The Influence of Obesity and Associated Fatty Acids on Placental Inflammation.
Abstract PURPOSE: Maternal obesity, affecting nearly 1 in 4 pregnancies, is associated with increased circulating saturated fatty acids, such as palmitate. These fatty acids are implicated in placental inflammation, which may in turn exacerbate both maternal-fetal tolerance and responses to pathogens, such as group B Streptococcus. In this review, we address the question, "How do obesity and associated fatty acids influence placental inflammation?" METHODS: In this narrative review, we searched PubMed and Google Scholar using combinations of the key words placental inflammation or pregnancy and lipi...
Source: Clinical Therapeutics - January 21, 2021 Category: Drugs & Pharmacology Authors: Eastman AJ, Moore RE, Townsend SD, Gaddy JA, Aronoff DM Tags: Clin Ther Source Type: research

Understanding Racial Disparities of Preterm Birth Through the Placenta.
This article reviews existing literature and current research gaps. Opportunities are discussed for future placental research that may reveal novel mechanisms leading to the development of new approaches in the prevention and management of preterm birth and its outcomes. PMID: 33483135 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - January 19, 2021 Category: Drugs & Pharmacology Authors: Matoba N, Mestan KK, Collins JW Tags: Clin Ther Source Type: research

Eating Disorders Update 2021: What We Know, What We Don't Know, and Next Steps.
PMID: 33478802 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - January 18, 2021 Category: Drugs & Pharmacology Authors: Citrome L, Grilo CM Tags: Clin Ther Source Type: research

Artificial Intelligence in Pharmacovigilance: Scoping Points to Consider.
Abstract Artificial intelligence (AI), a highly interdisciplinary science, is an increasing presence in pharmacovigilance (PV). A better understanding of the scope of artificial intelligence in pharmacovigilance (AIPV) may be advantageous to more sharply defining, for example, which terms, methods, tasks, and data sets are suitably subsumed under the application of AIPV. Accordingly, this article explores relevant points to consider regarding defining the scope of AIPV and offers a potential working definition of the scope of AIPV. PMID: 33478803 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - January 18, 2021 Category: Drugs & Pharmacology Authors: Hauben M, Hartford CG Tags: Clin Ther Source Type: research

Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Henagliflozin, a Novel Selective Inhibitor of Sodium-Glucose Cotransporter 2, in Healthy Subjects following Single- and Multiple-dose Administration.
Abstract BACKGROUND: Henagliflozin, a novel selective inhibitor of sodium-glucose cotransporter 2, is under development as a treatment for type 2 diabetes mellitus. PURPOSE: To evaluate the tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of henagliflozin in healthy Chinese volunteers. METHODS: Two clinical studies were conducted. One was a single ascending dose (SAD) study (2.5-200 mg) involving 80 healthy subjects, and the other was a multiple ascending dose (MAD) study (1.25-100 mg for 10 days) involving 48 healthy subjects. The tolerability, PK profiles of henagliflozin...
Source: Clinical Therapeutics - January 13, 2021 Category: Drugs & Pharmacology Authors: Zhang YF, Liu YM, Yu C, Wang YT, Zhan Y, Liu HY, Zou JJ, Jia JY, Chen Q, Zhong DF Tags: Clin Ther Source Type: research

Influence of ADRB1, ADRB2, and COMT Genetic Polymorphisms on Postoperative Outcomes of Patients Undergoing Cardiac Valve Surgery.
Abstract PURPOSE: The aim of this study is to prospectively investigate the influence of ADRB and COMT gene polymorphisms on postoperative outcomes of patients undergoing cardiac surgery. METHODS: This prospective cohort study included 223 patients undergoing elective cardiac valve surgery using cardiopulmonary bypass. Demographic information, intraoperative data, postoperative data, and blood samples were collected. Patients were genotyped for single-nucleotide polymorphisms (SNPs) of ADRB1 rs1801253, ADRB2 rs1042713, and COMT rs4680. Major adverse cardiovascular and cerebrovascular events (MACCEs) were used...
Source: Clinical Therapeutics - January 12, 2021 Category: Drugs & Pharmacology Authors: Dai S, Ma W, Qin G, Wang L, Wang E Tags: Clin Ther Source Type: research

Targeting the Dysfunctional Placenta to Improve Pregnancy Outcomes Based on Lessons Learned in Cancer.
Abstract In recent decades, our understanding of the disrupted mechanisms that contribute to major obstetrical diseases, including preeclampsia, fetal growth restriction, preterm birth, and gestational diabetes, has increased exponentially. Common to many of these obstetric diseases is placental maldevelopment and dysfunction; the placenta is a significant component of the maternal-fetal interface involved in coordinating, facilitating, and regulating maternal and fetal nutrient, oxygen and waste exchange, and hormone and cytokine production. Despite the advances in our understanding of placental development and f...
Source: Clinical Therapeutics - January 11, 2021 Category: Drugs & Pharmacology Authors: Wilson RL, Jones HN Tags: Clin Ther Source Type: research

