Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors
This study assessed the relative bioavailability (BA) and bioequivalence (BE) between a 1 × 300-mg tablet relative to 3 × 100-mg niraparib capsules. In addition, the food effect (FE) of a high-fat meal on the pharmacokinetic (PK) properties of tablet-formulated niraparib was investigated.METHODS: This was a US-based, 3-stage, open-label, multicenter, single-crossover, randomized-sequence study. Enrolled patients were 18 years and older, with histologically or cytologically confirmed advanced solid tumors (metastatic or local) and disease progression despite standard therapy. Patients were randomly assigned 1:1 to receive...
Source: Clinical Therapeutics - February 29, 2024 Category: Drugs & Pharmacology Authors: Gerald Falchook Amita Patnaik Debra L Richardson R Donald Harvey Manish R Sharma Navid Hafez Erika Hamilton Sarina A Piha-Paul Minal Barve Trisha Wise-Draper Manish R Patel Afshin Dowlati Joseph Pascuzzo Shou-Ching Tang Christina Faltermeier Izabela A Mal Source Type: research
A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors
This study assessed the relative bioavailability (BA) and bioequivalence (BE) between a 1 × 300-mg tablet relative to 3 × 100-mg niraparib capsules. In addition, the food effect (FE) of a high-fat meal on the pharmacokinetic (PK) properties of tablet-formulated niraparib was investigated.METHODS: This was a US-based, 3-stage, open-label, multicenter, single-crossover, randomized-sequence study. Enrolled patients were 18 years and older, with histologically or cytologically confirmed advanced solid tumors (metastatic or local) and disease progression despite standard therapy. Patients were randomly assigned 1:1 to receive...
Source: Clinical Therapeutics - February 29, 2024 Category: Drugs & Pharmacology Authors: Gerald Falchook Amita Patnaik Debra L Richardson R Donald Harvey Manish R Sharma Navid Hafez Erika Hamilton Sarina A Piha-Paul Minal Barve Trisha Wise-Draper Manish R Patel Afshin Dowlati Joseph Pascuzzo Shou-Ching Tang Christina Faltermeier Izabela A Mal Source Type: research
Effectiveness, Tolerability, and Safety of Different Amphotericin B Formulations in Invasive Fungal Infections: A Multicenter, Retrospective, Observational Study
This study aimed to evaluate the effectiveness, tolerability, and safety of different amphotericin B (AMB) intravenously administered in the context of hospital practice for the treatment of invasive fungal infections (IFI) and to provide new insights into the profile of ABLC.METHODS: This is a multicenter, retrospective, observational study conducted at 10 tertiary Brazilian hospitals. Patients first exposed to any formulation of AMB for treating endemic and opportunistic IFI who had received at least 2 intravenous doses were screened. Retrospective data (from January 2014 to December 2019) were extracted from the patient...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Francelise Bridi Cavassin Marcello Mihailenko Chaves Magri Jose Ernesto Vidal Fabianne Altruda de Moraes Costa Carlesse Diego Rodrigues Falci Jo ão Luís Baú-Carneiro Giovanni Lu ís Breda F ábio de Araújo Motta C ássia Silva de Miranda Godoy Renata Source Type: research
Comparison of Empiric Antibiotic Treatment Regimens for Hospitalized, Non-severe Community-acquired Pneumonia: A Retrospective, Multicenter Cohort Study
Clin Ther. 2024 Feb 24:S0149-2918(24)00020-1. doi: 10.1016/j.clinthera.2024.01.009. Online ahead of print.ABSTRACTPURPOSE: Consensus guidelines for hospitalized, non-severe community-acquired pneumonia (CAP) recommend empiric macrolide + β-lactam or respiratory fluoroquinolone monotherapy in patients with no risk factors for resistant organisms. In patients with allergies or contraindications, doxycycline + β-lactam is a recommended alternative. The purpose of this study was to compare differences in outcomes among guideline-recommended regimens in this population.METHODS: This retrospective, multicenter cohort study inc...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Sidney D Reeves Aaron P Hartmann Amanda C Tedder Paul A Juang Mikaela Hofer Marin H Kollef Scott T Micek Kevin D Betthauser Source Type: research
Effectiveness, Tolerability, and Safety of Different Amphotericin B Formulations in Invasive Fungal Infections: A Multicenter, Retrospective, Observational Study
