Clinical Drug Investigation

BACKGROUND AND OBJECTIVES: Sacubitril/valsartan has shown effectiveness in reducing hospitalization compared with valsartan in HFpEF patients with heart failure with preserved ejection fraction (HFpEF). We aimed to investigate the cost effectiveness of sacubitril/valsartan as an alternative to valsartan in Chinese patients with heart failure with HFpEF. METHODS: A Markov model was built to investigate the cost effectiveness of sacubitril/valsartan as an alternative to valsartan in Chinese patients with HFpEF, from the healthcare system perspective...

BACKGROUND AND OBJECTIVE: The efficacy and safety of iGlarLixi, a fixed-ratio combination (FRC) of basal insulin glargine plus lixisenatide, have been demonstrated in type 2 diabetes mellitus (T2DM) patients. However, no relevant economic analysis of iGlarLixi has been done in China. Thus, the primary objective of this study is to evaluate the cost effectiveness of iGlarLixi versus IDegAsp in Chinese T2DM patients, and then back-calculate the appropriate drug price of iGlarLixi to support its pricing after listing in China...

BACKGROUND AND OBJECTIVE: Approximately 38 million people worldwide experience heart failure (HF), with more than 10 million in China. Heart failure exacerbations are the main cause of HF hospitalization, and hospitalizations are the main driver of HF-associated costs. Vericiguat is recommended to treat patients who have had worsening HF despite guideline-directed medical therapy. However, the cost effectiveness of adding vericiguat to the standard treatment of this population in China remains unclear...

Therapeutic repurposing emerged as an alternative to the traditional drug discovery and development model (DDD) of new molecular entities (NMEs). It was anticipated that by being faster, safer, and cheaper, the development would result in lower-cost drugs. As defined in this work, a repurposed cancer drug is one approved by a health regulatory authority against a non-cancer indication that then gains new approval for cancer. With this definition, only three drugs are repurposed for cancer: Bacillus Calmette-Guerin (BCG) vaccine (superficial bladder cancer, thalidomide [multiple myeloma], and propranolol [infantile hemangioma])...

BACKGROUND AND OBJECTIVE: While the current landscape of opioid use disorder (OUD) is complicated by the increase in use of non-prescription opioids, prescription opioids continue to be frequently used in non-medical ways. In response to this abuse, pharmaceutical companies have developed abuse deterrent formulations (ADFs) for extended-release (ER) opioids. To test the effectiveness of Xtampza ER ADF (oxycodone myristate) at reducing tampering, its rate of tampering in a treatment-center population was compared to immediate release (IR) single entity (SE) oxycodone, other ER oxycodone opioids, and ER oxymorphone...

No abstract text is available yet for this article.

BACKGROUND: Nivolumab has been used for the treatment of various types of cancers and has achieved improvements in overall survival. However, nivolumab can cause a variety of adverse events (AEs). Among these, cardiac-specific AEs have received little attention in clinical trials, despite their life-threatening potential. OBJECTIVE: The present study aimed to determine the risk of nivolumab-induced cardiac AEs, time to onset, incidence rates, and post hoc outcomes using the Japanese Adverse Drug Event Report database...

BACKGROUND AND OBJECTIVE: Perampanel is a once-daily oral anti-seizure medication indicated for focal-onset seizures and generalized tonic-clonic seizures. This study investigated the single- and multiple-dose pharmacokinetics of perampanel in healthy Chinese adults. METHODS: Study 052 (NCT03424564) was a phase I, single-center, open-label, parallel-group study. In the single-dose part of the study, subjects received a single oral dose of perampanel 2, 4, or 8 mg...

BACKGROUND AND OBJECTIVE: Although improving adherence to adjuvant endocrine therapies (AETs) is critical to ensure better patient outcomes, the evidence is still lacking on differences in 5-year AET adherence trajectories. This study aimed to estimate the time trend of adherence by the type of individual AET and the association of adherence to AETs with overall survival among older women with hormone receptor-positive breast cancer. METHODS: This study used the Surveillance, Epidemiology, and End Results-Medicare database 2006-2016...

