QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol

INITIATING ASTHMA
CONTROL THERAPY

Asthma Control Can Be Achieved Using ICS Treatment Alone

The UK's General Practice Research Database (GPRD) is a 1-year, real-world, observational, retrospective, matched-cohort analysis.1 This study found that:

  • 86% of patients initiated on QVAR® achieved asthma control
  • 92% of patients initiated on QVAR® had no asthma exacerbations during the course of the study

Asthma control was defined as: no recorded hospital attendance for asthma; no prescription for oral corticosteroid; and not consultation, hospital admission, or emergency department attendance for lower respiratory tract infection requiring antibiotics.

Match Medication to Symptom Severity

In order to achieve and maintain asthma control, NHLBI guidelines for the treatment of asthma generally recommend a stepwise approach, which may include the following:2

  • Initiating therapy for persistent asthma with a low- to medium-dose ICS.
  • Stepping up ICS dose if necessary.
  • Gradually reducing medication if asthma is well controlled for at least 3 months.
  • Identifying the minimum therapy required for maintaining control of asthma symptoms.
Stepwise approach to therapy. See NHLBI guidelines, p 328-329, 366 of PDF.]

FDA Guidelines on the Use of LABAs and ICS/LABA Combination Products

When used for the treatment of asthma, LABAs are associated with an increased risk of severe exacerbation of asthma symptoms, which may lead to hospitalizations or death in some patients.3 Given the benefits and well known safety profiles of ICSs in patients with asthma, the FDA believes that it is prudent to:4

  • Emphasize the use of ICSs
  • Limit the long-term use of LABAs with or without ICS

ICSs such as QVAR® are considered first-line therapy for mild to moderate persistent asthma by the FDA, while Advair® and other ICS/LABA combination products are recommended for use only when disease severity clearly warrants treatment with both an ICS and a LABA.3

An analysis of claims data has suggested that combination therapy may be overused: 69% of adult patients who had mild persistent asthma and were prescribed Advair® had not filled a single-entity ICS prescription during the previous year.5

In addition, QVAR® provides greater lung deposition, with less deposition in the throat and gut, compared with Advair® HFA.6*

QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age or older. QVAR® is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR® may reduce or eliminate the need for systemic corticosteroids.

Important Safety Information

  • QVAR® is not a bronchodilator and is not indicated for relief of acute bronchospasm
  • Common side effects associated with the use of QVAR® and placebo in clinical trials include, but are not limited to, headache (12% and 9%, respectively) and pharyngitis (8% and 4%, respectively)
CAUTION: Adrenal insufficiency may occur when transferring patients from systemic steroids (see WARNINGS, Prescribing Information).
  • A reduction in growth velocity in growing children and teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment

* The relationship of better lung deposition and particle size to clinical efficacy is unknown.

The brands listed are the registered trademarks of their respective owners.

References

  1. Price D, Martin RJ, Barnes N, et al. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010;126(3): 511-518.
  2. NHLBI Expert Panel Report 3 (EPR3): Guidelines for the Diagnosis and Management of Asthma. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm. Accessed April 20, 2010.
  3. Center for Drug Evaluation and Research. FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs). Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm [Accessed July 7, 2010].
  4. Chowdhury BA. Long-acting beta-agonists safety trials. Presentation at: FDA Advisory Committee Meeting; March 10-11, 2010; Silver Spring, MD.
  5. Friedman H, Wilcox T, Reardon G, Crespi S, Yawn BP. A retrospective study of the use of fluticasone propionate/salmeterol combination as initial asthma controller therapy in a commercially insured population. Clin Ther. 2008;30(10):1908-1917.
  6. Data on file. Teva Respiratory, LLC; 2010.
111768