Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database
ConclusionsThis study suggests that there is no association between exposure to golimumab and an increased risk of prespecified outcomes. Increased depression risk in the as-treated analysis was not replicated in other analyses and may be associated with residual imbalance in baseline history or severity of depression. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 10, 2020 Category: Drugs & Pharmacology Source Type: research

Proton Pump Inhibitors are Risk Factors for Viral Infections: Even for COVID-19?
AbstractDuring the ongoing pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), more attention should be paid to the balance of risks and benefits associated with proton pump inhibitors for the following reasons. One of the main functions of gastric juice is to inactivate swallowed microorganisms, thereby inhibiting infectious agents from reaching the intestine. Studies have documented that proton pump inhibitors are a risk factor for rotavirus, influenza virus, norovirus, and Middle East respiratory syndrome coronavirus infections, and are associated with an increased risk of acute gastroenteritis dur...
Source: Clinical Drug Investigation - August 10, 2020 Category: Drugs & Pharmacology Source Type: research

Remifentanil Target-Controlled Infusion for Conscious Sedation in Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Case Series
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 7, 2020 Category: Drugs & Pharmacology Source Type: research

Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France
AbstractBackground and ObjectivesNon-interventional studies are a valuable source of evidence that is complementary to traditional randomised, blinded and controlled clinical trials, for evaluating antidepressants in a real-world setting. The aim of the present  study was to document the use of agomelatine in current medical practice and evaluate its effectiveness and safety in outpatients prescribed agomelatine to treat their current depressive episode.MethodsThis 12-month observational French study included patients initiating agomelatine treatment. The intensity and severity of depression were assessed using t...
Source: Clinical Drug Investigation - July 29, 2020 Category: Drugs & Pharmacology Source Type: research

Sodium-Glucose Cotransporter Inhibitors for the Treatment of Type 1 Diabetes Mellitus
AbstractSodium-glucose cotransporter inhibitors are a new class of oral antihyperglycemic drugs that have been approved for the treatment of patients with type 2 diabetes mellitus. Sodium-glucose cotransporter inhibitors reduce glucose reabsorption in the kidneys, which lowers blood glucose. In addition, they offer significant cardiovascular benefits and renal protection. Multiple phase III trials of sodium-glucose cotransporter inhibitors in patients with type 1 diabetes have been completed. The European Medicines Agency approved dapagliflozin as an adjuvant therapy to insulin for patients with type 1 diabetes who have po...
Source: Clinical Drug Investigation - July 28, 2020 Category: Drugs & Pharmacology Source Type: research

Comprehensive Pulmonary Safety Review of Inhaled Technosphere ® Insulin in Patients with Diabetes Mellitus
ConclusionsPulmonary safety assessment of the TI inhalation system did not identify any safety issues in individuals with either T1DM or T2DM. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 27, 2020 Category: Drugs & Pharmacology Source Type: research

Cefiderocol, a New Siderophore Cephalosporin for the Treatment of Complicated Urinary Tract Infections Caused by Multidrug-Resistant Pathogens: Preclinical and Clinical Pharmacokinetics, Pharmacodynamics, Efficacy and Safety
AbstractCefiderocol (Fetroja®) is a siderophore cephalosporin and has demonstrated potent activity against extended-spectrum beta-lactamases producingEnterobacteriaceae, carbapenem-resistantEnterobacteriaceae, and nonfermenting Gram-negative bacilli, includingPseudomonas aeruginosa,Stenotrophomonas maltophilia, andAcinetobacter baumannii, Burkholderia cepacia, andKlebsiella pneumoniae. However, cefiderocol has limited activity against Gram-positive bacteria and anaerobes likeBacterodies fragilis. In the APEKS-cUTI study, 183 (73%) of 252 patients in the cefiderocol group versus 65 (55%) of 119 patients in the imipenem-...
Source: Clinical Drug Investigation - July 22, 2020 Category: Drugs & Pharmacology Source Type: research

