Pharmacokinetics and Safety of Single-Dose Amphotericin B Colloidal Dispersion in Healthy Chinese Subjects and Population Pharmacokinetic/Pharmacodynamic Analysis to Inform Clinical Efficacy in Invasive Infections Caused by Candida albicans
Clin Ther. 2021 Oct 19:S0149-2918(21)00385-4. doi: 10.1016/j.clinthera.2021.09.012. Online ahead of print.ABSTRACTPURPOSE: Amphotericin B colloidal dispersion (ABCD) is a less toxic formulation of amphotericin B for the treatment of invasive fungal infections. The pharmacokinetic (PK) profile and safety of a generic ABCD were investigated after a single dose (0.5 to 1.5 mg/kg) administered as an intravenous infusion in 30 healthy Chinese subjects.METHODS: PK data from healthy Chinese male subjects were applied for developing a population PK model to predict the PK profiles of standard doses (3 or 4 mg/kg) in patients. A 50...
Source: Clinical Therapeutics - October 23, 2021 Category: Drugs & Pharmacology Authors: Zhi-Wei Huang Ji-Cheng Yu Jing-Jing Wang Yuan-Cheng Chen Ju-Fang Wu Yi-Jian Chen Guo-Ying Cao Hai-Jing Yang Jin-Jie He Jing-Yi Dai Ji-Yin Zhang Wei Zhang Jing Yuan Chun-Lei Li Feng-Yan Xu Kun Wang Xiao-Jie Wu Jing Zhang Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Use of the Electronic Health Record to Optimize Antimicrobial Prescribing
Clin Ther. 2021 Oct 10:S0149-2918(21)00381-7. doi: 10.1016/j.clinthera.2021.09.009. Online ahead of print.ABSTRACTPURPOSE: This review summarizes how interventions in the electronic health record (EHR) can optimize antimicrobial stewardship across the continuum of antimicrobial decision making, from diagnosis of infection to discontinuation of therapy. In addition, opportunities to optimize provider communication and patient education are identified.METHODS: A narrative review was conducted to identify how interventions in the EHR can influence antimicrobial prescribing behavior. Examples from pediatrics were specifically ...
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Simon Parzen-Johnson Kenny D Kronforst Rohan M Shah Grant R Whitmer Tonya Scardina Meg Chandarraju Sameer J Patel Source Type: research

The Yin and the Yang of the Electronic Health Record
Clin Ther. 2021 Oct 10:S0149-2918(21)00383-0. doi: 10.1016/j.clinthera.2021.09.010. Online ahead of print.NO ABSTRACTPMID:34645575 | DOI:10.1016/j.clinthera.2021.09.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 14, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Impact of Area Under the Concentration-Time Curve on the Prevalence of Vancomycin-Induced Nephrotoxicity in Combination With Tazobactam/Piperacillin or Cefepime: A Single-Institution Retrospective Study
Clin Ther. 2021 Oct 9:S0149-2918(21)00360-X. doi: 10.1016/j.clinthera.2021.09.007. Online ahead of print.ABSTRACTPURPOSE: Risk for vancomycin-induced nephrotoxicity (VIN) is reportedly reduced by AUC-guided vancomycin dosing. However, it remains unknown whether the increased VIN risk in combination treatment with vancomycin and tazobactam/piperacillin, which is a VIN risk factor, can be diminished by AUC-guided vancomycin dosing (vancomycin-AUC). The aim of this study was to assess whether the evaluation of vancomycin-AUC + tazobactam/piperacillin (VT) combination therapy could prevent VIN.METHODS: The data from patients w...
Source: Clinical Therapeutics - October 13, 2021 Category: Drugs & Pharmacology Authors: Naoto Okada Yuki Izumi Aki Nakamoto Masayuki Chuma Mitsuhiro Goda Kenta Yagi Fuka Aizawa Hirofumi Hamano Yoshito Zamami Momoyo Azuma Keisuke Ishizawa Source Type: research

