The 90% Effective Dose of Sufentanil for Epidural Analgesia in the Early First Stage of Labor: A Double-blind, Sequential Dose-Finding Study
Clin Ther. 2021 Jun 7:S0149-2918(21)00217-4. doi: 10.1016/j.clinthera.2021.05.002. Online ahead of print.ABSTRACTPURPOSE: Epidural analgesia in the latent phase of the first stage of labor has been recognized and accepted by anesthesiologists worldwide. However, there is no unified consensus on the exact dosage of sufentanil with the combination of ropivacaine in the induction of epidural analgesia in the early first stage of labor. In this sequential dose-finding study, the 90% effective dose (ED90) of sufentanil for epidural administration in the early first stage of labor was estimated to minimize the adverse effects of...
Source: Clinical Therapeutics - June 10, 2021 Category: Drugs & Pharmacology Authors: Ting Shen Jing Zheng Zifeng Xu Chen Zhang Ying Shen Tao Xu Source Type: research

Results of two Phase 1, Randomized, Double-blind, Placebo-controlled, Studies (Ascending Single-Dose and Multiple-Dose Studies) to Determine the Safety, Tolerability, and Pharmacokinetics of Orally Administered LX9211 in Healthy Participants
We present 2 Phase I studies of LX9211, a new small-molecule AP2-associated kinase 1 inhibitor with preclinical effectiveness in pain relief.METHODS: Both randomized, placebo-controlled studies' primary objectives evaluated the tolerability and pharmacokinetic properties of oral LX9211. In the single-ascending dose (SAD) study, single, oral, liquid doses of 5, 10, 15, 20, 30, 40, 80, 120, 160, 200, and 300 mg of LX9211 or placebo were administered in the fasted state and 40 mg in a fed group. In the multiple-ascending dose (MAD) study, a loading dose was administered on day 1 and maintenance doses were administered daily o...
Source: Clinical Therapeutics - June 10, 2021 Category: Drugs & Pharmacology Authors: LuAnn Bundrant Thomas L Hunt Phil Banks Suma Gopinathan Kristi A Boehm Kenneth Kassler-Taub Praveen Tyle Alan Wilson Chris Warner Suman Wason Source Type: research

Modifiable Risk Factors in Alzheimer Disease and Related Dementias: A Review
Clin Ther. 2021 Jun 6:S0149-2918(21)00221-6. doi: 10.1016/j.clinthera.2021.05.006. Online ahead of print.ABSTRACTPURPOSE: Although Alzheimer disease and related dementias (ADRDs) have long been considered nonpreventable and even an inevitable consequence of aging, recent findings from longitudinal studies indicate a downtrend in age-adjusted incidence and prevalence of ADRDs in Western countries. This remarkable trend might be the result of improved management of so-called modifiable risk factors. The aim of this review is to present evidence of modifiable factors of ADRDs in a life-course approach.METHODS: A PubMed databa...
Source: Clinical Therapeutics - June 10, 2021 Category: Drugs & Pharmacology Authors: Rachel Litke Lorena Cancino Garcharna Salima Jiwani Judith Neugroschl Source Type: research

Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Intermittent Hemodialysis: A Multicenter, Observational Study
Clin Ther. 2021 Jun 6:S0149-2918(21)00210-1. doi: 10.1016/j.clinthera.2021.04.015. Online ahead of print.ABSTRACTPURPOSE: Data on aminoglycoside stewardship in critically ill septic patients with acute kidney injury (AKI) needing intermittent hemodialysis (IH) are scarce. The first objective of the study was to evaluate whether aminoglycoside administration occurs before vs after IH in the real-life management of critically ill septic patients with AKI needing IH. The second objective was to assess the delay in achieving a potential reinjection window for a second dose of aminoglycoside, which should be obtained with a pos...
Source: Clinical Therapeutics - June 10, 2021 Category: Drugs & Pharmacology Authors: Alexandre Boyer Jean-Fran çois Timsit Kada Klouche Emmanuel Canet Thuy-Nga Phan Julien Boh é Sebastien Rubin Arthur Orieux Alexandre Lautrette Didier Gruson Bertrand Souweine Source Type: research

