Efficacy and safety of antiplatelet therapy in COVID-19: Insights from a  meta-analysis of randomized controlled trials
CONCLUSION: Antiplatelet therapy does not confer mortality benefit in COVID-19 patients but lowers major thrombotic events while increasing major bleeding risks. Ongoing large RCTs will provide more information on the therapeutic value of this therapy.PMID:38469705 | DOI:10.5414/CP204497 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 12, 2024 Category: Drugs & Pharmacology Authors: Guoying Kao Yunlin Chen Jinqi Fan Source Type: research

Efficacy and safety of antiplatelet therapy in COVID-19: Insights from a  meta-analysis of randomized controlled trials
CONCLUSION: Antiplatelet therapy does not confer mortality benefit in COVID-19 patients but lowers major thrombotic events while increasing major bleeding risks. Ongoing large RCTs will provide more information on the therapeutic value of this therapy.PMID:38469705 | DOI:10.5414/CP204497 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 12, 2024 Category: Drugs & Pharmacology Authors: Guoying Kao Yunlin Chen Jinqi Fan Source Type: research

Efficacy and safety of antiplatelet therapy in COVID-19: Insights from a  meta-analysis of randomized controlled trials
CONCLUSION: Antiplatelet therapy does not confer mortality benefit in COVID-19 patients but lowers major thrombotic events while increasing major bleeding risks. Ongoing large RCTs will provide more information on the therapeutic value of this therapy.PMID:38469705 | DOI:10.5414/CP204497 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 12, 2024 Category: Drugs & Pharmacology Authors: Guoying Kao Yunlin Chen Jinqi Fan Source Type: research

Impact of Treatment Modality and Route of Administration on Cytokine Release Syndrome in Relapsed or Refractory Multiple Myeloma: A Meta-Analysis
This study utilized a meta-analysis approach to compare the CRS profile in BCMA-targeting CAR-T vs. BsAb immunotherapies administered either i.v. or s.c. in patients with RRMM. A total of 36 studies including 1,560 patients with RRMM treated with BCMA-targeting CAR-T and BsAb therapies were included in the analysis. The current analysis suggests that compared with BsAbs, CAR-T therapies were associated with higher CRS incidences (88% vs. 59%), higher rates of grade ≥ 3 CRS (7% vs. 2%), longer CRS duration (5 vs. 2 days), and more prevalent tocilizumab use (44% vs. 25%). The proportion of CRS grade ≥ 3 may also be lower...
Source: Clinical Pharmacology and Therapeutics - March 9, 2024 Category: Drugs & Pharmacology Authors: Pooneh Soltantabar Sheena Sharma Diane Wang Hoi-Kei Lon Akos Czibere Anne Hickmann Mohamed Elmeliegy Source Type: research

Algorithmic Identification of Treatment-Emergent Adverse Events From Clinical Notes Using Large Language Models: A Pilot Study in Inflammatory Bowel Disease
Clin Pharmacol Ther. 2024 Mar 8. doi: 10.1002/cpt.3226. Online ahead of print.ABSTRACTOutpatient clinical notes are a rich source of information regarding drug safety. However, data in these notes are currently underutilized for pharmacovigilance due to methodological limitations in text mining. Large language models (LLMs) like Bidirectional Encoder Representations from Transformers (BERT) have shown progress in a range of natural language processing tasks but have not yet been evaluated on adverse event (AE) detection. We adapted a new clinical LLM, University of California - San Francisco (UCSF)-BERT, to identify seriou...
Source: Clinical Pharmacology and Therapeutics - March 9, 2024 Category: Drugs & Pharmacology Authors: Anna L Silverman Madhumita Sushil Balu Bhasuran Dana Ludwig James Buchanan Rebecca Racz Mahalakshmi Parakala Samer El-Kamary Ohenewaa Ahima Artur Belov Lauren Choi Monisha Billings Yan Li Nadia Habal Qi Liu Jawahar Tiwari Atul J Butte Vivek A Rudrapatna Source Type: research

Impact of Treatment Modality and Route of Administration on Cytokine Release Syndrome in Relapsed or Refractory Multiple Myeloma: A Meta-Analysis
This study utilized a meta-analysis approach to compare the CRS profile in BCMA-targeting CAR-T vs. BsAb immunotherapies administered either i.v. or s.c. in patients with RRMM. A total of 36 studies including 1,560 patients with RRMM treated with BCMA-targeting CAR-T and BsAb therapies were included in the analysis. The current analysis suggests that compared with BsAbs, CAR-T therapies were associated with higher CRS incidences (88% vs. 59%), higher rates of grade ≥ 3 CRS (7% vs. 2%), longer CRS duration (5 vs. 2 days), and more prevalent tocilizumab use (44% vs. 25%). The proportion of CRS grade ≥ 3 may also be lower...
Source: Clinical Pharmacology and Therapeutics - March 9, 2024 Category: Drugs & Pharmacology Authors: Pooneh Soltantabar Sheena Sharma Diane Wang Hoi-Kei Lon Akos Czibere Anne Hickmann Mohamed Elmeliegy Source Type: research

