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

1. Tudorza Pressair®
(aclidinium bromide)
By Katrina Korn
3rd-Year Professional Pharmacy Student
kkorn@purdue.edu

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. Background1,2
 Dry-powder inhaler
 Marketed by Forrest Labs, Inc.
 Indication: FDA-approved in July 2012
for maintenance treatment of COPD
bronchospasms

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. Dosing1
 400 mcg twice daily via oral inhalation
 Each puff delivers 400 mcg of
medicine

6. Side Effects1
 Paradoxical bronchospasm
 Dry mouth
 Constipation
 Worsening narrow-angle glaucoma
 Worsening urinary retention

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. 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. 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. 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
both
Disadvantage 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. 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. 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. References
1. 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-week
treatment with twice-daily aclidinium bromide in COPD patients. (ACCORD
COPD 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-daily
aclidinium bromide in COPD patients: The ATTAIN study. [abstract]. Eur Respir J
2012 Mar 22. [Epub ahead of print].
<http://www.ncbi.nlm.nih.gov.ezproxy.lib.purdue.edu/pubmed?term=efficacy%20
of%20aclidinium%20bromide%2024-week>. Accessed September 15, 2012.
PMID: 22441743.
5. Fuhr R, Magnussen H, Sarem K, et al. Efficacy of aclidinium bromide 400 μg
twice daily compared with placebo and tiotropium in patients with moderate to
severe COPD. [abstract]. Chest 2012 Mar;141(3):745-52.
<http://www.ncbi.nlm.nih.gov.ezproxy.lib.purdue.edu/pubmed/21903737>.

14. Questions?