This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (53)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Aging/ Geriatrics  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

A Pooled Analysis of Randomized Controlled Trials

Jacob Lalezari, MD; Katrina Campion, MA; Oliver Keene, MA, MSc; Chris Silagy, MD

Arch Intern Med. 2001;161:212-217.

Background  Influenza 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.

Methods  A 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.

Results  Zanamivir-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.

Conclusion  This 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.

From Quest Clinical Research, San Francisco, Calif (Dr Lalezari); Glaxo Wellcome Australia, Melbourne, Victoria, Australia (Ms Campion); Glaxo Wellcome Research and Development, Greenford, England (Mr Keene); and Monash Institute of Public Health and Health Services Research, Monash University, Clayton, Victoria, Australia (Dr Silagy).

Corresponding author and reprints: Jacob Lalezari, MD, Quest Clinical Research, 2300 Sutter St, Suite 202, San Francisco, CA 94115 (e-mail: drjay{at}questclinical.com).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Pathogen-directed Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Martinez
Proc Am Thorac Soc 2007;4:647-658.
ABSTRACT | FULL TEXT  

Pulmonary Complications of Solid Organ and Hematopoietic Stem Cell Transplantation
Kotloff et al.
Am. J. Respir. Crit. Care Med. 2004;170:22-48.
ABSTRACT | FULL TEXT  

Management of Influenza in Adults Older than 65 Years of Age: Cost-Effectiveness of Rapid Testing and Antiviral Therapy
Rothberg et al.
ANN INTERN MED 2003;139:321-329.
ABSTRACT | FULL TEXT  

Effectiveness of neuraminidase inhibitors in treatment and prevention of influenza A and B: systematic review and meta-analyses of randomised controlled trials
Cooper et al.
BMJ 2003;326:1235-1235.
ABSTRACT | FULL TEXT  

The treatment of influenza with antiviral drugs
Stiver
CMAJ 2003;168:49-57.
ABSTRACT | FULL TEXT