Cost-effectiveness of Oral Versus Intravenous Ibuprofen Therapy in Preterm Infants With Patent Ductus Arteriosus in the Neonatal Intensive Care Setting: A Cohort-based Study.
This study aimed to evaluate the clinical and economic impact of oral ibuprofen versus intravenous ibuprofen for PDA among preterm infants. METHODS: This retrospective, cohort-based pilot study examined the clinical and economic associations of oral versus intravenous ibuprofen for PDA. A decision-analytic model was constructed, from the hospital perspective, to follow the oral versus intravenous administrations of ibuprofen for PDA and their clinical and economic consequences. The course regimen of either formulation was an initial 10 mg/kg followed by 5 mg/kg at 24- and 48-h intervals. Clinical and resourc...
Source: Clinical Therapeutics - January 8, 2021 Category: Drugs & Pharmacology Authors: Abushanab D, Rouf PA, Al Hail M, Kamal R, Viswanathan B, Parappil H, Elkassem W, Al-Shaibi S, Al-Badriyeh D Tags: Clin Ther Source Type: research

The Role of Advanced Practice Providers in the Care of Nonalcoholic Fatty Liver Disease.
This article reviews the nature and scope of APP practice, the specific needs posed by NAFLD, and the evidence supporting the comparative advantages of APPs in optimizing the outcomes of patients with NAFLD. Our goal is to show how APPs are uniquely suited to addressing the needs of patients with NAFLD who are seen in hepatology practice, with an emphasis on training philosophy and behavioral intervention. PMID: 33388173 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - December 30, 2020 Category: Drugs & Pharmacology Authors: Gajos A, Tapper EB Tags: Clin Ther Source Type: research

Low Serum Zinc Levels and Associated Risk Factors in Hospitalized Patients Receiving Oral or Enteral Nutrition: A Case-Control Study.
Abstract PURPOSE: To assess whether hospitalization and feeding strategy impact the risk of hypozincemia and associated risk factors. METHODS: In this case-control study, serum zinc levels were compared between inpatients fed oral nutrition (ON) (n = 76) or enteral nutrition (EN) (n = 191) with outpatient controls (n = 1095). FINDINGS: Zinc levels were significantly lower in inpatients receiving EN compared with those receiving ON (P = 0.001). Significant (P 60 years of age fed EN had a zinc concentration
Source: Clinical Therapeutics - December 30, 2020 Category: Drugs & Pharmacology Authors: Pereira CGM, Santana ERS, Ramos JER, da Silva HMBS, Nunes MAP, Forbes SC, Santos HO Tags: Clin Ther Source Type: research

Bempedoic Acid: A New Tool in the Battle Against Hyperlipidemia.
This article discusses the pharmacology of bempedoic acid, the trials that led to United States Food and Drug Administration (FDA) approval of its use, and the overall safety and efficacy of this therapy in heterozygous familial hypercholesterolemia, established atherosclerotic cardiovascular disease (ASCVD), and hyperlipidemia. METHODS: A database search of PubMed and ClinicalTrials.gov was conducted for articles published between January 2012 to September 2020 and containing the key words bempedoic acid, ezetimibe, Nexletol and Nexlizet. Trials from the CLEAR series were selected, as they played a pivotal role in th...
Source: Clinical Therapeutics - December 28, 2020 Category: Drugs & Pharmacology Authors: Powell J, Piszczatoski C Tags: Clin Ther Source Type: research

Relationship Between Vitamin D Level and Mortality in Adults With Psoriasis: A Retrospective Cohort Study of NHANES Data.
This study investigated the association between 25(OH)D level and all-cause mortality in US adults with psoriasis. METHODS: Data from NHANES (1999-2014 and mortality data through December 31, 2015) were analyzed. Quartiles of 25(OH)D level were created based on 25(OH)D levels among patients. Cox proportional hazards models were used for estimating hazard ratios (95% CI) for all-cause mortality. FINDINGS: A total of 82,091 participants were enrolled in the NHANES study from 1999 to 2014. Overall, 610 patients with psoriasis were identified in NHANES. The mean (SD) duration of follow-up was 5.61 (3.38) years (3427....
Source: Clinical Therapeutics - December 24, 2020 Category: Drugs & Pharmacology Authors: Fu H, Tang Z, Wang Y, Ding X, Rinaldi G, Rahmani J, Xing F Tags: Clin Ther Source Type: research