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database
ConclusionsOur study shows increased reporting of facial paralysis following influenza vaccination as compared with other vaccines. Considering the inherent limitations of the VAERS database analysis, and the fact that disproportionality measures only indicate the presence of a signal, our study findings need to be explored in well-designed prospective pharmacoepidemiologic studies. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 21, 2020 Category: Drugs & Pharmacology Source Type: research

High Doses of Δ 9 -Tetrahydrocannabinol Might Impair Irinotecan Chemotherapy: A Review of Potentially Harmful Interactions
AbstractThis review proposes the hypothesis that the effectiveness of irinotecan chemotherapy might be impaired by high doses of concomitantly administered Δ9-tetrahydrocannabinol (THC). The most important features shared by irinotecan and THC, which might represent sources of potentially harmful interactions are: first-pass hepatic metabolism mediated by cytochrome P450 (CYP) enzyme CYP3A4; glucuronidation mediated by uridine diphosphate glycosyltransferase (UGT) enzymes, isoforms 1A1 and 1A9; transport of parent compounds and their metabolites via canalicular ATP-binding cassette (ABC) transporters ABCB1 and ABCG2;...
Source: Clinical Drug Investigation - July 21, 2020 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Neutropenia During Treatment of Non-Neoplastic Dermatologic Diseases: A Review
AbstractIdiosyncratic drug-induced neutropenia (DIN) is a rare, potentially fatal adverse reaction. A literature search was performed on Pubmed and Embase, targeting articles indicating neutropenia as a complication during the treatment of non-neoplastic dermatological disorders. In 66 identified articles, the common incriminated drugs included conventional oral immunomodulators, topical cytotoxic agents, antibacterials, antifungals, biologics and targeted synthetic disease-modifying antirheumatic drugs, non-steroidal anti-inflammatory drugs, and retinoids, with dapsone being reported most often. The duration of drug expos...
Source: Clinical Drug Investigation - July 21, 2020 Category: Drugs & Pharmacology Source Type: research

Efficacy of Statin/Ezetimibe for Secondary Prevention  of Atherosclerotic Cardiovascular Disease in Asian Populations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
This study aimed to summarize study results regarding the effect of statin/ezetimibe combination therapy on lipid parameters and highly sensitive C-reactive protein (HsCRP) biomarkers in ASCVD patients from Asian countries.MethodsWe searched the PubMed/MEDLINE, Web of Science, Scopus, and Google Scholar databases for relevant papers published from 2008 to June 2020. We included randomized controlled trials (RCTs) that (1) were conducted in ASCVD patients in Asian countries; (2) examined the effects of statin/ezetimibe combination therapies compared with a control group; and (3) reported sufficient data on lipid parameters ...
Source: Clinical Drug Investigation - July 15, 2020 Category: Drugs & Pharmacology Source Type: research

P2Y12 Inhibitor Monotherapy After a Short Dual Antiplatelet Therapy Versus Standard-Term Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Contemporary Meta-Analysis
AbstractBackground and ObjectivesDual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) reduces the incidence of thrombotic events but increases the risk of bleeding, which is associated with a substantial and durable risk of death and could offset the benefits of a reduction in thrombotic events. P2Y12 inhibitor monotherapy after short-term DAPT could be an option to reduce the risk of bleeding. We carried out a meta-analysis comparing P2Y12 inhibitor monotherapy after short-term DAPT with standard-term DAPT in patients undergoing PCI.MethodsWe searched the PubMed and EMBASE databases through 11 A...
Source: Clinical Drug Investigation - July 13, 2020 Category: Drugs & Pharmacology Source Type: research

Effects of Tranexamic Acid on Hemoptysis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
ConclusionTXA use was observed to reduce bleeding volume, further intervention risk, and length of hospital stay in patients with hemoptysis; however, our results may have low statistical power because of limited sample size. Additional large-scale RCTs are thus warranted to confirm the effectiveness and safety of TXA use. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 13, 2020 Category: Drugs & Pharmacology Source Type: research

Tocilizumab, Adipokines and Severe Complications of COVID-19
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 13, 2020 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to: Tocilizumab, Adipokines and Severe Complications of COVID-19
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 13, 2020 Category: Drugs & Pharmacology Source Type: research

