Commentary on "Sex and Gender Differences in Clinical Pharmacology: Implications for Transgender Medicine"
Clin Pharmacol Ther. 2021 Jul 30. doi: 10.1002/cpt.2305. Online ahead of print.NO ABSTRACTPMID:34327704 | DOI:10.1002/cpt.2305 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 30, 2021 Category: Drugs & Pharmacology Authors: Monette M Cotreau Source Type: research

Advancing Precision Medicine Through the New Pharmacogenomics Global Research Network
Clin Pharmacol Ther. 2021 Jul 28. doi: 10.1002/cpt.2340. Online ahead of print.NO ABSTRACTPMID:34318925 | DOI:10.1002/cpt.2340 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 28, 2021 Category: Drugs & Pharmacology Authors: Kathleen M Giacomini Jason H Karnes Kristine R Crews Andrew A Monte William A Murphy Akinyemi Oni-Orisan Laura B Ramsey Jun J Yang Michelle Whirl-Carrillo Source Type: research

Factors influencing plasma coproporphyrin-I concentration as biomarker of OATP1B activity in patients with rheumatoid arthritis
In conclusion, the present results suggest that inflammatory cytokines do not have clinically significant effects on OATP1B activity, whereas the effects of genetic polymorphisms and uremic toxins should be considered.PMID:34319605 | DOI:10.1002/cpt.2375 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 28, 2021 Category: Drugs & Pharmacology Authors: Hiroyuki Ono Ryota Tanaka Yosuke Suzuki Ayako Oda Takashi Ozaki Ryosuke Tatsuta Keisuke Maeshima Koji Ishii Keiko Ohno Hirotaka Shibata Hiroki Itoh Source Type: research

Advancing Precision Medicine Through the New Pharmacogenomics Global Research Network
Clin Pharmacol Ther. 2021 Jul 28. doi: 10.1002/cpt.2340. Online ahead of print.NO ABSTRACTPMID:34318925 | DOI:10.1002/cpt.2340 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 28, 2021 Category: Drugs & Pharmacology Authors: Kathleen M Giacomini Jason H Karnes Kristine R Crews Andrew A Monte William A Murphy Akinyemi Oni-Orisan Laura B Ramsey Jun J Yang Michelle Whirl-Carrillo Source Type: research

Factors influencing plasma coproporphyrin-I concentration as biomarker of OATP1B activity in patients with rheumatoid arthritis
In conclusion, the present results suggest that inflammatory cytokines do not have clinically significant effects on OATP1B activity, whereas the effects of genetic polymorphisms and uremic toxins should be considered.PMID:34319605 | DOI:10.1002/cpt.2375 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 28, 2021 Category: Drugs & Pharmacology Authors: Hiroyuki Ono Ryota Tanaka Yosuke Suzuki Ayako Oda Takashi Ozaki Ryosuke Tatsuta Keisuke Maeshima Koji Ishii Keiko Ohno Hirotaka Shibata Hiroki Itoh Source Type: research

Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia
Clin Pharmacol Ther. 2021 Jul 27. doi: 10.1002/cpt.2377. Online ahead of print.ABSTRACTSerious hypoglycemia is a major adverse event associated with insulin secretagogues. Previous studies have suggested a potential relationship between angiotensin-converting enzyme inhibitors (ACEIs) used with sulfonylureas and serious hypoglycemia, and widely used drug compendia warn of this potential drug-drug interaction. We investigated the association between serious hypoglycemia and concomitant use of ACEIs in patients receiving insulin secretagogues, using the self-controlled case series design and Medicaid claims data from 5 US st...
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Young Hee Nam Colleen M Brensinger Warren B Bilker James H Flory Charles E Leonard Sean Hennessy Source Type: research

Mapping the miRNA-mRNA Interactome in Human Hepatocytes and Identification of Functional mirSNPs in Pharmacogenes
Clin Pharmacol Ther. 2021 Jul 27. doi: 10.1002/cpt.2379. Online ahead of print.ABSTRACTMiRNAs regulate the expression of hepatic genes involved in pharmacokinetics and pharmacodynamics. Genetic variants affecting miRNA binding (mirSNPs) have been associated with altered drug response, but previously used methods to identify miRNA binding sites and functional mirSNPs in pharmacogenes are indirect and limited by low throughput. We utilized the high-throughput chimeric-eCLIP assay to directly map thousands of miRNA-mRNA interactions and define the miRNA binding sites in primary hepatocytes. We then used the high-throughput PA...
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Nicholas R Powell Harrison Zhao Joseph Ipe Yunlong Liu Todd C Skaar Source Type: research

