New Data on Tiotropium show major treatment benefits in COPD (Chronic Obstructive Pulmonary Disease)

31  August 2000

Florence, Italy, 31st August 2000: New data presented today at the World Congress on Lung Health and 10th European Respiratory Society (ERS) Annual Congress show that tiotropium, the world’s first once-daily inhaled bronchodilator, is effective in improving key clinical and health outcomes in chronic obstructive pulmonary disease (COPD). Tiotropium, a product of original research from Boehringer Ingelheim, is in its late stages of development and has been profiled specifically for the treatment of COPD.

COPD is a chronic respiratory disorder characterised by airflow limitation, accompanied by symptoms such as shortness of breath, cough, wheezing and increased sputum production. Its main cause is smoking. COPD results in disability and limitations in performing daily activities. Exacerbations of COPD represent a marked worsening in symptoms necessitating increased therapy and often hospitalisation. As well as increasing the burden of the disease on the patient, exacerbations are associated with an increase in the use of healthcare resources. These symptoms can contribute to the decline in the patient’s quality of life.

The goals of effective COPD management are to promote smoking cessation, optimise lung function, improve symptoms, reduce exacerbations and improve the patient’s quality of life.

"We are convinced that with Spiriva® we have a very effective drug to treat patients suffering from COPD. In light of these exciting data, Boehringer Ingelheim has initiated an extensive pulmonary clinical research program. We are convinced that tiotropium will become the gold standard of COPD treatment in the near future", said Dr Andreas Barner, member of the Board of Managing Directors of Boehringer Ingelheim, responsible for Research, Development and Medicine.

Tiotropium is an effective, well-tolerated bronchodilator over 24 hours
In four, one-year studies, tiotropium significantly improved lung function versus placebo, and ipratropium, currently recommended as a first line maintenance therapy in many COPD treatment guidelines. These improvements in lung function were maintained over the one year treatment period. A common measure of lung function is forced expiratory volume in one second (FEV1), which evaluates the amount of air patients can exhale in one second. Tiotropium improved the six-hour average of FEV1 by 21 % versus placebo, and 24 hours after dosing there was still sustained improvement of 15 %. Tiotropium’s once-daily dosing profile can be important in aiding compliance, particularly with elderly patients. It is well tolerated, with dryness of the mouth being the most frequently reported adverse event, occurring in approximately 15% of patients, the vast majority describing this as mild.

Tiotropium is effective at reducing patient’s breathlessness
Dyspnea, the perception of breathlessness, is a distressing symptom of COPD, and most often results in initial presentation to the physician. Throughout the trials, tiotropium provided statistical and clinically meaningful reductions in shortness of breath, based on activities of daily living. Results were measured by the Baseline Dyspnea Index (BDI) and Transitional Dyspnea Index (TDI).

Tiotropium is effective at reducing exacerbations and hospitalisations
Tiotropium has a positive and substantial effect on exacerbations in patients with COPD. Preliminary data from the abstracts presented at the ERS describe that patients receiving tiotropium experienced a reduction in the incidence of exacerbations of about 22% versus comparators. This significant improvement, less hospital admissions, as well as a delay in the time to first exacerbation and hospitalisation are clinically proven. In addition, the length of hospital stay was reduced over the one year trial.

Tiotropium is effective at improving patients’ quality of life
Once-daily tiotropium has been shown to produce significant and sustained improvements in lung function and is associated with clinically meaningful improvements from baseline health-related quality of life (HR-QoL). The St.George’s Respiratory Questionnaire (SGRQ) was used to measure results.

“The results from the tiotropium development programme are very exciting, indicating that this new treatment can be a very effective therapy in patients with COPD,” said Dr Bartolome R Celli from St Elizabeth’s Medical Center, Tufts University in Boston Massachusetts, USA. “Based on this research, tiotropium holds significant promise for the future treatment of COPD,” he added.

Boehringer Ingelheim
Boehringer Ingelheim has for a long time been in the forefront of treatment and research of COPD with its inhaled anticholinergic bronchodilators, which are recommended in the first-line of maintenance treatment for COPD by many guidelines. As COPD is underdiagnosed and undertreated, Boehringer Ingelheim has, campaigned to raise awareness and understanding of COPD worldwide. It has widely supported COPD research, development and implementation of COPD guidelines, patient and medical education in COPD, public awareness campaigns for COPD etc. An important feature of these activities has been close partnership with healthcare organisations.

The Boehringer Ingelheim group of companies, with headquarters in Ingelheim (Germany) is one of the 20 leading pharmaceutical firms in the world and reported revenues of almost DEM 10 billion in 1999.

Boehringer Ingelheim has world-wide some 140 affiliated companies. The focus is on the human pharmaceutical as well as on the animal health business. The human pharmaceutical business which is responsible for 92% of sales, includes mainly prescription medicines and products for consumer health care but also for industrial customers (chemicals and biopharmaceuticals).

Substantial research and development, production, and distribution facilities are located around the globe. In 1999 Boehringer Ingelheim spent DEM 1.6 billion on R&D, equivalent to 16% of total sales.

For more information on Boehringer Ingelheim please see also the Internet website www.boehringer-ingelheim.com