Effect of Social Determinants of Health on Cognition and Risk of Alzheimer Disease and Related Dementias
This article examines the impact of various social determinants of health, which are potentially reversible, on the incidence, prevalence, and risk of ADRDs and cognition. Various social determinants of health affect cognition and risk of ADRDs. Lower socioeconomic status (SES) and less education are associated with a higher incidence of ADRDs, whereas higher SES and education level appear to be protective, leading to a deceleration of time to diagnosis. In terms of employment, manual labor is associated with a higher risk of ADRDs. Higher body mass index in midlife and a decreasing body mass index in old age are associate...
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: Muniza Anum Majoka Corbett Schimming Source Type: research

Circulating IRAPe, Irisin, and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes
This study aimed to evaluate the role of the extracellular part of insulin-regulated aminopeptidase (IRAPe), interleukin (IL)-34, irisin, and visfatin in the development of insulin resistance (IR) in patients with type 2 diabetes mellitus (T2DM).METHODS: This observational parallel-group study was conducted in 60 subjects without T2DM who served as a control group and 60 patients with newly diagnosed T2DM. The 2 groups were matched for age, sex ratio, and body mass index. Anthropometric parameters; fasting blood glucose; fasting plasma insulin; Homeostatic Model Assessment for IR (HOMA-IR) index; glycated hemoglobin (HbA1c...
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: Tarek M Mostafa Nashwa M El-Gharbawy Rehab H Werida Source Type: research

Conversations With the Editors: Combating Caregiver and Patient-Perceived Obesity Stigmatization
Clin Ther. 2021 Jun 5:S0149-2918(21)00214-9. doi: 10.1016/j.clinthera.2021.05.001. Online ahead of print.NO ABSTRACTPMID:34103177 | DOI:10.1016/j.clinthera.2021.05.001 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: Fatima Cody Stanford Jill L Maron Source Type: research

Older Adults with Alzheimer's Disease: the Need to Improve Systems of Care
Clin Ther. 2021 Jun 5:S0149-2918(21)00222-8. doi: 10.1016/j.clinthera.2021.05.007. Online ahead of print.NO ABSTRACTPMID:34103178 | DOI:10.1016/j.clinthera.2021.05.007 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: William W Hung Source Type: research

Effect of Social Determinants of Health on Cognition and Risk of Alzheimer Disease and Related Dementias
This article examines the impact of various social determinants of health, which are potentially reversible, on the incidence, prevalence, and risk of ADRDs and cognition. Various social determinants of health affect cognition and risk of ADRDs. Lower socioeconomic status (SES) and less education are associated with a higher incidence of ADRDs, whereas higher SES and education level appear to be protective, leading to a deceleration of time to diagnosis. In terms of employment, manual labor is associated with a higher risk of ADRDs. Higher body mass index in midlife and a decreasing body mass index in old age are associate...
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: Muniza Anum Majoka Corbett Schimming Source Type: research

Circulating IRAPe, Irisin, and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes
This study aimed to evaluate the role of the extracellular part of insulin-regulated aminopeptidase (IRAPe), interleukin (IL)-34, irisin, and visfatin in the development of insulin resistance (IR) in patients with type 2 diabetes mellitus (T2DM).METHODS: This observational parallel-group study was conducted in 60 subjects without T2DM who served as a control group and 60 patients with newly diagnosed T2DM. The 2 groups were matched for age, sex ratio, and body mass index. Anthropometric parameters; fasting blood glucose; fasting plasma insulin; Homeostatic Model Assessment for IR (HOMA-IR) index; glycated hemoglobin (HbA1c...
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: Tarek M Mostafa Nashwa M El-Gharbawy Rehab H Werida Source Type: research

Conversations With the Editors: Combating Caregiver and Patient-Perceived Obesity Stigmatization
Clin Ther. 2021 Jun 5:S0149-2918(21)00214-9. doi: 10.1016/j.clinthera.2021.05.001. Online ahead of print.NO ABSTRACTPMID:34103177 | DOI:10.1016/j.clinthera.2021.05.001 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: Fatima Cody Stanford Jill L Maron Source Type: research

