Introduction: Studies have used various epidemiological approaches to study the association between central nervous system (CNS) drugs use in pregnancy and CNS outcomes in children. Clinical adverse effects were generally focused on, while, variations in methodologies were not given sufficient attention. Objective: To review the methodological characteristics of existing studies in order to identify any limitations and recommend further research.

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The Cochrane library #1 MeSH descriptor: [Safety] explode all trees #2 Safet* (Word variations have been searched) #3 Side effect* (Word variations have been searched) #4 Undesirable effect* (Word variations have been searched) #5 Toxicit* (Word variations have been searched) #6 Adverse drug reaction* (Word variations have been searched) #7 Adverse drug effect* (Word variations have been searched) #8 Adverse drug outcome* (Word variations have been searched) #9 Adverse drug event* (Word variations have been searched) #10 Tolerab* (Word variations have been searched)

Study selection: Of 38 reports initially identified as being of potential interest, 13 studies met our inclusion criteria: English observational studies that examined the association between gestational antipsychotic use and congenital malformations in children.Data extraction: Data were extracted independently by 2 investigators including the publication year, study site, study period, data source, study design, sample size, medication exposure, exposure period and pregnancy definition, exposure as well as outcome ascertainment, selection of study and comparison group, confounding adjustment, statistical analysis, and method of linkage between mother and children.Risk estimates were pooled using a random-effect model and the I 2 statistic was used to evaluate the degree of heterogeneity.Results: Thirteen studies met our systematic review inclusion criteria. Six studies with a total of 2 515 272 pregnancy episodes were included in our meta-analysis, which provided a pooled adjusted risk ratio of 1.23, 95% confidence interval: 0.96-1.58. The I 2 result showed moderate heterogeneity between studies (I 2 = 35.2%, P = .173). Conclusion:We did not find strong evidence of an association between prenatal exposure to antipsychotic medications and the risk of congenital malformations in children. We recommend further studies investigate this association, focusing on Abbreviations: aRR, adjusted risk ratio; CI, confidence interval; FGA, first-generation antipsychotic; NOS, Newcastle-Ottawa Scale; OR, odds ratio; PS, propensity score; RR, risk ratio; SGA, second-generation antipsychotic.

BackgroundThe combination pharmacotherapy of antiplatelet agents, lipid-modifiers, ACE inhibitors/ARBs and beta-blockers are recommended by international guidelines. However, data on effectiveness of the evidence-based combination pharmacotherapy (EBCP) is limited.ObjectivesTo determine the effect of EBCP on mortality and Cardiovascular events in patients with Coronary Heart Disease (CHD) or cerebrovascular disease.MethodsPublications in EMBASE and Medline up to October 2018 were searched for cohort and case-control studies on EBCP for the secondary prevention of cardiovascular disease. The main outcomes were all-cause mortality and major cardiovascular events. Meta-analyses were performed based on random effects models.Results21 studies were included. Comparing EBCP to either monotherapy or no therapy, the pooled risk ratios were 0.60 (95% confidence interval 0.55 to 0.66) for all-cause mortality, 0.70 (0.62 to 0.79) for vascular mortality, 0.73 (0.64 to 0.83) for myocardial infarction and 0.79 (0.68 to 0.91) for cerebrovascular events. Optimal EBCP (all 4 classes of drug prescribed) had a risk ratio for all-cause mortality of 0.50 (0.40 to 0.64). This benefit became more dilute as the number of different classes of drug comprising EBCP was decreased—for 3 classes of drug prescribed the risk ratio was 0.58 (0.49 to 0.69) and for 2 classes, the risk ratio was 0.67 (0.60 to 0.76).ConclusionsEBCP reduces the risk of all-cause mortality and cardiovascular events in patients with CHD or cerebrovascular disease. The different classes of drugs comprising EBCP work in an additive manner, with optimal EBCP conferring the greatest benefit.