The prescription of modified release oral dosage forms

The development of modified release oral dosage forms (retard dosage forms) is one of the main goals of pharmaceutical industry for drugs having a short half-life. The rationale of these dosage forms would be the reduction of interdose fluctuations throughout 24 hours owing to the decreased number of daily administrations. Consequently, the incidence of side effects is reduced and the patient compliance is improved. The drug prescription both in conventional and in retard dosage forms has been analysed in order to evaluate the impact of modified release dosage forms over the period from January 1990 to July 1993. As the analysis of the prescriptions shows, the consumption of the retard dosage forms is regularly increased. Usually, the preference toward retard dosage forms is different according to the drug and does not appear affected by the cost of the therapy

Comparative safety profiles of intravitreal bevacizumab, ranibizumab and pegaptanib: the analysis of the WHO database of adverse drug reactions

Purpose The purpose of this study is to conduct a comparative analysis of the suspected adverse drug reactions (ADRs) associated with intravitreal bevacizumab, ranibizumab and pegaptanib in the WHO database in order to have a real-life information on these drugs, which now is only based on data coming from clinical trials. Methods ADR reports for intravitreal use of bevacizumab, ranibizumab and pegaptanib from January 2002 to December 2012 were selected from the WHO-VigiBase. Reporting odds ratio (ROR) with confidence interval of 95 % and p value was calculated. The analysis was performed for drug-reaction pairs. The Medical Dictionary for Regulatory Activities (MedDRA) terminology for ADRs was used. Results The analysis was performed on 3180 reports corresponding to 7753 drug-reaction pairs. Significant RORs for endophthalmitis and uveitis (1.90, 95 % confidence interval (CI) 1.48–2.43, and 10.62, 6.62–17.05, respectively) were retrieved for bevacizumab, and cerebrovascular accident and myocardial infarction produced significant ROR (1.54, 1.14– 2.10 and 1.73, 1.18–2.53, respectively) for ranibizumab. Pegaptanib was significantly associated with visual impairment (1.98, 1.12–3.5, p=0.02), nausea (3.29, 1.57– 6.86, p<0.001), vomiting (2.91, 1.2–7.07, p=0.01) and drug hypersensitivity (8.75, 3.1–24.66, p<0.001). Conclusions Our data showed an elevated disproportionality for cardiovascular ADRs in patients treated with ranibizumab and for infective ocular reactions in those treated with bevacizumab. No relevant safety issues were identified for pegaptanib. These findings suggest bevacizumab as a suitable choice for AMD therapy due to its effectiveness similar to that of ranibizumab, its favourable safety profile and for its lower cost

Disease management of the metabolic syndrome in a community. Study design and process analysis on baseline data

ABSTRACT Background: A comprehensive lifestyle approach is suggested as first-line treatment for the individual features of the metabolic syndrome, but the results in community medicine are usually discouraging. No study has tested the feasibility of an integrated approach between general practitioners (GPs) and specialist centers. Methods: We report the process analysis on baseline data of a randomized study based on the integration between GPs, selecting patients on the basis of a pre-defined grid and specific targets, and a specialist center, providing informative material and arranging courses of counseling and cognitive-behavioral therapy, using a shared database. After initial visits by GPs for clinical assessment and motivation to treatment, patients were randomly assigned to: (a) prescriptive diet, managed by GPs; (b) counseling (four group lessons); (c) cognitive-behavioral treatment (12 group lessons), both managed by specialist center. Data of the first 503 subjects were compared with those of 139 cases self-referring to the specialist center for the treatment of obesity. Results: Subjects enrolled by GPs were more frequently males, had lower obesity grades, and a higher number of features of metabolic syndrome, compared with the control group. Only 10% of subjects randomized to counseling and 27% randomized to behavior declined participation in the intensive treatments; attendance at sessions averaged 90%. GPs were satisfied with their participation and reported that treatments met patients\u2019 needs. Conclusions: An integrated approach to lifestyle changes between GPs and a specialist center is feasible in the metabolic syndrome and may be cost-effective, considering the high burden of disease