Older Adults with Alzheimer's Disease: the Need to Improve Systems of Care
Clin Ther. 2021 Jun 5:S0149-2918(21)00222-8. doi: 10.1016/j.clinthera.2021.05.007. Online ahead of print.NO ABSTRACTPMID:34103178 | DOI:10.1016/j.clinthera.2021.05.007 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - June 9, 2021 Category: Drugs & Pharmacology Authors: William W Hung Source Type: research

Effect of More Intensive LDL-C-Lowering Therapy on Long-term Cardiovascular Outcomes in Early-Phase Acute Coronary Syndrome: A Systematic Review and Meta-analysis
Clin Ther. 2021 Jun 3:S0149-2918(21)00215-0. doi: 10.1016/j.clinthera.2021.04.019. Online ahead of print.ABSTRACTPURPOSE: The effect of more intensive LDL-C-lowering therapy (ILLT) on long-term cardiovascular outcomes during the early phase of acute coronary syndromes (ACSs) remains uncertain. We aimed to explore the influence of more intensive LDL-C-lowering therapyduring the early disease phase on long-term cardiovascular events among patients with ACSs.METHODS: Randomized controlled trials that focused on the effect of more ILLT during early-phase ACSs on long-term major adverse cardiac events (MACEs) were searched in e...
Source: Clinical Therapeutics - June 7, 2021 Category: Drugs & Pharmacology Authors: Siyao Jin Xiaolu Nie Yuxi Li Jinjie Yuan Yimin Cui Libo Zhao Source Type: research

Effect of More Intensive LDL-C-Lowering Therapy on Long-term Cardiovascular Outcomes in Early-Phase Acute Coronary Syndrome: A Systematic Review and Meta-analysis
Clin Ther. 2021 Jun 3:S0149-2918(21)00215-0. doi: 10.1016/j.clinthera.2021.04.019. Online ahead of print.ABSTRACTPURPOSE: The effect of more intensive LDL-C-lowering therapy (ILLT) on long-term cardiovascular outcomes during the early phase of acute coronary syndromes (ACSs) remains uncertain. We aimed to explore the influence of more intensive LDL-C-lowering therapyduring the early disease phase on long-term cardiovascular events among patients with ACSs.METHODS: Randomized controlled trials that focused on the effect of more ILLT during early-phase ACSs on long-term major adverse cardiac events (MACEs) were searched in e...
Source: Clinical Therapeutics - June 7, 2021 Category: Drugs & Pharmacology Authors: Siyao Jin Xiaolu Nie Yuxi Li Jinjie Yuan Yimin Cui Libo Zhao Source Type: research

Oral Anticoagulation Therapy for Venous Thromboembolism in Norway: Time Trends and Treatment Patterns
This study sought to address this scarcity by describing demographic and clinical characteristics, trends in the use of oral anticoagulants (OACs), and treatment patterns in patients treated for VTE in Norway between 2013 and 2017.METHODS: Using data from Norway's nationwide registries, a cohort study included patients newly (after 2008) treated OACs who were diagnosed with VTE between January 2013 and December 2017 and were dispensed an OAC (warfarin, apixaban, rivaroxaban, dabigatran, or edoxaban) within 30 days. Patient characteristics and the percentage of patients with VTE who initiated treatment with each OAC for eac...
Source: Clinical Therapeutics - June 4, 2021 Category: Drugs & Pharmacology Authors: Waleed Ghanima Anna Schultze Robert Donaldson Ellen Brodin Sigrun Halvorsen Sophie Graham Robert Carroll Maria Ulvestad Dimitra Lambrelli Source Type: research