No abstract text is available yet for this article.

BACKGROUND AND OBJECTIVE: Various dipeptidyl peptidase-4 (DPP-4) inhibitors have been approved for the treatment of diabetes. The frequencies of known serious side effects might differ among DPP-4 inhibitors, therefore a large sample size is needed to study them in prospective clinical trials. We examined the adverse events that occurred during the administration of a DPP-4 inhibitor in patients with diabetes using FDA Adverse Event Reporting System (FAERS) data. METHODS: We used FAERS data reported between January 2013 and March 2022 in patients with diabetes who received a DPP-4 inhibitor...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

BACKGROUND: Vascular anomalies that exhibit a slow velocity of blood flow, specifically venous malformations (VM), are associated with hypercoagulability. There is limited literature on the utilization of hormonal contraceptives (HCs) and the development of clotting events in female individuals diagnosed with VM. OBJECTIVE: We aimed to characterize HC utilization and associated odds of hypercoagulopathy in patients with VM of child-bearing age. METHODS: Using a national administrative claims database, we identified female patients with VM aged 15-49 years and a control population, matched for age and length of insurance enrollment, from 2016 to 2021...

BACKGROUND AND OBJECTIVE: The expanding use of botulinum toxin (BoNT) in medical practice demonstrates the need to highlight whether there is adequate information regarding its safety profile. The aim of our study was to identify completeness of harms reporting for BoNT treatment within systematic reviews (SRs), assess quality of SRs using the AMSTAR-2 tool, and determine the degree of overlap among primary studies within each SR. METHODS: On May 31, 2022, we searched Embase, Epistemonikos, MEDLINE, and the Cochrane Database of Systematic Reviews for SRs on BoNT therapy...

BACKGROUND AND OBJECTIVE: Data on real-world healthcare costs for ixekizumab (IXE) and secukinumab (SEC) in biologic-experienced patients with psoriasis are limited. This study compared real-world costs and healthcare resource utilization between IXE and SEC in biologic-experienced patients with psoriasis over an 18-month follow-up period in the USA. METHODS: Adult patients with a diagnosis of psoriasis between 1 March, 2015 and 31 October, 2019 were identified using health insurance claims data from IBM Watson Health MarketScan® ...

BACKGROUND AND OBJECTIVE: Individuals with diabetes mellitus may prefer different body regions for subcutaneous insulin administration. This trial investigated whether choice of injection region affects exposure and glucose-lowering effect of once-weekly basal insulin icodec. METHODS: In a randomised, open-label, crossover trial, 25 individuals with type 2 diabetes received single subcutaneous icodec injections (5.6 U/kg) in the thigh, abdomen or upper arm (9-13 weeks' washout)...

BACKGROUND AND OBJECTIVES: Depletion of B cells is shown to be clinically effective for rheumatoid arthritis (RA) treatment. Although B-cell depletion therapy with rituximab is indicated for RA patients who have failed to other disease-modifying anti-rheumatic drugs (DMARDs), primary cost-effectiveness evidence is inconsistent. We aimed to provide synthesised cost-effectiveness evidence of rituximab in the treatment of RA compared to other DMARDs, since the published cost-effectiveness evidence is mixed...

The coronavirus disease 2019 (COVID-19) pandemic has swept the whole world and brought about a public health crisis of unprecedented proportions. To combat the rapid transmission and possible deaths due to the disease, researchers and companies around the world are developing all possible strategies. Due to the advantages of safety, specificity, and fewer adverse effects, polypeptide and peptidomimetic drugs are considered promising strategies. This review comprehensively summarizes and discusses the progress in development of peptide drugs for use in the treatment of COVID-19...

No abstract text is available yet for this article.