Following the introduction of salmeterol in the United Kingdom, three cases of respiratory arrest occurring shortly after patients had been commenced on the drug were reported. 11 At the same time, the United Kingdom Committee on the Safety of Medicines reported 26 cases of deterioration in asthma soon after the introduction of long-acting beta-agonists. 12 Withdrawal of the drug resulted in improvement. Like the cases recorded in New Zealand, such events appear to be sporadic and rare but nevertheless cause concern. They appear to follow a pattern but do not lend themselves easily to explanation either in terms of paradoxical bronchospasm or the advent of tolerance .
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of AirDuo™ RespiClick® and its Authorized Generic, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
Patients in GOLD groups C and D should be prescribed a long-acting anticholinergic or a combination of an inhaled corticosteroid and long-acting beta 2 agonist. 3 Compared with tiotropium alone, fluticasone/salmeterol (Advair) improved daily symptom scores and decreased mortality (number needed to treat = 40), but increased the incidence of pneumonia (number needed to harm = 25) and did not change the rate of exacerbations. 33 Patients with poorly controlled symptoms should start triple therapy with an inhaled corticosteroid, long-acting anticholinergic, and long-acting beta 2 agonist. The data for triple therapy are inconsistent, with studies showing improvement in lung function and symptom scores but conflicting results regarding reduction in exacerbation rates compared with tiotropium alone. 28 , 34 A summary of initial treatment options and common medications is presented in Table 4 8 and Table 5 , 35 and patient instructions for inhaler use are reviewed in eFigure B .