A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization
Clin Pharmacol Ther. 2024 Mar 4. doi: 10.1002/cpt.3207. Online ahead of print.ABSTRACTThe quality of warfarin treatment may be improved if management is guided by the use of models based upon pharmacokinetic-pharmacodynamic theory. A prospective, two-armed, single-blind, randomized controlled trial compared management aided by a web-based dose calculator (NextDose) with standard clinical care. Participants were 240 adults receiving warfarin therapy following cardiac surgery, followed up until the first outpatient appointment at least 3 months after warfarin initiation. We compared the percentage of time spent in the intern...
Source: Clinical Pharmacology and Therapeutics - March 5, 2024 Category: Drugs & Pharmacology Authors: Ling Xue Guangda Ma Nick Holford Qiong Qin Yinglong Ding Jacqueline A Hannam Xiaoliang Ding Hongyou Fan Zhenchun Ji Biwen Yang Han Shen Zhenya Shen Liyan Miao Source Type: research

How Much More Efficient Are Adaptive Platform Trials Than Multiple Stand-Alone Trials? A Comprehensive Simulation Study for Streamlining Drug Development During a Pandemic
In this study, we simulated the total development period, total sample size, and statistical operating characteristics of APTs and multiple stand-alone trials in drug development settings for hospitalized patients with COVID-19. Simulation studies using selected scenarios reconfirmed several findings regarding the efficiency of APTs. The APTs without staggered addition of drugs showed a shorter total development period than stand-alone trials, but the difference rapidly diminished if patient's enrollment was accelerated during the trials owing to the spread of infection. APTs with staggered addition of drugs still have the...
Source: Clinical Pharmacology and Therapeutics - March 5, 2024 Category: Drugs & Pharmacology Authors: Masanao Sasaki Hiroyuki Sato Yukari Uemura Ayako Mikami Nao Ichihara Shigeki Fujitani Masashi Kondo Yohei Doi Eriko Morino Daisuke Tokita Norio Ohmagari Wataru Sugiura Akihiro Hirakawa Source Type: research

Balancing efficacy and adverse reactions using everolimus in a patient with metastatic malignant insulinoma: Case report
CONCLUSION: Balancing the benefits of enhanced glycemic control with the difficulties posed by side effect management of everolimus underscores the need to carefully consider both efficacy and potential adverse events.PMID:38431828 | DOI:10.5414/CP204503 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Siham Rouf Khadija Boujtat Tijani El Harroudi Hanane Latrech Source Type: research

Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part  2: Modulation of hypoxia, redox status, and mitochondrial protection in a neuroblastoma cell line, SH-SY5Y
CONCLUSION: Evidence has been obtained showing that the core components: icariin, naringenin, kaempferol, and formononetin in BSJP formula have anti-hypoxic and mitochondrial protective activity of potential clinical importance in the treatment of amyotrophic lateral sclerosis and patients with symptoms of hypoxia.PMID:38431829 | DOI:10.5414/CP204505 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Wenli Yuan Jiacheng Lin Jun Wang Chenghui Wang Yuetong Shan Wei Jing Zhimin Fei Weidong Pan Source Type: research

Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part  3: Alleviation of hypoxia, muscle-wasting, and modulation of redox functions in amyotrophic lateral sclerosis
CONCLUSION: BSJP treatment reduced the rate of progression of amyotrophic lateral sclerosis according to the ALS-SSITS and ALSFRS scores and significantly reduced the rate of deterioration in muscle function in the limbs of amyotrophic lateral sclerosis patients. The modes of action of BSJP in treating amyotrophic lateral sclerosis are probably diverse and multi targeted, some of which may involve regulation of serum vitamin D3 and alleviation of the impairments in liver and kidney function.PMID:38431830 | DOI:10.5414/CP204520 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Rui Li Xiaojing Han Qiudong Wang Chenghui Wang Wei Jing Haihan Zhang Jun Wang Weidong Pan Source Type: research

Clinical and research implications of uricase knockout and renal injury
Int J Clin Pharmacol Ther. 2024 Mar 3. doi: 10.5414/CPP62149. Online ahead of print.NO ABSTRACTPMID:38431831 | DOI:10.5414/CPP62149 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: ShaoJun Zheng Source Type: research

Evaluation of the risk factors for the failure of a single prophylactic dose of anticholinergic drugs for irinotecan-induced cholinergic symptoms
CONCLUSION: We determined that colorectal cancer, female sex, and prophylactic use of scopolamine butyl bromide were risk factors associated with the failure of a single prophylactic dose of anticholinergic drugs, and that multiple prophylactic doses for wearing-off can be a promising method.PMID:38431832 | DOI:10.5414/CP204531 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Takuya Watanabe Yoshitaka Saito Yoh Takekuma Yasushi Shimizu Ichiro Kinoshita Yoshito Komatsu Mitsuru Sugawara Source Type: research