State of the Art: The Therapeutic Approaches to Bulimia Nervosa.
Abstract PURPOSE: Bulimia nervosa (BN) is an eating disorder characterized by binge eating, inappropriate compensatory behaviors, and body image concerns in persons at or above a healthy weight. BN is a serious disorder with medical sequelae and marked psychosocial impairment. To reduce and eliminate symptoms of BN, psychological and pharmacologic treatments for BN have been developed. We review the current state-of-the-art treatments for BN. METHODS: We conducted a narrative review of the BN treatment literature to synthesize the current evidence base, provide recommendations, and propose future directions f...
Source: Clinical Therapeutics - December 23, 2020 Category: Drugs & Pharmacology Authors: Hagan KE, Walsh BT Tags: Clin Ther Source Type: research

Effects of Postoperative Percutaneous Coronary Intervention, Pharmacologic Treatment, and Predisposing Factors on Clinical Outcomes in Patients With and Without Type 2 Diabetes Along With Critical Limb Ischemia.
Abstract PURPOSE: Critical limb ischemia (CLI) has been identified as being connected to rates of cardiovascular mortality and lower extremity amputation (LEA). This prospective study investigated the effects of percutaneous coronary intervention (PCI), pharmacologic treatment, and predisposing factors on clinical outcomes in patients with and without type 2 diabetes mellitus (DM) along with CLI after endovascular intervention. METHODS: 249 consecutive patients with CLI (Fontaine stages III-IV) received pharmacologic treatment after successful endovascular intervention. Their primary patency rates of infrapop...
Source: Clinical Therapeutics - December 22, 2020 Category: Drugs & Pharmacology Authors: Lee CY, Wu TC, Lin SJ Tags: Clin Ther Source Type: research

Placental Impact of Dietary Supplements: More Than Micronutrients.
Abstract PURPOSE: Maternal nutrition is a key modifier of fetal growth and development. However, many maternal diets in the United States do not meet nutritional recommendations. Dietary supplementation is therefore necessary to meet nutritional goals. The effects of many supplements on placental development and function are poorly understood. In this review, we address the therapeutic potential of maternal dietary supplementation on placental development and function in both healthy and complicated pregnancies. METHODS: This is a narrative review of original research articles published between February 1970 ...
Source: Clinical Therapeutics - December 22, 2020 Category: Drugs & Pharmacology Authors: Rasool A, Alvarado-Flores F, O'Tierney-Ginn P Tags: Clin Ther Source Type: research

Dose Optimization of Vancomycin Using a Mechanism-Based Exposure-Response Model in Pediatric Infectious Disease Patients.
This study aimed to determine the appropriate vancomycin dosage, considering patient size and organ maturation, by simulating the bacterial count and biomarker level for drug administration in pediatric patients with gram-positive bacterial (GPB) infections. METHODS: Natural language processing for n-gram analysis was used to detect appropriate pharmacodynamic (PD) markers in infectious disease patients. In addition, a mechanism-based model was established to describe the systemic exposure and evaluate the PD marker simultaneously in pediatric patients. A simulation study was then conducted by using a mechanism-based ...
Source: Clinical Therapeutics - December 22, 2020 Category: Drugs & Pharmacology Authors: Jung WJ, Park JH, Goo S, Chae JW, Kim J, Shin S, Yun HY Tags: Clin Ther Source Type: research

Psychotherapy and Medications for Eating Disorders: Better Together?
This study was a critical review of randomized controlled trials (RCTs) testing combined psychological and pharmacologic treatment approaches for eating disorders with a focus on anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). FINDINGS: For AN, 3 of the 4 RCTs reported no significant advantage for combining treatments; the fourth reported a statistically significant, albeit clinically modest, advantage. For BN, 10 of the 12 RCTs reported no significant advantage for combining treatments; 2 RCTs found that combining fluoxetine with specific psychological treatments enhanced outcomes relati...
Source: Clinical Therapeutics - December 17, 2020 Category: Drugs & Pharmacology Authors: Reas DL, Grilo CM Tags: Clin Ther Source Type: research

Disordered Eating Is All About Context.
PMID: 33341240 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - December 17, 2020 Category: Drugs & Pharmacology Authors: Jhaveri R Tags: Clin Ther Source Type: research

Short-Term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial.
This study investigated the effect of alfacalcidol treatment on the length of hospital stay in patients undergoing valve-replacement surgery. METHODS: This single-center, randomized, open-label, controlled trial was conducted at El-Demerdash Cardiac Academy Hospital (Cairo, Egypt), from April 2017 to January 2018. This study included adult patients undergoing valve-replacement surgery who were randomized to the intervention group (n = 47; alfacalcidol 2 μg/d started 48 h before surgery and continued throughout the hospital stay) or to the control group (n = 42). The primary end points ...
Source: Clinical Therapeutics - December 15, 2020 Category: Drugs & Pharmacology Authors: Naguib SN, Sabry NA, Farid SF, Alansary AM Tags: Clin Ther Source Type: research