Big Data and Behavioral Economics in Infectious Diseases
Clin Ther. 2021 Oct 8:S0149-2918(21)00358-1. doi: 10.1016/j.clinthera.2021.09.006. Online ahead of print.NO ABSTRACTPMID:34635348 | PMC:PMC8500733 | DOI:10.1016/j.clinthera.2021.09.006 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 12, 2021 Category: Drugs & Pharmacology Authors: Ravi Jhaveri Source Type: research

Big Data and Behavioral Economics in Infectious Diseases
Clin Ther. 2021 Oct 8:S0149-2918(21)00358-1. doi: 10.1016/j.clinthera.2021.09.006. Online ahead of print.NO ABSTRACTPMID:34635348 | DOI:10.1016/j.clinthera.2021.09.006 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - October 12, 2021 Category: Drugs & Pharmacology Authors: Ravi Jhaveri Source Type: research

Electronic Health Record Network Research in Infectious Diseases
Clin Ther. 2021 Oct 7:S0149-2918(21)00354-4. doi: 10.1016/j.clinthera.2021.09.002. Online ahead of print.ABSTRACTWith the marked increases in electronic health record (EHR) use for providing clinical care, there have been parallel efforts to leverage EHR data for research. EHR repositories offer the promise of vast amounts of clinical data not easily captured with traditional research methods and facilitate clinical epidemiology and comparative effectiveness research, including analyses to identify patients at higher risk for complications or who are better candidates for treatment. These types of studies have been relativ...
Source: Clinical Therapeutics - October 11, 2021 Category: Drugs & Pharmacology Authors: Ravi Jhaveri Jordan John Marc Rosenman Source Type: research

Electronic Health Record Network Research in Infectious Diseases
Clin Ther. 2021 Oct 7:S0149-2918(21)00354-4. doi: 10.1016/j.clinthera.2021.09.002. Online ahead of print.ABSTRACTWith the marked increases in electronic health record (EHR) use for providing clinical care, there have been parallel efforts to leverage EHR data for research. EHR repositories offer the promise of vast amounts of clinical data not easily captured with traditional research methods and facilitate clinical epidemiology and comparative effectiveness research, including analyses to identify patients at higher risk for complications or who are better candidates for treatment. These types of studies have been relativ...
Source: Clinical Therapeutics - October 11, 2021 Category: Drugs & Pharmacology Authors: Ravi Jhaveri Jordan John Marc Rosenman Source Type: research

Risks and Outcomes of Perioperative Pulmonary Embolism in Major Surgeries: A Population-Based Study
This study aimed to investigate the risks and outcomes of perioperative PE in major surgery.METHODS: Discharge records of the Nationwide Readmission Database from 2010 to 2015 were extracted and analyzed. Length of stay, charges, death, and 30-day hospital readmission rate were compared for patients with and without perioperative PE. In addition, surgery-specific risk factors and therapies associated with PE were explored in a multivariable model.FINDINGS: A total of 12,376,153 hospitalizations for major surgeries were involved, and perioperative PE occurred in 22,676 hospitalizations (0.18%). The length of stay, charges, ...
Source: Clinical Therapeutics - October 10, 2021 Category: Drugs & Pharmacology Authors: Tao Chen Qi Chen Weihao Xu Jun Guo Jia He Source Type: research

The Health Care Resource Utilization and Costs Among Patients With Type 2 Diabetes and Either Cardiovascular Disease or Cardiovascular Risk Factors An Analysis of a US Health Insurance Database
Clin Ther. 2021 Oct 5:S0149-2918(21)00355-6. doi: 10.1016/j.clinthera.2021.09.003. Online ahead of print.ABSTRACTPURPOSE: Health care costs and cardiovascular (CV) outcomes were evaluated among US patients with type 2 diabetes (T2D) and cardiovascular disease (CVD) or CV risk factors.METHODS: Patients with ≥24 months of continuous enrollment were selected from the MarketScan Commercial and Medicare databases from January 1, 2014, to September 30, 2018. For the first qualifying 24-month period, months 1 to 12 defined the baseline period and months 13 to 24 defined the follow-up period. All patients had ≥2 T2D diagnose...
Source: Clinical Therapeutics - October 9, 2021 Category: Drugs & Pharmacology Authors: Juliana Meyers Meredith Hoog Reema Mody Maria Yu Keith Davis Source Type: research

