Future Perspectives of Pulmonary Arterial Hypertension: A Review of Novel Pipeline Treatments and Indications
AbstractPulmonary arterial hypertension is characterized by elevated blood pressure and pathological changes in the pulmonary arterioles, leading to the development of right-heart failure and potentially fatal outcomes if left untreated. This review aims to provide an overview of novel drugs or formulations and new drug indications for pulmonary arterial hypertension that are currently in phases II –III of randomized controlled trials, and describe the rationale for the use of these targeted therapies, as well as their efficacy, safety profile, and impact on quality of life and survival. The literature research was condu...
Source: Drugs in R&D - March 22, 2024 Category: Drugs & Pharmacology Source Type: research
Application of Transthoracic Echocardiography for Cardiac Safety Evaluation in the Clinical Development Process of Vaccines Against Streptococcus pyogenes
AbstractSuperficial infections withStreptococcus pyogenes (Strep A), pharyngitis and impetigo can induce acute rheumatic fever, an autoimmune sequela manifesting mostly with arthritis and rheumatic carditis. Valvular heart damage can persist or advance following repeated episodes of acute rheumatic fever, causing rheumatic heart disease. Acute rheumatic fever and rheumatic heart disease disproportionately affect children and young adults in developing countries and disadvantaged communities in developed countries. People living with rheumatic heart disease are at risk of experiencing potentially fatal complications such as...
Source: Drugs in R&D - March 18, 2024 Category: Drugs & Pharmacology Source Type: research
Linezolid-Induced Thrombocytopenia in Patients with Renal Impairment: A Case Series, Review and Dose Advice
ConclusionRe-evaluation of the current dose advice is necessary. We advocate for a standard dose reduction to 50% after 2 days of standard dosing for all patients with an estimated glomerular filtration of<60 mL/min/1.73 m2. Besides this, therapeutic drug monitoring and thrombocytes monitoring may be executed weekly when patients have renal impairment or other risk factors for developing linezolid-induced thrombocytopenia. (Source: Drugs in R&D)
Source: Drugs in R&D - March 14, 2024 Category: Drugs & Pharmacology Source Type: research
Effect of Daridorexant on the Pharmacokinetics of Midazolam, and on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects
ConclusionsDaridorexant at 50 mg is classified as a weak CYP3A4 inhibitor after single- and multiple-dose administration once daily at steady state. Daridorexant 50 mg did not induce CYP3A4 activity or inhibit CYP2C9 activity.Clinical Trial RegistrationThis trial (NCT05480488) was registered on 29 July, 2022. (Source: Drugs in R&D)
Source: Drugs in R&D - March 13, 2024 Category: Drugs & Pharmacology Source Type: research
Bioequivalence Study of Tebipenem Pivoxil in Healthy Chinese Adults
ConclusionPreparations T and R of TP were bioequivalent in the fasting and postprandial groups in clinical trials, and TP was safe. (Source: Drugs in R&D)
Source: Drugs in R&D - March 7, 2024 Category: Drugs & Pharmacology Source Type: research
Case Report: Life-Threatening Fluoxetine-Linked Postoperative Bleeding Informed by Pharmacogenetic Evaluation
ConclusionSSRI-induced bleeding is dose-related and strongly influenced by individual variations in drug metabolizing enzymes and transporters.Video abstractSupplementary file1 (MP4 8441 KB) (Source: Drugs in R&D)
Source: Drugs in R&D - February 28, 2024 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetic and Safety Study of Bismuth Potassium Citrate Formulations in Healthy Subjects
ConclusionThe concentration of bismuth in the blood of healthy subjects in the T formulation was not greater than that in the R formulation. Similarly, the safety of oral administration of 120 mg of bismuth potassium citrate formulations to healthy subjects was good. The trial registration number (TRN) was [2018] 013, 6 December 2018. (Source: Drugs in R&D)