This study aimed to evaluate the effectiveness, tolerability, and safety of different amphotericin B (AMB) intravenously administered in the context of hospital practice for the treatment of invasive fungal infections (IFI) and to provide new insights into the profile of ABLC.METHODS: This is a multicenter, retrospective, observational study conducted at 10 tertiary Brazilian hospitals. Patients first exposed to any formulation of AMB for treating endemic and opportunistic IFI who had received at least 2 intravenous doses were screened. Retrospective data (from January 2014 to December 2019) were extracted from the patient...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Francelise Bridi Cavassin Marcello Mihailenko Chaves Magri Jose Ernesto Vidal Fabianne Altruda de Moraes Costa Carlesse Diego Rodrigues Falci Jo ão Luís Baú-Carneiro Giovanni Lu ís Breda F ábio de Araújo Motta C ássia Silva de Miranda Godoy Renata Source Type: research
Comparison of Empiric Antibiotic Treatment Regimens for Hospitalized, Non-severe Community-acquired Pneumonia: A Retrospective, Multicenter Cohort Study
Clin Ther. 2024 Feb 24:S0149-2918(24)00020-1. doi: 10.1016/j.clinthera.2024.01.009. Online ahead of print.ABSTRACTPURPOSE: Consensus guidelines for hospitalized, non-severe community-acquired pneumonia (CAP) recommend empiric macrolide + β-lactam or respiratory fluoroquinolone monotherapy in patients with no risk factors for resistant organisms. In patients with allergies or contraindications, doxycycline + β-lactam is a recommended alternative. The purpose of this study was to compare differences in outcomes among guideline-recommended regimens in this population.METHODS: This retrospective, multicenter cohort study inc...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Sidney D Reeves Aaron P Hartmann Amanda C Tedder Paul A Juang Mikaela Hofer Marin H Kollef Scott T Micek Kevin D Betthauser Source Type: research
Effectiveness, Tolerability, and Safety of Different Amphotericin B Formulations in Invasive Fungal Infections: A Multicenter, Retrospective, Observational Study
This study aimed to evaluate the effectiveness, tolerability, and safety of different amphotericin B (AMB) intravenously administered in the context of hospital practice for the treatment of invasive fungal infections (IFI) and to provide new insights into the profile of ABLC.METHODS: This is a multicenter, retrospective, observational study conducted at 10 tertiary Brazilian hospitals. Patients first exposed to any formulation of AMB for treating endemic and opportunistic IFI who had received at least 2 intravenous doses were screened. Retrospective data (from January 2014 to December 2019) were extracted from the patient...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Francelise Bridi Cavassin Marcello Mihailenko Chaves Magri Jose Ernesto Vidal Fabianne Altruda de Moraes Costa Carlesse Diego Rodrigues Falci Jo ão Luís Baú-Carneiro Giovanni Lu ís Breda F ábio de Araújo Motta C ássia Silva de Miranda Godoy Renata Source Type: research
Comparison of Empiric Antibiotic Treatment Regimens for Hospitalized, Non-severe Community-acquired Pneumonia: A Retrospective, Multicenter Cohort Study
Clin Ther. 2024 Feb 24:S0149-2918(24)00020-1. doi: 10.1016/j.clinthera.2024.01.009. Online ahead of print.ABSTRACTPURPOSE: Consensus guidelines for hospitalized, non-severe community-acquired pneumonia (CAP) recommend empiric macrolide + β-lactam or respiratory fluoroquinolone monotherapy in patients with no risk factors for resistant organisms. In patients with allergies or contraindications, doxycycline + β-lactam is a recommended alternative. The purpose of this study was to compare differences in outcomes among guideline-recommended regimens in this population.METHODS: This retrospective, multicenter cohort study inc...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Sidney D Reeves Aaron P Hartmann Amanda C Tedder Paul A Juang Mikaela Hofer Marin H Kollef Scott T Micek Kevin D Betthauser Source Type: research
Effectiveness, Tolerability, and Safety of Different Amphotericin B Formulations in Invasive Fungal Infections: A Multicenter, Retrospective, Observational Study