The Health Care Resource Utilization and Costs Among Patients With Type 2 Diabetes and Either Cardiovascular Disease or Cardiovascular Risk Factors An Analysis of a US Health Insurance Database
Clin Ther. 2021 Oct 5:S0149-2918(21)00355-6. doi: 10.1016/j.clinthera.2021.09.003. Online ahead of print.ABSTRACTPURPOSE: Health care costs and cardiovascular (CV) outcomes were evaluated among US patients with type 2 diabetes (T2D) and cardiovascular disease (CVD) or CV risk factors.METHODS: Patients with ≥24 months of continuous enrollment were selected from the MarketScan Commercial and Medicare databases from January 1, 2014, to September 30, 2018. For the first qualifying 24-month period, months 1 to 12 defined the baseline period and months 13 to 24 defined the follow-up period. All patients had ≥2 T2D diagnose...
Source: Clinical Therapeutics - October 9, 2021 Category: Drugs & Pharmacology Authors: Juliana Meyers Meredith Hoog Reema Mody Maria Yu Keith Davis Source Type: research

Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years
Clin Ther. 2021 Oct 1:S0149-2918(21)00306-4. doi: 10.1016/j.clinthera.2021.08.007. Online ahead of print.ABSTRACTPURPOSE: Acne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose o...
Source: Clinical Therapeutics - October 5, 2021 Category: Drugs & Pharmacology Authors: Christopher R Piszczatoski Jason Powell Source Type: research

Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years
Clin Ther. 2021 Oct 1:S0149-2918(21)00306-4. doi: 10.1016/j.clinthera.2021.08.007. Online ahead of print.ABSTRACTPURPOSE: Acne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose o...
Source: Clinical Therapeutics - October 5, 2021 Category: Drugs & Pharmacology Authors: Christopher R Piszczatoski Jason Powell Source Type: research

Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years
Clin Ther. 2021 Oct 1:S0149-2918(21)00306-4. doi: 10.1016/j.clinthera.2021.08.007. Online ahead of print.ABSTRACTPURPOSE: Acne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose o...
Source: Clinical Therapeutics - October 5, 2021 Category: Drugs & Pharmacology Authors: Christopher R Piszczatoski Jason Powell Source Type: research

Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years
Clin Ther. 2021 Oct 1:S0149-2918(21)00306-4. doi: 10.1016/j.clinthera.2021.08.007. Online ahead of print.ABSTRACTPURPOSE: Acne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose o...
Source: Clinical Therapeutics - October 5, 2021 Category: Drugs & Pharmacology Authors: Christopher R Piszczatoski Jason Powell Source Type: research

Ethnic Sensitivity Study of the Extrafine, Single-Inhaler, Triple Therapy Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide Pressurized Metered Dose Inhaler in Japanese and Caucasian Healthy Individuals: A Randomized, Double-Blind, Single-Dose Crossover Study
Clin Ther. 2021 Sep 29:S0149-2918(21)00353-2. doi: 10.1016/j.clinthera.2021.09.001. Online ahead of print.ABSTRACTPURPOSE: A number of single-inhaler, fixed-dose, triple combinations are available for the management of chronic obstructive pulmonary disease and/or asthma. One of these is the extrafine formulation beclomethasone dipropionate, formoterol fumarate, glycopyrronium bromide (BDP/FF/GB). Given that differences in ethnicity can result in differences in systemic exposure, we evaluated the relative pharmacokinetic (PK) profiles of BDP/FF/GB in Japanese vs Caucasian healthy volunteers to assess the need for dose adjus...
Source: Clinical Therapeutics - October 3, 2021 Category: Drugs & Pharmacology Authors: Massimo Cella J örg Täubel Irisz Delestre-Levai Anne Tulard Andrea Vele George Georges Source Type: research

