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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Objective: This paper presents and discusses recent evidence on the pathophysiological mechanisms of pain. The role of tapentadol - an opioid characterized by an innovative mechanism of action (i.e. µ-opioid receptor [MOR] agonism and inhibition of noradrenaline [NA] reuptake [NRI]) - in the modulation of pain, and the most recent pharmacological evidence on this molecule (e.g. the µ-load concept) are also presented and commented upon. Methods: Narrative review. ⋯ Of note, the reduced µ-load of tapentadol limits the risk of opioid-related adverse events, such as gastrointestinal disturbances. Moreover, the NA component becomes predominant, at least, in some types of pain, with consequent specific clinical efficacy in the treatment of neuropathic and chronic pain. Conclusions: According to these characteristics, tapentadol appears suitable in the treatment of severe uncontrolled chronic pain characterized by both a nociceptive and a neuropathic component, such as osteoarthritis or back pain.
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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: 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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Objective: To examine the potential sociodemographic disparities in type 2 diabetes (T2D) management and care among US adult individuals, after controlling for clinical and behavioral factors. Methods: This was a retrospective cohort study of individuals with T2D (N = 4552) from a linked database of the National Health and Wellness Survey and a large US ambulatory electronic health record (EHR) database. This study period was between 1 January 2015 and 31 December 2018 and individuals were followed up for at least 6 months through EHR after the completion of the survey. ⋯ Uninsured individuals had a lower likelihood of receiving HbA1c, BP, or LDL-C testing compared with commercial insurers. Individuals with low income were more likely to have higher ER visits and hospitalizations. Conclusion: Potential sociodemographic disparities exist in T2D management and care in the US, indicating the needs for improvement in healthcare access, educational and behavioral programs, as well as disease and treatment management in these subgroups.