Objective:To determine the adverse drug reaction (ADR) profile of risperidone and their association with dopamine (DRD2 − 141 C Ins/Del/rs1799732) and serotonin receptor (5HTR2C −759 C>T/rs3813929) gene polymorphisms in patients with schizophrenia.Materials and Methods:The study was conducted among 289 patients who were diagnosed with schizophrenia and were on treatment with risperidone (4–8 mg/day)-based therapy for a minimum of 4 weeks. Genotyping was carried by real-time quantitative polymerase chain reaction. All the patients were observed for the occurrences of ADRs during the study. Changes in prolactin levels and body weight were analyzed for a subgroup of 102 and 97 patients, respectively.Results:Risperidone-induced extrapyramidal symptoms (EPSs) were seen in 36.7% of patients. Among them, tremors were the most common symptom 31.8%. Risperidone-induced hyperprolactinemia and weight gain were seen in 87.2% and 53.6% in subgroup patients. Adverse effects such as sedation, gastrointestinal effects, and amenorrhea were seen in 9.7% (28/289), 5.1% (15/289), and 6.1% (7/114), respectively. Occurrence of DRD2 − 141 Ins/Del and Del/Del polymorphisms were significantly associated with increased prolactin levels in response to risperidone (odds ratio [OR] = 10.45; 95% confidence interval = 1.29–84.89, P = 0.004). No such association was observed with 5HTR2C (−759 C>T) polymorphism. Weight gain and EPS were not associated with the above genetic polymorphisms.Conclusion:Hyperprolactinemia, weight gain, and EPSs (>36.7%) were common adverse effects of risperidone. DRD2 – 141C Ins/Del and Del/Del polymorphisms were significantly associated with increased prolactin levels (OR = 10.45) in response to risperidone.
Background Poor quality use of medicines (QUM) has adverse outcomes. Governments' implementation of essential medicines (EM) policies is often suboptimal and there is limited information on which policies are most effective. Methods We analysed data on policy implementation from World Health Organisation (WHO) surveys in 2007 and 2011, and QUM data from surveys during 2006-2012 in developing and transitional countries. We compared QUM scores in countries that did or did not implement specific policies and regressed QUM composite scores on the numbers of policies implemented. We compared the ranking of policies in this and two previous studies, one from the same WHO databases (2003-2007) the other from data obtained during country visits in SouthEast Asia (2010-2015). The rankings of a common set of 17 policies were correlated and we identified those that were consistently highly ranked. Findings Fifty-three countries had data on both QUM and policy implementation. Forty policies were associated with effect sizes ranging from +13% to-5%. There was positive correlation between the composite QUM indicator and the number of policies reported implemented: (r) = 0.437 (95% CI 0.188 to 0.632). Comparison of policy rankings between the present and previous studies showed positive correlation with the WHO 2003-7 study: Spearman's rank correlation coefficient 0.498 (95% CI 0.022 to 0.789). Across the three studies, five policies were in the top five ranked positions 11 out of a possible 15 times: drugs available free at the
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