Erratum: A Model Averaging/Selection Approach Improves the Predictive Performance of Model-Informed Precision Dosing: Vancomycin as a Case Study
Clin Pharmacol Ther. 2021 Jul 27. doi: 10.1002/cpt.2353. Online ahead of print.NO ABSTRACTPMID:34314510 | DOI:10.1002/cpt.2353 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Source Type: research

DrugWAS: Drug-wide association studies for COVID-19 drug repurposing
In conclusion, this cohort study leveraged EHR data to identify a list of drugs that could be repurposed to improve COVID-19 outcomes. Further randomized clinical trials are needed to investigate the efficacy of the proposed drugs.PMID:34314511 | DOI:10.1002/cpt.2376 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Cosmin A Bejan Katherine N Cahill Patrick J Staso Leena Choi Josh F Peterson Elizabeth J Phillips Source Type: research

Pharmacokinetics of intravenous paracetamol (acetaminophen) and ductus arteriosus closure after premature birth
In this study, we aimed to develop a population PK model for paracetamol and investigate the relationship between paracetamol exposure levels and time to contraction of the ductus. Data were modeled using the Monolix software. A one-compartment model adequately described the paracetamol concentration time-course. A Weibull model adequately described the time to contraction of the ductus. Our results suggest that the dosage used in this study (i.e., first day 42.5 mg/kg, then 30 mg/kg/d) allows reaching the maximum inhibition response from paracetamol regarding the time to close the ductus. However, this study pointed out a...
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Na ïm Bouazza Jean-Marc Treluyer Frantz Foissac Sa ïk Urien Outi Aikio Jean-Christophe Roze Mikko Hallman Source Type: research

Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia
Clin Pharmacol Ther. 2021 Jul 27. doi: 10.1002/cpt.2377. Online ahead of print.ABSTRACTSerious hypoglycemia is a major adverse event associated with insulin secretagogues. Previous studies have suggested a potential relationship between angiotensin-converting enzyme inhibitors (ACEIs) used with sulfonylureas and serious hypoglycemia, and widely used drug compendia warn of this potential drug-drug interaction. We investigated the association between serious hypoglycemia and concomitant use of ACEIs in patients receiving insulin secretagogues, using the self-controlled case series design and Medicaid claims data from 5 US st...
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Young Hee Nam Colleen M Brensinger Warren B Bilker James H Flory Charles E Leonard Sean Hennessy Source Type: research

Mapping the miRNA-mRNA Interactome in Human Hepatocytes and Identification of Functional mirSNPs in Pharmacogenes
Clin Pharmacol Ther. 2021 Jul 27. doi: 10.1002/cpt.2379. Online ahead of print.ABSTRACTMiRNAs regulate the expression of hepatic genes involved in pharmacokinetics and pharmacodynamics. Genetic variants affecting miRNA binding (mirSNPs) have been associated with altered drug response, but previously used methods to identify miRNA binding sites and functional mirSNPs in pharmacogenes are indirect and limited by low throughput. We utilized the high-throughput chimeric-eCLIP assay to directly map thousands of miRNA-mRNA interactions and define the miRNA binding sites in primary hepatocytes. We then used the high-throughput PA...
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Nicholas R Powell Harrison Zhao Joseph Ipe Yunlong Liu Todd C Skaar Source Type: research

Erratum: A Model Averaging/Selection Approach Improves the Predictive Performance of Model-Informed Precision Dosing: Vancomycin as a Case Study
Clin Pharmacol Ther. 2021 Jul 27. doi: 10.1002/cpt.2353. Online ahead of print.NO ABSTRACTPMID:34314510 | DOI:10.1002/cpt.2353 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Source Type: research

DrugWAS: Drug-wide association studies for COVID-19 drug repurposing
In conclusion, this cohort study leveraged EHR data to identify a list of drugs that could be repurposed to improve COVID-19 outcomes. Further randomized clinical trials are needed to investigate the efficacy of the proposed drugs.PMID:34314511 | DOI:10.1002/cpt.2376 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Cosmin A Bejan Katherine N Cahill Patrick J Staso Leena Choi Josh F Peterson Elizabeth J Phillips Source Type: research

