Clinical therapeutics
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Clinical therapeutics · Mar 2019
Multicenter StudyA New Sustained-release, 3-Month Leuprolide Acetate Formulation Achieves and Maintains Castrate Concentrations of Testosterone in Patients With Prostate Cancer.
This clinical trial investigated the effectiveness, pharmacokinetic properties, and safety profile of leuprolide acetate 22.5-mg depot, a new 3-month leuprolide depot formulation, as androgen deprivation therapy for patients with prostate cancer. ⋯ Leuprolide acetate 22.5-mg depot was effective in achieving and maintaining testosterone suppression. Safety and tolerability profiles were consistent with established profiles of androgen deprivation therapy. Clinical Trials.gov identifier: NCT01415960.
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Clinical therapeutics · Mar 2019
Outpatient Antimicrobial Stewardship: Targets for Community-acquired Pneumonia.
Community-acquired pneumonia (CAP) is one of the leading causes of death in the United States. The primary objective of this study was to determine the prevalence of appropriate diagnosis and treatment of outpatients treated for CAP. Knowledge of problems with CAP treatment can be helpful in developing stewardship initiatives to improve care of outpatients with CAP. ⋯ Improvement in prescribing is needed for CAP. An outpatient stewardship program that targets patients with risk factors for DRSP would improve adherence to guidelines.
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Clinical therapeutics · Mar 2019
Observational StudyComparative Effectiveness of Pemetrexed-platinum Doublet Chemotherapy With or Without Bevacizumab as First-line Therapy for Treatment-naive Patients With Advanced Nonsquamous Non-small-cell Lung Cancer in China.
Bevacizumab plus platinum-based doublet chemotherapy is recommended by the National Comprehensive Cancer Network as a category 1 regimen and is widely used in patients with advanced nonsquamous non-small-cell lung cancer (NS-NSCLC). In China, a common first-line chemotherapy for NS-NSCLC is the pemetrexed-platinum doublet regimen (Pem-Pt). However, limited evaluation exists to show the effectiveness of the Pem-Pt + bevacizumab (Bev) regimen in advanced NS-NSCLC. This study describes the treatment patterns, effectiveness, and safety profile of Pem-Pt + Bev in patients with NS-NSCLC in China in clinical practice. ⋯ These results from clinical practice further support the concept that pemetrexed-platinum doublet plus bevacizumab could be an effective and tolerable regimen in patients with advanced NS-NSCLC in China.
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Clinical therapeutics · Mar 2019
Risk Factors of QTc Prolongation in Women With Hormone Receptor‒positive/Human Epidermal Growth Factor Receptor 2‒negative Metastatic Breast Cancer: A Retrospective Analysis of Health Care Claims Data.
In addition to biomarker status, treatment selection for metastatic breast cancer (mBC) includes individual patient and clinical characteristics such as tumor burden, timing of disease recurrence, and comorbidities. Women with mBC may take medications that can increase the risk of drug-induced toxicities, including prolongation of cardiac repolarization (prolongation of QT interval). Corrected QT (QTc) prolongation, a toxicity associated with many cancer treatments, can lead to potentially life-threatening ventricular arrhythmias. As such, it is important to identify patients at risk for QTc prolongation due to comorbid conditions, concomitant medications, or electrolyte abnormalities. This real-world study estimated the proportion of women with hormone receptor‒positive (HR+)/human epidermal growth factor receptor 2‒negative (HER2‒) mBC who may be at risk of developing QTc prolongation. Results in the elderly are also included. ⋯ This analysis of real-world data indicates that almost 1 in 3 women with HR+/HER2‒ mBC had congenital long QT syndrome, cardiovascular disease, and/or electrolyte abnormalities or received a concomitant medication that could increase the risk of developing QTc prolongation. The risk factors for congenital long QT syndrome, cardiovascular disease, or electrolyte abnormalities were more common in older patients. This analysis emphasizes the importance of individualized benefit/risk assessment during treatment decisions, especially when considering drugs with known or possible QTc prolongation risk.
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Clinical therapeutics · Feb 2019
Randomized Controlled TrialA Phase I, Randomized, Crossover, Open-label Study of the Pharmacokinetics of Solriamfetol (JZP-110) in Healthy Adult Subjects With and Without Food.
Solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, is currently being evaluated for the reduction of sleepiness and improvement of wakefulness in patients with narcolepsy and obstructive sleep apnea. The purpose of this study was to evaluate the effect of food on the pharmacokinetic (PK) parameters and bioavailability of solriamfetol at the highest intended therapeutic dose in healthy adults and to characterize its renal excretion under fasting conditions. ⋯ Solriamfetol relative bioavailability was bioequivalent in the fed and fasted conditions, showing that solriamfetol can be taken without regard to meals; furthermore, tolerability was similar in both conditions. Renal excretion of unchanged drug is the primary route of elimination.