Use Of Fluticasone Propionate Research Articles

Fluticasone propionate for external use: pharmacological properties and clinical effectiveness

Topical corticosteroids are first-line medications in the treatment of an overwhelming number of both acute and chronic inflammatory noninfectious skin diseases. These drugs can be characterized as the drugs of choice in dermatological practice, which is determined by anti-inflammatory, immunosuppressive and antiproliferative effects of corticosteroids. Nevertheless, the use of these drugs in some cases may be limited by the potential risk of adverse side effects, which, in turn, determines a rather widespread corticophobia among patients, as well as among some doctors. In this regard, the current efforts of pharmaceutical companies are focused on the development of topical corticosteroids with the least number of side effects without loss of clinical efficacy. The synthetic carbothioate corticosteroid fluticasone propionate (FP) is a medium strength (class III) synthetic fluorinated corticosteroid for topical treatment of skin conditions. Its molecule has a high degree of lipophilicity, which allows it to be actively absorbed into the skin. The drug has a high affinity to glucocorticoid receptors against the background of the absence of mineralcorticoid activity. In addition, FP is relatively quickly subjected to enzymatic hydrolysis to inactive metabolites. This determines the high clinical efficacy of this drug with minimal risk of both local and systemic adverse events. It is available as cream and ointment with the same efficacy, but with different concentrations (0.05 or 0.005%) of the active substance. This article reviews the pharmacology and safety profile as well as the use of topical FP in clinical practice.

Health-care utilization and costs with fluticasone propionate and fluticasone propionate/salmeterol in asthma patients at risk for exacerbations

Although studies have established that adding long-acting beta agonists (LABA) to inhaled corticosteroid (ICS) monotherapy among patients with inadequately controlled asthma is associated with better outcomes than increasing ICS dosage, outcomes with ICS versus fixed-dose ICS/LABA combination among patients with recent asthma exacerbation or frequent use of rescue medication are unavailable. This study was designed to compare health-care utilization/costs among patients with recent asthma exacerbation or frequent rescue medication use who received fluticasone propionate (FP) alone versus fixed-dose FP/salmeterol combination (FSC). A retrospective cohort study was conducted using a large health insurance data set. Patients with one or more claims with asthma diagnosis, two or more prescriptions for FSC (250/50- or 100/50-mg formulations) or FP (220- or 110-mg formulations), and one or more asthma exacerbations or five or more short-acting beta agonist (SABA) prescriptions within 1 year before initial receipt of study medications were included. Health-care utilization/costs and controller therapy compliance were compared for patients receiving FSC versus FP using multivariate regression analysis controlling for FP dose and baseline characteristics. A total of 7779 patients met inclusion criteria (5769, FSC, and 2010, FP) with comparable mean follow-up (FSC, 685 days; FP, 670 days; p = 0.151). Controlling for FP dosage and baseline characteristics, FSC patients had lower risks of asthma-related exacerbations, fewer SABAs and systemic corticosteroids, higher costs of asthma medications and total asthma-related health care, and lower total asthma-related health-care costs excluding study medication cost. In asthma patients with recent exacerbation or frequent SABA use, receipt of FSC reduced asthma-related exacerbation risks and rescue medication use versus receipt of FP.

An evaluation of asthma medication utilization for risk evaluation and mitigation strategies (REMS) in the United States: 2005–2011

Purpose: The purpose of this study was to assess drug utilization patterns of fluticasone propionate (FP)/salmeterol (SAL) combination (FSC) and SAL over the 7-year period of 2005–2011 in patients with asthma as part of the Risk Evaluation and Mitigation Strategies (REMS). Methods: A descriptive, retrospective observational study utilizing national pharmacy data and employer-based claims data to characterize drug utilization patterns. Results: For patients with asthma, the total number of FSC and SAL dispensings and users of FSC and SAL has declined between 2005 and 2011. During this period, FSC and SAL dispensing for asthma decreased 24% and 76%, respectively, with a more pronounced decline between 2010 and 2011 relative to other years. The total number of patients with asthma who were dispensed FSC has decreased by 10% among adults and by 40% in children and adolescents. While SAL-containing medications decreased, dispensing of FP monotherapy increased 39% during the same 7-year period. The number of patients dispensed FP for asthma has increased 47% in children 4–11 years of age, 72% in adolescents 12–17 years of age, and 6% in adults. SAL use without a controller was infrequent and decreasing, reported by 1.7% and 0.5% of patients with asthma in 2005 and 2011, respectively. Conclusions: In patients with asthma, use of FSC and SAL decreased between 2005 and 2011, while the use of FP increased. Use of SAL monotherapy was infrequent and declined during the study period. The data suggest that the substantial communication activities have encouraged appropriate prescribing of long-acting β2-adrenergic agonist (LABA).