Pharmacokinetics of intravenous paracetamol (acetaminophen) and ductus arteriosus closure after premature birth
In this study, we aimed to develop a population PK model for paracetamol and investigate the relationship between paracetamol exposure levels and time to contraction of the ductus. Data were modeled using the Monolix software. A one-compartment model adequately described the paracetamol concentration time-course. A Weibull model adequately described the time to contraction of the ductus. Our results suggest that the dosage used in this study (i.e., first day 42.5 mg/kg, then 30 mg/kg/d) allows reaching the maximum inhibition response from paracetamol regarding the time to close the ductus. However, this study pointed out a...
Source: Clinical Pharmacology and Therapeutics - July 27, 2021 Category: Drugs & Pharmacology Authors: Na ïm Bouazza Jean-Marc Treluyer Frantz Foissac Sa ïk Urien Outi Aikio Jean-Christophe Roze Mikko Hallman Source Type: research

The bioequivalence of a single dose of a generic solifenacin succinate tablet or vesicare in fasting or postprandial healthy Chinese adults
CONCLUSION: A single administration of a 5-mg tablet of either the test preparation, generic solifenacin succinate, or the reference preparation, solifenacin succinate with the brand-name vesicare, was safe and bioequivalent in healthy Chinese subjects in either fasting or postprandial states according to the criteria of bioequivalence of the State Drug Administration of China.PMID:34308834 | DOI:10.5414/CP203860 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 26, 2021 Category: Drugs & Pharmacology Authors: Hao Jin Liping Shi Jungang Yin Jingmei Yu Meng Jiang Fang Liu Jun Zhang Yuxian Zhu Chong Zou Hanyue Yang Source Type: research

Machine Learning as a Novel Method to Support Therapeutic Drug Management and Precision Dosing
Clin Pharmacol Ther. 2021 Aug;110(2):273-276. doi: 10.1002/cpt.2326.NO ABSTRACTPMID:34311506 | DOI:10.1002/cpt.2326 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 26, 2021 Category: Drugs & Pharmacology Authors: Teun van Gelder Alexander A Vinks Source Type: research

The bioequivalence of a single dose of a generic solifenacin succinate tablet or vesicare in fasting or postprandial healthy Chinese adults
CONCLUSION: A single administration of a 5-mg tablet of either the test preparation, generic solifenacin succinate, or the reference preparation, solifenacin succinate with the brand-name vesicare, was safe and bioequivalent in healthy Chinese subjects in either fasting or postprandial states according to the criteria of bioequivalence of the State Drug Administration of China.PMID:34308834 | DOI:10.5414/CP203860 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 26, 2021 Category: Drugs & Pharmacology Authors: Hao Jin Liping Shi Jungang Yin Jingmei Yu Meng Jiang Fang Liu Jun Zhang Yuxian Zhu Chong Zou Hanyue Yang Source Type: research

Methadone Destabilizes Cardiac Repolarization during Sleep
The objective of this study was to determine whether methadone's arrhythmogenic effects increase during sleep, with a focus on cardiac repolarization instability using QT variability index (QTVI), a measure shown to predict arrhythmias and mortality. Sleep study data of 24 patients on chronic methadone therapy referred to a tertiary clinic for overnight polysomnography were compared with two matched groups not on methadone: 24 patients referred for overnight polysomnography to the same clinic (Clinic group), and 24 volunteers who had overnight polysomnography at home (Community group). Despite similar values for heart rate...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Soroosh Solhjoo Naresh M Punjabi Andrada E Ivanescu Ciprian Crainiceanu Irina Gaynanova Cassie Wicken Chester Buckenmaier Mark C Haigney Source Type: research

Association between Use of Pharmacokinetic-Interacting Drugs and Effectiveness and Safety of Direct Acting Oral Anticoagulants: Nested Case-Control Study
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2369. Online ahead of print.ABSTRACTConcomitant use of direct oral anticoagulants (DOACs) and medications with inhibition/induction effect on P-gp/CYP3A might increase risk of bleeding/treatment failure, respectively. We designed a nested case-control study within a Clalit cohort of atrial fibrillation (AF) patients and a cohort of venous thromboembolic patients, new users of a DOAC (1.1.2010-24.8.2020). Propensity scores were constructed from demographic, clinical and medications at cohort entry. Each case of: 1) serious bleeding event; 2) stroke/systemic emboli (SE) in A...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Naomi Gronich Nilli Stein Mordehcai Muszkat Source Type: research

Association of Parenteral Anticoagulation Therapy with Outcomes in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Without Invasive Therapy
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2370. Online ahead of print.ABSTRACTOur previous study showed that parenteral anticoagulation therapy (PACT) in the context of aggressive antiplatelet therapy failed to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, the roles of PACT in patients managed medically remains unknown. This observational cohort study enrolled NSTE-ACS patients receiving medical therapy from November 2014 to June 2017 in the Improving Care for Cardiovascular Disease in China-Acute ...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Yuan-Hui Liu Hua-Lin Fan Li-Huan Zeng Chong-Yang Duan Guo Chen Peng-Yuan Chen Dong Zhao Jing Liu Yong-Chen Hao Wen-Fei He Sha Tao Xue-Biao Wei Lei Jiang Wei Guo Yan-Song Guo Wei Chen Jun Li Yun-Zhao Hu Wen-Sheng Li Yi-Yue Chen Jian-Fang Luo Ying-Ling Zhou Source Type: research

