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Study Finds Children With Influenza 53 Percent Less Likely to Contract Pneumonia When Treated With Tamiflu(R)

Posted on: Friday, 29 September 2006, 21:00 CDT

SAN FRANCISCO, Sept. 29 /PRNewswire/ -- Pediatric patients diagnosed with influenza and treated with the prescription antiviral medication Tamiflu(R) (oseltamivir phosphate) showed a significantly reduced risk of pneumonia, according to a new retrospective data analysis of more than 15,000 children aged one to 12 years. Children who received Tamiflu within one day of influenza diagnosis were 53 percent less likely to contract pneumonia, compared with patients receiving no antiviral treatment. The study was presented today at the 46th Annual Interscience Congress on Antimicrobial Agents and Chemotherapy (ICAAC) by researchers from Roche and Thomson Medstat during a session on respiratory viruses.

Approximately 2.6 percent (n=389/15,161) of the influenza patients included in the analysis were subsequently diagnosed with pneumonia. Children aged one to two years and six to twelve years had the largest reductions in pneumonia risk of 52 percent and 57 percent, respectively (see Fig.1 for more details). The study also showed a 43 percent reduction in hospitalization for pneumonia among children receiving Tamiflu, although this trend did not achieve statistical significance.

"This study suggests that early treatment with Tamiflu can have a significant impact on pneumonia, one of flu's most serious complications, which takes a considerable toll on children," said Dominick Iacuzio, Ph.D., medical director at Roche, which manufactures Tamiflu and commissioned the study. "This study represents an important part of Roche's ongoing research into the most effective use of Tamiflu and its potential benefits in treating influenza and its complications."

Tamiflu is indicated for the treatment and prevention of influenza in adults and in children one year and older. People considered at high risk for pneumonia, which often occurs as a complication of the flu, include the elderly, the very young, and those with underlying health problems.(1) Community-acquired pneumonia is one of the most common serious infections in children, with an annual incidence of 34 to 40 cases per 1,000 children.(2)

About the Study

This retrospective cohort study compared outcomes in patients receiving a prescription for oseltamivir within one day of influenza diagnosis versus those who did not receive antiviral therapy, using health insurance claims data (Thomson Medstat) from 2000-2005 influenza seasons to identify a total of 15,161 patients aged 1-12 years diagnosed with influenza. Primary outcomes included frequency of pneumonia and rates of hospitalization. The occurrence of pneumonia was assessed within 14 days of influenza diagnosis.

Figure 1: Patients with Any Pneumonia Diagnosis* Patients with Any Relative 95% Confidence Relative Age Pneumonia Diagnosis Risk Interval on Risk (years) With No Relative Risk Reduction oseltamivir oseltamivir claim claim 1-2 11/ 24/ .48 .24-.99 52% 1,303 1,379 3-5 16/ 271/ .63 .34-1.18 37% 1,820 1,961 6-12 22/ 45/ .43 .26-.71 57% 4,649 4,049 Total 49/ 340/ (1-12) 7,772 7,389 * Adjusted for baseline patient characteristics Flu's Impact on Children

Influenza is a serious illness that affects up to 40 million Americans every year, leading to approximately 200,000 hospitalizations and 36,000 deaths.(3) It is estimated that children are two to three times more likely than adults to get influenza.(4)

While most healthy people recover from the flu without complications, certain populations (including older people, young children, and people with certain health conditions) are at high risk for serious complications, such as pneumonia.(5,6) According to the National Center for Health Statistics, influenza and pneumonia combined were responsible for more than 65,000 deaths in the U.S. in 2003, making them the seventh leading cause of death.(7)

Role of Antiviral Medications

Prescription antiviral medications like Tamiflu are an important complement to vaccines in the prevention of seasonal influenza. In addition, antiviral medications play a unique role in the treatment of influenza by reducing the duration of illness.

Tamiflu belongs to a class of antiviral medicines called neuraminidase inhibitors (NAI), which help prevent the flu virus from spreading inside the body. Virtually all common flu viruses have the neuraminidase protein on their surface, which enables them to migrate from cell to cell, replicating and spreading throughout the body. Inhibiting the neuraminidase activity is believed to interfere with this process, possibly causing the viruses to become trapped and die out. Tamiflu is given orally and is systemically absorbed, meaning that it can reach all key sites in the body where the virus multiplies.

When taken within 48 hours of symptom onset, research shows Tamiflu can reduce duration of illness by 1.3 days. Clinical trials also indicate that Tamiflu is up to 89 percent effective in preventing flu, when taken within 48 hours of exposure.

About Tamiflu

Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is a systemic treatment for the most common strains of influenza (types A and B). Tamiflu is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have been symptomatic for no more than two days. Tamiflu is also indicated for the prophylaxis of influenza in patients one year and older.

In treatment studies in adult patients, the most frequently reported adverse events (incidence >1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking Tamiflu compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients one to 12 years old, the most frequently reported adverse event (incidence >1%) was vomiting. Other events reported more frequently in patients taking Tamiflu compared with placebo included abdominal pain, epistaxis, ear disorder and conjunctivitis.

In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking Tamiflu compared with placebo (incidence >1%) were nausea, vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a household prophylaxis trial that included patients one to 12 years old, adverse events were consistent with those observed in pediatric treatment studies, with GI events being the most frequently observed.

Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

In post-marketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu.

Tamiflu is available for the treatment of influenza in more than 80 countries worldwide.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com/ or http://www.roche.us/ .

(1) http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=35692 (2) http://www.aafp.org/afp/20040901/899.html (3) http://www.cdc.gov/flu/keyfacts.htm (4) http://www.niaid.nih.gov/factsheets/flu.htm (5) http://www.cdc.gov/flu/symptoms.htm (6) http://www.cdc.gov/flu/about/qa/disease.htm (7) http://www.cdc.gov/nchs/fastats/lcod.htm

Roche

CONTACT: Terence Hurley of Roche, +1-973-562-2882,terence_j.hurley@roche.com; or Sue Preziotti of Fleishman-Hillard for Roche,+1-212-453-2144, preziots@fleishman.com

Source: PRNewswire

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