Current medical research and opinion
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Objective: Autoinjectors are a convenient and efficient way to self-administer subcutaneous injections of biopharmaceuticals. Differences in device mechanical design can affect the autoinjector functionality and performance. This study investigates the performance differences of two single-spring-actuated autoinjectors. ⋯ Lastly, confirmation "click" sound of Emgality occurs 0.75-1.53 s after dose completion, while in Aimovig, the confirmation "click" sound occurs 0.26-0.46 s before dose completion. Conclusions: This study revealed performance differences between Emgality and Aimovig autoinjector devices, despite the fact that the delivery principle of these single-spring-actuated autoinjectors are the same. These differences may result in different risk of intramuscular injection and premature device removal, both of which need to be further verified in clinical trials.
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Background: In the United States, the number of new cases of hepatitis C virus infection has risen in recent years, driven largely by transmission among young white adults in their 20s and 30s. Herein, we report an integrated analysis of participants with hepatitis C virus infection aged ≤35 years from 12 phase II/III clinical trials of elbasvir/grazoprevir. Methods: Treatment-naive and -experienced adults with hepatitis C virus genotype 1 or 4 infection received elbasvir (50 mg/day)/grazoprevir (100 mg/day) for 12 weeks without ribavirin. ⋯ Safety was favorable, with the incidence of drug-related adverse events similar in younger and older participants (30.1% vs 30.6%). One participant (0.4%) aged ≤35 years and 15 participants (0.7%) aged >35 years discontinued treatment owing to adverse events. Conclusions: Elbasvir/grazoprevir for 12 weeks was safe and highly effective in participants aged ≤35 years with hepatitis C virus genotype 1 or 4 infection.
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Evidence suggests that integrase strand transfer inhibitors (INSTIs) are associated with greater weight gain than other antiretrovirals. This real-world study compares weight/body mass index (BMI) change between insured US patients with human immunodeficiency virus (HIV-1) initiating a protease inhibitor (PI) or INSTI. ⋯ Relative to INSTI, patients initiating a new PI were less likely to experience ≥5% weight/BMI gain post-index. Additionally, mean weight/BMI gain was lower in the PI than in the INSTI cohort.
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Objective: To estimate the prevalence and economic burden of hyperkalemia in the United States (US) Medicare population. Methods: Patients were selected from a 5% random sample of Medicare beneficiaries (01 January 2010-31 December 2014) to estimate the prevalence and economic burden of hyperkalemia. The prevalence for each calendar year was calculated as the number of patients with hyperkalemia divided by the total number of eligible patients per year. ⋯ Patients with hyperkalemia incurred on average $7208 higher 30-day costs ($8894 vs. $1685) and $19,348 higher 1-year costs ($34,362 vs. $15,013) than controls (both p < .001). Among patients with CKD and/or heart failure, the 30-day and 1-year total cost differences between cohorts were $7726 ($9906 vs. $2180) and $21,577 ($41,416 vs. $19,839), respectively (both p < .001). Conclusions: Hyperkalemia had an estimated prevalence of 2.6-2.7% in the Medicare population and was associated with markedly high healthcare costs.
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Comparative Study
FDA Approved vs. Pharmacy Compounded 17-OHPC - Current Issues for Obstetricians to Consider in Reducing Recurrent Preterm Birth.
17α-hydroxyprogesterone caproate (17-OHPC; MAKENA and generic equivalents) is the only FDA-approved medicine available to reduce the risk of preterm birth (PTB) in pregnant women with a singleton pregnancy who have a history of singleton spontaneous PTB. The FDA held an Advisory Committee meeting in October 2019 to review conflicting data between one positive U. S.-based study and one international study that failed to confirm the benefit. ⋯ Compounded drugs may be associated with significant safety risks, as poor compounding practices have resulted in serious problems with drug quality (lack of sterility or stability) and potency. Given the markedly higher rates of PTB in the U. S. compared with other industrialized nations, it is imperative that FDA-approved, GMP-produced 17-OHPC (FDA-approved brand and generic formulations) is available while additional research on its optimal use is conducted, without providers and patients resorting to pharmacist-compounded formulations for their high-risk pregnant patients.