Methadone Destabilizes Cardiac Repolarization during Sleep
The objective of this study was to determine whether methadone's arrhythmogenic effects increase during sleep, with a focus on cardiac repolarization instability using QT variability index (QTVI), a measure shown to predict arrhythmias and mortality. Sleep study data of 24 patients on chronic methadone therapy referred to a tertiary clinic for overnight polysomnography were compared with two matched groups not on methadone: 24 patients referred for overnight polysomnography to the same clinic (Clinic group), and 24 volunteers who had overnight polysomnography at home (Community group). Despite similar values for heart rate...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Soroosh Solhjoo Naresh M Punjabi Andrada E Ivanescu Ciprian Crainiceanu Irina Gaynanova Cassie Wicken Chester Buckenmaier Mark C Haigney Source Type: research

Association between Use of Pharmacokinetic-Interacting Drugs and Effectiveness and Safety of Direct Acting Oral Anticoagulants: Nested Case-Control Study
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2369. Online ahead of print.ABSTRACTConcomitant use of direct oral anticoagulants (DOACs) and medications with inhibition/induction effect on P-gp/CYP3A might increase risk of bleeding/treatment failure, respectively. We designed a nested case-control study within a Clalit cohort of atrial fibrillation (AF) patients and a cohort of venous thromboembolic patients, new users of a DOAC (1.1.2010-24.8.2020). Propensity scores were constructed from demographic, clinical and medications at cohort entry. Each case of: 1) serious bleeding event; 2) stroke/systemic emboli (SE) in A...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Naomi Gronich Nilli Stein Mordehcai Muszkat Source Type: research

Association of Parenteral Anticoagulation Therapy with Outcomes in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Without Invasive Therapy
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2370. Online ahead of print.ABSTRACTOur previous study showed that parenteral anticoagulation therapy (PACT) in the context of aggressive antiplatelet therapy failed to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, the roles of PACT in patients managed medically remains unknown. This observational cohort study enrolled NSTE-ACS patients receiving medical therapy from November 2014 to June 2017 in the Improving Care for Cardiovascular Disease in China-Acute ...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Yuan-Hui Liu Hua-Lin Fan Li-Huan Zeng Chong-Yang Duan Guo Chen Peng-Yuan Chen Dong Zhao Jing Liu Yong-Chen Hao Wen-Fei He Sha Tao Xue-Biao Wei Lei Jiang Wei Guo Yan-Song Guo Wei Chen Jun Li Yun-Zhao Hu Wen-Sheng Li Yi-Yue Chen Jian-Fang Luo Ying-Ling Zhou Source Type: research

Methadone Destabilizes Cardiac Repolarization during Sleep
The objective of this study was to determine whether methadone's arrhythmogenic effects increase during sleep, with a focus on cardiac repolarization instability using QT variability index (QTVI), a measure shown to predict arrhythmias and mortality. Sleep study data of 24 patients on chronic methadone therapy referred to a tertiary clinic for overnight polysomnography were compared with two matched groups not on methadone: 24 patients referred for overnight polysomnography to the same clinic (Clinic group), and 24 volunteers who had overnight polysomnography at home (Community group). Despite similar values for heart rate...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Soroosh Solhjoo Naresh M Punjabi Andrada E Ivanescu Ciprian Crainiceanu Irina Gaynanova Cassie Wicken Chester Buckenmaier Mark C Haigney Source Type: research

Association between Use of Pharmacokinetic-Interacting Drugs and Effectiveness and Safety of Direct Acting Oral Anticoagulants: Nested Case-Control Study
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2369. Online ahead of print.ABSTRACTConcomitant use of direct oral anticoagulants (DOACs) and medications with inhibition/induction effect on P-gp/CYP3A might increase risk of bleeding/treatment failure, respectively. We designed a nested case-control study within a Clalit cohort of atrial fibrillation (AF) patients and a cohort of venous thromboembolic patients, new users of a DOAC (1.1.2010-24.8.2020). Propensity scores were constructed from demographic, clinical and medications at cohort entry. Each case of: 1) serious bleeding event; 2) stroke/systemic emboli (SE) in A...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Naomi Gronich Nilli Stein Mordehcai Muszkat Source Type: research

