News Release

Patients with COPD may be missing out on appropriate treatment because of incorrect or no diagnosis

Peer-Reviewed Publication

Shire Health International

GLASGOW, UNITED KINGDOM, Tuesday 7 September – Patients with Chronic Obstructive Pulmonary Disease (COPD) are frequently misdiagnosed or remain undiagnosed, and may therefore be missing out on appropriate treatment, according to the results of a primary care study presented today at the annual European Respiratory Society (ERS) meeting in Glasgow, Scotland.1

COPD is a progressive respiratory disease that causes significant deterioration of lung function and chronic breathlessness that can lead to severe disability.2 Limited airflow associated with COPD leads to excess air being trapped in the lungs after a person has exhaled. This condition, known as "air trapping", is a primary cause of breathlessness, which often restricts a person's ability to perform daily activities such as walking up stairs or taking a shower.3,4

Although COPD is the fourth leading cause of death worldwide, claiming 2.75 million lives annually,5 it is estimated that up to 75% of patients in Europe6 and 50% in the United States are undiagnosed.7 Results of the study presented today at the ERS congress showed that more than half of those affected with COPD may first be incorrectly diagnosed with asthma by their primary care physician.1

"The level of misdiagnosis and under diagnosis seen in this study is very concerning," said Professor David Price, Chair of Primary Care, Respiratory, University of Aberdeen, UK, and principal study investigator. "Although recent guidelines for COPD emphasise the importance of accurate diagnosis, this has been challenging in primary care. There has been varied evidence for COPD signs and symptoms, and insufficient tools to make an accurate diagnosis. As a result, patients are suffering unnecessarily because they're not receiving appropriate treatment."

The study presented at ERS enrolled 597 patients recruited from primary care practices in the UK and US aged 40 years or older with prior diagnoses or medications consistent with obstructive lung disease, but not previously diagnosed with COPD.1 Patients were given a study diagnosis based on spirometry.

Approximately 40% of patients in the study were found to have COPD.1 Of these:

  • 51.5% reported a prior diagnosis of asthma only1
  • 10.6% reported no prior diagnosis of obstructive lung disease1
  • 37.9% reported a prior diagnosis of COPD component diseases (chronic bronchitis or emphysema).1

Among those COPD sufferers originally misdiagnosed with asthma, or with no prior diagnosis of obstructive lung disease, only 3.5% were receiving anticholinergic treatments,1 which together with beta-agonists are central to the symptomatic management of COPD.8

"It's time for primary care professionals to re-think their approach to COPD to ensure patients receive an early, correct diagnosis and appropriate, effective treatment. Early intervention with smoking cessation therapy may slow disease progression, and appropriate medical therapy may slow the deterioration in patient quality of life seen with COPD," Professor Price said.

Additional study results presented at ERS showed that diagnosis of COPD in 'at risk' groups (smokers and ex-smokers over 40 years of age) could be vastly improved if patients were asked a few symptom-based diagnostic questions to assess their lung health.9 If these questions were used for screening purposes in a primary care practice setting, testing 1000 people at high risk would lead to 297 spirometric examinations and 110 new diagnoses of COPD.9

"This simple questionnaire promises to be a cost-effective means of improving diagnosis rates, and thus appropriate management of one of the most common, debilitating and costly conditions seen in primary care," Professor Price said.

###
About SPIRIVA® (tiotropium)
SPIRIVA®, a novel, inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. SPIRIVA® works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction. SPIRIVA® helps COPD patients breathe more easily by opening narrowed airways and helping to keep them open for 24 hours. According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting bronchodilators, including tiotropium, are a preferred treatment option for COPD maintenance therapy.

The SPIRIVA® clinical trials programme has recruited over 9,400 patients.10 SPIRIVA® has demonstrated significant and sustained bronchodilation (expansion of the lungs airways). 11-13 SPIRIVA® also demonstrated improvements in lung function (FEV1) vs ATROVENT® (ipratropium bromide inhalation aerosol), a current first-line therapy for COPD, which were maintained over one year.11,12 In addition, in one-year, placebo-controlled studies, patients treated with SPIRIVA® required fewer doses of rescue medications.13

In clinical trials, the most common adverse reaction reported with SPIRIVA® was dry mouth, which was usually mild and often resolved during treatment.11,13

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 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 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro while spending more than one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit www.boehringer-ingelheim.com

About 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 www.pfizer.com

Contact:

Boehringer Ingelheim GmbH
Judith von Gordon
Corporate Division Communications
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132 77 35 82
Pfizer Inc
Mariann Caprino
Corporate Media Relations
235 E. 42nd St.
New York, N.Y. 10017USA
Phone: +1/212 733-4554

References

1. Tinkelman DG, Price D, Nordyke RJ, et al. Misdiagnosis of COPD in primary care. Abstract presented at ERS 2004, Glasgow, Scotland. 4-8 September 2004.
2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease: NHLBI/WHO Workshop Report . National Institute of Health; 2001. NIH Publication No. 2701 Available at http://www.goldcopd.com.
3. Celli B, Zu, Wallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003;#124:1743-1748.
4. Mahler DA. How should health related quality of life be assessed in patients with COPD? Chest 2000; 117:54 S-57S.
5. World Health Organization. World Health Report 2003. Statistical Annex. Annex table 2:154-159.
6. Rudolf M. The reality of drug use in COPD. Chest 2000; 117:29S-32S.
7. Centers for Disease Control and Prevention. Surveillance Summaries, August 2, 2002. MMWR 2002:51 (No SS-6); 1
8. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO workshop report. Bethesda, National Heart, Lung and Blood Institute, April 2001; Update of the Management Sections, GOLD website (http://www.goldcopd.com). Date updated: July 2003.
9. Price D, Tinkelman DG, Nordyke RJ, et al. Underdiagnosis of COPD and impact of a new diagnostic questionnaire. Abstract presented at ERS 2004, Glasgow, Scotland. 4-8 September 2004.
10. Boehringer Ingelheim. Data on file.
11. Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. European Respiratory Journal 2002; 19:209-216.
12. Van Noord JA, Smeets JJ, Custers FJL, et al. Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease. European Respiratory Journal 2002; 19:639-644.
13. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. European Respiratory Journal 2002; 19:217-224.


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