Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma

BACKGROUND: In a pivotal, phase 2b study (NCT01854047) in patients with uncontrolled persistent asthma, despite using medium-to-high-dose inhaled corticosteroids plus long-acting β2 agonists, dupilumab improved lung function, reduced severe exacerbations, and showed an acceptable safety profile. OBJECTIVE: To assess the impact of dupilumab on asthma control, symptoms, quality of life (QoL), and productivity. METHODS: Data are shown for the intention-to-treat population receiving dupilumab 200/300 mg every 2 weeks (doses being assessed in phase 3; NCT02414854), or placebo. Predefined analyses of total scores were conducted at week 24 for the 5-item Asthma Control Questionnaire (ACQ-5), patient-reported morning/evening (AM/PM) asthma symptoms, Asthma Quality of Life Questionnaire (AQLQ), and asthma-related productivity loss. Responder rate analyses for these measures, subgroup analyses by baseline characteristics, and asthma-related productivity loss analyses were conducted post hoc. RESULTS: Data from 465 patients were analyzed (158 placebo; 307 dupilumab). Both dupilumab doses significantly improved scores through week 24 (all outcomes, overall population). The proportion of patients meeting or exceeding the minimal clinically important difference for the overall population were significantly greater vs placebo (P \u3c .05) for ACQ-5 (range, 72.6%-76.7% vs 61.4%), for AM/PM asthma symptoms score (48.7%-54.1% vs 34.2% and 52.7%-53.5% vs 34.2%, respectively) and for AQLQ (64.0%-65.0% vs 51.3%). The effect of dupilumab was consistent across most subgroups. Productivity loss was significantly higher in placebo- vs dupilumab-treated patients (P \u3c .0001). CONCLUSION: Dupilumab produced significant, clinically meaningful improvements in asthma control, symptoms, QoL, and productivity. REGISTRATION: ClinicalTrials.gov Identifier: NCT01854047

Which Antifungal Agent for Onychomycosis?: A Pharmacoeconomic Analysis

The incidence of fungal nail infections is increasing and this is possibly because of several factors: better methods of detection, a growing population of immunocompromised patients who have a greater susceptibility to such infections, the increased use of immunosuppressive drugs, the increasing number of elderly people, worldwide travel, and the use of communal bathing facilities. Onychomycosis is a fungal infection of the fingernails and toenails that accounts for about 30% of all superficial fungal infections. It is characterised by nail discoloration, thickening and ultimately destruction of the nail plate. Management of this disease has improved significantly and treatment patterns have dramatically changed in recent years as a result of advances in new treatment options (e.g. oral antifungal agents) and changes in treatment regimens (e.g. pulse therapy). Also, newer drugs for onychomycosis have improved tolerability profiles compared with older agents. The overall costs of treating onychomycosis are substantial, and it has been estimated that direct cost for US Medicare patients with the disease is $US43 million per year (year of costing not available). Pharmacoeconomic studies help in the decision-making process when selecting the most cost-effective antifungal agents to treat onychomycosis. To date there have been a number of national and international economic studies aimed at effectively assessing the efficacy and costs of the treatment options available to cure onychomycosis. The objectives of this paper are to 1. review the published findings regarding the epidemiology of onychomycosis; 2. summarise the original pharmacoeconomic studies that describe the economic impact of the disease; and 3. address the impact of the disease on patients' health-related quality of life.Antifungals, Cost analysis, Fluconazole, Griseofulvin, Itraconazole, Ketoconazole, Onychomycosis, Pharmacoeconomics, Terbinafine

Onychomycosis: Health-Related Quality of Life Considerations

The symptoms of onychomycosis and their impact on personal appearance are important determinants of patients' perceptions of their own health. The effect of onychomycosis is greater on psychosocial than physical functioning and is directly related to the extent of nail involvement. This review identified a number of disease-targeted questionnaires that have been developed to assess the impact of onychomycosis and its treatment on health-related quality of life (HR-QOL). The instruments differ considerably in the extent to which they have been psychometrically tested. Most have been shown to provide both valid and reliable measurement of HR-QOL in patients with onychomycosis of the toes. However, not all have been tested in patients with fingernail disease. The generic and disease-targeted scales of most of the available questionnaires exhibit poor variability, which may limit their responsiveness to clinically important change. Only one instrument, the Onychomycosis Disease-Specific Questionnaire, has been incorporated into a clinical trial. Thus, information relating to the impact of onychomycosis treatment on HR-QOL is limited. Future efforts should focus on the systematic evaluation of existing questionnaires in all populations for which they were developed. In addition, it is important that disease-targeted measures be included in future clinical trials so that a better understanding of the impact of onychomycosis treatment on patient HR-QOL may be gained.Onychomycosis, Onychomycosis, Pharmacoeconomics, Quality of life, Quality of life rating scales