Source: Drugs in R&D - February 12, 2024 Category: Drugs & Pharmacology Source Type: research
Real-World Experience of Carglumic Acid for Methylmalonic and Propionic Acidurias: An Interim Analysis of the Multicentre Observational PROTECT Study
ConclusionsIn this group of patients with MMA and PA, treatment with carglumic acid for at least 1 year reduced peak plasma ammonia levels in the total patient population and reduced the frequency of metabolic decompensation events, as well as the duration of inpatient stay due to metabolic decompensations in a subset of patients.Clinical Trial RegistrationClinicalTrials.gov, NCT04176523. Registered 25 November, 2019, retrospectively registered,https://clinicaltrials.gov/ct2/show/NCT04176523. (Source: Drugs in R&D)
Source: Drugs in R&D - January 10, 2024 Category: Drugs & Pharmacology Source Type: research
Drug –Drug Interaction Studies of Esmethadone (REL-1017) Involving CYP3A4- and CYP2D6-Mediated Metabolism
ConclusionsIn summary, esmethadone demonstrated a negligible effect on CYP3A4 induction and its metabolism was not meaningfully affected by strong CYP3A4 inhibitors while it increased exposure of CYP2D6-metabolized drugs. (Source: Drugs in R&D)
Source: Drugs in R&D - November 27, 2023 Category: Drugs & Pharmacology Source Type: research
Efficacy and Safety of Methylphenidate and Atomoxetine in Medication-Naive Children with Attention-Deficit Hyperactivity Disorder in a Real-World Setting
ConclusionsOverall, MPH was more effective and better tolerated than ATX. The incidence of AEs in children treated with MPH varied with age, and was higher in young children and lower in children over 10 years of age. (Source: Drugs in R&D)
Source: Drugs in R&D - November 20, 2023 Category: Drugs & Pharmacology Source Type: research
Unveiling the Influence of a High-Fat Meal on the Pharmacokinetics of Oral Globalagliatin, A Glucokinase Activator, in Healthy Chinese Volunteers
ConclusionA high-fat meal increased theCmax, AUCt, and AUC∞ of globalagliatin compared with fasting conditions in healthy Chinese adult volunteers. Meanwhile, globalagliatin showed favorable safety and tolerability under fasting or high-fat meal conditions. (Source: Drugs in R&D)
Source: Drugs in R&D - November 20, 2023 Category: Drugs & Pharmacology Source Type: research
A Guide to Expanding the Use of Buprenorphine Beyond Standard Initiations for Opioid Use Disorder
This article briefly discusses the opioid epidemic and the diagnosis and treatment of opioid use disorder (OUD). We then describe the basic and complex pharmacologic propertie s of buprenorphine, linking these properties to their clinical implications. We guide readers through the process of initiating buprenorphine in patients using full agonist opioids. As there is no single recommended approach for buprenorphine initiation, we discuss the details, advantages, and disad vantages of the standard, low-dose, bridging-strategy, and naloxone-facilitated initiation techniques. We consider the pharmacology of, and evidence base...
Source: Drugs in R&D - November 8, 2023 Category: Drugs & Pharmacology Source Type: research
Acknowledgement to Referees
(Source: Drugs in R&D)
Source: Drugs in R&D - November 8, 2023 Category: Drugs & Pharmacology Source Type: research
Effect of High-Fat Food on the Pharmacokinetic Profile and Safety of SAF-189s, an ALK/ROS1 Inhibitor, in Healthy Chinese Adults
ConclusionsA high-fat meal had minimal effect on the pharmacokinetic profile of SAF-189s compared with a fasted state following a single dose of 160 mg. Administration with a high-fat meal led to a lower incidence of TEAEs. (Source: Drugs in R&D)
Source: Drugs in R&D - November 7, 2023 Category: Drugs & Pharmacology Source Type: research
Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist
ConclusionASC42 was well tolerated with a pharmacokinetic profile suitable for QD dosing, and demonstrated dose-dependent targets engagement without altering plasma cholesterol in healthy subjects.Trial registration numberNCT04679129. (Source: Drugs in R&D)
Source: Drugs in R&D - November 2, 2023 Category: Drugs & Pharmacology Source Type: research