Oral Anticoagulation Therapy for Venous Thromboembolism in Norway: Time Trends and Treatment Patterns
This study sought to address this scarcity by describing demographic and clinical characteristics, trends in the use of oral anticoagulants (OACs), and treatment patterns in patients treated for VTE in Norway between 2013 and 2017.METHODS: Using data from Norway's nationwide registries, a cohort study included patients newly (after 2008) treated OACs who were diagnosed with VTE between January 2013 and December 2017 and were dispensed an OAC (warfarin, apixaban, rivaroxaban, dabigatran, or edoxaban) within 30 days. Patient characteristics and the percentage of patients with VTE who initiated treatment with each OAC for eac...
Source: Clinical Therapeutics - June 4, 2021 Category: Drugs & Pharmacology Authors: Waleed Ghanima Anna Schultze Robert Donaldson Ellen Brodin Sigrun Halvorsen Sophie Graham Robert Carroll Maria Ulvestad Dimitra Lambrelli Source Type: research

Oral Anticoagulation Therapy for Venous Thromboembolism in Norway: Time Trends and Treatment Patterns
This study sought to address this scarcity by describing demographic and clinical characteristics, trends in the use of oral anticoagulants (OACs), and treatment patterns in patients treated for VTE in Norway between 2013 and 2017.METHODS: Using data from Norway's nationwide registries, a cohort study included patients newly (after 2008) treated OACs who were diagnosed with VTE between January 2013 and December 2017 and were dispensed an OAC (warfarin, apixaban, rivaroxaban, dabigatran, or edoxaban) within 30 days. Patient characteristics and the percentage of patients with VTE who initiated treatment with each OAC for eac...
Source: Clinical Therapeutics - June 4, 2021 Category: Drugs & Pharmacology Authors: Waleed Ghanima Anna Schultze Robert Donaldson Ellen Brodin Sigrun Halvorsen Sophie Graham Robert Carroll Maria Ulvestad Dimitra Lambrelli Source Type: research

Evaluation of Prescribing Practices and Outcomes Using Direct-Acting Oral Anticoagulants After Cardiac Surgery
Clin Ther. 2021 May 30:S0149-2918(21)00203-4. doi: 10.1016/j.clinthera.2021.04.009. Online ahead of print.ABSTRACTPURPOSE: Cardiac surgery patients frequently require anticoagulation. Warfarin remains the preferred agent, and a few trials have reported negative outcomes with the use of direct-acting oral anticoagulants (DOACs) in these patients. Therefore, limited literature exists that supports the dosing, safety, and efficacy of DOACs within the cardiac surgery population.METHODS: This single-center, retrospective analysis was conducted at a tertiary academic medical center. All data were extrapolated from electronic med...
Source: Clinical Therapeutics - June 3, 2021 Category: Drugs & Pharmacology Authors: Dareen M Kanaan Bryan M Cook Julie Kelly Rhynn Malloy Source Type: research

Evaluation of Prescribing Practices and Outcomes Using Direct-Acting Oral Anticoagulants After Cardiac Surgery
Clin Ther. 2021 May 30:S0149-2918(21)00203-4. doi: 10.1016/j.clinthera.2021.04.009. Online ahead of print.ABSTRACTPURPOSE: Cardiac surgery patients frequently require anticoagulation. Warfarin remains the preferred agent, and a few trials have reported negative outcomes with the use of direct-acting oral anticoagulants (DOACs) in these patients. Therefore, limited literature exists that supports the dosing, safety, and efficacy of DOACs within the cardiac surgery population.METHODS: This single-center, retrospective analysis was conducted at a tertiary academic medical center. All data were extrapolated from electronic med...
Source: Clinical Therapeutics - June 3, 2021 Category: Drugs & Pharmacology Authors: Dareen M Kanaan Bryan M Cook Julie Kelly Rhynn Malloy Source Type: research

Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma
This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).FINDINGS: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (...
Source: Clinical Therapeutics - June 1, 2021 Category: Drugs & Pharmacology Authors: Kevin Zarca Maroua Mimouni Helena Pereira Gilles Chatellier Val érie Vilgrain Isabelle Durand-Zaleski SARAH Trial Group Source Type: research

Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies
Clin Ther. 2021 May 28:S0149-2918(21)00127-2. doi: 10.1016/j.clinthera.2021.03.015. Online ahead of print.ABSTRACTPURPOSE: Mirogabalin besylate has been approved in several countries to treat peripheral neuropathic pain. This pooled analysis, using data from the two pivotal Phase III studies in Asian patients with diabetic peripheral neuropathic pain and post-herpetic neuralgia, aimed to provide clinicians with more detailed and precise information relating to mirogabalin's safety and efficacy.METHODS: Data were pooled from 2 multicenter, double-blind, placebo-controlled, parallel-group, 14-week treatment studies of miroga...
Source: Clinical Therapeutics - June 1, 2021 Category: Drugs & Pharmacology Authors: Jitsu Kato Masayuki Baba Masanori Kuroha Yoshihiro Kakehi Emiko Murayama Yosuke Wasaki Shoichi Ohwada Source Type: research

Pharmacoeconomic Evaluation of Erlotinib for the Treatment of Pancreatic Cancer
Clin Ther. 2021 May 28:S0149-2918(21)00207-1. doi: 10.1016/j.clinthera.2021.04.012. Online ahead of print.ABSTRACTPURPOSE: To evaluate the cost-effectiveness of gemcitabine and gemcitabine plus erlotinib as first-line treatments for advanced pancreatic cancer.METHODS: On the basis of the Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer (PA.3) trial, the Markov model was constructed to simulate the development of advanced pancreatic cancer. Cost-effectiveness analysis was used to determine the economic level of the treatments, according to the willingness-to-pay (WTP) threshold. T...
Source: Clinical Therapeutics - June 1, 2021 Category: Drugs & Pharmacology Authors: Kunxi Bao Xiaobing Li Xiaojing He Lingyan Jian Source Type: research

Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma
This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).FINDINGS: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (...
Source: Clinical Therapeutics - June 1, 2021 Category: Drugs & Pharmacology Authors: Kevin Zarca Maroua Mimouni Helena Pereira Gilles Chatellier Val érie Vilgrain Isabelle Durand-Zaleski SARAH Trial Group Source Type: research

Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies
Clin Ther. 2021 May 28:S0149-2918(21)00127-2. doi: 10.1016/j.clinthera.2021.03.015. Online ahead of print.ABSTRACTPURPOSE: Mirogabalin besylate has been approved in several countries to treat peripheral neuropathic pain. This pooled analysis, using data from the two pivotal Phase III studies in Asian patients with diabetic peripheral neuropathic pain and post-herpetic neuralgia, aimed to provide clinicians with more detailed and precise information relating to mirogabalin's safety and efficacy.METHODS: Data were pooled from 2 multicenter, double-blind, placebo-controlled, parallel-group, 14-week treatment studies of miroga...
Source: Clinical Therapeutics - June 1, 2021 Category: Drugs & Pharmacology Authors: Jitsu Kato Masayuki Baba Masanori Kuroha Yoshihiro Kakehi Emiko Murayama Yosuke Wasaki Shoichi Ohwada Source Type: research

Pharmacoeconomic Evaluation of Erlotinib for the Treatment of Pancreatic Cancer
Clin Ther. 2021 May 28:S0149-2918(21)00207-1. doi: 10.1016/j.clinthera.2021.04.012. Online ahead of print.ABSTRACTPURPOSE: To evaluate the cost-effectiveness of gemcitabine and gemcitabine plus erlotinib as first-line treatments for advanced pancreatic cancer.METHODS: On the basis of the Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer (PA.3) trial, the Markov model was constructed to simulate the development of advanced pancreatic cancer. Cost-effectiveness analysis was used to determine the economic level of the treatments, according to the willingness-to-pay (WTP) threshold. T...
Source: Clinical Therapeutics - June 1, 2021 Category: Drugs & Pharmacology Authors: Kunxi Bao Xiaobing Li Xiaojing He Lingyan Jian Source Type: research

