OBJECTIVES: Kaplan-Meier (KM) curves are commonly used to report time-toevent outcomes like overall survival (OS) and progression-free survival. For studies not explicitly reporting hazard ratio (HR) and confidence intervals (CI), KM curves can be utilised to estimate these summary statistics for conducting a meta-analysis. Here, we validate the method proposed by Parmar and colleagues for estimating HR (95%CI) by reading the KM curves. METHODS: Ten randomised controlled trials reporting HR (95%CI) and the associated KM curve for OS were randomly A459
Three additional sub-states: without exacerbation, mild and severe exacerbation were considered. The effectiveness of treatment options and utilities for each health state were taken from the literature. Only direct health care costs were considered. Disease management and exacerbation costs were obtained from the literature. Drug costs were calculated based on ex-factory prices with mandatory 7.5% rebate. All costs were updated to € 2012. A 3% annual discount rate on costs and health outcomes was applied. Incremental ratios in terms of cost per life-year gained (LYG) and cost per quality-adjusted life-year gained (QALY) of the most effective therapy versus the comparator were calculated. One-way sensitivity analyses were performed modifying the following parameters: time horizon (10 years, lifetime), discount rate (0%, 5%), drug costs (±10%, ±20%) and utilities (±10%). Probabilistic sensitivity analysis (PSA) was also performed. Results: At 5 years, glycopyrronium bromide accounted a total cost of € 2,225.18 compared to € 2,374.81 accounted for tiotropium bromide. Glycopyrronium bromide yielded higher health benefits (4,321 LYG and 3,388 QALY) than tiotropium bromide (4,315 LYG and 3,377 QALY). In all oneway sensitivity analyses performed and in 100% of PSA simulations (1,000 iterations), glycopyrronium bromide compared to tiotropium bromide remained as a dominant strategy. ConClusions: Glycopyrronium bromide therapy in COPD patients is associated to less costs and higher health benefits than tiotropium in Spain.
The leading cause of mortality in Ukraine are cardiac and vascular diseases. Hypercholesteremia is an important risk factor for development of cardiovascular disease (CVD). A high preventive efficacy of statins for correction of hypercholesteremia and reduction of the risk of CVD has been proven by a great number of meta-analyzes. The purpose of our research is analysis of the consumption dynamics of the statins group drugs (C 10 A) in Ukraine during 2008-2012. To determine the volume of drug consumption the ATC/DDD-methodology and the data of the reference retrieval system "Medicines" of Morion company for 2008-2012 have been used. Based on the analysis of the Ukrainian pharmaceutical market of statins it has been shown that currently all 7 statins INN, which are available in the world, have been registered in the country; they are presented as a whole by 186 drugs, both of foreign and domestic manufacture. Thus, there is a real opportunity to use drugs of the group of statins in clinical practice. It has been determined that by the volume of consumption in DDDs/1000/ day index as of the beginning of 2013 statins are in the following order: atorvastatin (4.89) > simvastatin (1.92) > rozuvastin (0.25) > lovastatin (0.10) > fluvastatin (0.0023) > pravastatin (0.00012). Over the past five years the total volume of consumption of statins in Ukraine increased by more than twice. The comparison of the volume of the total consumption of statins and the incidence rates of CVD among the population has shown that only 0.12 million (0.26% of the Ukrainian population) take daily one DDD of one of statin drugs. Taking into account the fact that the prophylactic administration of statins should be done daily throughout the life the use of these drugs in Ukraine are now to be regarded as very low and does not correspond to the morbidity level of cardiovascular diseases.
A475compare the effectiveness with CAS and CEA in 677 patients with symptomatic carotid artery stenosis in korean clinical practice. Methods: From January 1 2008 to December 31 2011, retrospective cohort study was conducted in 677 symptomatic carotid stenosis patients with more than 50% stenosis) (CAS= 346, CEA= 331) in the Korean hospitals (Asan medical center, Samsung medical center, Severance hospital, Inha university hospital, Chonnam university hospital). The primary outcome was stroke, myocardial infarction, or death during periprocedural (30-day) and postprocedural period. Results: For 677 patients over 2-year follow-up period, All death, major stroke, minor stroke were higher in CAS group than CEA (1.45% vs. 0.30%, 4.05% vs. 1.81%, 3.47% vs. 3.02%, 0.58% vs. 0%). All outcomes were higher in CAS than in CEA within 30-day after treatment and in subsequent years, except the incidence of 30 days-minor stroke. ConClusions: CEA was superior to CAS in symptomatic patients with carotid stenosis. This study suggests that CEA can be considered the first-line therapy for symptomatic carotid artery stenosis in South Korea.
Background. The incidence of breast cancer tends to be increasing worldwide in recent years. It is characterized by various clinical manifestations and potential treatment approaches. The choice of treatment strategy, its sequence as well as the efficiency of administered chemotherapy is quite relevant these days. Purpose – assessing economic feasibility of targeted therapy with pertuzumab (Perjeta®) in patients with metastatic HER2+ BC from the perspective of the health care system of Ukraine. Materials and methods. The treatment outcomes as well as related costs were determined by means of Markov analytical modelling based on a randomized multicenter open clinical study of CLEOPATRA phase III [2]. The model time horizon was 20 years. The alternative schemes of frontline therapy of metastatic HER2+ breast cancer were compared: PTD regimen pertuzumab + trastuzumab + docetaxel and TD regimen trastuzumab + docetaxel. Based on Markov modelling, pharmacoeconomic analysis by means of cost-effectiveness and cost-utility methods was carried out. As an efficiency criterion, LYG amount was used, as a utility criterion − QALY indicator. Direct medical costs were counted, the structure of which had been determined according to the current Protocol. The cost of drugs was calculated in accordance with the Register of wholesale prices for pharmaceuticals of the Ministry of Health of Ukraine; the cost of treatment procedures was determined in accordance with the available price lists of paid medical services provided by licensed medical institutions. Discounting at the level of 3 % per year was applied. Sensitivity analysis of the outcomes was carried out before pertuzumab price changed. Results. According to the modelling, the average life expectancy of patients with HER2+ BC, receiving PTD scheme is 15.69 years compared to 13.95 years in the TD group. Along with prolonging life, associated with PTD scheme, its quality increases. Patients in the TD group gain 7.8 QALY on average, while in the PTD group it is 9.24. The total expenses for the simulated (involved into modeling) study period in the PTD group averaged UAH 1 970 369.6 per patient, in the TD group − UAH 732 517.7. ICER (cost of 1 additional life year) and ICUR (cost of 1 additional qualityadjusted life year) incremental coefficients amounted to UAH 710924.6 and UAH 861175.4 respectively. Conclusions. 1. Pertuzumab target drug is an effective pharmaceutical when administered to patients with metastatic HER2 + breast cancer. 2. The frontline therapy regimen for patients with metastatic HER2 + breast cancer with pertuzumab being included is more expensive in comparison with trastuzumab + docetaxel regimen; at the same time it makes it possible to achieve better results, i. e. to provide on average extra 1.74 life years and 1.44 QALY in 20-year perspective. 3. Pharmacoeconomic analysis based on Markov model and cost-effectiveness and cost-benefit calculations make it possible to consider pertuzumab (Perjeta®), included into frontline targeted therapy regimen of trastuzumab + docetaxel in patients with metastatic HER2+ breast cancer, as an economically feasible medical technology under current health care conditions in Ukraine.
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