Norman

BROVANA may be the right fit

GOLD guidelines recommend:

  • Adding 1 or more classes of long-acting bronchodilators when necessary1
  • A stepwise approach, adding inhaled glucocorticosteroids only in the most severe cases and with a history of repeated exacerbations1

Improvement in FEV12

Mean change in FEV1 from study baseline at Week 2 in a 2-week, prospective, multicenter, randomized, modified-blind, double-dummy, parallel-group study designed to evaluate the efficacy and safety of the combination of nebulized BROVANA 15 mcg twice daily and tiotropium 18 mcg once daily am vs the individual monotherapies in the treatment of COPD patients (N=234).

* Dosed sequentially. Patients instructed to use nebulizer first, followed immediately (within 5 minutes) by the DPI.2

  • Occurrence of headache was greater in the BROVANA/tiotropium group (5.1%) than in the BROVANA (1.3%) or tiotropium (3.8%) monotherapy groups3
  • Percentage of patients with change from baseline in heart rate of >25 bpm was greater in the BROVANA/tiotropium group (14.1%) than in the BROVANA (7.9%) or tiotropium (6.3%) monotherapy groups. Systolic blood pressure (SBP) >180 mm Hg and diastolic blood pressure (DBP) >105 mm Hg were greater with BROVANA/tiotropium therapy than with either monotherapy. SBP >180 mm Hg occurred in 3.9%, 2.5%, and 6.4% of patients in the BROVANA, tiotropium, and BROVANA/tiotropium groups, respectively. DBP >105 mm Hg occurred in 2.6%, 3.8%, and 5.1% of patients, respectively3
  • Treatment-emergent adverse events (AEs) occurred in 25.0%, 27.5%, and 30.8% of patients in the BROVANA, tiotropium, and BROVANA/tiotropium therapy groups, respectively
  • The most frequently reported AEs were diarrhea, nausea, chest pain, bronchitis, dizziness, headache, cough, nasal congestion, pharyngolaryngeal pain, and hypertension3

BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists. BROVANA should not be used with other medications containing long-acting beta2-agonists.

All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication.

BROVANA, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Please see accompanying full Prescribing Information for BROVANA, including Boxed Warning.


References:

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2010). http://www.goldcopd.org. Accessed March 15, 2011. 2. Tashkin DP, Donohue JF, Mahler DA, et al. Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. Respir Med. 2009;103(4):516-524. 3. Data on file, CSR 091-902. Sunovion Pharmaceuticals Inc.