New Study Shows Significant Improvements in Health-Related Quality-of-Life Measures in Chronic Obstructive Pulmonary Disease Patients Using SPIRIVA(R) HandiHaler(R)
Posted on: Monday, 23 May 2005, 18:00 CDT
SAN DIEGO, May 23 /PRNewswire/ -- According to study data presented today at the International Conference of the American Thoracic Society, patients with chronic obstructive pulmonary disease (COPD) experienced significant improvements in health-related quality-of-life measures after nine months of treatment with tiotropium bromide inhalation powder (SPIRIVA(R) HandiHaler(R)), a once-daily inhaled anticholinergic agent.(1) SPIRIVA(R) is indicated for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.
The study, a nine-month randomized, double-blind, placebo-controlled trial known as TIPHON, was conducted to evaluate the effects of tiotropium on health-related quality-of-life measurements in patients with COPD, a progressive airway disease characterized by loss of lung function over time.
The primary instrument used to evaluate study participants was their response to the Saint George's Respiratory Questionnaire (SGRQ), a tool used to assess health-related quality-of-life (HRQoL). The questionnaire consists of three components: social, physical and psychological, which are weighted on a scale of 0 to 100 (100 representing the worst possible state by the patient).(2) The SGRQ measures were considered significantly improved in patients who showed more than four points improvement at the study's conclusion.
Other instruments used to evaluate patients included their responses to the visual simplified respiratory questionnaires (VSRQ), examination by a physician, and measures of lung function such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), inspiratory capacity (IC), slow vital capacity (SVC), and forced inspiratory volume in one second (FIV1).
"Chronic obstructive pulmonary disease is a slowly progressive disease that is associated with significant disability," said Andre-Bernard Tonnel, MD, Service de Pneumologie et Immuno-Allergologie Centre Hospitalier Regional et Universitaire de Lille Boulevard J. Leclercq, Lille, France. "The TIPHON study results are encouraging because they show that Spiriva provides clinically significant improvements in health-related quality-of-life measures for patients with COPD."
The TIPHON study evaluated 554 COPD patients who were randomly assigned to either tiotropium or placebo. At the ninth month, 59.1 percent of the patients receiving tiotropium showed more than four points improvement on the SGRQ, compared with 48.2 percent of those on placebo. The group on tiotropium also had a higher mean VSRQ score than the placebo group. Additionally, the tiotropium group showed significant improvements in lung function as compared with the placebo group, shown in all measures of lung function.
The incidence of adverse events in the tiotropium group was similar to the placebo group.
About COPD
COPD is a slowly progressive disease of the airways that is characterized by a loss of lung function over time.(3) The symptoms that patients may experience include chronic cough, excess mucus production, wheezing and shortness of breath even after mild exertion or at rest.(3) COPD is often associated with exacerbations of these symptoms, which can account for a high proportion of health care costs associated with this disease.(3) COPD is primarily caused by cigarette smoking.(3) Other causes of the disease include exposure to industrial dusts and chemicals.(2) An estimated 24 million adults in the United States have COPD, but only about 10 million have been diagnosed. Globally, this disabling disease is the fourth leading cause of death, claiming more than 2.7 million lives annually.(4)
About SPIRIVA
SPIRIVA is indicated for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA is not indicated for rescue therapy and is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product. The most common adverse reaction was dry mouth, which was usually mild and often resolved during treatment.(5) Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention.
Please see http://www.spiriva.com/ for full prescribing information.
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2004, Boehringer Ingelheim posted net sales of US $10.2 billion (8.2 billion euro) while spending nearly one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit http://us.boehringer-ingelheim.com/
Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products. For further information on Pfizer, please see http://www.pfizer.com/ .
References
(1) Tonnel AB, Bravo M-L, Brun M. Clinically significant improvements of
health status of COPD patients after 9 months treatment with
tiotropium bromide: the TIPHON study. Abstract presented at ATS 2005,
San Diego, California. May 20-25, 2005.
(2) Kugler, Christiane. Quality of life one year after lung
transplantation. Progress in Transplantation. December 1, 2004.
(3) National Heart, Lung, and Blood Institute. Data Fact Sheet: Chronic
Obstructive Pulmonary Disease (COPD).
(4) World Health Organization. World health report 2003. Statistical
Annex. Annex table 2: 154-159.
(5) Spiriva HandiHaler (tiotropium bromide inhalation powder) Prescribing
Information. Boehringer Ingelheim and Pfizer 2004. Available at
http://www.spiriva.com/.
Boehringer Ingelheim Pharmaceuticals, Inc.
Lara Crissey
203-798-4740 (office)
203-482-4073 (mobile)
Pfizer Inc
Paul Ewing
212-733-0179 (office)
917-715-1547 (mobile)
Boehringer Ingelheim Pharmaceuticals, Inc.
CONTACT: Lara Crissey of Boehringer Ingelheim Pharmaceuticals, Inc.,+1-203-798-4740 (office), +1-203-482-4073 (mobile); or Paul Ewing of PfizerInc, +1-212-733-0179 (office), or +1-917-715-1547 (mobile)
Web site: http://us.boehringer-ingelheim.com/http://www.spiriva.com/
Source: PRNewswire
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