Ethnic Sensitivity Study of the Extrafine, Single-Inhaler, Triple Therapy Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide Pressurized Metered Dose Inhaler in Japanese and Caucasian Healthy Individuals: A Randomized, Double-Blind, Single-Dose Crossover Study
Clin Ther. 2021 Sep 29:S0149-2918(21)00353-2. doi: 10.1016/j.clinthera.2021.09.001. Online ahead of print.ABSTRACTPURPOSE: A number of single-inhaler, fixed-dose, triple combinations are available for the management of chronic obstructive pulmonary disease and/or asthma. One of these is the extrafine formulation beclomethasone dipropionate, formoterol fumarate, glycopyrronium bromide (BDP/FF/GB). Given that differences in ethnicity can result in differences in systemic exposure, we evaluated the relative pharmacokinetic (PK) profiles of BDP/FF/GB in Japanese vs Caucasian healthy volunteers to assess the need for dose adjus...
Source: Clinical Therapeutics - October 3, 2021 Category: Drugs & Pharmacology Authors: Massimo Cella J örg Täubel Irisz Delestre-Levai Anne Tulard Andrea Vele George Georges Source Type: research

Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST
Clin Ther. 2021 Sep 28:S0149-2918(21)00313-1. doi: 10.1016/j.clinthera.2021.08.014. Online ahead of print.ABSTRACTReported incidences of neuroendocrine tumors (NETs) appear to be increasing, possibly due to greater disease awareness and increased accuracy of diagnosis. Approximately 20% of patients with NETs develop carcinoid syndrome (CS), which arises from elevated secretion of bioactive compounds, including serotonin, from NETs. This leads to symptoms including diarrhea and flushing, which result in weight loss and are associated with considerable negative impact on patients' quality of life. We previously reported sign...
Source: Clinical Therapeutics - October 2, 2021 Category: Drugs & Pharmacology Authors: Rajaventhan Srirajaskanthan Marianne Pavel Matthew Kulke Dominique Clement Aude Houchard Lucie Keeber Martin O Weickert Source Type: research

Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST
Clin Ther. 2021 Sep 28:S0149-2918(21)00313-1. doi: 10.1016/j.clinthera.2021.08.014. Online ahead of print.ABSTRACTReported incidences of neuroendocrine tumors (NETs) appear to be increasing, possibly due to greater disease awareness and increased accuracy of diagnosis. Approximately 20% of patients with NETs develop carcinoid syndrome (CS), which arises from elevated secretion of bioactive compounds, including serotonin, from NETs. This leads to symptoms including diarrhea and flushing, which result in weight loss and are associated with considerable negative impact on patients' quality of life. We previously reported sign...
Source: Clinical Therapeutics - October 2, 2021 Category: Drugs & Pharmacology Authors: Rajaventhan Srirajaskanthan Marianne Pavel Matthew Kulke Dominique Clement Aude Houchard Lucie Keeber Martin O Weickert Source Type: research

Prevention of Vertical Transmission of Hepatitis B Within a North Carolina Hospital System
This study provides a current assessment of prevention practices in vertical transmission of HBV compared to published guidelines. The tertiary hospital studied generally implemented AASLD recommendations for prevention of vertical transmission. However, our data revealed that appropriate risk status testing could be improved. With improvement in risk status testing, antiviral prophylaxis can be provided, decreasing the likelihood of breakthrough HBV vertical transmission. Follow-up for HBV-infected birthing persons and HBV-exposed neonates is also a priority. Achieving full compliance with AASLD guidelines to prevent vert...
Source: Clinical Therapeutics - October 1, 2021 Category: Drugs & Pharmacology Authors: Wesley Sayre Peyton Thompson Source Type: research