Binge Eating Disorder: A Psychiatrist's Commentary on Clinical Considerations.
Abstract PURPOSE: Of the 3 major eating disorders, anorexia nervosa, bulimia nervosa, and binge eating disorder (BED), BED is the most common and exists in the practices of most primary care and psychiatric clinicians. However, BED often goes unrecognized and thus untreated. METHODS: Reviewed in this commentary are the basic elements in the diagnosis of BED, demographic and clinical characteristics, screening options, the importance of comorbidities, pathophysiology, and available treatments. FINDINGS: Psychological treatments, including cognitive-behavioral therapy, interpersonal therapy, and behavioral...
Source: Clinical Therapeutics - December 8, 2020 Category: Drugs & Pharmacology Authors: Citrome L Tags: Clin Ther Source Type: research

Current Therapeutic Approaches to Anorexia Nervosa: State of the Art.
Abstract Anorexia nervosa (AN) is a devastating psychiatric disorder characterized by extreme restriction of food intake and low body weight, both associated with significant medical and psychological morbidity. The clinical severity of AN has prompted the consideration and study of behavioral and pharmacological treatments in efforts to establish empirically based methods to reduce the burden of the disorder. Among adolescents, family-based treatment is considered a first-line behavioral treatment. Research continues to explore the efficacy of family-based treatment and predictors of treatment response to further...
Source: Clinical Therapeutics - December 5, 2020 Category: Drugs & Pharmacology Authors: Muratore AF, Attia E Tags: Clin Ther Source Type: research

Citicoline as Adjuvant Therapy in Parkinson's Disease: A Systematic Review.
Abstract PURPOSE: Parkinson disease (PD) medications are not readily available in all countries. Citicoline increases dopamine synthesis and inhibits dopamine uptake. This systematic review aims to synthesize current existing evidence on the efficacy of citicoline adjunctive therapy in improving PD symptoms. METHODS: An extensive literature search of Scopus, Embase, PubMed, Cochrane Library, and Google Scholar was conducted for articles published on or before December 31, 2019. The studies were screened and selected by 2 independent reviewers. We included all studies that explored the efficacy of citicoline a...
Source: Clinical Therapeutics - December 3, 2020 Category: Drugs & Pharmacology Authors: Que DS, Jamora RDG Tags: Clin Ther Source Type: research

Reduced Mortality After Oral Polio Vaccination and Increased Mortality After Diphtheria-Tetanus-Pertussis Vaccination in Children in a Low-Income Setting.
aby P Abstract PURPOSE: The diphtheria-tetanus-pertussis vaccine (DTP) and oral polio vaccine (OPV) were introduced in children 3 of 5 months of age in 1981-1983 in Bandim, in the capital of Guinea-Bissau. Because DTP has been linked to deleterious nonspecific effects (NSEs) and OPV to beneficial NSEs, we followed up this cohort to 3 years of age and examined the effects of DTP with OPV on all-cause mortality and the interactions of DTP and OPV with the measles vaccine (MV). METHODS: DTP and OPV were offered at 3 monthly community weighing sessions. Vaccination groups were defined by the last vaccine received...
Source: Clinical Therapeutics - December 2, 2020 Category: Drugs & Pharmacology Authors: Øland CB, Mogensen SW, Rodrigues A, Benn CS, Aaby P Tags: Clin Ther Source Type: research

Conversations With the Editors: Promoting Science and Combating Anti-science: The Past and Present of the Antivaccine Movement.
PMID: 33272642 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 30, 2020 Category: Drugs & Pharmacology Authors: Baker J, Jhaveri R Tags: Clin Ther Source Type: research

Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: a Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial.
This study compared the efficacy and safety of controlled-release pregabalin (GLA5PR GLARS-NF1 tablets) with those of an immediate-release pregabalin capsule after 12 weeks' administration to patients with peripheral neuropathic pain. METHODS: In this multicenter, randomized, double-blind, active-controlled, parallel-group, Phase III study, the primary outcome was to confirm that a single treatment with the study drug (after the evening meal) is clinically noninferior to the control drug (BID regimen) at improving the mean Daily Pain Rating Scale score for treating peripheral neuropathic pain. Secondary outcomes were ...
Source: Clinical Therapeutics - November 30, 2020 Category: Drugs & Pharmacology Authors: Lee MK, Jeon Y, Choi SS, Lee PB, Kim YC, Suh JH, Sim SE, Song SO, Ko Y, Yu JM, Min K, Lee JH Tags: Clin Ther Source Type: research

Comorbidities, Age, and Polypharmacy Limit the Use by US Older Adults with Nocturia of the Only FDA-approved Drugs for the Symptom.
Abstract PURPOSE: The goal of this study was to determine if the US adult population with nocturia (waking from sleep at night to void) can easily take medications (desmopressin acetate) approved by the US Food and Drug Administration for nocturia. The study examined: (1) the prevalence of comorbid conditions, laboratory abnormalities, and concomitant medications that increase risk of desmopressin use; and (2) whether these factors are associated with age or nocturia frequency. METHODS: Using a cross-sectional analysis of four US National Health and Nutrition Examination Survey (NHANES) waves (2005-2012), a t...
Source: Clinical Therapeutics - November 27, 2020 Category: Drugs & Pharmacology Authors: Suvada K, Plantinga L, Vaughan CP, Markland AD, Mirk A, Burgio KL, Erni SM, Ali MK, Okosun I, Young H, Goode PS, Johnson TM Tags: Clin Ther Source Type: research