Fluticasone versus placebo for chronic asthma in adults and children

Inhaled fluticasone propionate (FP) is a relatively new inhaled corticosteroid for the treatment of asthma. To assess efficacy and safety outcomes in studies that compared FP to placebo for treatment of chronic asthma. We searched the Cochrane Airways Group Specialised Register (January 2008), reference lists of articles, contacted trialists and searched abstracts of major respiratory society meetings (1997-2006). Randomised trials in children and adults comparing FP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and risk of bias. Two review authors extracted data. Quantitative analyses were undertaken using Review Manager software. Eighty-six studies met the inclusion criteria, recruiting 16,160 participants. In non-oral steroid treated asthmatics with mild and moderate disease FP resulted in improvements from baseline compared with placebo across all dose ranges (100 to 1000 mcg/d) in FEV1 (between 0.1 to 0.43 litres); morning PEF (between 23 and 46 L/min); symptom scores (based on a standardised scale, between 0.44 and 0.7); reduction in rescue beta-2 agonist use (between 1 and 1.4 puffs/day). High dose FP increased the number of patients who could withdraw from prednisolone: FP 1000-1500 mcg/day Peto Odds Ratio 14.07 (95% CI 7.17 to 27.57). FP at all doses led to a greater likelihood of sore throat, hoarseness and oral Candidiasis. Doses of FP in the range 100-1000 mcg/day are effective. In most patients with mild-moderate asthma improvements with low dose FP are only a little less than those associated with high doses when compared with placebo. High dose FP appears to have worthwhile oral-corticosteroid reducing properties. FP use is accompanied by an increased likelihood of oropharyngeal side effects.

Estimating the Cost-Effectiveness of Fluticasone Propionate for Treating Chronic Obstructive Pulmonary Disease in the Presence of Missing Data

To explore the cost-effectiveness of fluticasone propionate (FP) for the treatment of chronic obstructive pulmonary disease (COPD), we estimated costs and quality-adjusted life-years (QALYs) over 3 years, based on an economic appraisal of a previously reported clinical trial (Inhaled Steroids in Obstructive Lung Disease in Europe [ISOLDE]). Seven hundred forty-two patients enrolled in the ISOLDE trial who received either FP or placebo had data available on health-care costs and quality of life over the period of the study. The SF-36-based utility scores for quality of life were used to calculate QALYs. A combined imputation and bootstrapping procedure was employed to handle missing data and to estimate statistical uncertainty in the estimated cumulative costs and QALYs over the study period. The imputation approach was based on propensity scoring and nesting this approach within the bootstrap ensured that multiple imputations were performed such that statistical estimates included imputation uncertainty. Complete data were available on mortality within the follow-up period of the study and a nonsignificant trend toward improved survival of 0.06 (95% confidence interval [CI]-0.01 to 0.15) life-years was observed. In an analysis based on a propensity scoring approach to missing data we estimated the incremental costs of FP versus placebo to be 1021 sterling pound(95% CI 619-1338 sterling pound) with an additional effect of 0.11 QALYs (CI 0.04-0.20). Cost-effectiveness estimates for the within-trial period of 17,700 sterling pound per life-year gained (6900 sterling pound to infinity) and 9500 sterling pound per QALY gained (CI 4300-26,500 sterling pound) were generated that include uncertainty due to the imputation process. An alternative imputation approach did not materially affect these estimates. Previous analyses of the ISOLDE study showed significant improvement on disease-specific health status measures and a trend toward a survival advantage for treatment with FP. This analysis shows that joint considerations of quality of life and survival result in a substantial increase in QALYs favoring treatment with FP. Based on these data, the inhaled corticosteroid FP appears cost-effective for the treatment of COPD. Confirmation or refutation of this result may be achieved once the Towards a Revolution in COPD Health (TORCH) study reports, a large randomized controlled trial powered to detect mortality changes associated with the use of FP alone, or in combination with salmeterol, which is also collecting resource use and utility data suitable for estimating cost-effectiveness.

Methodological issues in evaluating measures of health as outcomes for COPD

Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with worse health and increased healthcare utilisation. The Inhaled Steroids in Obstructive Lung Disease in Europe (ISOLDE) study in COPD showed a 26% reduction in the yearly rate of exacerbations in patients treated with fluticasone propionate (FP) compared to placebo, but did not indicate which patients showed greatest benefit. In this study the patients were stratified into mild and moderate‐to‐severe COPD using the American Thoracic Society criterion of forced expiratory volume in one second (FEV₁) 50% predicted, and the total number of exacerbations and those requiring treatment with oral corticosteroids were examined. There were 391 (195 FP) patients with mild COPD and 359 (180 FP) patients with moderate‐to‐severe disease. The exacerbation rate was highly skewed in mild disease, but more normally distributed in moderate‐to‐severe disease. FP reduced the overall exacerbation rate in moderate‐to‐severe disease (FP median rate 1.47 yr⁻¹, placebo 1.75 yr⁻¹), but not in mild disease (FP 0.67 yr⁻¹, placebo 0.92 yr⁻¹). FP use was associated with fewer patients with ≥1 exacerbation·yr⁻¹ being treated with oral corticosteroids (mild: FP 8%, placebo 16%; moderate‐to‐severe: FP 17%, placebo 30%). Effects of fluticasone propionate on exacerbations were seen predominantly in patients with a postbronchodilator forced expiratory volume in one second <50% predicted. These data support recommendations in the Global Initiative for Chronic Obstructive Disease treatment guidelines that inhaled corticosteroids should be considered in patients with moderate‐to‐severe chronic obstructive pulmonary disease who experience recurrent exacerbations.

