Tudorza Pressair® (Aclidinium Bromide)


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Drug topic overview of aclidinium, a new drug approved in July of 2012 presented to pharmacy classmates September 2012

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Tudorza Pressair® (Aclidinium Bromide)

  1. 1. Tudorza Pressair® (aclidinium bromide)By Katrina Korn3rd-Year Professional Pharmacy Studentkkorn@purdue.edu
  2. 2. Learning Objectives State the mechanism of action for Tudorza Pressair® (aclidinium bromide) Provide information on indication, dosing and side effects for aclidinium to patients and professionals Discuss advantages and disadvantages of aclidinium with reference to clinical trials results Formulate an opinion regarding this drug’s impact on clinical practice. List important patient counseling points for aclidinium
  3. 3. Background1,2 Dry-powder inhaler Marketed by Forrest Labs, Inc. Indication: FDA-approved in July 2012 for maintenance treatment of COPD bronchospasms
  4. 4. Mechanism of Action1,2 Reversible, long-acting muscarinic antagonist (anticholinergic) Blocks M3 receptors in bronchiolar smooth muscle Leads to enhanced bronchodilation Decreased bronchospasms
  5. 5. Dosing1 400 mcg twice daily via oral inhalation Each puff delivers 400 mcg of medicine
  6. 6. Side Effects1 Paradoxical bronchospasm Dry mouth Constipation Worsening narrow-angle glaucoma Worsening urinary retention
  7. 7. ACCORD COPD 13 Phase III, 12-week, double- blind, randomized multicenter clinical trial Compared twice-daily 200 mcg aclidinium, daily 400 mcg aclidinium, and placebo Outcomes: change from baseline in trough FEV1, COPD symptoms Results: both active groups showed improvement in FEV1, similar adverse events compared to placebo Comments: mean age 64 years, smoking status unknown, longer studies needed
  8. 8. ATTAIN4 24-week, double-blind, placebo-controlled trial Compared twice-daily 200 mcg aclidinium vs. twice-daily 400 mcg aclidinium vs. placebo Outcomes: mean change in trough FEV1, COPD symptoms Significant improvement in FEV1 and symptoms compared to placebo SE were low and similar to placebo for both groups Comments: Smoking status unknown, not comparative
  9. 9. Clinical trial comparing Spiriva®(tiotropium) to aclidinium5 Phase IIa randomized, double-blind, double- dummy crossover trial Tiotropium 18 mcg vs. aclidinium 400 mcg vs. placebo 15-day trial Outcomes included change in peak FEV1 and change in FEV1 AUC Showed greater improvement in FEV1 AUC values for aclidinium over tiotropium COPD symptom scores improved with aclidinium but not tiotropium Comments: short, small study, symptom scoring system unknown, FEV1 AUC not standard
  10. 10. Clinical trial comparing Spiriva® to aclidinium2,3,4,5 aclidinium Spiriva® ipratropium Advantages Improved FEV1 more studies, Cost, well- over Spiriva, currently first- studied and lower line long-acting characterized, incidence of cholinergic available in Anticholinergic antagonist for combination with side effects COPD, once albuterol compared to daily dosing bothDisadvantage cost ($261 for more anticholinergic s one device), anticholinergic side effects, four twice daily side effects times daily dosing, 400 compared to dosing mcg twice daily aclidinium vs. 18 mcg once daily for
  11. 11. Impact on Practice Currently would argue against formulary so it is not used as first-line agent Consider using in patients who are on combo therapy including corticosteroids who are not experiencing relief Consider using in patients who cannot tolerate anticholinergic side effects High cost, generic a possibility
  12. 12. Patient Counseling1 Inhalation technique – dry-powder inhaler Dose counter decreases by ten Not a rescue inhaler – use twice every day Smoking cessation Difficult urination, blurry vision, bronchospasm Discard after 45 days Pregnancy category C
  13. 13. References1. CenterWatch. Drug Information. Available at:http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1211. Accessed September 13, 2012.2. TUDORZA PRESSAIR®. [package insert]. St. Louis, MO: Forrest Labs, Inc. ;2012.3. Kerwin EM, D’Urzo AD, Gelb AF, et al. Efficacy and safety of a twelve-weektreatment with twice-daily aclidinium bromide in COPD patients. (ACCORDCOPD 1). [abstract]. COPD 2012 Apr;9(2):90-101.<http://www.ncbi.nlm.nih.gov.ezproxy.lib.purdue.edu/pubmed/2232014>.Accessed September 15, 2012. PMID:22320148.4. Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of twice-dailyaclidinium bromide in COPD patients: The ATTAIN study. [abstract]. Eur Respir J2012 Mar 22. [Epub ahead of print].<http://www.ncbi.nlm.nih.gov.ezproxy.lib.purdue.edu/pubmed?term=efficacy%20of%20aclidinium%20bromide%2024-week>. Accessed September 15, 2012.PMID: 22441743.5. Fuhr R, Magnussen H, Sarem K, et al. Efficacy of aclidinium bromide 400 μgtwice daily compared with placebo and tiotropium in patients with moderate tosevere COPD. [abstract]. Chest 2012 Mar;141(3):745-52.<http://www.ncbi.nlm.nih.gov.ezproxy.lib.purdue.edu/pubmed/21903737>.
  14. 14. Questions?