STRIVERDI RESPIMAT Rx
Pharmacological Class:
Long-acting 2-adrenergic agonist (LABA).

Active Ingredient(s):
Olodaterol 2.5mcg; per actuation; inhalation spray; contains benzalkonium chloride.

Company
Boehringer Ingelheim Pharmaceuticals

Indication(s):
Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Limitations of use: not for treating asthma or acute deteriorations of COPD.

Pharmacology:
Olodaterol binds and activates ?2-adrenoreceptors in the airways, resulting in a stimulation of intracellular adenyl cyclase that mediates the synthesis of cAMP. Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells.

Clinical Trials:
The Striverdi Respimat clinical development program included 3 dose-ranging trials in COPD patients, 4 dose-ranging trials in asthma patients, and 8 confirmatory trials in patients with COPD.

The first COPD dose-ranging trial was a 5-way cross-over trial in 36 patients. Results showed dose-related improvements in forced expiratory volume in one second (FEV1) vs. placebo. The difference in trough FEV1 from placebo for the 2mcg, 5mcg, 10mcg, and 20mcg doses were 0.07L (95% CI: 0.03, 0.11), 0.10L (95% CI: 0.06, 0.14), 0.11L (95% CI: 0.07, 0.15), and 0.12L (95% CI: 0.08, 0.16), respectively.

In the second COPD dose-ranging trial, dose-related improvements in lung function were also seen with no added benefit of the 20mcg dose vs. 10mcg dose.

In the third COPD dose-ranging trial, treatment arms included 2mcg twice daily, 5mcg once daily, 5mcg twice daily, and 10mcg once daily. No clear difference in effect was seen when comparing the twice-daily vs. once-daily dosing.

In all four 48-week confirmatory trials, Striverdi 5mcg showed significant improvements in FEV1 AUC 0–3 hour vs. placebo at Week 12 and at Week 24. In these trials, Striverdi 5mcg showed significant improvements in trough FEV1 vs. placebo at Week 12 (3 of 4 trials) and at Week 24 (4 trials). Striverdi 5mcg showed a bronchodilatory effect at 5 minutes after the first dose with a mean increase in FEV1 vs. placebo of 0.11L (range: 0.10L to 0.12L). The 10mcg dose showed no additional benefit over the 5mcg dose.

For more clinical trials data, see full labeling.

Legal Classification:
Rx

Adults:
Take at same time each day. 2 inhalations once daily; max 2 inhalations/day.

Children:
Not established.

Contraindication(s):
LABA use in asthma patients without use of long-term control medication.

Warnings/Precautions:
LABA increase risk of asthma-related death. Do not initiate in patients with acutely deteriorating COPD. Not for relief of acute bronchospasm. Prescribe a short-acting ?2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Not for use with other long-acting ?2-agonists. Discontinue if paradoxical bronchospasm or hypersensitivity reactions occur; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension). Convulsive disorders. Thyrotoxicosis. Prolongation of the QT interval. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Risk of hypokalemia or hyperglycemia. Severe hepatic impairment. Labor & delivery. Pregnancy (Category C). Nursing mothers.

Interaction(s)
Caution with concomitant other adrenergic drugs. Concomitant xanthine derivatives, steroids, K+-depleting diuretics may potentiate hypokalemia. Extreme caution with MAOIs, tricyclics, or drugs known to prolong QTc interval. Antagonized by ?-blockers; if needed, consider cardioselective agents. Potentiated by strong CYP450 and P-gp inhibitors (eg, ketoconazole).

Adverse Reaction(s)
Nasopharyngitis, URTI, bronchitis, UTI, cough, dizziness, rash, diarrhea, back pain, arthralgia.

How Supplied:
Inhaler (w. cartridge)—4g (60 inhalations)

LAST UPDATED:
10/21/2014