BackgroundIt is important to establish the cardiovascular (CV) safety profile of novel antidiabetic drugs.MethodsPooled analyses were performed of 20 randomized controlled studies (N = 9156) of saxagliptin as monotherapy or add-on therapy in patients with type 2 diabetes mellitus (T2DM) as well as a subset of 11 saxagliptin + metformin studies. Adjudicated major adverse CV events (MACE; CV death, myocardial infarction [MI], and stroke) and investigator-reported heart failure were assessed, and incidence rates (IRs; events/100 patient-years) and IR ratios (IRRs; saxagliptin/control) were calculated (Mantel-Haenszel method).ResultsIn pooled datasets, the IR point estimates for MACE and individual components of CV death, MI, and stroke favored saxagliptin, but the 95% CI included 1. IRR (95% CI) for MACE in the 20-study pool was 0.74 (0.45, 1.25). The Cox proportional hazard ratio (95% CI) was 0.75 (0.46, 1.21), suggesting no increased risk of MACE in the 20-study pool. In the 11-study saxagliptin + metformin pool, the IRR for MACE was 0.93 (0.44, 1.99). In the 20-study pool, the IRR for heart failure was 0.55 (0.27, 1.12).ConclusionsAnalysis of pooled data from 20 clinical trials in patients with T2DM suggests that saxagliptin is not associated with an increased CV risk.
Polycystic ovary syndrome (PCOS) affects ∼1 in 10 women worldwide. Hypomagnesemia may worsen insulin resistance (IR) due to the role magnesium (Mg) plays in glucose metabolism. This review explores the relation between serum Mg and IR among women with PCOS. A review of primary research focusing on both serum Mg and women with PCOS was conducted from 2011 to 2019. Studies reviewed included human subjects, written in the English language, and limited to community-dwelling women aged ≥18 y. A total of 7 articles were reviewed. The findings from 4 epidemiological analytic studies evaluating serum Mg status suggest there may be a relation between serum Mg concentrations and IR among women with PCOS. However, among the 3 experimental trials, Mg supplementation inconsistently impacted IR among women with PCOS. Women with PCOS are more likely to underconsume Mg-rich foods and have a greater likelihood of lower serum Mg concentrations. Although it remains unclear if dietary Mg and/or supplementation should be a nutritional strategy for all women with PCOS, current research indicates an association between adequate Mg status and improved IR. Further research evaluating dietary interventions and supplementation is warranted.
Bronchopulmonary dysplasia (BPD) is a common complication of premature birth and is associated with significant morbidity. Vitamin A supplementation has been suggested as a potential preventative measure against BPD due to its role in lung maturation and because preterm infants are particularly predisposed to vitamin A deficiency. The aim of this review was to determine whether vitamin A supplementation reduces BPD risk among preterm infants. PubMed, CINAHL, and Web of Science databases were searched with the keywords "bronchopulmonary dysplasia," "vitamin A," and "preterm infants" and with the time frame of 2006-2016, and 4 studies were selected for review per the inclusion criteria. Only 1 study found a significant reduction in BPD risk associated with vitamin A supplementation; however, 2 studies indicated a nonsignificant benefit and may have been underpowered to show statistical significance. One study revealed an increased risk of sepsis associated with vitamin A supplementation (for infants weighing >1000 g at birth), but no risk was seen with vitamin A supplementation in the other studies. Because intramuscular vitamin A has shown benefit with minimal risk, continued supplementation for preterm infants is warranted. Future studies aimed at assessing infant groups that are most likely to benefit from supplementation (based on birth weight or other conditions), as well as determining the optimal dosing while minimizing injections, would be beneficial.
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