Prevention of Vertical Transmission of Hepatitis B Within a North Carolina Hospital System
This study provides a current assessment of prevention practices in vertical transmission of HBV compared to published guidelines. The tertiary hospital studied generally implemented AASLD recommendations for prevention of vertical transmission. However, our data revealed that appropriate risk status testing could be improved. With improvement in risk status testing, antiviral prophylaxis can be provided, decreasing the likelihood of breakthrough HBV vertical transmission. Follow-up for HBV-infected birthing persons and HBV-exposed neonates is also a priority. Achieving full compliance with AASLD guidelines to prevent vert...
Source: Clinical Therapeutics - October 1, 2021 Category: Drugs & Pharmacology Authors: Wesley Sayre Peyton Thompson Source Type: research

How COVID-19 Is Helping Us Learn More About Diabetes Pathogenesis
Clin Ther. 2021 Sep 10:S0149-2918(21)00312-X. doi: 10.1016/j.clinthera.2021.08.013. Online ahead of print.NO ABSTRACTPMID:34588131 | PMC:PMC8429364 | DOI:10.1016/j.clinthera.2021.08.013 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - September 30, 2021 Category: Drugs & Pharmacology Authors: Ravi Jhaveri Source Type: research

How COVID-19 Is Helping Us Learn More About Diabetes Pathogenesis
Clin Ther. 2021 Sep 10:S0149-2918(21)00312-X. doi: 10.1016/j.clinthera.2021.08.013. Online ahead of print.NO ABSTRACTPMID:34588131 | DOI:10.1016/j.clinthera.2021.08.013 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - September 30, 2021 Category: Drugs & Pharmacology Authors: Ravi Jhaveri Source Type: research

Analysis of Drug-Drug Interaction Labeling Language and Clinical Recommendations for Newly Approved Drugs Evaluated With Digoxin, Midazolam, and S-Warfarin
Clin Ther. 2021 Sep 24:S0149-2918(21)00315-5. doi: 10.1016/j.clinthera.2021.08.016. Online ahead of print.ABSTRACTPURPOSE: To best promote drug tolerability and efficacy in the clinic, data from drug-drug interaction (DDI) evaluations and subsequent translation of the results to DDI prevention and/or management strategies must be incorporated into the US Food and Drug Administration (FDA) product labeling in a consistent manner because differences in language might result in varied interpretations. This analysis aimed to assess the consistency in DDI labeling language in New Drug Applications (NDAs).METHODS: NDAs of recent...
Source: Clinical Therapeutics - September 28, 2021 Category: Drugs & Pharmacology Authors: Lindsay M Henderson Claire E Steinbronn Jingjing Yu Catherine K Yeung Isabelle Ragueneau-Majlessi Source Type: research

Comparative Prevalence of Acute Kidney Injury in Chinese Patients Receiving Vancomycin with Concurrent β-Lactam Antibiotics: A Retrospective Cohort Study
Clin Ther. 2021 Sep 24:S0149-2918(21)00307-6. doi: 10.1016/j.clinthera.2021.08.008. Online ahead of print.ABSTRACTPURPOSE: The combination of vancomycin and piperacillin/tazobactam (VAN + PTZ) provides a broad spectrum of activity against multiple pathogens. However, a major issue in previous research concerned significant nephrotoxicity associated with this drug combination, and most studies have been conducted in American and European countries, with no similar data available from China. Therefore, this study evaluated the nephrotoxic effects of VAN + PTZ in a large-scale Chinese cohort to determine the prevalence of acu...
Source: Clinical Therapeutics - September 28, 2021 Category: Drugs & Pharmacology Authors: Kang Liu Ying Zhang Xueqiang Xu Buyun Wu Juan Ni Ting Li Changying Xing Huijuan Mao Source Type: research

