, S., Carewicz, O., Mercier, C. H., ... Ward, P. (2000). Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet (London, England), 355(9218), pp. 1845-50.
    Nicholson KG, et al. Efficacy and Safety of Oseltamivir in Treatment of Acute Influenza: a Randomised Controlled Trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet. 2000 May 27;355(9218):1845-50. PubMed PMID: 10866439.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. AU - Nicholson,K G, AU - Aoki,F Y, AU - Osterhaus,A D, AU - Trottier,S, AU - Carewicz,O, AU - Mercier,C H, AU - Rode,A, AU - Kinnersley,N, AU - Ward,P, PY - 2000/6/24/pubmed PY - 2000/7/15/medline PY - 2000/6/24/entrez SP - 1845 EP - 50 JF - Lancet (London, England) JO - Lancet VL - 355 IS - 9218 N2 - BACKGROUND: Use of some antiviral drugs for influenza infection is limited by potential rapid emergence of resistance. We studied the efficacy and safety of oseltamivir, the oral prodrug of the neuraminidase inhibitor GS4071, in adults with naturally acquired laboratory-confirmed influenza. METHODS: We did a randomised controlled trial of 726 previously healthy non-immunised adults with febrile influenza-like illness of up to 36 h duration. Patients were assigned oral oseltamivir 75 mg (n=243), oseltamivir 150 mg (n=245), or placebo (n=238) twice daily for 5 days. We assessed recovery by questionnaire and temperature recordings. The primary endpoint was time to resolution of illness in influenza-infected patients. FINDINGS: 475 (66%) patients had confirmed infection. Duration of illness was significantly shorter by 29 h (25% reduction, median duration 87.4 h [95% CI 73.3-104.7], p=0.02) with oseltamivir 75 mg and by 35 h (30%, 81.8 h [68.2-100.0], p=0.01) with oseltamivir 150 mg than with placebo (116.5 h [101.5-137.8]). The effect of oseltamivir was apparent within 24 h of the start of treatment. In patients treated within 24 h of symptom onset, symptoms were alleviated 43 h (37% reduction) and 47 h (40%) earlier with oseltamivir 75 mg and 150 mg, respectively, compared with placebo (75 mg 74.5 h [68.2-98.0], p=0.02; 150 mg 70.7 h [54.0-89.4], p=0.01; placebo 117.5 h [103.0-143.8]). Oseltamivir was associated with lower [corrected] symptom scores, less viral shedding, and improved health, activity, and sleep quality, and was well tolerated. INTERPRETATION: Oseltamivir was effective and well tolerated in the treatment of natural influenza infection in adults. The efficacy, tolerability, and ease of administration warrant further investigation in children, elderly patients, and at-risk patients. SN - 0140-6736 UR - https://www.unboundmedicine.com/medline/citation/10866439/Efficacy_and_safety_of_oseltamivir_in_treatment_of_acute_influenza:_a_randomised_controlled_trial__Neuraminidase_Inhibitor_Flu_Treatment_Investigator_Group_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140673600022881 DB - PRIME DP - Unbound Medicine ER -