The Role of Delafloxacin in Patients with Community-Acquired Bacterial Pneumonia in the Outpatient Setting: A Budget Impact Model
ConclusionThe results of the budget impact analyses provide conservative estimates of the impact of adding delafloxacin to outpatient formularies in substitution of moxifloxacin. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 10, 2020 Category: Drugs & Pharmacology Source Type: research

Signals of Adverse Drug Reactions of Paliperidone Compared to Other Atypical Antipsychotics Using the Korean Adverse Event Reporting System Database
ConclusionWe detected new AE signals of paliperidone that were not listed on the drug labels of six countries, and many that were related to psychotic symptoms, metabolic problems, and endocrine disorders. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 9, 2020 Category: Drugs & Pharmacology Source Type: research

Cost of Relapse Management in Patients with Schizophrenia in Italy and Spain: Comparison Between Lurasidone and Quetiapine XR
ConclusionsThe use of lurasidone (74  mg) for the treatment of patients affected with schizophrenia, compared with quetiapine XR (300 mg), would be a cost-saving strategy in the two contexts investigated assuming the National Health Service point of view. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 9, 2020 Category: Drugs & Pharmacology Source Type: research

Long-Term Safety and Effectiveness of the Xanthine Oxidoreductase Inhibitor, Topiroxostat in Japanese Hyperuricemic Patients with or Without Gout: A 54-week Open-label, Multicenter, Post-marketing Observational Study
ConclusionsThis study suggests that there is no particular concern about adverse drug reactions or the efficacy of topiroxostat for hyperuricemic patients with or without gout in a post-marketing setting in Japan. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 3, 2020 Category: Drugs & Pharmacology Source Type: research

Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements
ConclusionsThis small, exploratory study found similar rates of thromboembolic complications and major bleeding events in patients who received a DOAC versus warfarin after a recent bioprosthetic AVR or MVR. This study was limited by its retrospective nature and its sample size. Larger, randomized controlled trials are needed to further determine the efficacy and safety of DOACs in this patient population. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 30, 2020 Category: Drugs & Pharmacology Source Type: research

Investigation of Potential Drug –Drug Interactions between Peficitinib (ASP015K) and Methotrexate in Patients with Rheumatoid Arthritis
ConclusionsPharmacokinetic results showed no significant interactions between peficitinib and methotrexate.ClinicalTrials.gov IdentifierNCT01754805. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 26, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain
ConclusionUsing DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 24, 2020 Category: Drugs & Pharmacology Source Type: research

Liraglutide: New Perspectives for the Treatment of Polycystic Ovary Syndrome
AbstractPolycystic ovary syndrome is a complex and heterogenous disorder involving multiple organ systems and different molecular pathways. It is tightly associated with obesity and especially abdominal obesity. As body weight reduction is the main modifiable risk factor for polycystic ovary syndrome, therapeutic approaches in overweight or obese women with polycystic ovary syndrome have been developed. Liraglutide is a glucagon-like peptide-1 receptor agonist that promotes sustained weight loss, as well as abdominal fat reduction, in individuals with obesity, prediabetes, and type 2 diabetes mellitus. The majority of curr...
Source: Clinical Drug Investigation - June 24, 2020 Category: Drugs & Pharmacology Source Type: research

RETRACTED ARTICLE: Fetal Safety of Dydrogesterone Exposure in the First Trimester of Pregnancy
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 23, 2020 Category: Drugs & Pharmacology Source Type: research

Economic Evaluation of Rivaroxaban Versus Enoxaparin for Prevention of Venous Thromboembolism After Total Knee Replacement and Total Hip Replacement: A Systematic Review
ConclusionThe results of this systematic review showed that using rivaroxaban in patients undergoing total knee or hip replacement reduced costs and increased quality of life. However, since most of the studies had been conducted in developed countries, it is not possible to generalize the results to developing countries. Nonetheless, given that rivaroxaban is administered orally and does not require continuous monitoring, it will be less costly for patients and health systems and is more appropriate to administer it as a thromboprophylactic drug following total knee or hip replacement surgery. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 23, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluation of the Potential Pharmacokinetic Interactions Between Vixotrigine and an Oral Contraceptive
ConclusionsCoadministration of vixotrigine and an oral contraceptive containing ethinyl estradiol and levonorgestrel had no clinically relevant effect on exposure of all three compounds.Trial RegistrationClinicalTrials.gov registration number: NCT03324685 (registered 25 October, 2017). (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 20, 2020 Category: Drugs & Pharmacology Source Type: research