Emerging Treatment Strategies for Impetigo in Endemic and Nonendemic Settings: A Systematic Review
Clin Ther. 2021 May 27:S0149-2918(21)00208-3. doi: 10.1016/j.clinthera.2021.04.013. Online ahead of print.ABSTRACTPURPOSE: Impetigo affects approximately 162 million children worldwide at any given time. Lack of consensus on the most effective treatment strategy for impetigo and increasing antibiotic resistance continue to drive research into newer and alternative treatment options. We conducted a systematic review to assess the effectiveness of new treatments for impetigo in endemic and nonendemic settings.METHODS: We searched PubMed, MEDLINE, CINAHL, Web of Science, and Embase via Scopus for studies that explored treatme...
Source: Clinical Therapeutics - May 31, 2021 Category: Drugs & Pharmacology Authors: Garima Gahlawat Wubshet Tesfaye Mary Bushell Solomon Abrha Gregory M Peterson Cynthia Mathew Mahipal Sinnollareddy Faye McMillan Indira Samarawickrema Tom Calma Aileen Y Chang Daniel Engelman Andrew Steer Jackson Thomas Source Type: research

Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors
This article reports the pharmacokinetic (PK) profile, safety, and tolerability of capmatinib 300 and 400 mg BID given with food in MET-dysregulated advanced solid tumors.METHODS: This multicenter, open-label, Phase I study enrolled adult patients with MET-dysregulated advanced solid tumors. In the dose escalation phase, capmatinib tablets were orally administered at a dose of 300 mg BID with food; if tolerated, the dose escalation cohort of 400 mg BID was to be opened to enrollment. In the expansion phase, patients were to be enrolled at the higher of the tolerated doses. Tablets were taken within 30 minutes of an unrestr...
Source: Clinical Therapeutics - May 31, 2021 Category: Drugs & Pharmacology Authors: Victor Moreno Richard Greil Jeffrey Yachnin Margarita Majem Martin Wermke Hendrik-Tobias Arkenau Jean-Rene Basque Prasanna Kumar Nidamarthy Shruti Kapoor Xiaoming Cui Monica Giovannini Source Type: research

Emerging Treatment Strategies for Impetigo in Endemic and Nonendemic Settings: A Systematic Review
Clin Ther. 2021 May 27:S0149-2918(21)00208-3. doi: 10.1016/j.clinthera.2021.04.013. Online ahead of print.ABSTRACTPURPOSE: Impetigo affects approximately 162 million children worldwide at any given time. Lack of consensus on the most effective treatment strategy for impetigo and increasing antibiotic resistance continue to drive research into newer and alternative treatment options. We conducted a systematic review to assess the effectiveness of new treatments for impetigo in endemic and nonendemic settings.METHODS: We searched PubMed, MEDLINE, CINAHL, Web of Science, and Embase via Scopus for studies that explored treatme...
Source: Clinical Therapeutics - May 31, 2021 Category: Drugs & Pharmacology Authors: Garima Gahlawat Wubshet Tesfaye Mary Bushell Solomon Abrha Gregory M Peterson Cynthia Mathew Mahipal Sinnollareddy Faye McMillan Indira Samarawickrema Tom Calma Aileen Y Chang Daniel Engelman Andrew Steer Jackson Thomas Source Type: research

Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors
This article reports the pharmacokinetic (PK) profile, safety, and tolerability of capmatinib 300 and 400 mg BID given with food in MET-dysregulated advanced solid tumors.METHODS: This multicenter, open-label, Phase I study enrolled adult patients with MET-dysregulated advanced solid tumors. In the dose escalation phase, capmatinib tablets were orally administered at a dose of 300 mg BID with food; if tolerated, the dose escalation cohort of 400 mg BID was to be opened to enrollment. In the expansion phase, patients were to be enrolled at the higher of the tolerated doses. Tablets were taken within 30 minutes of an unrestr...
Source: Clinical Therapeutics - May 31, 2021 Category: Drugs & Pharmacology Authors: Victor Moreno Richard Greil Jeffrey Yachnin Margarita Majem Martin Wermke Hendrik-Tobias Arkenau Jean-Rene Basque Prasanna Kumar Nidamarthy Shruti Kapoor Xiaoming Cui Monica Giovannini Source Type: research

