An objective method to predict individual visual field progression will contribute to realise personalised medication. The purpose of this study was to establish a predictive formula for glaucomatous visual field progression in patients with Primary open-angle glaucoma, mainly including normal tension glaucoma. This study was a large-scale, longitudinal and retrospective study including 498 eyes of 312 patients visiting from June 2009 to May 2015. In this analysis, 191 eyes of 191 patients meeting all eligible criteria were used. A predictive formula to calculate the rate of glaucomatous visual field progression (mean deviation slope) was obtained through multivariate linear regression analysis by adopting “Angle of Retinal Nerve Fibre Layer Defect” at the baseline, “Vertical Cup-Disc ratio” at the baseline, “Presence or absence of Disc Haemorrhage” during the follow-up period, and “Mean IOP change (%)” during the follow-up period as predictors. Coefficient of determination of the formula was 0.20. The discriminative ability of the formula was evaluated as moderate performance using receiver operating characteristic analysis, and the area under the curve was approximately 0.75 at all cut-off values. Internal validity was confirmed by bootstrapping. The predictive formula established by this type of approach might be useful for personalised medication.
Background
Lemborexant has demonstrated statistically significant improvements in sleep onset and sleep maintenance compared with placebo and zolpidem tartrate extended release, measured both objectively using polysomnography and subjectively using sleep diaries, in the phase 3 clinical trial SUNRISE 1. This study evaluated the cost-effectiveness of lemborexant compared with suvorexant, zolpidem immediate release (IR), and untreated insomnia.
Methods
A decision-tree model was developed for falls, motor vehicle collisions, and workplace accidents associated with insomnia and insomnia treatments from a Japanese healthcare perspective and with a 6-month time horizon. The model extracted subjective sleep onset latency treatment responses and disutility values for non-responders from SUNRISE 1. Cost-effectiveness was assessed using incremental cost per quality-adjusted life year (QALY) gained. One-way and probabilistic sensitivity analyses were conducted to evaluate the impact of parameter uncertainty on the results.
Results
In the base-case analysis, the mean estimated QALYs for lemborexant, suvorexant, zolpidem-IR, and untreated insomnia were 0.4220, 0.4204, 0.4113, and 0.4163, and expected medical costs were JPY 34 034, JPY 38 371, JPY 38 139, and JPY 15 383, respectively. Lemborexant saved JPY 4337 and JPY 4105 compared with suvorexant or zolpidem-IR, respectively, while conferring QALY benefits. The incremental cost-effectiveness ratio (ICER) of lemborexant compared with that of untreated insomnia was JPY 3 220 975 /QALY. Lemborexant was dominant over suvorexant and zolpidem-IR and was cost-effective when compared with untreated insomnia. Sensitivity analyses supported the results' robustness.
Conclusions
In a Japanese clinical practice setting, lemborexant may represent a better investment for treating insomnia in the healthcare system in Japan.
Objectives: Italian recommendations for human papillomavirus (HPV) immunization currently consider females only. However, males can be vectors in viral transmission and at risk of infection. The BEST II study was designed to evaluate: the cost-effectiveness (CE) of different interventions targeting females as well as males; and the economic impact of vaccination on a wide range of HPV-induced diseases. MethOds: A dynamic Bayesian Markov model was developed to investigate the transmission between sexual partners and the cost-effectiveness of vaccination targeting female and male cohorts in comparison to screening and female cohorts only. A range of HPV-induced diseases was considered (cervical, vaginal, vulvar, anal, head and neck and penile cancer, the associated pre-cancerous stages and anogenital warts). The process of sexual mixing was calculated based on age, gender and sexual behavioural specific matrices to estimate th force of infection dynamically. Increased susceptibility to the virus, associated with early sexual début, a high number of partners, smoking and previous STDs, were included. We considered several scenarios; the baseline assumes universal vaccination to be implemented for 12-year-old females and males. The follow-up period was 55 years. Results: According to our preliminary analysis, universal vaccination resulted in incremental CE ratios (ICERs) corresponding to € 910 and € 5,770, when compared to screeningonly and female-only vaccination, respectively. We performed extensive sensitivity analysis, which confirmed the good CE profile of universal vaccination in Italy. cOnclusiOns: A universal HPV vaccination of male and female programme is more cost-effective than screening and female-only vaccination when accounting for all HPV-related diseases. Universal vaccination programme increase herd immunity and provide indirect protection to unvaccinated girls against HPV. The herd immunity plays a significant role in the economic evaluation of HPV immunization programmes. A universal vaccination may be further useful considering that males are both at risk of infection and vectors in viral transmission.
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