Association Between an Acute, Drug-Induced Decrease in High-Density Lipoprotein Cholesterol Levels and Risk of Cardiovascular Events
ConclusionPatients with a short-term, drug-induced decrease in HDL-C had a moderately increased long-term risk of CV events compared with those with constant HDL-C levels.Trial Registration Number207595 (GlaxoSmithKline Trial registry;https://www.gsk-studyregister.com/). (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 18, 2020 Category: Drugs & Pharmacology Source Type: research

Azithromycin for COVID-19: More Than Just an Antimicrobial?
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 12, 2020 Category: Drugs & Pharmacology Source Type: research

Novel Adherence Interventions in Perinatally Acquired HIV: PEG Insertion and Pill Glide
AbstractBackground and ObjectivesChildren, adolescents and young adults (CAYA) with perinatally acquired human immunodeficiency virus (PaHIV) need lifelong antiretroviral therapy (ART) to suppress viral load (VL), maintain health and prevent onward transmission. Many struggle with adherence despite multidisciplinary input. We assessed ART adherence outcomes following two novel interventions: percutaneous endoscopic gastrostomy (PEG) and Pill Glide®, a fruit-flavoured lubricant spray aiding tablet swallowing.MethodsRetrospective cohort analysis by database and case-note review of PaHIV CAYA aged  
Source: Clinical Drug Investigation - June 9, 2020 Category: Drugs & Pharmacology Source Type: research

The Problem with Amphotericin
AbstractPatient harm from inadvertent administration of amphotericin B (Fungizone ™) instead of liposomal amphotericin (AmBisome®) has been described in the literature and has been the subject of patient safety alerts in the UK. Safe use of intravenous amphotericin depends on the knowledge and awareness of practitioners of the availability and differences between the different presentations of intravenous amphotericin. Knowledge is a weak barrier to error. Recommendations to reduce the risk of error following adverse drug events in the UK, USA and The Netherlands have largely focused on actions to be taken at an ...
Source: Clinical Drug Investigation - June 8, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Heart Failure Events in Patients with Type 2 Diabetes Mellitus: A Cost Per Outcome Analysis
The original version of this article unfortunately contained a mistake. The correct information is given below. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 6, 2020 Category: Drugs & Pharmacology Source Type: research

Post-approval Safety Monitoring of Quadrivalent and Bivalent Human Papillomavirus Vaccines Based on Real-world Data from the Korea Adverse Events Reporting System (KAERS)
ConclusionsBoth application site disorders and systemic AEs were somewhat more frequent with the bHPV vaccine than with the qHPV vaccine. This might be caused by an immune response induced by adjuvants contained within the vaccines. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 30, 2020 Category: Drugs & Pharmacology Source Type: research

An Updated Systematic Review of the Therapeutic Role of Hydroxychloroquine in Coronavirus Disease-19 (COVID-19)
ConclusionThe results of efficacy and safety of HCQ in COVID-19, as obtained from the clinical studies, are not satisfactory, although many of these studies had major methodological limitations. Stronger evidence from well-designed robust randomized clinical trials is required before conclusively determining the role of HCQ in the treatment of COVID-19. Clinical prudence is required in advocating HCQ as a therapeutic armamentarium in COVID-19. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 28, 2020 Category: Drugs & Pharmacology Source Type: research

Acute Renal Failure, Ketoacidosis, and Urogenital Tract Infections with SGLT2 Inhibitors: Signal Detection Using a Japanese Spontaneous Reporting Database
ConclusionThe results suggested a correlation between SGLT2 inhibitors and the onset of ketoacidosis and UTIs, but not between SGLT2 inhibitors and ARF. Further verification of the safety of SGLT2 inhibitors, through continued risk assessments and large-scale clinical studies, are necessary. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 25, 2020 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics of Anti-tuberculous Drugs Delivered Via Nasogastric Tube Feeding in a Critically Ill Patient: A Case Study
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 25, 2020 Category: Drugs & Pharmacology Source Type: research

Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Heart Failure Events in Patients with Type 2 Diabetes Mellitus: A Cost Per Outcome Analysis
ConclusionsOur findings suggest that empagliflozin prescribed for preventing CV death or hHF in T2DM patients seems to be cost saving compared to treatment with canagliflozin, and dapagliflozin. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 24, 2020 Category: Drugs & Pharmacology Source Type: research

Treatment of Severe Hypertriglyceridemia-Induced Acute Pancreatitis with Subcutaneous Insulin: Case Report
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 24, 2020 Category: Drugs & Pharmacology Source Type: research

New Oral Anticoagulants for Thromboprophylaxis in Patients with Cancer Receiving Chemotherapy: An Economic Evaluation in a Chinese Setting
ConclusionsThromboprophylaxis with NOACs is not likely to be cost effective in patients initiating chemotherapy in the Chinese context. The decision about thromboprophylaxis should be tailored based on the survival of patients with cancer, the risks of venous thromboembolism, and major bleeding. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 22, 2020 Category: Drugs & Pharmacology Source Type: research

An Economic Evaluation of Pembrolizumab Versus Other Adjuvant Treatment Strategies for Resected High-Risk Stage III Melanoma in the USA
ConclusionsAs adjuvant treatment for resected stage III melanoma, pembrolizumab was found to be dominant and therefore cost-effective compared with the active comparators ipilimumab and dabrafenib  + trametinib. Pembrolizumab increased costs relative to observation in the overall population, with sufficient incremental benefit to be considered cost-effective based on typical willingness-to-pay thresholds. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 16, 2020 Category: Drugs & Pharmacology Source Type: research

Effect of Cytochrome P450 and ABCB1 Polymorphisms on Imatinib Pharmacokinetics After Single-Dose Administration to Healthy Subjects
ConclusionCYP2B6 G516Tand CYP3A4 *20,*22 polymorphisms could influence imatinib plasma concentrations and safety profile, after single-dose administration to healthy subjects. This finding needs to be confirmed before it is implemented in clinical practice in oncological patients under treatment with imatinib. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 15, 2020 Category: Drugs & Pharmacology Source Type: research

Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses
ConclusionSUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile.Clinical Trials Registration (https://clinicaltrials.gov): NCT04072380 and NCT02342041. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 12, 2020 Category: Drugs & Pharmacology Source Type: research

Comments on: “A Systematic Review and Meta‑analysis of the Adverse Effects of Levonorgestrel Emergency Oral Contraceptive”
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 5, 2020 Category: Drugs & Pharmacology Source Type: research

Efficacy of Collagenase Clostridium histolyticum (Xiapex ® ) in Patients with the Acute Phase of Peyronie’s Disease
The objective of this study was to evaluate the advantages of using a single intralesional injection of collagenaseClostridium histolyticum in patients with the active phase of Peyronie ’s disease and to assess its effect on disease progression by reducing penile curvature and ameliorating pain during sexual intercourse.MethodsSexually active men aged older than 18  years with the acute phase of Peyronie’s disease were enrolled. All patients received treatment with a single intralesional injection of collagenaseClostridium histolyticum. The primary outcome of the study was the change in penile curvature af...
Source: Clinical Drug Investigation - April 27, 2020 Category: Drugs & Pharmacology Source Type: research

Rational Use of Tocilizumab in the Treatment of Novel Coronavirus Pneumonia
AbstractSince December 2019, a novel coronavirus pneumonia (COVID-19) has broken out in Wuhan, China and spread rapidly. Recent studies have found that ⁓ 15.7% of patients develop severe pneumonia, and cytokine storm is an important factor leading to rapid disease progression. Currently, there are no specific drugs for COVID-19 and the cytokine storm it causes. IL-6 is one of the key cytokines involved in infection-induced cytokine storm. Tocil izumab, which is the IL-6 receptor antagonist, has been approved by the US FDA for the treatment of cytokine release syndrome (CRS), is expected to treat cytokine storm cau...
Source: Clinical Drug Investigation - April 26, 2020 Category: Drugs & Pharmacology Source Type: research