Association of Parenteral Anticoagulation Therapy with Outcomes in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Without Invasive Therapy
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2370. Online ahead of print.ABSTRACTOur previous study showed that parenteral anticoagulation therapy (PACT) in the context of aggressive antiplatelet therapy failed to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, the roles of PACT in patients managed medically remains unknown. This observational cohort study enrolled NSTE-ACS patients receiving medical therapy from November 2014 to June 2017 in the Improving Care for Cardiovascular Disease in China-Acute ...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Yuan-Hui Liu Hua-Lin Fan Li-Huan Zeng Chong-Yang Duan Guo Chen Peng-Yuan Chen Dong Zhao Jing Liu Yong-Chen Hao Wen-Fei He Sha Tao Xue-Biao Wei Lei Jiang Wei Guo Yan-Song Guo Wei Chen Jun Li Yun-Zhao Hu Wen-Sheng Li Yi-Yue Chen Jian-Fang Luo Ying-Ling Zhou Source Type: research

Methadone Destabilizes Cardiac Repolarization during Sleep
The objective of this study was to determine whether methadone's arrhythmogenic effects increase during sleep, with a focus on cardiac repolarization instability using QT variability index (QTVI), a measure shown to predict arrhythmias and mortality. Sleep study data of 24 patients on chronic methadone therapy referred to a tertiary clinic for overnight polysomnography were compared with two matched groups not on methadone: 24 patients referred for overnight polysomnography to the same clinic (Clinic group), and 24 volunteers who had overnight polysomnography at home (Community group). Despite similar values for heart rate...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Soroosh Solhjoo Naresh M Punjabi Andrada E Ivanescu Ciprian Crainiceanu Irina Gaynanova Cassie Wicken Chester Buckenmaier Mark C Haigney Source Type: research

Association between Use of Pharmacokinetic-Interacting Drugs and Effectiveness and Safety of Direct Acting Oral Anticoagulants: Nested Case-Control Study
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2369. Online ahead of print.ABSTRACTConcomitant use of direct oral anticoagulants (DOACs) and medications with inhibition/induction effect on P-gp/CYP3A might increase risk of bleeding/treatment failure, respectively. We designed a nested case-control study within a Clalit cohort of atrial fibrillation (AF) patients and a cohort of venous thromboembolic patients, new users of a DOAC (1.1.2010-24.8.2020). Propensity scores were constructed from demographic, clinical and medications at cohort entry. Each case of: 1) serious bleeding event; 2) stroke/systemic emboli (SE) in A...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Naomi Gronich Nilli Stein Mordehcai Muszkat Source Type: research

Association of Parenteral Anticoagulation Therapy with Outcomes in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Without Invasive Therapy
Clin Pharmacol Ther. 2021 Jul 19. doi: 10.1002/cpt.2370. Online ahead of print.ABSTRACTOur previous study showed that parenteral anticoagulation therapy (PACT) in the context of aggressive antiplatelet therapy failed to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, the roles of PACT in patients managed medically remains unknown. This observational cohort study enrolled NSTE-ACS patients receiving medical therapy from November 2014 to June 2017 in the Improving Care for Cardiovascular Disease in China-Acute ...
Source: Clinical Pharmacology and Therapeutics - July 21, 2021 Category: Drugs & Pharmacology Authors: Yuan-Hui Liu Hua-Lin Fan Li-Huan Zeng Chong-Yang Duan Guo Chen Peng-Yuan Chen Dong Zhao Jing Liu Yong-Chen Hao Wen-Fei He Sha Tao Xue-Biao Wei Lei Jiang Wei Guo Yan-Song Guo Wei Chen Jun Li Yun-Zhao Hu Wen-Sheng Li Yi-Yue Chen Jian-Fang Luo Ying-Ling Zhou Source Type: research

Comparison of the efficacy and safety of tocilizumab, sarilumab, and sirukumab in comparison with adalimumab as monotherapy in patients with active rheumatoid arthritis: A  Bayesian network meta-analysis of randomized controlled trials
CONCLUSION: Based on ACR20 and ACR50 response rates, monotherapy with tocilizumab 8 mg, followed by sarilumab and sirukumab monotherapy, was optimal for patients with RA responding inadequately to MTX or showing intolerance.PMID:34281633 | DOI:10.5414/CP204017 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 20, 2021 Category: Drugs & Pharmacology Authors: Yoon-Kyoung Sung Young Ho Lee Source Type: research