Analysis of Drug-Drug Interaction Labeling Language and Clinical Recommendations for Newly Approved Drugs Evaluated With Digoxin, Midazolam, and S-Warfarin
Clin Ther. 2021 Sep 24:S0149-2918(21)00315-5. doi: 10.1016/j.clinthera.2021.08.016. Online ahead of print.ABSTRACTPURPOSE: To best promote drug tolerability and efficacy in the clinic, data from drug-drug interaction (DDI) evaluations and subsequent translation of the results to DDI prevention and/or management strategies must be incorporated into the US Food and Drug Administration (FDA) product labeling in a consistent manner because differences in language might result in varied interpretations. This analysis aimed to assess the consistency in DDI labeling language in New Drug Applications (NDAs).METHODS: NDAs of recent...
Source: Clinical Therapeutics - September 28, 2021 Category: Drugs & Pharmacology Authors: Lindsay M Henderson Claire E Steinbronn Jingjing Yu Catherine K Yeung Isabelle Ragueneau-Majlessi Source Type: research

Comparative Prevalence of Acute Kidney Injury in Chinese Patients Receiving Vancomycin with Concurrent β-Lactam Antibiotics: A Retrospective Cohort Study
Clin Ther. 2021 Sep 24:S0149-2918(21)00307-6. doi: 10.1016/j.clinthera.2021.08.008. Online ahead of print.ABSTRACTPURPOSE: The combination of vancomycin and piperacillin/tazobactam (VAN + PTZ) provides a broad spectrum of activity against multiple pathogens. However, a major issue in previous research concerned significant nephrotoxicity associated with this drug combination, and most studies have been conducted in American and European countries, with no similar data available from China. Therefore, this study evaluated the nephrotoxic effects of VAN + PTZ in a large-scale Chinese cohort to determine the prevalence of acu...
Source: Clinical Therapeutics - September 28, 2021 Category: Drugs & Pharmacology Authors: Kang Liu Ying Zhang Xueqiang Xu Buyun Wu Juan Ni Ting Li Changying Xing Huijuan Mao Source Type: research

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection
Clin Ther. 2021 Aug 23:S0149-2918(21)00308-8. doi: 10.1016/j.clinthera.2021.08.009. Online ahead of print.ABSTRACTPURPOSE: Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.METHODS: In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or pl...
Source: Clinical Therapeutics - September 23, 2021 Category: Drugs & Pharmacology Authors: Jin Yong Kim Young Rock Jang Jang Hee Hong Jin Gyu Jung Jae-Hyeong Park Adrian Streinu-Cercel Anca Streinu-Cercel Oana S ăndulescu Sang Joon Lee Sung Hyun Kim Na Hyun Jung Seul Gi Lee Jeong Eun Park Min Kyung Kim Da Bee Jeon Yeo Jin Lee Bum Soo Kim Yeon Source Type: research

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection
Clin Ther. 2021 Aug 23:S0149-2918(21)00308-8. doi: 10.1016/j.clinthera.2021.08.009. Online ahead of print.ABSTRACTPURPOSE: Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.METHODS: In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or pl...
Source: Clinical Therapeutics - September 23, 2021 Category: Drugs & Pharmacology Authors: Jin Yong Kim Young Rock Jang Jang Hee Hong Jin Gyu Jung Jae-Hyeong Park Adrian Streinu-Cercel Anca Streinu-Cercel Oana S ăndulescu Sang Joon Lee Sung Hyun Kim Na Hyun Jung Seul Gi Lee Jeong Eun Park Min Kyung Kim Da Bee Jeon Yeo Jin Lee Bum Soo Kim Yeon Source Type: research