Algorithmic Identification of Treatment-Emergent Adverse Events From Clinical Notes Using Large Language Models: A Pilot Study in Inflammatory Bowel Disease
Clin Pharmacol Ther. 2024 Mar 8. doi: 10.1002/cpt.3226. Online ahead of print.ABSTRACTOutpatient clinical notes are a rich source of information regarding drug safety. However, data in these notes are currently underutilized for pharmacovigilance due to methodological limitations in text mining. Large language models (LLMs) like Bidirectional Encoder Representations from Transformers (BERT) have shown progress in a range of natural language processing tasks but have not yet been evaluated on adverse event (AE) detection. We adapted a new clinical LLM, University of California - San Francisco (UCSF)-BERT, to identify seriou...
Source: Clinical Pharmacology and Therapeutics - March 9, 2024 Category: Drugs & Pharmacology Authors: Anna L Silverman Madhumita Sushil Balu Bhasuran Dana Ludwig James Buchanan Rebecca Racz Mahalakshmi Parakala Samer El-Kamary Ohenewaa Ahima Artur Belov Lauren Choi Monisha Billings Yan Li Nadia Habal Qi Liu Jawahar Tiwari Atul J Butte Vivek A Rudrapatna Source Type: research

A Randomized Crossover Trial of Mixed Meal Tolerance Test Response in People with Type  1 Diabetes on Insulin Pump Therapy and YG1699 or Dapagliflozin
Clin Pharmacol Ther. 2024 Mar 8. doi: 10.1002/cpt.3225. Online ahead of print.ABSTRACTYG1699 is a novel inhibitor of sodium-glucose cotransporter 1 (SGLT1) and SGLT2. This double-blind, 3-way crossover trial compared YG1699 to dapagliflozin as an adjunct to insulin in people with type 1 diabetes (T1D) on insulin pump therapy. Treatment periods included four mixed meal tolerance tests (MMTTs) and insulin withdrawal tests per person. Nineteen adults with T1D were randomized to YG1699 10 mg, YG1699 25 mg, and dapagliflozin 10 mg once daily for 1 week in different orders. The primary end point was the difference in area under ...
Source: Clinical Pharmacology and Therapeutics - March 8, 2024 Category: Drugs & Pharmacology Authors: Pablo Lapuerta Silvia Urbina Jiaojuan He Alyssa Wittle Chenghai Li Tong Li Helen Wang Marcus Hompesch Source Type: research

Chinese Expert Consensus on the Clinical Diagnosis and Management of Statin Intolerance
Clin Pharmacol Ther. 2024 Mar 8. doi: 10.1002/cpt.3213. Online ahead of print.ABSTRACTThe clinical benefits of statins have well-established and recognized worldwide. Although statins are well-tolerated generally, however, the report of statin-related adverse event and statin intolerance are common in China, which results in insufficient use of statins and poor adherence. The main reason may be attributed to confusions or misconceptions in the clinical diagnosis and management in China, including the lack of unified definitions and diagnostic standards, broad grasp of diagnosis, and unscientific management strategies. Base...
Source: Clinical Pharmacology and Therapeutics - March 8, 2024 Category: Drugs & Pharmacology Authors: Jian-Jun Li Ke-Fei Dou Zhi-Guang Zhou Dong Zhao Ping Ye Hong Chen Zhen-Yue Chen Dao-Quan Peng Yuan-Lin Guo Na-Qiong Wu Jie Qian contributing experts Source Type: research

A Randomized Crossover Trial of Mixed Meal Tolerance Test Response in People with Type  1 Diabetes on Insulin Pump Therapy and YG1699 or Dapagliflozin
Clin Pharmacol Ther. 2024 Mar 8. doi: 10.1002/cpt.3225. Online ahead of print.ABSTRACTYG1699 is a novel inhibitor of sodium-glucose cotransporter 1 (SGLT1) and SGLT2. This double-blind, 3-way crossover trial compared YG1699 to dapagliflozin as an adjunct to insulin in people with type 1 diabetes (T1D) on insulin pump therapy. Treatment periods included four mixed meal tolerance tests (MMTTs) and insulin withdrawal tests per person. Nineteen adults with T1D were randomized to YG1699 10 mg, YG1699 25 mg, and dapagliflozin 10 mg once daily for 1 week in different orders. The primary end point was the difference in area under ...
Source: Clinical Pharmacology and Therapeutics - March 8, 2024 Category: Drugs & Pharmacology Authors: Pablo Lapuerta Silvia Urbina Jiaojuan He Alyssa Wittle Chenghai Li Tong Li Helen Wang Marcus Hompesch Source Type: research