Comparison of the efficacy and safety of tocilizumab, sarilumab, and sirukumab in comparison with adalimumab as monotherapy in patients with active rheumatoid arthritis: A  Bayesian network meta-analysis of randomized controlled trials
CONCLUSION: Based on ACR20 and ACR50 response rates, monotherapy with tocilizumab 8 mg, followed by sarilumab and sirukumab monotherapy, was optimal for patients with RA responding inadequately to MTX or showing intolerance.PMID:34281633 | DOI:10.5414/CP204017 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 20, 2021 Category: Drugs & Pharmacology Authors: Yoon-Kyoung Sung Young Ho Lee Source Type: research

Drug-Drug-Gene Interactions: A Call for Clinical Consideration
Clin Pharmacol Ther. 2021 Jul 18. doi: 10.1002/cpt.2348. Online ahead of print.NO ABSTRACTPMID:34278570 | DOI:10.1002/cpt.2348 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 19, 2021 Category: Drugs & Pharmacology Authors: Henrike Bruckmueller Ingolf Cascorbi Source Type: research

Evidence, in Context: A Regulatory Perspective on Pharmacogenetics
Clin Pharmacol Ther. 2021 Jul 18. doi: 10.1002/cpt.2347. Online ahead of print.NO ABSTRACTPMID:34278575 | DOI:10.1002/cpt.2347 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 19, 2021 Category: Drugs & Pharmacology Authors: Michael Pacanowski Robert N Schuck Source Type: research

Drug-Drug-Gene Interactions: A Call for Clinical Consideration
Clin Pharmacol Ther. 2021 Jul 18. doi: 10.1002/cpt.2348. Online ahead of print.NO ABSTRACTPMID:34278570 | DOI:10.1002/cpt.2348 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 19, 2021 Category: Drugs & Pharmacology Authors: Henrike Bruckmueller Ingolf Cascorbi Source Type: research

Evidence, in Context: A Regulatory Perspective on Pharmacogenetics
Clin Pharmacol Ther. 2021 Jul 18. doi: 10.1002/cpt.2347. Online ahead of print.NO ABSTRACTPMID:34278575 | DOI:10.1002/cpt.2347 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 19, 2021 Category: Drugs & Pharmacology Authors: Michael Pacanowski Robert N Schuck Source Type: research

The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis
Clin Pharmacol Ther. 2021 Jul 16. doi: 10.1002/cpt.2366. Online ahead of print.ABSTRACTDupilumab demonstrated efficacy with an acceptable safety profile in two randomized, double-blind, placebo-controlled, parallel-group, phase III trials in adolescents (12-17 years; LIBERTY AD ADOL) and children (6-11 years; LIBERTY AD PEDS) with atopic dermatitis (AD) treated for 16 weeks. Here, we present the pharmacokinetic profiles and exposure-response relationships of dupilumab that guided the posology in these populations. A total of 251 adolescent patients with moderate-to-severe AD were randomized to subcutaneous dupilumab monoth...
Source: Clinical Pharmacology and Therapeutics - July 16, 2021 Category: Drugs & Pharmacology Authors: Mohamed A Kamal Pavel Kovalenko Matthew P Kosloski Kamal Srinivasan Yi Zhang Manoj Rajadhyaksha Ching-Ha Lai Vanaja Kanamaluru Christine Xu Xian Sun Eric L Simpson Amy S Paller Elaine C Siegfried Brad Shumel Ashish Bansal Nidal Al-Huniti John D Davis Source Type: research

The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis
Clin Pharmacol Ther. 2021 Jul 16. doi: 10.1002/cpt.2366. Online ahead of print.ABSTRACTDupilumab demonstrated efficacy with an acceptable safety profile in two randomized, double-blind, placebo-controlled, parallel-group, phase III trials in adolescents (12-17 years; LIBERTY AD ADOL) and children (6-11 years; LIBERTY AD PEDS) with atopic dermatitis (AD) treated for 16 weeks. Here, we present the pharmacokinetic profiles and exposure-response relationships of dupilumab that guided the posology in these populations. A total of 251 adolescent patients with moderate-to-severe AD were randomized to subcutaneous dupilumab monoth...
Source: Clinical Pharmacology and Therapeutics - July 16, 2021 Category: Drugs & Pharmacology Authors: Mohamed A Kamal Pavel Kovalenko Matthew P Kosloski Kamal Srinivasan Yi Zhang Manoj Rajadhyaksha Ching-Ha Lai Vanaja Kanamaluru Christine Xu Xian Sun Eric L Simpson Amy S Paller Elaine C Siegfried Brad Shumel Ashish Bansal Nidal Al-Huniti John D Davis Source Type: research