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection
Clin Ther. 2021 Aug 23:S0149-2918(21)00308-8. doi: 10.1016/j.clinthera.2021.08.009. Online ahead of print.ABSTRACTPURPOSE: Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.METHODS: In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or pl...
Source: Clinical Therapeutics - September 23, 2021 Category: Drugs & Pharmacology Authors: Jin Yong Kim Young Rock Jang Jang Hee Hong Jin Gyu Jung Jae-Hyeong Park Adrian Streinu-Cercel Anca Streinu-Cercel Oana S ăndulescu Sang Joon Lee Sung Hyun Kim Na Hyun Jung Seul Gi Lee Jeong Eun Park Min Kyung Kim Da Bee Jeon Yeo Jin Lee Bum Soo Kim Yeon Source Type: research

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection
Clin Ther. 2021 Aug 23:S0149-2918(21)00308-8. doi: 10.1016/j.clinthera.2021.08.009. Online ahead of print.ABSTRACTPURPOSE: Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.METHODS: In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or pl...
Source: Clinical Therapeutics - September 23, 2021 Category: Drugs & Pharmacology Authors: Jin Yong Kim Young Rock Jang Jang Hee Hong Jin Gyu Jung Jae-Hyeong Park Adrian Streinu-Cercel Anca Streinu-Cercel Oana S ăndulescu Sang Joon Lee Sung Hyun Kim Na Hyun Jung Seul Gi Lee Jeong Eun Park Min Kyung Kim Da Bee Jeon Yeo Jin Lee Bum Soo Kim Yeon Source Type: research

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection
Clin Ther. 2021 Aug 23:S0149-2918(21)00308-8. doi: 10.1016/j.clinthera.2021.08.009. Online ahead of print.ABSTRACTPURPOSE: Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies.METHODS: In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or pl...
Source: Clinical Therapeutics - September 23, 2021 Category: Drugs & Pharmacology Authors: Jin Yong Kim Young Rock Jang Jang Hee Hong Jin Gyu Jung Jae-Hyeong Park Adrian Streinu-Cercel Anca Streinu-Cercel Oana S ăndulescu Sang Joon Lee Sung Hyun Kim Na Hyun Jung Seul Gi Lee Jeong Eun Park Min Kyung Kim Da Bee Jeon Yeo Jin Lee Bum Soo Kim Yeon Source Type: research

Effects of Glucocorticoids on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis
Clin Ther. 2021 Sep 18:S0149-2918(21)00265-4. doi: 10.1016/j.clinthera.2021.07.021. Online ahead of print.ABSTRACTPURPOSE: Delirium is a common neurologic complication after cardiac surgery and is associated with a poor prognosis. Several studies have explored the effects of glucocorticoids on postoperative delirium (POD). However, conclusion have been inconsistent. The purpose of this systematic review and meta-analysis is to evaluate the effects of glucocorticoids on POD in adult patients undergoing cardiac surgery.METHODS: A systematic literature search was conducted using PubMed/MEDLINE, Embase, Cochrane Library/Centra...
Source: Clinical Therapeutics - September 22, 2021 Category: Drugs & Pharmacology Authors: Wenxue Liu Yali Wang Junxia Wang Jian Shi Jun Pan Dongjin Wang Source Type: research

Global Burden of Dry Age-Related Macular Degeneration: A Targeted Literature Review
Clin Ther. 2021 Sep 18:S0149-2918(21)00310-6. doi: 10.1016/j.clinthera.2021.08.011. Online ahead of print.ABSTRACTPURPOSE: Age-related macular degeneration (AMD) is a leading cause of blindness, particularly in higher-income countries. Although dry AMD accounts for 85% to 90% of AMD cases, a comprehensive understanding of the global dry AMD burden is needed.METHODS: A targeted literature review was conducted in PubMed, MEDLINE, Embase, and the Cochrane Database of Systematic Reviews (1995-2019) to identify data on the epidemiology, management, and humanistic and economic burden of dry AMD in adults. A landscape analysis of...
Source: Clinical Therapeutics - September 22, 2021 Category: Drugs & Pharmacology Authors: Neil M Schultz Shweta Bhardwaj Claudia Barclay Luis Gaspar Jason Schwartz Source Type: research