This study aimed to evaluate the effectiveness, tolerability, and safety of different amphotericin B (AMB) intravenously administered in the context of hospital practice for the treatment of invasive fungal infections (IFI) and to provide new insights into the profile of ABLC.METHODS: This is a multicenter, retrospective, observational study conducted at 10 tertiary Brazilian hospitals. Patients first exposed to any formulation of AMB for treating endemic and opportunistic IFI who had received at least 2 intravenous doses were screened. Retrospective data (from January 2014 to December 2019) were extracted from the patient...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Francelise Bridi Cavassin Marcello Mihailenko Chaves Magri Jose Ernesto Vidal Fabianne Altruda de Moraes Costa Carlesse Diego Rodrigues Falci Jo ão Luís Baú-Carneiro Giovanni Lu ís Breda F ábio de Araújo Motta C ássia Silva de Miranda Godoy Renata Source Type: research
Comparison of Empiric Antibiotic Treatment Regimens for Hospitalized, Non-severe Community-acquired Pneumonia: A Retrospective, Multicenter Cohort Study
Clin Ther. 2024 Feb 24:S0149-2918(24)00020-1. doi: 10.1016/j.clinthera.2024.01.009. Online ahead of print.ABSTRACTPURPOSE: Consensus guidelines for hospitalized, non-severe community-acquired pneumonia (CAP) recommend empiric macrolide + β-lactam or respiratory fluoroquinolone monotherapy in patients with no risk factors for resistant organisms. In patients with allergies or contraindications, doxycycline + β-lactam is a recommended alternative. The purpose of this study was to compare differences in outcomes among guideline-recommended regimens in this population.METHODS: This retrospective, multicenter cohort study inc...
Source: Clinical Therapeutics - February 25, 2024 Category: Drugs & Pharmacology Authors: Sidney D Reeves Aaron P Hartmann Amanda C Tedder Paul A Juang Mikaela Hofer Marin H Kollef Scott T Micek Kevin D Betthauser Source Type: research
Physiologically Based Pharmacokinetic Modeling of Lacosamide in Patients With Hepatic and Renal Impairment and Pediatric Populations to Support Pediatric Dosing Optimization
This study was conducted to develop a physiologically based pharmacokinetic (PBPK) model to characterize the pharmacokinetics of LCM in Chinese populations and predict the pharmacokinetics of LCM in Chinese pediatric populations and patients with renal or hepatic impairment. Using data from clinical investigations, the developed PBPK model was validated by comparing predicted and observed blood concentration data.FINDINGS: Doses should be reduced to approximately 82%, 75%, 63%, and 76% of the Chinese healthy adult dose in patients with mild, moderate, and severe renal impairment and end-stage renal disease; and approximate...
Source: Clinical Therapeutics - February 18, 2024 Category: Drugs & Pharmacology Authors: Xinyu Zhu Lingfeng Guo Lei Zhang Yichao Xu Source Type: research
Physiologically Based Pharmacokinetic Modeling of Lacosamide in Patients With Hepatic and Renal Impairment and Pediatric Populations to Support Pediatric Dosing Optimization
This study was conducted to develop a physiologically based pharmacokinetic (PBPK) model to characterize the pharmacokinetics of LCM in Chinese populations and predict the pharmacokinetics of LCM in Chinese pediatric populations and patients with renal or hepatic impairment. Using data from clinical investigations, the developed PBPK model was validated by comparing predicted and observed blood concentration data.FINDINGS: Doses should be reduced to approximately 82%, 75%, 63%, and 76% of the Chinese healthy adult dose in patients with mild, moderate, and severe renal impairment and end-stage renal disease; and approximate...
Source: Clinical Therapeutics - February 18, 2024 Category: Drugs & Pharmacology Authors: Xinyu Zhu Lingfeng Guo Lei Zhang Yichao Xu Source Type: research
Physiologically Based Pharmacokinetic Modeling of Lacosamide in Patients With Hepatic and Renal Impairment and Pediatric Populations to Support Pediatric Dosing Optimization
This study was conducted to develop a physiologically based pharmacokinetic (PBPK) model to characterize the pharmacokinetics of LCM in Chinese populations and predict the pharmacokinetics of LCM in Chinese pediatric populations and patients with renal or hepatic impairment. Using data from clinical investigations, the developed PBPK model was validated by comparing predicted and observed blood concentration data.FINDINGS: Doses should be reduced to approximately 82%, 75%, 63%, and 76% of the Chinese healthy adult dose in patients with mild, moderate, and severe renal impairment and end-stage renal disease; and approximate...
Source: Clinical Therapeutics - February 18, 2024 Category: Drugs & Pharmacology Authors: Xinyu Zhu Lingfeng Guo Lei Zhang Yichao Xu Source Type: research