Prevalence of avoidable and bias-inflicting methodological pitfalls in real-world studies of medication safety and effectiveness
Clin Pharmacol Ther. 2021 Jul 14. doi: 10.1002/cpt.2364. Online ahead of print.ABSTRACTMany real-word evidence (RWE) studies that utilize existing healthcare data to evaluate treatment effects incur substantial, but avoidable bias from methodologically flawed study design; however, the extent of preventable methodological pitfalls in current RWE is unknown. To characterize the prevalence of avoidable methodological pitfalls with potential for bias in published claims-based studies of medication safety or effectiveness, we conducted an English-language search of PubMed for articles published from January 1, 2010 to May 20, ...
Source: Clinical Pharmacology and Therapeutics - July 14, 2021 Category: Drugs & Pharmacology Authors: Katsiaryna Bykov Elisabetta Patorno Elvira D'Andrea Mengdong He Hemin Lee Jennifer S Graff Jessica M Franklin Source Type: research

Prevalence of avoidable and bias-inflicting methodological pitfalls in real-world studies of medication safety and effectiveness
Clin Pharmacol Ther. 2021 Jul 14. doi: 10.1002/cpt.2364. Online ahead of print.ABSTRACTMany real-word evidence (RWE) studies that utilize existing healthcare data to evaluate treatment effects incur substantial, but avoidable bias from methodologically flawed study design; however, the extent of preventable methodological pitfalls in current RWE is unknown. To characterize the prevalence of avoidable methodological pitfalls with potential for bias in published claims-based studies of medication safety or effectiveness, we conducted an English-language search of PubMed for articles published from January 1, 2010 to May 20, ...
Source: Clinical Pharmacology and Therapeutics - July 14, 2021 Category: Drugs & Pharmacology Authors: Katsiaryna Bykov Elisabetta Patorno Elvira D'Andrea Mengdong He Hemin Lee Jennifer S Graff Jessica M Franklin Source Type: research

Prevalence of avoidable and bias-inflicting methodological pitfalls in real-world studies of medication safety and effectiveness
Clin Pharmacol Ther. 2021 Jul 14. doi: 10.1002/cpt.2364. Online ahead of print.ABSTRACTMany real-word evidence (RWE) studies that utilize existing healthcare data to evaluate treatment effects incur substantial, but avoidable bias from methodologically flawed study design; however, the extent of preventable methodological pitfalls in current RWE is unknown. To characterize the prevalence of avoidable methodological pitfalls with potential for bias in published claims-based studies of medication safety or effectiveness, we conducted an English-language search of PubMed for articles published from January 1, 2010 to May 20, ...
Source: Clinical Pharmacology and Therapeutics - July 14, 2021 Category: Drugs & Pharmacology Authors: Katsiaryna Bykov Elisabetta Patorno Elvira D'Andrea Mengdong He Hemin Lee Jennifer S Graff Jessica M Franklin Source Type: research

Key Considerations For Selecting a Genomic Decision Support Platform For Implementing Pharmacogenomics
Clin Pharmacol Ther. 2021 Jul 13. doi: 10.1002/cpt.2328. Online ahead of print.NO ABSTRACTPMID:34254671 | DOI:10.1002/cpt.2328 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 13, 2021 Category: Drugs & Pharmacology Authors: Kelsey J Cook Benjamin Q Duong Nathan D Seligson Pamela Arn Vicky L Funanage Karen W Gripp Susan M Kirwin Stephen T Lawless Mary M Lee Katherine M Robbins David West Kathryn V Blake Source Type: research

Differences in the platelet mRNA landscape portend racial disparities in platelet function and suggest novel therapeutic targets
This study identifies gene expression differences at the population level that may affect platelet function and serve as potential biomarkers to identify CVD risk. Additionally, our analysis uncovers candidate novel druggable targets for future anti-platelet therapies.PMID:34255863 | DOI:10.1002/cpt.2363 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 13, 2021 Category: Drugs & Pharmacology Authors: Kaitlin Garofano C Sehwan Park Cristina Alarcon Juan Avitia April Barbour David Diemert Claire M Fraser Paula N Friedman Anelia Horvath Kameron Rashid Mohammed Shaazuddin Alfateh Sidahmed Travis J O'Brien Minoli A Perera Norman H Lee Source Type: research

Key Considerations For Selecting a Genomic Decision Support Platform For Implementing Pharmacogenomics
Clin Pharmacol Ther. 2021 Jul 13. doi: 10.1002/cpt.2328. Online ahead of print.NO ABSTRACTPMID:34254671 | DOI:10.1002/cpt.2328 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 13, 2021 Category: Drugs & Pharmacology Authors: Kelsey J Cook Benjamin Q Duong Nathan D Seligson Pamela Arn Vicky L Funanage Karen W Gripp Susan M Kirwin Stephen T Lawless Mary M Lee Katherine M Robbins David West Kathryn V Blake Source Type: research

