Changing patterns of asthma medication use related to US Food and Drug Administration long-acting β₂-agonist regulation from 2005-2011

详细信息    查看全文

• 作者：Melissa G. Butler ; PharmD ; MPH ; PhD^a ; ^b ; Esther H. Zhou ; MD ; PhD^c ; Fang Zhang ; PhD^d ; Yu-te Wu ; PhD^e ; Ann Chen Wu ; MD ; MPH^d ; Mark S. Levenson ; PhD^e ; Pingsheng Wu ; PhD^f ; Sally Seymour ; MD^g ; Sengwee Toh ; ScD^d ; Aarthi Iyer ; MPH^d ; Solomon Iyasu ; MD ; MPH^c ; Meghan A. Baker ; MD ; ScD^d ; ^h ; ^{meghan_baker@harvardpilgrim.org" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Long-acting β2-agonist ; asthma ; US Food and Drug Administration ; medication use ; drug safety
• 刊名：Journal of Allergy and Clinical Immunology
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：137
• 期：3
• 页码：710-717
• 全文大小：1070 K

文摘

Safety concerns associated with long-acting β₂-agonists (LABAs) have led to many US Food and Drug Administration (FDA) regulatory activities for this class of drugs. Little is known about the effect of these regulatory activities on use of LABA-containing agents or other asthma medications.

Methods

We created rolling cohorts of pediatric and adult asthmatic patients in the Mini-Sentinel Distributed Database between January 2005 and June 2011. The proportions of asthmatic patients using LABA-containing products, inhaled corticosteroids (ICSs), leukotriene modifiers, short-acting β₂-agonists, oral corticosteroids, other bronchodilators, and no medications were measured on a monthly basis, and the changes were evaluated by using interrupted time series with segmented regression analysis.

Results

When the 2005 regulatory activity was announced, there were statistically significant decreases in the use of fixed-dose ICS-LABA agents in children (−0.98 percentage points) and adults (−1.24 percentage points). Increased use of ICSs and leukotriene modifiers was observed just after the regulatory activities were announced in both children and adults. Although of smaller magnitude, continued favorable changes in the use of LABA agents were observed after the 2010 FDA regulatory activity.

Conclusion

The 2005 and 2010 FDA regulatory activities might have contributed to reduced use of LABA agents, as intended; however, their effect, independent of other factors, cannot be determined. Use of other classes of asthma medications was similarly affected.