The Neurobiology of Binge-eating Disorder Compared with Obesity: Implications for Differential Therapeutics.
Abstract PURPOSE: Emerging work indicates divergence in the neurobiologies of binge-eating disorder (BED) and obesity despite their frequent co-occurrence. This review highlights specific distinguishing aspects of BED, including elevated impulsivity and compulsivity possibly involving the mesocorticolimbic dopamine system, and discusses implications for differential therapeutics for BED. METHODS: This narrative review describes epidemiologic, clinical, genetic, and preclinical differences between BED and obesity. Subsequently, this review discusses human neuroimaging work reporting differences in executive fu...
Source: Clinical Therapeutics - November 27, 2020 Category: Drugs & Pharmacology Authors: Boswell RG, Potenza MN, Grilo CM Tags: Clin Ther Source Type: research

Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1  Year of Treatment in the PROMISE-1 Study.
Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. Clin Ther. 2020 Nov 26;: Authors: Smith TR, Janelidze M, Chakhava G, Cady R, Hirman J, Allan B, Pederson S, Smith J, Schaeffler B Abstract PURPOSE: The Prevention of Migraine via Intravenous ALD403 Safety and Efficacy 1 (PROMISE-1) study was a phase III, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability, and pharmacokinetic properties of repeat intravenous (IV) doses of the calcitonin gene-related peptide‒targeted monoclonal a...
Source: Clinical Therapeutics - November 26, 2020 Category: Drugs & Pharmacology Authors: Smith TR, Janelidze M, Chakhava G, Cady R, Hirman J, Allan B, Pederson S, Smith J, Schaeffler B Tags: Clin Ther Source Type: research

Real-time Assessment of the Development and Function of the Placenta Across Gestation to Support Therapeutics in Pregnancy.
Abstract The placenta is vital to the health and development of the fetus, serving to deliver oxygen and nutrients, facilitate the removal of waste products, and provide a barrier to pathogens and other harmful substances present in the maternal circulation. When these processes fail to operate normally, they can lead to complications of pregnancy such as preeclampsia or fetal growth restriction. The development of novel therapeutics for the mother, fetus, or placenta requires a mechanistic understanding of the development and functions of the placenta. For the obstetric clinician, being able to monitor the placen...
Source: Clinical Therapeutics - November 24, 2020 Category: Drugs & Pharmacology Authors: Weinberg DH Tags: Clin Ther Source Type: research

Rethinking Our Approach to the Public Mistrust of Science.
PMID: 33234287 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 21, 2020 Category: Drugs & Pharmacology Authors: Maron JL Tags: Clin Ther Source Type: research

Conversations With the Editors: Promoting Science and Combating Antiscience: A Focus on Communication Strategies.
PMID: 33234288 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 21, 2020 Category: Drugs & Pharmacology Authors: Lindenfeld L, Jhaveri R Tags: Clin Ther Source Type: research

The 5% Lidocaine Patch for Decreasing Postoperative Pain and Rescue Opioid Use in Sternotomy: A Prospective, Randomized, Double-blind Trial.
Abstract PURPOSE: Poststernotomy pain (PSP), a primary concern after sternotomy, can negatively affect patients' satisfaction with surgery and quality of life. Many clinical trials have been conducted to examine the usefulness of lidocaine patches (LPs) for postoperative pain control for multiple types of surgery; however, the results of these trials are inconsistent. In addition, little is known about the use of LPs after cardiac procedures that require sternotomy. This prospective, double-blind, placebo-controlled trial aimed to determine the efficacy of the 5% LP application at the sternotomy site for reducing ...
Source: Clinical Therapeutics - November 20, 2020 Category: Drugs & Pharmacology Authors: Park S, Nahm FS, Han WK, Park S, Han S, Park KH, Lim C Tags: Clin Ther Source Type: research

Treatment of Eating Disorders in Adults Versus Adolescents: Similarities and Differences.
Abstract FINDINGS: Although several individual psychotherapies for adults with eating disorders are empirically supported, with family-based treatment (FBT) being the leading recommended empiric treatment in adolescents, patients with eating disorders are still difficult to treat, and outcomes are often poor. In some countries, the clinical services for adolescents and adults are separate, and it is common for patients to receive treatments that differ in terms of both theory and content when they are switched from adolescent to adult services. Changes in the nature of treatment also often occur when patients move...
Source: Clinical Therapeutics - November 20, 2020 Category: Drugs & Pharmacology Authors: Dalle Grave R, Sartirana M, Sermattei S, Calugi S Tags: Clin Ther Source Type: research

