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Costs of treating serious adverse effects of drugs used for treatment of obesity: comparison of selected European countries
(Informa UK Limited, 2024-11-03)
Raičević, Branislava
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Stević, Ivana
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Lakić, Dragana
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Männik, Agnes
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Drugs for the treatment of obesity show significant effectiveness, but the adverse effects (ADRs) of these drugs are numerous and varied, and some of them are highly cost-generating. Our research aimed to define the health care utilization pattern in treating ADRs of antiobesity therapy, to compare the costs of treating these ADRs among selected European countries, and to identify the key cost drivers. A comparative analysis of the costs of treating the ADRs of antiobesity drugs in 10 European countries (seven EU members and three from the Western Balkans) was conducted, and the impact of parameters of global health expenditures on them was assessed. There are considerable differences in costs of treating adverse antiobesity drug reactions among European countries: costs of treating gastroesophageal reflux disease varied almost 20 times between North Macedonia (12.6 EUR) and Estonia (202.9 EUR). The Gross Domestic Product per capita was an important cost driver in treating the majority of the ADRs studied (p < .001), except for retinopathy, anaphylaxis, and respiratory disorders. The Domestic Private Health Expenditure increased the costs of treating depression (p = .012), upper respiratory tract infection (p = .008), melanocytic naevus (p = .027), and drug-induced hepatitis (p = .023). Investment in pharmaceuticals, medical goods, and preventive care tended to reduce the costs of treating several ADRs, which are seemingly unrelated to the body site or mechanism. Healthcare utilization and costs of treating ADRs to antiobesity drugs vary significantly among European countries. These differences should be considered when creating inputs for cost-effectiveness and budget impact models to decrease their uncertainty.
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RESULTS FROM POST - MARKETING OBSERVATIONAL STUDY FOR THE ASSESSMENT OF SAFETY OF INTRAVENOUS IBANDRONIC ACID IN POSTMENOPAUSAL WOMEN
(SHMSHM - AAMD, 2020-12-23)
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Stefanovska, Dushica
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Our study was non interventional, observational, open, uncontrolled and prospective- retrospective study, multicentre and one branch - during 2009-2011 at secondary and tertiary medical level. 5 medical centres and two clinics from N. Macedonia were included. The study entered 611 pts, but finished 153 pts. 146 were bisphosphonate naive, 7 had previous received peroral bisphosphonate therapy. In our group of patients 36 side effects were registered in 31 patients. 35/36 appeared during first 7 days of application,15/36 did not appeared after first application, 28/36 were with mild intensity and 5 were with moderate intensity and 2 were SAERS. We analyzed review database (2009 to 2011), from the perspective of recent studies. And to point out, that DXA results, together with CMAJ guidelines and FRAX questionnaire, were not changed during last 10 years. Both of them (CMAJ and FRAX), together or without DXA, are solid foundation to begin antiresorbtive bisphosphonate therapy. DXA finding of osteoporosis, sex, and presence of one major or two minor risk factors was the basis of initiating the therapy. All of our patients were female. With the major risk factors 2,1 present in 129 (84%) from 153 patients. In 123 (80,09%) we have registered more than 1 minor risk factors (1,7). Intravenous bisphosphonate therapy, is still most useful steadily in the last decade. It is due to the simple dosing regimens, the adherence, excellent compliance and persistence accurate for certain group of patients. This therapy have few adverse effects.
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ML28133 -A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION STUDY OF WA 19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS
(Македонско лекарско друштво = Macedonian Medical Association, 2017)
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Snezhana Mishevska-Percinkova
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Dubravka Antova
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Mimoza Kotevska Nikolova
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Anzhelika Stojanovska
Introduction. Biologic DMARDs (Disease Modifying Anti Rheumatic Drugs) have shown to be effective in the treatment of rheumatoid arthritis (RA) resistant to the use of synthetic DMARDs. The primary goal of this study was to assess the long-term safety of the use of tocilizumab in patients with early rheumatoid arthritis, moderate to severe disease activity. The secondary goal was to assess the efficiency of tocilizumab in achieving and maintaining clinical remission of the disease. Methods. ML28133 is a long-term, extended study of 13 patients with rheumatoid arthritis treated with tocilizumab. Two patients were male (15.4%), 11(84.61%) female. The average age of patients was 53.27+/-10.68. Patients received 8mg/kg tocilizumab i.v. every four weeks, 104 weeks overall. Safety was assessed following side effects, blood tests, physical examination and vital signs. Efficiency was assessed by achieving and maintaining clinical remission according to DAS28 (Disease Activity Score 28), global assessment of disease activity, VAS score and HAQ-DI (Health Activity Score) questionnaire. Results. Incidence of side effects was 76.92%. Infections were of special interest and were most common (15.3%). Four patients had serious adverse events, three of which associated with tocilizumab, and therapy was stopped. In 11 (84.6%) of the 13 treated patients clinical remission was achieved at times. At the end of the study, 8 out of 9 patients were in remission. Conclusion. The results have shown significant therapeutic effect of tocilizumab even in the most severe forms of the disease, which gives hope for its use as a monotherapy

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