麻豆传媒

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SAN DIEGO -- Tiotropium (Spiriva) Respimat improved lung function and cut exacerbations in severe asthma patients who had already maxed out other treatment options, pooled analysis of two phase III trials showed.

Tiotropium cut severe exacerbations only in the heavily-treated group on a leukotriene modifier in addition to high-dose inhaled corticosteroids and long-acting beta₂ agonist (LABA), , of Denmark's Odense University Hospital, and colleagues found.

The hazard ratio was 0.58 for time to first event (95% CI 0.62-0.90), they reported here at the American Academy of Allergy, Asthma, and Immunology meeting.

Cutting exacerbations in this tough but all-too-common scenario is "holy grail stuff," , of Rutgers New Jersey Medical School in Newark, commented in an interview with 麻豆传媒.

"For a while, we believed that tiotropium would not do as well as beta agonists, but what we're seeing in patients is that LAMAs [long-acting muscarinic antagonists] may play a role," he said. "The real question that's still unanswered ... is there a specific phenotype; is there a specific group of patients that we're not achieving goals with present regimens for whom this may be of greater effect?"

The trials met primary endpoints of improvement in forced expiratory volume in 1 second (FEV₁) over baseline at both peak and trough concentrations of the LAMA, without a difference by whether patients were on a leukotriene modifier.

The adjusted mean gain from baseline to 24 weeks was 103 mL in those on versus 111 mL in those off a leukotriene modifier (P=0.5747 for interaction).

Asthma worsening was reduced across the board on tiotropium, but it again showed the most significant benefit in the most heavily-treated group on a leukotriene modifier (HR 0.54, 95% CI 0.37-0.77).

The two pooled trials included 205 patients on a leukotriene modifier among the 912 severe asthma patients on at least inhaled corticosteroids and a LABA as background medication, continued after randomization to tiotropium or placebo for 48 weeks.

A few studies have explored anticholinergics like tiotropium in severe asthma, but guidelines haven't been swayed, commented , director of the asthma program at National Jewish Health in Denver.

He predicted that this type of study would support the addition of tiotropium as add-on therapy in future guidelines.

He called the safety findings in the study generally reassuring, though acknowledging the debate about Respimat safety compared with the older Handihaler inhaler for tiotropium.

Other pooled analyses presented at the meeting suggested generally similar efficacy in symptomatic moderate asthma between tiotropium and the LAMA salmeterol (Serevent) as add-on therapy to inhaled corticosteroids and efficacy compared with placebo as add-on to inhaled corticosteroids in mild asthma.