Current medical research and opinion
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Meta Analysis Comparative Study
The importance of considering differences in study and patient characteristics before undertaking indirect treatment comparisons: a case study of siponimod for secondary progressive multiple sclerosis.
Background: Indirect treatment comparisons (ITCs) provide valuable evidence on comparative efficacy where head-to-head clinical trials do not exist; however, differences in patient populations may introduce bias. Therefore, it is essential to assess between-trial heterogeneity to determine the suitability of synthesizing ITC results. We provide an illustrative case study in multiple sclerosis (MS) where we assess the feasibility of conducting ITCs between siponimod and interferon beta-1b (IFN β-1b) and between siponimod and ocrelizumab. ⋯ ITCs were not feasible between siponimod and ocrelizumab because study designs and patient populations were too dissimilar to conduct a reliable ITC. Conclusions: This study highlights the importance of conducting a detailed feasibility assessment before undertaking ITCs to illuminate when excessive between-trial heterogeneity would cause biased results. MAIC was performed for siponimod and IFN β-1b in the absence of a head-to-head trial and was considered a more valid approach than a traditional ITC to examine comparative effectiveness.
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Randomized Controlled Trial
Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.
Objective: To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM). Methods: Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. ⋯ Conclusion: Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.
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Observational Study
Chemotherapy treatments, costs of care, and survival for elderly patients diagnosed with cervical cancer: an observational study.
Objective: To describe chemotherapy treatments, associated health care use and costs, and survival for women diagnosed with cervical cancer in the United States. Methods: This was a retrospective cohort study of patients aged ≥65 years, identified in linked Surveillance, Epidemiology, and End Results (SEER) and Medicare databases. Women with a new primary diagnosis of cervical cancer between January 2007 and December 2013 were followed until December 2014. ⋯ Conclusion: Elderly patients with advanced cervical cancer had a poor prognosis, with a median survival of 14 months or less, and had no standard of care for 2L therapy. Systemic chemotherapies pose a substantial economic burden in the range of $7000 to $9000 per patient per month. These results highlight the high unmet medical need among elderly patients with cervical cancer.
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Cardiac arrhythmias are the most common cardiac complication reported in pregnant women with and without structural heart disease (SHD); they are more frequent among women with SHD, such as cardiomyopathy and congenital heart disease (CHD). While older studies had indicated supraventricular tachycardia as the most common tachyarrhythmia in pregnancy, more recent data indicate an increase in the frequency of arrhythmias, with atrial fibrillation (AF) emerging as the most frequent arrhythmia in pregnancy, attributed to an increase in maternal age, cardiovascular risk factors and CHD in pregnancy. Importantly, the presence of any tachyarrhythmia during pregnancy may be associated with adverse maternal and fetal outcomes, including death. ⋯ Regarding the anticoagulation regimen in patients with AF, warfarin should be substituted with heparin during the first trimester, while direct oral anticoagulants are not indicated given the lack of data in pregnancy. Finally, for refractory arrhythmias, ablation and/or device implantation can be performed with current techniques in pregnant women, when needed, using minimal exposure to radiation. All these issues and relevant current guidelines are herein reviewed.
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Objective: This study aimed to describe the current status of lung cancer in Spain, including patient characteristics and in-hospital mortality, and to revise disease management and the direct medical costs of secondary care. Methods: A retrospective observational study was set to analyse anonymized primary and secondary care records of patients admitted with lung cancer in Spain between 2011 and 2016. Data were obtained from the Primary Care Dataset and the Centralised Hospital Discharge Database. ⋯ Cost per patient was higher in those diagnosed with a squamous cell carcinoma. Conclusions: Preventive and early detection measures are recommended, continuing to focus on females. In parallel, a multidisciplinary approach could optimize patient journey considering the presence of disease comorbidities, although its role in lung cancer mortality should be further explored.