Current medical research and opinion
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Multicenter Study Observational Study
Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study.
Objective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice. Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control. ⋯ Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was -1.2 (p = .066) and 0.0 (p = .915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was -0.5% (p < .001) and -0.9% (p < .001), respectively, and -1.5% (p < .001) in insulin-naive T2DM. Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice.
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Background: To investigate the association between Graves' disease (GD) and polycystic ovary syndrome (PCOS) and its comorbidities. Methods: Logistic regression was performed to determine the association between the two conditions. Cumulative incidence curves were obtained using the Kaplan-Meier method and log-rank test. ⋯ The adjusted hazard ratio for PCOS in patients with GD compared with patients without GD was 1.47 (95%CI = 1.09-1.98). The adjusted odds ratio of hyperlipidemia in patients with GD and PCOS was 2.18 (95%CI = 1.14-4.17) higher than that in patients with GD only. Conclusion: Our study demonstrated that women with GD could be at risk of developing PCOS; additionally, a higher incidence of comorbidities, including hyperlipidemia, was noted in women with GD and PCOS.
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Objectives: Childhood asthma is a common chronic illness that has been associated with mode of delivery. However, the effect of cesarean delivery alone does not fully account for the increased prevalence of childhood asthma. We tested the hypothesis that neuraxial anesthesia used for labor analgesia and cesarean delivery alters the risk of developing childhood asthma. ⋯ Additionally, a unit increase in the composite dose of local anesthetics and opioid analgesics administered via the spinal route was associated with a lower risk of asthma in both male (OR = 0.59, 95% CI = 0.36-0.96) and female children (OR 0.26, 95% CI 0.09-0.82). Conclusion: Our data suggest that peripartum exposure to neuraxial anesthesia may reduce the risk of childhood asthma primarily in males. Larger human studies and model systems with longer follow-up are required to elucidate these findings.
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Objective: To explore whether newly diagnosed iron deficiency anemia (IDA) is associated with subsequent systemic autoimmune disease onset. Methods: The study identified 22,440 patients who received a diagnosis of IDA between 2000 and 2012 from a random sample of 1 million people from Taiwan's National Health Insurance Research Database. The patients with IDA were randomly matched with 89,528 patients with no IDA by age, gender, and index year. ⋯ The autoimmune disease was significantly more likely to occur within 2 years after a new diagnosis of IDA. Conclusions: IDA significantly increases autoimmune disease risk, particularly in female patients and patients with certain comorbidities. Clinicians should conduct further clinical evaluations and laboratory tests of autoimmune disease in patients with IDA.
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Background: Chronic obstructive pulmonary disease (COPD) is one of the diseases that leads to a higher number of hospitalizations in internal medicine departments. These patients are usually older and have greater multimorbidity than COPD patients hospitalized in other departments, which hinders the implementation of clinical guidelines necessarily focused on the management of a single disease. Aims: To ascertain the opinion of Spanish internists on the management of COPD in scenarios in which the available evidence is sparse and to produce a consensus document designed to assist in decision-making in COPD patients with comorbidities treated in internal medicine services. ⋯ Of all the questions posed, a consensus was reached for 51 (57.3%) in the first round and for 67 (75.3%) in the second round. The result of the process is a series of 67 suggestions that may assist in the care of these patients. Conclusions: Our study allows us to ascertain the views of a large number of internists experienced in the management of COPD and to learn how the recommendations for guidelines are applied in clinical practice.