• J Lalezari, K Campion, O Keene, and C Silagy.
• Quest Clinical Research, 2300 Sutter St, Suite 202, San Francisco, Calif 94115, USA. drjay@questclinical.com
• Arch Intern Med. 2001 Jan 22; 161 (2): 212217212-7.

BackgroundInfluenza can cause significant morbidity and mortality, particularly in patients considered to be at high risk (such as the elderly and those with chronic disease) of developing influenza-related complications. Data on the efficacy of zanamivir in high-risk patients are lacking because individual studies recruited a limited number of these patients.MethodsA retrospective pooled analysis of data from high-risk patients in studies completed before or during the 1998-1999 winter season was performed to investigate the efficacy and safety of inhaled zanamivir (10 mg twice daily for 5 days) for the treatment of confirmed influenza. All studies were randomized, double-blind, and placebo-controlled with 21- to 28-day follow-up. A total of 2751 patients was recruited. Of these, 321 (12%) were considered high risk and 154 were randomized to zanamivir. The median time to alleviation of influenza symptoms and time to return to normal activities were the main outcome measures.ResultsZanamivir-treated high-risk patients had a treatment benefit of 2.5 days compared with those given placebo (P = .015). Patients treated with zanamivir returned to normal activities 3.0 days earlier (P = .022) and had an 11% reduction (P = .039) in the median total symptom score over 1 to 5 days relative to those taking placebo. In addition, zanamivir reduced the incidence of complications requiring antibiotic use by 43% relative to placebo users (P = .045). Adverse events reported were of a similar nature and frequency between the two groups.ConclusionThis pooled analysis shows that zanamivir is an effective and well-tolerated treatment for influenza in patients considered at high-risk of developing influenza-related complications.

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