Papi, Alberto and Mansur, Adel H. and Pertseva, Tetyana and Kaiser, Kirsten and McIver, Tammy and Grothe, Birgit and Dissanayake, Sanjeeva (2016) Long-Term Fluticasone Propionate/Formoterol Fumarate Combination Therapy Is Associated with a Low Incidence of Severe Asthma Exacerbations. Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol.29 (No 4). pp. 346-361. ISSN 1941-2711 (Print), 1941-2703 (Online)
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Abstract
Background: A primary goal of asthma management is the reduction of exacerbation risk. We assessed the occurrence of oral corticosteroid-requiring exacerbations (OCS exacerbations) with long-term fluticasone/formoterol therapy, and compared it with the occurrence of similar events reported with other inhaled corticosteroid/long acting b2-agonist (ICS/LABA) combinations. Methods: The occurrence of OCS exacerbations was assessed in two open-label trials of fixed-dose fluticasone/ formoterol administered for between 26 to 60 weeks in adults and adolescents with asthma. The incidence of OCS exacerbations with fluticasone/formoterol was compared with those reported in three recent Cochrane meta-analyses of other ICS/LABAs. Results: The pooled incidence of OCS exacerbations with long-term fluticasone/formoterol was 2.1% (95% CI: 1.1, 3.2%, n/N¼ 16/752). In only two of the nineteen treatment arms summarized by Cochrane did OCS exacerbation incidence approximate that seen in the two fluticasone/formoterol trials (single-inhaler fluticasone/salmeterol [2.9%]; separate inhaler budesonide, beclometasone, or flunisolide plus formoterol [3.4%]). In Lasserson’s review the pooled incidence of OCS exacerbations for single-inhaler combinations was 9.5% (95% CI: 8.4, 10.6%; n/N¼ 239/2516) for fluticasone/salmeterol, and 10.6% (95% CI: 9.3, 11.8%; n/N¼ 257/2433) for budesonide/formoterol. In Ducharme’s and Chauhan’s meta-analyses (primarily incorporating separate inhaler combinations [fluticasone, budesonide, beclometasone, or flunisolide plus salmeterol or formoterol]), the pooled incidences of OCS exacerbations were 16.0% (95% CI: 14.2, 17.8%, n/N¼ 258/1615) and 16.7% (95% CI: 14.9, 18.5, n/N¼ 275/1643), respectively. Conclusions: The incidence of exacerbations in two fixed-dose fluticasone/formoterol studies was low and less than in the majority of comparable published studies involving other ICS/LABA combinations. This difference could not be readily explained by differences in features of the respective studies and may be related to the favorable pharmacological/mechanistic characteristics of the constituent components fluticasone and formoterol compared to other drugs in their respective classes.
| Item Type: | Article |
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| Additional Information: | DOI: 10.1089/jamp.2015.1255 |
| Uncontrolled Keywords: | asthma, fluticasone propionate, fluticasone/formoterol, flutiform, formoterol, severe exacerbations |
| Subjects: | Pulmonology |
| Divisions: | Departments > Department of Internal Medicine 1 (formerly - Faculty Therapy and Endocrinology) |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 26 Feb 2019 09:40 |
| Last Modified: | 26 Feb 2019 09:40 |
| URI: | http://repo.dma.dp.ua/id/eprint/3848 |
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