Clinical Pharmacology Perspective on Development of Adeno-Associated Virus Vector-Based Retina Gene Therapy
Clin Pharmacol Ther. 2024 Mar 7. doi: 10.1002/cpt.3230. Online ahead of print.ABSTRACTAdeno-associated virus (AAV) vector-based gene therapy is an innovative modality being increasingly investigated to treat diseases by modifying or replacing defective genes or expressing therapeutic entities. With its unique anatomic and physiological characteristics, the eye constitutes a very attractive target for gene therapy. Specifically, the ocular space is easily accessible and is generally considered "immune-privileged" with a low risk of systemic side effects following local drug administration. As retina cells have limited cellu...
Source: Clinical Pharmacology and Therapeutics - March 7, 2024 Category: Drugs & Pharmacology Authors: Jennifer Lynn Ford Eleni Karatza Hardik Mody Prathap Nagaraja Shastri Sana Khajeh Pour Tong-Yuan Yang Michael Swanson Daniel Chao Damayanthi Devineni Source Type: research

Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level
This study aimed to compare the effects of dapagliflozin on kidney injury biomarkers in patients with CKD stratified by albuminuria level. We prospectively enrolled healthy volunteers (HVs; n = 20) and patients with CKD (n = 54) with and without diabetes mellitus. Patients with CKD were divided into two age-matched and sex-matched subgroups according to urinary albumin-creatinine ratio (uACR) levels (<300 mg/g and ≥300 mg/g). The CKD group received dapagliflozin (10 mg/day). Urine samples were collected before treatment and after 3 and 6 months of dapagliflozin. Urinary kidney injury molecule-1 (KIM-1), interleukin-1Î...
Source: Clinical Pharmacology and Therapeutics - March 7, 2024 Category: Drugs & Pharmacology Authors: Junghyun Cho Seung Whan Doo Nayoung Song Minsul Lee Haekyung Lee Hyongnae Kim Jin Seok Jeon Hyunjin Noh Soon Hyo Kwon Source Type: research

Clinical Pharmacology Perspective on Development of Adeno-Associated Virus Vector-Based Retina Gene Therapy
Clin Pharmacol Ther. 2024 Mar 7. doi: 10.1002/cpt.3230. Online ahead of print.ABSTRACTAdeno-associated virus (AAV) vector-based gene therapy is an innovative modality being increasingly investigated to treat diseases by modifying or replacing defective genes or expressing therapeutic entities. With its unique anatomic and physiological characteristics, the eye constitutes a very attractive target for gene therapy. Specifically, the ocular space is easily accessible and is generally considered "immune-privileged" with a low risk of systemic side effects following local drug administration. As retina cells have limited cellu...
Source: Clinical Pharmacology and Therapeutics - March 7, 2024 Category: Drugs & Pharmacology Authors: Jennifer Lynn Ford Eleni Karatza Hardik Mody Prathap Nagaraja Shastri Sana Khajeh Pour Tong-Yuan Yang Michael Swanson Daniel Chao Damayanthi Devineni Source Type: research

Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level
This study aimed to compare the effects of dapagliflozin on kidney injury biomarkers in patients with CKD stratified by albuminuria level. We prospectively enrolled healthy volunteers (HVs; n = 20) and patients with CKD (n = 54) with and without diabetes mellitus. Patients with CKD were divided into two age-matched and sex-matched subgroups according to urinary albumin-creatinine ratio (uACR) levels (<300 mg/g and ≥300 mg/g). The CKD group received dapagliflozin (10 mg/day). Urine samples were collected before treatment and after 3 and 6 months of dapagliflozin. Urinary kidney injury molecule-1 (KIM-1), interleukin-1Î...
Source: Clinical Pharmacology and Therapeutics - March 7, 2024 Category: Drugs & Pharmacology Authors: Junghyun Cho Seung Whan Doo Nayoung Song Minsul Lee Haekyung Lee Hyongnae Kim Jin Seok Jeon Hyunjin Noh Soon Hyo Kwon Source Type: research

The US Food and Drug Administration's Model-Informed Drug Development Meeting Program: From Pilot to Pathway
Clin Pharmacol Ther. 2024 Mar 6. doi: 10.1002/cpt.3228. Online ahead of print.NO ABSTRACTPMID:38445751 | DOI:10.1002/cpt.3228 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 6, 2024 Category: Drugs & Pharmacology Authors: Rajanikanth Madabushi Jessica Benjamin Hao Zhu Issam Zineh Source Type: research