The Safety of Tiotropium — The FDA's Conclusions

Usage of inhalation devices in asthma and chronic obstructive pulmonary disease: a Delphi consensus statement

“…In previous studies, ID switches have been associated with reduced disease control, and healthcare professionals have suggested that patients should be involved in the choice of their ID [24][25][26][27][28]. Moreover, the US FDA recently pointed to significant safety problems related to the use of different IDs for the same drug [5]. There was also a good consensus against the choice of the least costly ID, provided that there was a technical difference, in particular when the choice was made by pharmacists.…”

“…What is the potential impact of ID switching and who should initiate the switching procedure? The consideration of these questions is important because incorrect treatment delivery may adversely affect the benefits gained from the therapy [2][3][4], dramatically change the side effects [5] and induce substantial cost increases associated with asthma and COPD [6,7].…”

Chronic Obstructive Pulmonary Disease: Official diagnosis and treatment guidelines of the Czech Pneumological and Phthisiological Society; a novel phenotypic approach to COPD with patient-oriented care

“…Available treatment guidelines describe the use of long-acting inhalation drugs (twice daily: long-acting muscarinic antagonist (LAMA) -aclidinium, long-acting beta2-adrenoreceptor agonist (LABA) -formoterol, salmeterol and once daily: ultra-long-acting muscarinic antagonist (U-LAMA) -tiotropium, glycopyrronium, umeclidinium and ultralong-acting beta2-adrenoreceptor agonist (U-LABA) -indacaterol, olodaterol, vilanterol) in symptomatic patients with post-BD FEV 1 60-80% of the predicted value, and these are highly recommended in symptomatic patients with post-BD FEV 1 <60% of the predicted value 1 . The choice of specific agent depends on the physician, or patient's preference 1,2,4,58,59, [64][65][66][67][68][69][70][71][72][73] .…”

Meta-analysis and moderation

“…At an FDA advisory committee meeting convened in 2009 to discuss the disparities between the conclusions of the two studies, it was almost unanimously voted that the UPLIFT study addressed the potential cardiovascular risk concerns for tiotropium 3 . In addition to the strength of the design of the UPLIFT study, a number of important limitations of the meta-analysis, including potentially biased study selection and the combination of long-acting and short-acting anticholinergic agents in the main analysis, were highlighted 3 .…”

“…Indeed, as the FDA authors note, the publication of such meta-analyses commonly results in urgent calls for regulatory action, without acknowledgement of potential pitfalls in the interpretation of data from such studies 3 . Heeding their conclusion 3 -"We must use measured restraint during our evaluations to ensure that safe drugs remain on the market and that their use is not restricted in a way that unnecessarily denies beneficial interventions to patients who need them" -should be a high priority.…”