Browsing by Subject "varfariini"

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  • Heinonen, Rita (University of Helsinki, 1995)
  • Siirola, Outi (Helsingfors universitet, 2013)
    There aren't always available suitable authorized drug products for different age and different weight pediatric patients. Hospital pharmacies have to prepare suitable doses and dosage form for these very young patients extemporaneously. In Finland oral powders are usually used in pediatric medication. In previous studies it has been found that part of drug dose sticks to paper of oral powder and the patient doesn't get the entire intended dose. It is suggested that hard capsules may be better dosage form than oral powders, because capsules have smaller area than oral powders, where the powder can stick. The aim of this study was to examine, whether warfarin- and spironolactone capsules prepared by hospital pharmacy meet European Pharmacopeia standards of uniformity of content. Capsules were compounded from commercial tablets and capsulated by Feton-capsulating device. In this study capsules manufactured with automatic capsule filling device attached to analytical balance, oral powders and capsules prepared from pure drug substance were also compared to capsules compounded from tablets. The three month stability of compounded capsules was also examined. In hospital pharmacy many different strengths are compounded from same drug substance, ordered by physician. Ordered strengths can be nearly identical, but whether the small differences in concentration can possibly be prepared in hospital pharmacy is unknown. From both drug substances two strengths with small difference in concentration were prepared and it was studied if statistically significant difference exists. The drug concentrations of preparations were measured by high performance chromatography (HPLC). Aqualab-water activity meter was used to study water activity of samples during the stability testing. Content uniformities of all capsule batches complied with test specified in the European Pharmacopeia.The drug concentrations of capsules were significantly lower than target concentrations. With these drug substances no difference, between the drug concentration of oral powder and capsules, was found. According to this study oral powders can be replaced by capsules. Warfarin and spironolactone capsules remain at least three months, when storaged in room temperature. Warfarin capsules can be prepared accuracy of 0,1 mg and spironolactone capsules accuracy of 0,5 mg.
  • Koivula, Teija (Helsingfors universitet, 2017)
    Atrial fibrillation is the most common sustained cardiac arythmia. It has been estimated that there will be 14 to 17 million atrial fibrillation patients in Europe by the year 2030. In Finland, there are over 50 000 atrial fibrillation patients. The prevalence of atrial fibrillation increases by age. In addition to age, people who have hearth failure, high blood pressure, coronary artery disease, valvular hearth disease, diabetes mellitus, chronic kidney disease or who suffer from obesity have increased prevalence. Atrial fibrillation is usually not a life threatening condition. However, people who suffer from atrial fibrillation have a greater risk of the stroke compared with people who have normal sinus rhythm. Warfarin has been the standard treatment for preventing the stroke in atrial fibrillation patients. However, there are many inconveniences in warfarin therapy such as food and drug interactions and frequent laboratory visits. Therefore, new oral anticoagulants have been introduced to prevent the stroke in non-valvular atrial fibrillation. These new drugs apixaban, dabigatran, edoxaban and rivaroxaban are more expensive than warfarin. Many people suffer from atrial fibrillation and the number of atrial fibrillation patients is increasing. Due to the expected increase in the number of atrial fibrillation patients in future the costs of the new drugs have led to a concern for their impact on the health care budget. The knowledge of the cost-effectiveness of the new anticoagulants is important for decision making. In this Master's thesis, the cost-effectiveness of rivaroxaban was compared with warfarin for stroke prevention in non-valvular atrial fibrillation. Systematic literature review was used as the study method and 363 studies were screened and 23 of them filled the inclusion criteria. One was a previously published systematic review and 22 were cost-utility studies. All of the cost-utility studies had used decision analytic modelling. The studies were conducted in 13 different countries. In the cost-utility studies included in this systematic review there was a great variability in the cost-effectiveness of rivaroxaban compared with warfarin. Rivaroxaban was cost-effective in more than half of the studies, for example in Belgium, Italy, Norway and Singapore. However, in China, Thailand and Slovenia the cost-effectiveness could not be established. Contradictory cost-effectiveness results were obtained in studies conducted in Germany, Canada and USA. The incremental cost-effectiveness ratio varied from 2580 € to 174915 € per quality adjusted life years (QALY) gained with warfarin over all the 22 cost-utility studies. In studies conducted in Europe the incremental cost effectiveness ratio varied from 4188 € 139163 €/QALY gained. In studies where rivaroxaban, apixaban, dabigatran and warfarin were compared together using an indirect comparison or a network meta-analysis it seemed that rivaroxaban was not the optimal treatment. The most common adverse effect of anticoagulation treatment is bleeding. This complication was included in all the cost-utility studies. However, there was only some uniformity of the bleeding events reported. In most cost-utility studies the acute care cost of intracranial hemorrhages was reported and in many studies, also the long term costs. The cost-utility studies included in this systematic review were quite heterogeneous. Because they were done in different countries their health care settings, treatment options and costs were different. There were also differences in cost-effective models. Modell structure, settings, data and assumptions were different. Due to the heterogeneous nature of the studies, no unambiguous answer could be reached to the question concerning the cost-effectiveness of rivaroxaban compared with warfarin. The quality assessment of the cost-utility studies revealed that some quality criteria were not met. Transferability of the results from one country to the other seemed to be poor. The strength of this master's thesis is the comprehensive literature search concerning the cost-effectiveness of rivaroxaban compared with warfarin. Also, the reporting of methods and results are transparent. There are also limitations in this study. One person was conducting the literature search, data extraction and quality assessment. This might have increased the risk for subjective interpretations and errors.