フルタイド導入による吸入ステロイドのコンプライアンスの改善 第１報 患者アンケートを中心として

It is generally known that the regular use of inhalation steroids plays an important role in asthma treatment. However, when giving instructions for the inhalation of beclomerasone dipropionate using Inspire Ease® spacers (BDP+IE), difficulty of inhalation techniques may sometimes lead to a reduction in patient compliance. The inhalation of fluticasone propionate (FP) using Diskhaler®, which was newly introduced in Japan in December 1998, shows a stronger antiinflammatory action and thus requires a simpler inhalation technique. It is thus considered that switching from BDP + IE to FP might therefore improve patient compliance with inhalation steroids.To investigate the patient preference for both inhalation agents, we conducted a questionnaire survey in 95 asthmatic patients in whom BDP + IE was switched to FP. Furthermore, we examined whether or not any improvement in the pulmonary functions was observed in the patient evaluation.As a result, 76.8% of the patients preferred FP because of its easier portability, it was easier to use and required a smaller numbers of inhalations. The subjective symptoms improved in 58.9% of the patients while the pulmonary functions improved in most patients. However, some elderly patients reported BDP + IE to be preferable mainly due to the fact that they were accustomed to the procedure.We conclude the use of FP improves compliance since 76.8 % of the patients preferred it to BDP+IE which thus increased patient compliance which therefore resulted in an improvement of pulmonary functions

Inhaled fluticasone propionate for chronic asthma.

Inhaled fluticasone propionate (FP) is a relatively new inhaled corticosteroid for the treatment of asthma. 1. To assess efficacy and safety outcomes in studies that compared FP to placebo for treatment of chronic asthma. 2. To explore the presence of a dose-response effect. We searched the Cochrane Airways Group Trial Register (1999), reference lists of articles, contacted trialists and searched abstracts of major respiratory society meetings (1997-1999). Randomised trials in children and adults comparing FP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data. Quantitative analyses where undertaken using Review Manager 4.0.3 with MetaView 3.1. 28 studies were selected for inclusion (5788 subjects). Methodological quality was high. In non-oral steroid treated asthmatics with mild-moderate disease FP produced improvements from baseline compared to placebo: FEV1 Weighted Mean Difference (WMD) 0.31 litres (95% confidence interval (CI) 0.27 to 0.36 litres); morning PEF WMD 29 /min (95% CI 24 to 33 L/min); symptom scores Standardised Mean Difference (SMD) 0.59 (95% CI 0.47 to 0.71); reduction in rescue beta2 agonist use WMD 1.1 puffs/d (95% CI 0.9 to 1.4). Similar effects were seen for all doses up to 1000 mcg/d. A shallow dose response effect was apparent: eg change in morning PEF with FP 1000 mcg/d WMD 49 L/min (95% CI 41 to 58 L/min). High dose FP reduced the number of patients dependent on prednisolone: FP 1000-1500 mcg/d Peto Odds Ratio 0.07 (95% CI 0.05 to 0.10). FP at all doses led to a greater likelihood of sore throat, hoarseness and oral Candidiasis. Doses of FP in the range 100-1000 mcg/d are effective. Although there appears to be a dose-response effect, in most patients with mild-moderate asthma improvements with low dose FP are only a little less than those with high doses. High dose FP appears to have worthwhile oral-corticosteroid reducing properties. FP use is accompanied by an increased likelihood of oropharyngeal side effects and this appears to be dose dependent.

Fluticasone propionate: an audit of outcomes and cost-effectiveness in primary care

The inhaled corticosteroid fluticasone propionate (FP) was introduced into the Thorpewood General Practice, Norwich, U.K. in 1993 -initially in treating relatively severe asthmatics. Observed beneficial effects led to expanded use particularly for poorly controlled asthma not responsive to increased inhaled anti-inflammatories. However, an early review suggested little advantage over existing agents (l), and FP was marketed at a price premium. The aims of this study were to investigate whether continued and expanding use of FP was justified in terms of improved clinical outcomes, and if such improvements were associated with reduced NHS costs (offsetting more expensive prescriptions). A controlled, retrospective, nonrandomized primary care audit compared clinical outcomes and asthma management costs 1 year prior to and 1 year into FP therapy.