Effects of Ivermectin in Patients With COVID-19: A Multicenter, Double-Blind, Randomized, Controlled Clinical Trial
This study aimed to evaluate the effects of the widely used antiparasitic drug ivermectin on outcomes in patients with COVID-19.METHODS: In this randomized, double-blind clinical trial, patients with COVID-19 admitted to 2 referral tertiary hospitals in Mazandaran, Iran, were randomly divided into 2 groups: intervention and control. In addition to standard treatment for COVID-19, the intervention group received a single weight-based dose (0.2 mg/kg) of ivermectin; the control group received the standard of care. Demographic, clinical, laboratory, and imaging data from participants were recorded at baseline. Patients were a...
Source: Clinical Therapeutics - May 30, 2021 Category: Drugs & Pharmacology Authors: Leila Shahbaznejad Alireza Davoudi Gohar Eslami John S Markowitz Mohammad Reza Navaeifar Fatemeh Hosseinzadeh Faeze Sadat Movahedi Mohammad Sadegh Rezai Source Type: research

Personalizing Therapies and Targeting Treatment Strategies Through Pharmacogenomics and Artificial Intelligence
Clin Ther. 2021 May 26:S0149-2918(21)00199-5. doi: 10.1016/j.clinthera.2021.04.005. Online ahead of print.NO ABSTRACTPMID:34052008 | DOI:10.1016/j.clinthera.2021.04.005 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - May 30, 2021 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

SARS-CoV-2 Monoclonal Antibodies in Children: Ethical Considerations
Clin Ther. 2021 May 6:S0149-2918(21)00202-2. doi: 10.1016/j.clinthera.2021.04.008. Online ahead of print.ABSTRACTThe use of monoclonal antibodies in children with certain conditions and at high risk for severe COVID-19 has been approved by the US Food and Drug Administration under the Emergency Use Authorization mechanism of the Federal Food, Drug, and Cosmetic Act. No data on the tolerability or efficacy of these therapies in persons
Source: Clinical Therapeutics - May 29, 2021 Category: Drugs & Pharmacology Authors: Ian D Wolfe Sameer J Patel Source Type: research

SARS-CoV-2 Monoclonal Antibodies in Children: Ethical Considerations
Clin Ther. 2021 May 6:S0149-2918(21)00202-2. doi: 10.1016/j.clinthera.2021.04.008. Online ahead of print.ABSTRACTThe use of monoclonal antibodies in children with certain conditions and at high risk for severe COVID-19 has been approved by the US Food and Drug Administration under the Emergency Use Authorization mechanism of the Federal Food, Drug, and Cosmetic Act. No data on the tolerability or efficacy of these therapies in persons
Source: Clinical Therapeutics - May 29, 2021 Category: Drugs & Pharmacology Authors: Ian D Wolfe Sameer J Patel Source Type: research

COVID-19 Vaccine Effectiveness
Clin Ther. 2021 May 5:S0149-2918(21)00211-3. doi: 10.1016/j.clinthera.2021.04.016. Online ahead of print.NO ABSTRACTPMID:34045122 | PMC:PMC8098041 | DOI:10.1016/j.clinthera.2021.04.016 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - May 28, 2021 Category: Drugs & Pharmacology Authors: Richard I Shader Source Type: research

COVID-19 Vaccine Effectiveness
Clin Ther. 2021 May 5:S0149-2918(21)00211-3. doi: 10.1016/j.clinthera.2021.04.016. Online ahead of print.NO ABSTRACTPMID:34045122 | DOI:10.1016/j.clinthera.2021.04.016 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - May 28, 2021 Category: Drugs & Pharmacology Authors: Richard I Shader Source Type: research

Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study
The objectives of the study were to determine, during CRRT, the time window with low likelihood for safe reinjection and the proportion of inappropriate reinjection.METHODS: A post hoc observational analysis of a multicenter randomized trial comparing the risk of hemodialysis catheter infection with ethanol lock vs placebo in critically ill patients with AKI was conducted. Eligible patients were adults in intensive care units from 6 French hospitals. Any patient with AKI needing CRRT and receiving an antimicrobial therapy for a septic episode occurring before (≤24 hours) or during CRRT was included. The aminoglycoside o...
Source: Clinical Therapeutics - May 27, 2021 Category: Drugs & Pharmacology Authors: Alexandre Boyer Jean-Fran çois Timsit Kada Klouche Emmanuel Canet Thuy-Nga Phan Julien Boh é Sebastien Rubin Arthur Orieux Alexandre Lautrette Didier Gruson Bertrand Souweine Source Type: research

Exploration and Ethical Analysis of Open-Label Pediatric Vaccine Trials in a Pandemic
Clin Ther. 2021 May 23:S0149-2918(21)00204-6. doi: 10.1016/j.clinthera.2021.04.010. Online ahead of print.ABSTRACTYoung children will ultimately need to be vaccinated to stop the spread of coronavirus disease 2019 (COVID-19). Initial studies of vaccine were performed in adults. Randomized controlled trials are the gold standard. In the COVID-19 pandemic, many questions need to be answered about the ethics and feasibility of these trials. Given the harms of the COVID-19 pandemic and the now-known efficacy of the vaccines in adults and teens, the question of whether clinical equipoise exists for a placebo-controlled trial of...
Source: Clinical Therapeutics - May 27, 2021 Category: Drugs & Pharmacology Authors: Ian D Wolfe Angira Patel Larry K Kociolek Asma Fazal Ravi Jhaveri John D Lantos Source Type: research

Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study
The objectives of the study were to determine, during CRRT, the time window with low likelihood for safe reinjection and the proportion of inappropriate reinjection.METHODS: A post hoc observational analysis of a multicenter randomized trial comparing the risk of hemodialysis catheter infection with ethanol lock vs placebo in critically ill patients with AKI was conducted. Eligible patients were adults in intensive care units from 6 French hospitals. Any patient with AKI needing CRRT and receiving an antimicrobial therapy for a septic episode occurring before (≤24 hours) or during CRRT was included. The aminoglycoside o...
Source: Clinical Therapeutics - May 27, 2021 Category: Drugs & Pharmacology Authors: Alexandre Boyer Jean-Fran çois Timsit Kada Klouche Emmanuel Canet Thuy-Nga Phan Julien Boh é Sebastien Rubin Arthur Orieux Alexandre Lautrette Didier Gruson Bertrand Souweine Source Type: research

Exploration and Ethical Analysis of Open-Label Pediatric Vaccine Trials in a Pandemic
Clin Ther. 2021 May 23:S0149-2918(21)00204-6. doi: 10.1016/j.clinthera.2021.04.010. Online ahead of print.ABSTRACTYoung children will ultimately need to be vaccinated to stop the spread of coronavirus disease 2019 (COVID-19). Initial studies of vaccine were performed in adults. Randomized controlled trials are the gold standard. In the COVID-19 pandemic, many questions need to be answered about the ethics and feasibility of these trials. Given the harms of the COVID-19 pandemic and the now-known efficacy of the vaccines in adults and teens, the question of whether clinical equipoise exists for a placebo-controlled trial of...
Source: Clinical Therapeutics - May 27, 2021 Category: Drugs & Pharmacology Authors: Ian D Wolfe Angira Patel Larry K Kociolek Asma Fazal Ravi Jhaveri John D Lantos Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research

Paid Caregivers in the Community-Based Dementia Care Team: Do Family Caregivers Benefit?
This study conceptualizes paid caregivers as part of the collaborative dementia care team and examines the association between receipt of paid care and primary family caregiver experience.METHODS: Using data from 3 waves (2011, 2015, and 2017) of the National Health and Aging Trends Study linked to the National Study of Caregiving, community-dwelling Medicare beneficiaries aged ≥67 years with advanced dementia (n = 338 observations) were identified. Primary family caregiver experiences were compared among those with zero, part-time (
Source: Clinical Therapeutics - May 11, 2021 Category: Drugs & Pharmacology Authors: Jennifer M Reckrey Kathrin Boerner Emily Franzosa Evan Bollens-Lund Katherine A Ornstein Source Type: research