Changes in Carcinoid Syndrome Symptoms Among Patients Receiving Telotristat Ethyl in US Clinical Practice: Findings from the TELEPRO-II Real-World Study.

Background: Inadequately controlled symptoms incur a substantial burden on patients with neuroendocrine tumors and carcinoid syndrome (CS). The effectiveness of telotristat ethyl (TE) with a somatostatin analog for uncontrolled CS diarrhea has been demonstrated in clinical trials and observational studies. TELEPRO-II was a prospective observational study evaluating TE\u27s effectiveness in clinical practice over the first 3 months of treatment. Methods: Patients initiating TE in 2018 participated in an optional nurse support program reporting CS symptoms during interviews at baseline and 1, 2, and 3 months after TE initiation. Eligible patients received TE for ≥3 months and reported symptom burden at baseline and ≥1 follow-up visit within the first 3 months. Daily bowel movement (BM) frequency and flushing episodes were reported as events/episodes per day. Stool consistency, nausea severity, urgency severity, and abdominal pain were reported on a severity scale (1-10). Symptom changes were evaluated using paired-sample Results: A total of 684/1603 (43%) patients were eligible for analysis. At baseline, patients reported a mean of 6.3 BM/day, nausea severity of 8.4/10 and stool urgency of 8.2/10. Significant improvements in all CS symptoms were observed after 3 months of TE. Mean daily BMs were reduced 64% after 3 months of TE (mean reduction [SD], -3.99 [3.8]; P Conclusion: Patients treated with TE in a real-world setting experienced significant, clinically meaningful improvements in CS symptoms

Burden of Chronic Sleep Maintenance Insomnia Characterized by Nighttime Awakenings

Abstract The objective of this study was to evaluate the economic and humanistic burden of chronic sleep maintenance insomnia characterized by nighttime awakenings (CINA). A database analysis of National Health and Wellness Survey, an annual cross-sectional study of health status and outcomes of US adults, was performed. CINA was defined as experiencing nighttime awakenings at least twice per week for more than 1 month that have moderate to severe impact on daily life and not experiencing difficulty falling asleep. No insomnia was defined as not self-reporting insomnia, sleep difficulties, or sleep symptoms. Outcomes included resource utilization in the past 6 months, the Work Productivity and Activity Impairment questionnaire, and the SF-8. Linear regression models were developed to assess the independent effects of CINA on outcomes while controlling for demographics and comorbidity. In all, 1523 respondents met the criteria for CINA and 24,106 met the criteria for no insomnia. Controlling for demographics and comorbidity, CINA sufferers had greater resource utilization (0.1 [P?<?0.001] more emergency room visits, 0.2 [P?=?0.001] more days hospitalized, and 2.5 [P?<?0.001] more provider visits), 22.4% (P?<?0.001) greater activity impairment, and SF-8 physical and mental summary scores that were 6.2 (P?<?0.001) and 6.8 (P?<?0.001) points lower than those with no insomnia, respectively. Among those employed full time, CINA sufferers had greater work productivity impairment (4.0% due to absenteeism, 17.6% due to presenteeism, and 15.6% greater overall productivity impairment) than those with no insomnia (P?<?0.001 for all). CINA in relative isolation was associated with a significant negative impact on health care utilization and its associated costs, health-related quality 16 of life, and work productivity. (Population Health Management 2010;13:15?20)Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/85123/1/pop_2009_0028.pd

[Vala Nurettin'e ait fotoğraf]

Taha Toros Arşivi, Dosya No: 8-Va-Nu (Vala Nurettin)Unutma İstanbul projesi İstanbul Kalkınma Ajansı'nın 2016 yılı "Yenilikçi ve Yaratıcı İstanbul Mali Destek Programı" kapsamında desteklenmiştir. Proje No: TR10/16/YNY/010