Effects of Baseline Left Ventricular Hypertrophy and Decreased Renal Function on Cardiovascular and Renal Outcomes in Patients with Fabry Disease Treated with Agalsidase Alfa: A Fabry Outcome Survey Study.
In this study, data from the Fabry Outcome Survey were used for the assessment of the risks for cardiovascular and renal events in patients who received agalsidase alfa treatment. METHODS: Eligible patients were males and females aged ≥18 years with Fabry disease treated with agalsidase alfa. Cardiovascular events included myocardial infarction, left ventricular hypertrophy (LVH), heart failure, arrhythmia, conduction abnormality, and cardiac surgery. Renal events included dialysis, transplantation, and renal failure. Kaplan-Meier curves and log-rank tests were used for comparing event-free probabilities and time t...
Source: Clinical Therapeutics - November 17, 2020 Category: Drugs & Pharmacology Authors: Feriozzi S, Linhart A, Ramaswami U, Kalampoki V, Gurevich A, Hughes D, Fabry Outcome Survey Study Group Tags: Clin Ther Source Type: research

Use of an Aortic Valve Replacement Simulation Model to Understand Hospital Costs and Resource Utilization Associated With Rapid-Deployment Valves.
This study examines specific outcomes and related costs of aortic valve replacement (AVR) before and after the introduction of RDVs. METHODS: We used the AVR simulator, an economic model developed to correlate cost and resource utilization associated with the adoption of RDVs, to compare 2 scenarios: (1) a current scenario based on standard AVR practices and (2) a proposed scenario based on increasing use of RDVs and an MIS approach. Both scenarios involved 3 subgroups of patients treated with (1) conventional AVR, (2) MIS, and (3) AVR combined with a coronary artery bypass graft. The current scenario (status quo) inv...
Source: Clinical Therapeutics - November 17, 2020 Category: Drugs & Pharmacology Authors: Cotroneo A, Novelli E, Barbieri G, Freddi R, Bobbio M, Stelian E, Visetti E, Martinelli GL Tags: Clin Ther Source Type: research

Naltrexone  + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study.
Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2020 Nov 17;: Authors: Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R Abstract PURPOSE: Binge-eating disorder (BED), the most prevalent eating disorder, is associated strongly with obesity and functional impairments. Few evidence-based treatments for BED exist; a pharmacotherapy effective in reducing both binge eating and weight needs to be identified. This placebo-controlled double-blind pilot RCT evaluated the acute effects of naltrexone + ...
Source: Clinical Therapeutics - November 17, 2020 Category: Drugs & Pharmacology Authors: Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R Tags: Clin Ther Source Type: research

A Post Hoc Comparison of Prior ADHD Medication Dose and Optimized Delayed-release and Extended-release Methylphenidate Dose in a Pivotal Phase III Trial.
Abstract PURPOSE: HLD200 is the first evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH) designed to delay initial release of MPH and provide treatment effects throughout the day and into the evening for individuals with attention-deficit/hyperactivity disorder (ADHD). Because DR/ER-MPH is uniquely absorbed in the colon, it cannot be substituted for other ADHD medications on a milligram-per-milligram basis. To provide clinicians with a target dose range for DR/ER-MPH when transitioning patients from a prior ADHD medication, dose conversion ratios (DCRs) between prior medication do...
Source: Clinical Therapeutics - November 6, 2020 Category: Drugs & Pharmacology Authors: Childress AC, Uchida CL, Po MD, DeSousa NJ, Incledon B Tags: Clin Ther Source Type: research

Effects of Ivabradine on Cardiac Remodeling in Patients With Stable Symptomatic Heart Failure: A Systematic Review and Meta-analysis.
Abstract PURPOSE: Ivabradine reduces heart rate (HR) in patients with heart failure (HF). However, its effect on cardiac remodeling is not obvious. The goal of this study was to explore the extra effect of ivabradine on cardiac remodeling in patients with HF. METHODS: We searched PubMed from database inception to January 31, 2020, Cochrane and Embase from database inception to February 2, 2020, and Web of Science and ClinicalTrials.gov from database inception to February 3, 2020, for randomized controlled trials on ivabradine treatments in patients with stable symptomatic HF, left ventricular ejection fraction (LVEF) 
Source: Clinical Therapeutics - November 4, 2020 Category: Drugs & Pharmacology Authors: Wan H, Huang T, Zhang H, Wu Q Tags: Clin Ther Source Type: research