Low albumin combined with low-molecular-weight heparin as risk factors for liver injury using azvudine: Evidence from an analysis of COVID-19 patients in a national prospective pharmacovigilance database
CONCLUSION: This study represents the first investigation of azvudine-induced liver injury and high-risk patients using the CHPS. The findings provide valuable insights to promote the safety of anti-COVID-19 drugs, serving as an important reference for future drug safety measures.PMID:38431833 | DOI:10.5414/CP204544 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Hong Lu Ying Zeng Qun-Zhi Shi Lin Liu Yong-Qing Gong Sen Li Pan Yan Source Type: research

Balancing efficacy and adverse reactions using everolimus in a patient with metastatic malignant insulinoma: Case report
CONCLUSION: Balancing the benefits of enhanced glycemic control with the difficulties posed by side effect management of everolimus underscores the need to carefully consider both efficacy and potential adverse events.PMID:38431828 | DOI:10.5414/CP204503 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Siham Rouf Khadija Boujtat Tijani El Harroudi Hanane Latrech Source Type: research

Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part  2: Modulation of hypoxia, redox status, and mitochondrial protection in a neuroblastoma cell line, SH-SY5Y
CONCLUSION: Evidence has been obtained showing that the core components: icariin, naringenin, kaempferol, and formononetin in BSJP formula have anti-hypoxic and mitochondrial protective activity of potential clinical importance in the treatment of amyotrophic lateral sclerosis and patients with symptoms of hypoxia.PMID:38431829 | DOI:10.5414/CP204505 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Wenli Yuan Jiacheng Lin Jun Wang Chenghui Wang Yuetong Shan Wei Jing Zhimin Fei Weidong Pan Source Type: research

Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part  3: Alleviation of hypoxia, muscle-wasting, and modulation of redox functions in amyotrophic lateral sclerosis
CONCLUSION: BSJP treatment reduced the rate of progression of amyotrophic lateral sclerosis according to the ALS-SSITS and ALSFRS scores and significantly reduced the rate of deterioration in muscle function in the limbs of amyotrophic lateral sclerosis patients. The modes of action of BSJP in treating amyotrophic lateral sclerosis are probably diverse and multi targeted, some of which may involve regulation of serum vitamin D3 and alleviation of the impairments in liver and kidney function.PMID:38431830 | DOI:10.5414/CP204520 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Rui Li Xiaojing Han Qiudong Wang Chenghui Wang Wei Jing Haihan Zhang Jun Wang Weidong Pan Source Type: research

Clinical and research implications of uricase knockout and renal injury
Int J Clin Pharmacol Ther. 2024 Mar 3. doi: 10.5414/CPP62149. Online ahead of print.NO ABSTRACTPMID:38431831 | DOI:10.5414/CPP62149 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: ShaoJun Zheng Source Type: research

Evaluation of the risk factors for the failure of a single prophylactic dose of anticholinergic drugs for irinotecan-induced cholinergic symptoms
CONCLUSION: We determined that colorectal cancer, female sex, and prophylactic use of scopolamine butyl bromide were risk factors associated with the failure of a single prophylactic dose of anticholinergic drugs, and that multiple prophylactic doses for wearing-off can be a promising method.PMID:38431832 | DOI:10.5414/CP204531 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Takuya Watanabe Yoshitaka Saito Yoh Takekuma Yasushi Shimizu Ichiro Kinoshita Yoshito Komatsu Mitsuru Sugawara Source Type: research

Low albumin combined with low-molecular-weight heparin as risk factors for liver injury using azvudine: Evidence from an analysis of COVID-19 patients in a national prospective pharmacovigilance database
CONCLUSION: This study represents the first investigation of azvudine-induced liver injury and high-risk patients using the CHPS. The findings provide valuable insights to promote the safety of anti-COVID-19 drugs, serving as an important reference for future drug safety measures.PMID:38431833 | DOI:10.5414/CP204544 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 3, 2024 Category: Drugs & Pharmacology Authors: Hong Lu Ying Zeng Qun-Zhi Shi Lin Liu Yong-Qing Gong Sen Li Pan Yan Source Type: research

Physiologically Based Pharmacokinetic Modeling to Investigate the Disease-Drug-Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID-19 Patients with CYP2C19 Phenotypes
In conclusion, COVID-19-induced IL-6 elevation and ritonavir increased voriconazole exposure, and the magnitude of interactions was influenced by CYP2C19 phenotype. Thus, caution is warranted when prescribing voriconazole concomitantly with Paxlovid in patients with COVID-19.PMID:38429919 | DOI:10.1002/cpt.3222 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 2, 2024 Category: Drugs & Pharmacology Authors: Peile Wang Shuaibing Liu Jing Yang Source Type: research