Results 201 to 210 of about 263,371 (305)

Emulating Six Cardiovascular Outcome Trials of Antidiabetic Drugs in Individuals with Type 2 Diabetes: Analyses Based on Real‐World Databases from Korea and Taiwan

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
With the increasing volume of clinical evidence derived from large‐scale Asian real‐world data (RWD) and the growing interest in its use in regulatory decision‐making, it is important to conduct benchmarking exercises that evaluate whether studies using Asian RWD can generate similar conclusions as randomized controlled trials (RCTs).
Hwa Yeon Ko   +15 more
wiley   +1 more source

Major Adverse Cardiac Events with Ondansetron: A Systematic Review

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Evidence base: 170 randomized trials, 23,421 adults, predominantly single‐dose IV ondansetron, mean follow‐up 20 days. Observed outcomes: Major adverse cardiac events were rare, no ventricular arrhythmias or torsades de pointes observed. Conclusion: Ondansetron was not associated with increased mortality or serious cardiac arrhythmias in adult ...
Michael Cristian Garcia   +11 more
wiley   +1 more source

Population Pharmacokinetics of Clesrovimab in Preterm and Full‐Term Infants

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Clesrovimab is a half‐life extended monoclonal antibody targeting the respiratory syncytial virus fusion protein. Three studies (phase Ib/IIa [MK‐1654‐002], phase IIb/III [CLEVER], and phase III [SMART]) were conducted to evaluate the efficacy, safety, and pharmacokinetics (PK) of clesrovimab in infants.
Ziheng Hu   +8 more
wiley   +1 more source

Assessing Overall Survival Benefits in Advanced Cancers: The Role of External Comparator Cohort Studies with Real‐World Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
External comparator cohort (ECC) studies with real‐world data (RWD) may provide more reliable estimates of treatment differences compared to single‐arm trials (SAT), yet they face limitations such as selection bias and data heterogeneity. This study assessed the perceived strength of evidence of ECC studies compared to SAT and randomized controlled ...
Francesco Pignatti   +19 more
wiley   +1 more source

Association of Pregabalin vs. Duloxetine with Cardiovascular Events: A Retrospective Cohort Study Among US Veterans With Chronic Musculoskeletal Pain

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Pregabalin and duloxetine are widely prescribed non‐opioid medications for chronic musculoskeletal pain. Pregabalin may increase the risk of heart failure, and duloxetine increases heart rate and blood pressure; however, little is known about their comparative cardiovascular safety.
Sachalee Campbell   +11 more
wiley   +1 more source

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