A 5-year Retrospective Analysis of Drug Survival, Safety, and Effectiveness of the Infliximab Biosimilar CT-P13 in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis
ConclusionUp to 5  years of CT-P13 treatment was safe and effective in patients with RA and AS, based on drug survival, incidence of TEAEs, and disease activity. Drug survival and safety were similar in naïve patients and switched groups, supporting switching from reference infliximab to CT-P13. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 23, 2020 Category: Drugs & Pharmacology Source Type: research

Clinical Drug-Drug Interaction Studies to Evaluate the Effects of a P-Glycoprotein Inhibitor, CYP3A Inhibitors, and a CYP3A Inducer on the Pharmacokinetics of Naldemedine in Healthy Subjects
ConclusionsCoadministration of naldemedine with a P-glycoprotein inhibitor or a strong/moderate CYP3A inhibitor increases naldemedine exposure; coadministration with a strong CYP3A inducer decreases its exposure. Coadministration of naldemedine with cyclosporine, itraconazole, fluconazole, or rifampin was generally safe and well tolerated. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 22, 2020 Category: Drugs & Pharmacology Source Type: research

Comparative Study of Traditional Ablative CO 2 Laser-Assisted Topical Antifungal with only Topical Antifungal for Treating Onychomycosis: A Multicenter Study
The objective of this clinical trial is to compare the efficacy and safety of a manually operated ablative CO2 laser combined with a topical antifungal agent in patients with onychomycosis.Study DesignWe conducted an open-label controlled prospective study of 160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai. It was a 6-month study where both groups were treated with a topical antifungal agent, with the treatment group also receiving ablation by the traditional CO2 laser once a month for the first 3  months....
Source: Clinical Drug Investigation - April 20, 2020 Category: Drugs & Pharmacology Source Type: research

Comparison of Anti-factor Xa Activity Among Three Different Factor Xa Inhibitors in Non-valvular Atrial Fibrillation Patients with Renal Impairment
ConclusionAmong Japanese NVAF patients with RI, the peak or trough AXA values were higher in patients with severe RI than in those with moderate RI when taking rivaroxaban and edoxaban, whereas both the peak and trough AXA values were similar between patients with severe RI and those with moderate RI when taking apixaban. The peak-to-trough ratio of AXA values was the lowest in patients taking apixaban. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 20, 2020 Category: Drugs & Pharmacology Source Type: research

Tumor-Agnostic Treatment for Cancer: When How is Better than Where
AbstractIn the evolving landscape of precision oncology, genomic characterization of tumor has become crucial in order to move toward a molecular-based therapy for the vast majority of cancers. Recently, translational research has offered new perspectives in systemic cancer treatment thanks to the identification of novel oncogenic targets and the development of new targeted therapies, followed by the latest applications of genomic sequencing. Simultaneously, next-generation sequencing (NGS) has expanded its accessibility, being incorporated into clinical studies at the time of the initial screening, disease progression, an...
Source: Clinical Drug Investigation - April 19, 2020 Category: Drugs & Pharmacology Source Type: research

Phase I, First-in-Human, Single and Multiple Ascending Dose- and Food-Effect Studies to Assess the Safety, Tolerability and Pharmacokinetics of a Novel Anti-hepatitis B Virus Drug, Bentysrepinine (Y101), in Healthy Chinese Subjects
ConclusionBentysrepinine exhibited acceptable safety and tolerability in healthy subjects in the dose range of 50 –900 mg in both single- and multiple-dose studies. The drug did not exhibit linear pharmacokinetic characteristics. No accumulation was observed after the administration of multiple 300 and 600 mg doses. Bentysrepinine is extensively metabolised in the body. Food may increase its bioavailability .Trials RegistrationCFDA registration numbers CTR20160096, CTR20160094, and CTR20140543 (www.chinadrugtrials.org.cn). (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 10, 2020 Category: Drugs & Pharmacology Source Type: research