Treatment Patterns and Relapses Among Newly Treated Multiple Sclerosis Patients From a Retrospective Claims Analysis.
This study sought to describe treatment patterns and relapses among newly treated adults with MS and by DMT route of administration (oral, injectable, and infusion). METHODS: IBM MarketScan research databases were used to identify MS adults newly initiating DMTs (index event) from January 1, 2011-April 1, 2016, who had 12 months of continuous preindex and postindex medical and pharmacy benefits. Newly treated patients were those with ≥2 nondiagnostic claims with an International Classification of Diseases, Ninth Revision, Clinical Modification (340) or Tenth Revision, Clinical Modification (G35) code and no DMT pre...
Source: Clinical Therapeutics - November 4, 2020 Category: Drugs & Pharmacology Authors: Kantor D, Mehta R, Pelletier C, Tian M, Noxon V, Johnson BH, Bonafede M Tags: Clin Ther Source Type: research

Therapeutic Efficacy of Piperazine Ferulate Combined With Irbesartan in Diabetic Nephropathy: A Systematic Review and Meta-analysis.
We present the latest meta-analysis that details the combination of PF and irbesartan therapy. METHODS: Before January 31, 2020, we searched various electronic databases for appropriate articles. Our search was not restricted by keyword or language. We then filtered all articles using certain criteria and assessed the quality of the qualified studies. FINDINGS: The meta-analysis included 12 trials that involved 1300 patients (650 in the experimental group and 650 in the control group). The ages of the patients ranged from 30 to 79 years. Compared with irbesartan alone, the total effective rate of PF combined with...
Source: Clinical Therapeutics - November 3, 2020 Category: Drugs & Pharmacology Authors: Li D, Li B, Peng LX, Liu R, Zeng N Tags: Clin Ther Source Type: research

Drug-Drug Interactions of the Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone with Midazolam, Warfarin, and Digoxin: A Phase 1 Studies in Healthy Volunteers.
Abstract PURPOSE: To characterize the clinical relevance of in vitro drug-drug interaction findings with apararenone (MT-3995), the effects of apararenone on the sensitive substrates of cytochrome P450 3A4 (midazolam) and 2C9 (warfarin), and P-glycoprotein (digoxin), were assessed through a series of studies conducted in healthy volunteers. METHODS: Three studies were conducted in 56 healthy adults. Study 1 investigated the effects of the administration of apararenone with midazolam; apararenone was administered on days 2 (320 mg) and days 3-15 (20 mg/d), and midazolam 2 mg, on days 1 and ...
Source: Clinical Therapeutics - November 2, 2020 Category: Drugs & Pharmacology Authors: Nakamura T, Shimizu H, Kawaguchi A Tags: Clin Ther Source Type: research

A Hidden Generation: Offspring from Sperm Donation in an Era of Medical Paternalism.
PMID: 33153728 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 2, 2020 Category: Drugs & Pharmacology Authors: Maron JL Tags: Clin Ther Source Type: research

Potential Drug-Drug Interactions with Combination Volasertib  + Itraconazole: A Phase I, Fixed-Sequence Study in Patients with Solid Tumors.
Potential Drug-Drug Interactions with Combination Volasertib + Itraconazole: A Phase I, Fixed-Sequence Study in Patients with Solid Tumors. Clin Ther. 2020 Oct 30;: Authors: Lang I, Liu D, Fritsch H, Taube T, Chizhikov E, Liptai B Abstract PURPOSE: This drug-drug interaction study determined whether the metabolism and distribution of the Polo-like kinase 1 inhibitor, volasertib, is affected by co-administration of the P-glycoprotein and cytochrome P-450 3A4 inhibitor, itraconazole. METHODS: This was an uncontrolled, open-label, fixed-sequence trial of two 21-day treatment cycles in patients ...
Source: Clinical Therapeutics - October 30, 2020 Category: Drugs & Pharmacology Authors: Lang I, Liu D, Fritsch H, Taube T, Chizhikov E, Liptai B Tags: Clin Ther Source Type: research

Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers.
The objectives of this study were to assess the effect of high-fat and high-calorie food on the pharmacokinetic and pharmacodynamic (PK/PD) profiles of hetrombopag in healthy volunteers. METHODS: An independent, single-dose, open-label, randomized-sequence, crossover trial was conducted. Healthy volunteers received hetrombopag 7.5-mg tablets in the fasted state or with a high-fat, high-calorie breakfast. The effects of the high-fat and high-calorie food on the PK/PD profiles of hetrombopag were evaluated by using a noncompartmental analysis and a semi-physiological model. FINDINGS: Twelve Chinese healthy voluntee...
Source: Clinical Therapeutics - October 24, 2020 Category: Drugs & Pharmacology Authors: Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L Tags: Clin Ther Source Type: research

