STEPS

Tiotropium (Spiriva) for COPD



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Am Fam Physician. 2004 Jun 15;69(12):2901-2902.

Synopsis: Tiotropium (Spiriva) is a long-acting, anticholinergic bronchodilator for the long-term, once-daily, maintenance treatment of bronchospasm and dyspnea associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.1 It will be an option for symptom control and an alternative to ipratropium or salmeterol, or in addition to the latter.

Name Starting dosage Dose form Approximate monthly cost*

Tiotropium (Spiriva)

18 mcg inhaled daily

18 mcg dose using HandiHaler device

$117*


*—Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2003.

Name Starting dosage Dose form Approximate monthly cost*

Tiotropium (Spiriva)

18 mcg inhaled daily

18 mcg dose using HandiHaler device

$117*


*—Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2003.

Safety: No safety issues have been identified with tiotropium at this time.1

Tolerability: Side effects reported with tiotropium are similar to those reported with ipratropium and salmeterol.1 Based on pooled rates, dry mouth was more common with tiotropium than placebo (16 percent versus 2.7 percent), ipratropium (12.1 percent versus 6.1 percent), and salmeterol (8.2 percent versus 1.7 percent).2 Pooled dropout rates are similar to placebo and ipratropium.

Effectiveness: In limited research published to date, tiotropium is at least as effective as ipratropium and salmeterol in relieving symptoms. The Transition Dyspnea Index (TDI) was used in clinical trials to assess tiotropium’s efficacy in treating dyspnea. Patients were asked about their sensation of dyspnea in three areas: functional impairment, magnitude of task needed to evoke dyspnea, and magnitude of effort needed to evoke dyspnea. Clinically significant improvements in TDI scores were seen in 31 percent of patients using tiotropium compared with 18 percent of patients using ipratropium (P = .004, NNT: 8).4 The incidence of COPD exacerbations was lower in the tiotropium group compared with the ipratropium group (35 percent versus 46 percent, P = .014, NNT: 9).3 Compared with salmeterol, tiotropium improved TDI scores and showed equal efficacy in decreasing COPD exacerebations.4 Patients taking tiotropium had borderline improvements in health-related quality of life.5 It also decreases albuterol use, increases mean trough one-second forced expiratory volume(FEV1), and reduces hospitalizations to a similar extent as ipratropium.3

Price: The cost of tiotropium is $117.12. Cost for a one-month supply of ipratropium MDI (Atrovent) is $46.77, salmeterol (Serevent) is $74.29 to $79.99 (MDI), and $76.97 (Diskus).

Simplicity: The standard dosage of tiotropium is 18 mcg tiotropium once daily for maintenance therapy. Each dry power capsule contains 18 mcg and is administered by oral inhalation using the hand-held, breath-actuated HandiHaler.1 This device may be difficult for elderly patients to coordinate because it involves placing a capsule into the device. However, in clinical trials, assessment of compliance showed that over 85 percent of patients took the medication at least 90 percent of the time.

Bottom line: Tiotropium improves dyspnea, decreases COPD exacerbations and hospitalizations, decreases albuterol use, improves health-related quality of life and increases mean trough FEV1. Tiotropium was more effective than ipratropium and salmeterol in improving TDI scores. It was more effective than ipratropium and equal to salmeterol in decreasing COPD exacerbations. However, it does have a greater incidence of dry mouth. With once-daily dosing, tiotropium will likely have greater patient compliance compared with current COPD therapy. Tiotropium will provide a more convenient option for bronchodilation in COPD patients and may eventually become first-line therapy.

Sarah F. Hutton, Pharm.D., is assistant professor in the Department of Clinical Pharmacy, South Dakota State University College of Pharmacy, Brookings. She also serves as clinical pharmacist in the Department of Pharmaceutical Services, Sioux Valley Hospital U.S.D. Medical Center, Sioux Falls, and at the University Physicians Clinic, Sioux Falls.

REFERENCES

1. Clinical briefing document for NDA 21-395 Spiriva (tiotropium bromide) inhalation powder for COPD. Pulmonary-Allergy Drugs Advisory Committee Meeting, Sept 6, 2004. Accessed online March 5, 2004, at:vhttp://www.fda.gov/ohrms/dockets/ac/02/briefing/3890B1_05_Clinical%20Briefing.pdf.

2. Tiotropium (Drug Consult). In: Hutchison TA, Shahan DR (Eds): DRUGDEX System. MICROMEDEX. Greenwood Village, Colorado.

3. Hvizdos KM, Goa KL. Tiotropium bromide. Drugs. 2002;62:1195–1203; discussion 1204–5.

4. Panning CA, DeBisschop M. Tiotropium: an inhaled, long-acting anticholinergic drug for chronic obstructive pulmonary disease. Pharmacotherapy. 2003;23:183–9.

5. Donohue JF, van Noord JA, Bateman ED, Langley SJ, Lee A, Witek TJ Jr, et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest. Jul 2002 ;122:47–55.

STEPS drug updates cover Safety, Tolerability, Effectiveness, Price, and Simplicity.

The series coordinator of STEPS is Allen F. Shaughnessy, Pharm.D., director of medical education at Pinnacle Health System, Harrisburg, Pa.



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