Clinical Question

In adults with stable chronic obstructive pulmonary disease (COPD), does aclidinium (Tudorza Pressair) decrease exacerbations and mortality or improve quality of life?

Evidence-Based Answer

Aclidinium did not decrease all-cause mortality or exacerbations requiring oral steroids, antibiotics, or both. However, aclidinium decreased the number of patients with exacerbations requiring hospitalization and improved quality of life in those with stable COPD. (Strength of Recommendation: A, based on consistent, good-quality patient-oriented evidence.)

Practice Pointers

COPD is the third leading cause of death in the United States after cardiovascular disease and malignancy.¹ COPD costs $30 billion in direct expenditures and $20 billion in indirect expenditures, such as those associated with work absenteeism and disability.² As a mainstay of therapy, long-acting bronchodilators are recommended for the treatment of patients with significant symptoms or at high risk of exacerbations.³ The authors looked at the use of aclidinium, an M3 muscarinic receptor–selective, long-acting anticholinergic medication, for the treatment of patients with COPD.

This Cochrane review included 12 randomized controlled trials with 9,547 patients who had stable COPD. Aclidinium did not impact all-cause mortality when compared with placebo (odds ratio [OR] = 0.92; 95% confidence interval [CI], 0.43 to 1.94), nor did it decrease the incidence of exacerbations requiring steroids, antibiotics, or both (OR = 0.88; 95% CI, 0.74 to 1.04). Aclidinium was associated with fewer exacerbation-related hospitalizations (OR = 0.64; 95% CI, 0.46 to 0.88; number needed to treat [NNT] = 77; 95% CI, 51 to 233) over the length of the studies (from four to 52 weeks). More patients taking aclidinium reported a clinically significant improvement in quality of life when compared with placebo (OR = 1.49; 95% CI, 1.31 to 1.70; NNT = 10; 95% CI, 8 to 15), and more patients reported an improvement in dyspnea (OR = 1.73; 95% CI, 1.52 to 1.98). Serious adverse events were similar between aclidinium and placebo (OR = 0.89; 95% CI, 0.70 to 1.14). Fewer people in the aclidinium group withdrew because of a lack of effectiveness (OR = 0.31; 95% CI, 0.23 to 0.43), although aclidinium was associated with increased reports of diarrhea (OR = 2.32; 95% CI, 1.14 to 4.74).

Aclidinium was also compared with tiotropium (Spiriva), another long-acting muscarinic antagonist. There were no deaths in the head-to-head trials, no statistically significant difference in exacerbations requiring steroids or antibiotics, and no difference in exacerbations requiring hospitalization. No differences were noted in nonfatal serious adverse events between the two medications. Aclidinium is dosed twice daily, whereas tiotropium is given once daily.

The Global Initiative for Chronic Obstructive Lung Disease recommends smoking cessation, physical activity, and influenza and pneumococcal vaccination for all patients with COPD.³ Pharmacotherapy is recommended to reduce symptoms and improve exercise tolerance.³ As with other long-acting muscarinics, aclidinium is a well-tolerated option for the pharmacologic management of persons with COPD who experience significant symptoms or are at high risk of exacerbations.