Source: Annual Congress 2002 - Prevalence and costs of COPD
Disease area: Airway diseases

Abstract

A number of Phase III trials are normally performed to evaluate the safety and efficacy of a new drug. Because these trials are conducted under controlled conditions and may differ in design, setting and comparators, the results of these trials cannot be compared without reservation. Modeling can help to combine results from different trials. A 1-year Markov model was developed to combine the results of different trials of tiotropium [TIO(SPIRIVA®)] in patients with COPD. Markov states were defined on the basis of COPD severity classified according to the GOLD guidelines. Transition and exacerbation probabilities were derived from trials performed in Europe, North America and Australia comparing TIO to ipratropium (IB) or salmeterol (SAL). The division of patient disease state at baseline and after 1 year were:

	Baseline	Disease state after 1 year
	Division	TIO	IB	SAL
Moderate A	25%	32%	15%	23%
Moderate B	50%	47%	49%	40%
Severe	25%	21%	36%	37%

The number of exacerbations over 1 year was 0.90, 1.21 and 1.07.for the TIO, IB and SAL groups, respectively. Validation showed the model reproduced the results of the individual trials. The difference between treatment groups could be modeled by classification of patients into disease severity states, the monthly transition probabilities between states and probability of experiencing an exacerbation associated with each state. The better outcomes for patients on TIO, than on the active comparators, are consistent with the findings of the individual trial analyses.

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J. B. Oostenbrink, M. P. M. H. Rutten-van Molken, S. Anton, P. Koch (Rotterdam, The Netherlands; Ridgefield, United States Of America; Ingelheim, Germany). A Markov model based on COPD disease severity to analyse the results from tiotropium trials. Eur Respir J 2002; 20: Suppl. 38, 833

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