Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease which results in thickening and scarring of the interstitial tissue. As the only 2 Food and Drug Administration (FDA)-approved medications on the market, it is valuable to compare the impact of nintedanib and pirfenidone on clinical outcomes. Records of patients who started nintedanib or pirfenidone between calendar years 2015 and 2016 at a national specialty pharmacy were retrospectively reviewed. Data collection was derived from patient management applications and statistical data analysis was completed in SAS (SAS Institute Inc®). The nintedanib population contained 2605 patients and of the population completing clinical assessment surveys (n = 1343), 46% of respondents (n = 612) reported no adverse events, with the remaining 54% reporting at least 1 adverse event. Average proportion of days covered (PDC) was 84.2% (SD = 17.0). Average final monthly copay for this group was $235. The pirfenidone population had 1322 patients, and of the surveyed population (n = 764), 58% of respondents (n = 445) reported no adverse events, with the remaining 42% reporting at least 1 adverse event. Average PDC was 83.4% (SD = 17.3). Average final monthly copay for this group was $339. Outcomes in the studied IPF population were similar for nintedanib and pirfenidone.
OBJECTIVES: Cystic Fibrosis (CF) is a life-limiting, genetic disorder that has a tremendous impact on patient's quality of life (QoL). The goal of this review is to summarize QoL literature in CF and identify instruments utilized to capture QoL data in adult patients. METHODS: A comprehensive literature search using PRISMA guidelines was conducted from January 2010 to October 2014 using electronic databases such as PubMed, Scopus, CINAHL, and Cochrane Reviews. Studies assessing physical, psychological, social and spiritual impact on patients with CF were identified. The QoL instruments from the studies were identified and a review of their psychometric properties in CF was conducted. The search strategy was limited to studies conducted in adult population. Full-text, published articles in the United States and Europe were included in the final review. RESULTS: A total of 14 QoL studies in CF which utilized 6 validated instruments were identified. Three instruments were disease-specific (CFQ-R, CF-QOL, and a single item measure) and the remaining three were generic instruments (SF-36, EQ-5D, and UK-SIP). CFQ-R was used in 11 studies, whereas 3 studies used the CF-QoL. Some important factors that influenced QoL in CF were pain, lung function, self-esteem, and ethnicity. Psychometric validation included validity (discriminant, convergent, and concurrent validity) and reliability testing. Reliability of the instruments was found to be within appropriate ranges (CFQ-R: Cronbach's alpha ≥ 0.70; CF-QOL: Test-Retest > 0.8; and Generic instruments: Internal Consistency > 0.8). CONCLUSIONS: Clinical outcomes, patient perception, and demographic variables were found to influence QoL in adult CF patients. CFQ-R is the most commonly reported QoL instrument in CF. Also, the time constraint physicians face in using QoL assessment in clinical practice can be addressed by the recently developed single-item, CF-specific QoL questionnaire. Overall, CF has a negative impact on the physical, mental, and social aspects of patient's life. PND61Does health-relateD quality of life evaluatioN iN multiPle sclerosis (ms) matter? a review of labels of ms ProDucts aPProveD by the fDa aND ema
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