Pyridoxine and Magnesium Administration-Induced Hyperactivity in Two Children With Autism Spectrum Disorder: Case Reports From a Clinical Trial.
We present a case report of 2 children with ASD who were administered pyridoxine-Mg for 2 months. METHODS: The Childhood Autism Rating Scale, Second Edition, was used to confirm the adverse reaction. The Naranjo Adverse Drug Reaction Probability Scale was used to assess causality. RESULTS: Children were reported by their parents as being hyperactive. Evaluation by the psychologist using the Childhood Autism Rating Scale, Second Edition, also confirmed the reaction. According to the Naranjo scale, hyperactivity had a possible and probable association with pyridoxine-Mg for child 1 and 2, respectively. IMPLICA...
Source: Clinical Therapeutics - October 6, 2020 Category: Drugs & Pharmacology Authors: Debi Ann A, Udayakumar N, Senta C, Rajanandh MG Tags: Clin Ther Source Type: research

Comparative Efficacy of Acalabrutinib in Frontline Treatment of Chronic Lymphocytic Leukemia: a Systematic Review and Network Meta-analysis.
Abstract PURPOSE: The goal of this study was to estimate the relative efficacy of acalabrutinib (monotherapy and in combination with obinutuzumab) compared with standard frontline treatments for chronic lymphocytic leukemia (CLL) in fludarabine-ineligible patients, through a network meta-analysis (NMA). METHODS: The efficacy of acalabrutinib from ELEVATE-TN (study of Obinutuzumab + Chlorambucil, Acalabrutinib [ACP-196] + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL) was compared to bendamustine + rituximab, chlorambucil-based therapy, alemtuzumab, ibrutinib mon...
Source: Clinical Therapeutics - October 5, 2020 Category: Drugs & Pharmacology Authors: Davids MS, Waweru C, Le Nouveau P, Padhiar A, Singh G, Abhyankar S, Leblond V Tags: Clin Ther Source Type: research

A Systematic Review and Meta-analysis of Isoniazid Pharmacokinetics in Healthy Volunteers and Patients with Tuberculosis.
Abstract PURPOSE: This systematic review and meta-analysis assesses the pharmacokinetic (PK) summary estimates of isoniazid (INH) between healthy volunteers and patients with tuberculosis (TB), evaluates whether the current INH dose regimen is appropriate in patients with TB, and evaluates the impact of N-acetyl-transferase-2 (NAT2) status on the PK properties of INH. METHODS: A systematic approach was conducted to find studies with relevant INH PK data published in the English language up to February 2018. The PK properties of INH were extracted with their respective INH dosages and were dose normalized to a...
Source: Clinical Therapeutics - October 5, 2020 Category: Drugs & Pharmacology Authors: Hong BL, D'Cunha R, Li P, Al-Shaer MH, Alghamdi WA, An G, Peloquin C Tags: Clin Ther Source Type: research

Cost-effectiveness of Osimertinib vs Docetaxel-Bevacizumab in Third-Line Treatment in EGFR T790M Resistance Mutation Advanced Non-Small Cell Lung Cancer in China.
This study aimed to evaluate the cost-effectiveness of osimertinib vs docetaxel and bevacizumab in third-line treatment in EGFR T790M resistance mutation advanced non-small cell lung cancer in China from the perspective of the health care system. METHODS: To explore modeling uncertainty, 2 different model methods (a Markov model and a partitioned survival [PS] model) were developed to simulate costs and health outcomes during a lifetime. Both models consisted of 3 health states: progression-free survival, postprogression survival, and death. Efficacy and safety data of osimertinib vs docetaxel and bevacizumab in patie...
Source: Clinical Therapeutics - October 4, 2020 Category: Drugs & Pharmacology Authors: Rui M, Li H Tags: Clin Ther Source Type: research

The Cardiac Injury Immune Response as a Target for Regenerative and Cellular Therapies.
Abstract PURPOSE: Despite modern reperfusion and pharmacologic therapies, myocardial infarction (MI) remains a leading cause of morbidity and mortality worldwide. Therefore, the development of further therapeutics affecting post-MI recovery poses significant benefits. This review focuses on the post-MI immune response and immunomodulatory therapeutics that could improve the wound-healing response. METHODS: This narrative review used OVID versions of MEDLINE and EMBASE searching for clinical therapeutics targeting the immune system during MI. Preclinical models and clinical trials were included. Additional stu...
Source: Clinical Therapeutics - September 29, 2020 Category: Drugs & Pharmacology Authors: Hume RD, Chong JJH Tags: Clin Ther Source Type: research

Potential Therapeutic Effects of Sodium Glucose-linked Cotransporter 2 Inhibitors in Stroke.
CONCLUSIONS: It is unlikely that SGLT inhibitors have a positive or negative effect on stroke risk, but the question that remains unanswered is whether SGLT inhibitors can yield a protective effect after acute ischemic stroke. Future observational studies and registries may be the first step to help answer this question. (Clin Ther. 2020; XX:XXX-XXX) © 2020 Elsevier HS Journals, Inc. PMID: 33008610 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - September 28, 2020 Category: Drugs & Pharmacology Authors: Al Hamed FA, Elewa H Tags: Clin Ther Source Type: research