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Tiotropium Reduces Effects of Chronic Obstructive Pulmonary Disease: Presented at ERS

By Cameron Johnston

Special to DG New

BERLIN, GERMANY -- September 24, 2001 -- Use of tiotropium bromide in addition to standard therapy, beta adrenergic agonists and inhaled corticosteroids, reduces hospitalization rates, length of hospital stays, and overall hospitalization resource costs in patients with chronic obstructive pulmonary disease.

Tiotropium also seems to offer an improvement in forced expiratory volume in one second (FEV₁) which might be a first, since few drugs currently used to treat chronic obstructive pulmonary disease (COPD) either stop the decline in lung function or offer any improvement. The disease is, or the most part, considered irreversible.

Tiotropium is a once daily, inhaled anticholinergic that provides sustained bronchodilation due to prolonged M3 receptor antagonism.

In a presentation yesterday (September 23) at the annual meeting of the European Respiratory Society, in Berlin, Germany, Dr. Theodore Witek, a research scientist with Boehringer Ingelheim, in Bracknell, England, outlined the results of two identical studies in which patients who added tiotropium to their existing therapy of theophylline, beta₂ blocking agents and either oral or inhaled corticosteroids.

American Food and Drug Administration requirements demand at least two controlled studies before a drug can be approved for use in the United States.

Over the course of the one-year study, 543 patients received either tiotropium 18 µg once daily (via the HandiHaler) plus their existing treatment, or placebo (n=371) plus existing treatment.

All healthcare costs incurred during each scheduled doctor's visit during the trial were recorded, while hospital costs were estimated based on Health Care Cost and Utilization Project, which is a nationwide inpatient database.

It was found that patients taking tiotropium plus their existing therapy reduced their daily dosing of existing medications by as much as 2.8 doses per day near the start of the trial, and though it increased over the course of the year, it did not reach baseline again.

There was a 20 percent decrease in the number of exacerbations between the two groups, from 0.76 exacerbations per year to 0.95 exacerbations per year). Similarly there was a difference in the number of hospitalization days between groups, from a mean of 1.17 days in the placebo group to 0.59 days in the study group - a reduction of 49 percent.

The reduction in exacerbations and hospitalization costs represented a saving to the US-healthcare system of $1043 per patient over the course of the year, Dr. Witek said. This figure was arrived at by calculating the cost of tiotropium, plus existing therapy, compared with the cost of existing therapy, plus placebo.

"It is those fewer hospitalizations that drive hospital costs," Dr. Witek said.

Many patients also experienced an increase in FEV₁ and if this can be repeated in other trials, would make tiotropium possibly the first drug to reverse, if not halt, the loss in lung function that people with COPD ultimately experience.

Besides the reduction in number of exacerbations for the condition, or the improvement in lung function and the improved health status, tiotropium has the potential to reduce the economic burden of COPD, which was pegged by health economists at $14 billion for 1993 - and doubtless will cost the healthcare system considerably more than that in 2001.

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