Introduction. Ibandronic acid 150 mg/month (Bonviva) is a bisphosphonate that was licensed in the UK in 2005 for the treatment of postmenopausal osteoporosis in women. Prescription-event monitoring (PEM) is a non-interventional observational cohort technique conducted by the Drug Safety Research Unit to monitor the safety of newly marketed drugs prescribed in general practice in England. Objective. To describe the utilization characteristics of the patients prescribed ibandronic acid based on an analysis of a completed PEM cohort and to assess, where possible, if the product is being used outside terms of license of marketing approval. Methods. An observational cohort PEM study was conducted. Exposure data were collected from dispensed prescriptions issued by general practitioners (GPs) between November 2005 and November 2007. Outcome data (event, patient demographic and selected clinical characteristics) were collected by sending questionnaires (green forms) to GPs at least six months after the drug was first prescribed for an individual patient. Summary descriptive statistics were calculated. For this study, menopause was defined by female age at 50þ years. Results. The cohort consisted of 11,034 patients, of which 9% (n ¼ 991 patients) were reported to be men. Where age was specified, 4.8% (529/11,017) were aged ,50 years, of which 0.4% (2/529) were ,20 years. A total of 398 deaths occurred (3.6% cohort). Where specified, primary indications other than postmenopausal osteoporosis were reported for 11.7% (1218/10,446) patients including 'prophylaxis' (n ¼ 715), 'osteopenia' (n ¼ 231) and 'fracture spontaneous' (n ¼ 41). The most frequently reported clinical reasons for stopping treatment were 'intolerance' (n ¼ 176) and 'dyspepsia' (n ¼ 158). There was one pregnancy, reported as the reason for stopping treatment. Where dose was specified, 99.9% of patients (8625/8637) were prescribed the approved dose of 150 mg per month. Conclusion. This study has highlighted that some clinicians are prescribing this product outside the recommended terms of the licence. Use in premenopausal women and men was reported. This study assumed natural menopause occurred when aged 50þ years, though this does not apply for surgically menopausal women. Prescribing for indications other than osteoporosis was common, but unusual dose regimens were uncommon. Drug utilization studies are important in describing populations that may not have been adequately studied in terms of risk in premarketing development programmes and are important in the postmarketing risk management of medicines.
PAHs (polycyclic aromatic hydrocarbons) are a type of organic compounds arising from the incomplete combustion of natural materials. PAHs are harmful organic pollutants and are omnipresent in the environment. It is well known that some hydrocarbons are highly carcinogenic, and for this reason, they become of great interest recently. Anthropogenic activities are considered as the primary sources of PAHs including the combustion of refuse, exhaust of motor vehicles, contaminated food, and industrial food processing such as smoking processes and some cooking practices like grilling and roasting. Consumption or exposure of hydrocarbons will elicit neurodegenerative diseases such as Parkinson's. This chapter offers a general review of PAHs origins, properties, human health effects, and the PAHs consumption in diverse food types and the route of dietary intake. The other aim is to highlight the potential relationship between hydrocarbon exposure and the risk of Parkinson's disease through gut microbiota and oxidative stress.
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