Differences in the platelet mRNA landscape portend racial disparities in platelet function and suggest novel therapeutic targets
This study identifies gene expression differences at the population level that may affect platelet function and serve as potential biomarkers to identify CVD risk. Additionally, our analysis uncovers candidate novel druggable targets for future anti-platelet therapies.PMID:34255863 | DOI:10.1002/cpt.2363 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 13, 2021 Category: Drugs & Pharmacology Authors: Kaitlin Garofano C Sehwan Park Cristina Alarcon Juan Avitia April Barbour David Diemert Claire M Fraser Paula N Friedman Anelia Horvath Kameron Rashid Mohammed Shaazuddin Alfateh Sidahmed Travis J O'Brien Minoli A Perera Norman H Lee Source Type: research

A Sponsor's View on Postmarketing Regulatory Commitments Involving Human Drug Products
Clin Pharmacol Ther. 2021 Jul 12. doi: 10.1002/cpt.2335. Online ahead of print.NO ABSTRACTPMID:34251029 | DOI:10.1002/cpt.2335 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 12, 2021 Category: Drugs & Pharmacology Authors: Laura McKinley Milton L Pressler Mary A Hiatt William Gregory Source Type: research

Association of Vitamin K and Non-Vitamin K Oral Anticogulant Use And Cancer Incidence In Atrial Fibrillation Patients
Clin Pharmacol Ther. 2021 Jul 9. doi: 10.1002/cpt.2362. Online ahead of print.ABSTRACTThe association between the use of Vitamin K antagonists (VKA) and cancer risk reduction remains unclear. We aimed to assess the association between the use of VKA or DOAC and the incidence of cancer in a large cohort of AF patients by meaans of a population-based, propensity-weighted cohort study using population-wide databases including patients diagnosed with non-valvular AF (NVAF) followed for up of 5 years (median 2.94 years). We created two cohorts based on the initiation therapy (VKA or DOAC). Initiation with VKA or DOAC was define...
Source: Clinical Pharmacology and Therapeutics - July 9, 2021 Category: Drugs & Pharmacology Authors: Adina A Iftimi Clara L Rodr íguez-Bernal Salvador Peir ó Santiago Bonanad Andreu Ferrero-Gregori Isabel Hurtado An íbal García-Sempere Gabriel Sanf élix-Gimeno Source Type: research

US Taxpayers Heavily Funded the Discovery of COVID-19 Vaccines
Clin Pharmacol Ther. 2021 Jul 9. doi: 10.1002/cpt.2344. Online ahead of print.NO ABSTRACTPMID:34243221 | DOI:10.1002/cpt.2344 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 9, 2021 Category: Drugs & Pharmacology Authors: Hussain S Lalani Jerry Avorn Aaron S Kesselheim Source Type: research

Association of Vitamin K and Non-Vitamin K Oral Anticogulant Use And Cancer Incidence In Atrial Fibrillation Patients
Clin Pharmacol Ther. 2021 Jul 9. doi: 10.1002/cpt.2362. Online ahead of print.ABSTRACTThe association between the use of Vitamin K antagonists (VKA) and cancer risk reduction remains unclear. We aimed to assess the association between the use of VKA or DOAC and the incidence of cancer in a large cohort of AF patients by meaans of a population-based, propensity-weighted cohort study using population-wide databases including patients diagnosed with non-valvular AF (NVAF) followed for up of 5 years (median 2.94 years). We created two cohorts based on the initiation therapy (VKA or DOAC). Initiation with VKA or DOAC was define...
Source: Clinical Pharmacology and Therapeutics - July 9, 2021 Category: Drugs & Pharmacology Authors: Adina A Iftimi Clara L Rodr íguez-Bernal Salvador Peir ó Santiago Bonanad Andreu Ferrero-Gregori Isabel Hurtado An íbal García-Sempere Gabriel Sanf élix-Gimeno Source Type: research

US Taxpayers Heavily Funded the Discovery of COVID-19 Vaccines
Clin Pharmacol Ther. 2021 Jul 9. doi: 10.1002/cpt.2344. Online ahead of print.NO ABSTRACTPMID:34243221 | DOI:10.1002/cpt.2344 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 9, 2021 Category: Drugs & Pharmacology Authors: Hussain S Lalani Jerry Avorn Aaron S Kesselheim Source Type: research