Factors Influencing Placebo Responses in Rheumatoid Arthritis Clinical Trials: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Studies
ConclusionsOur meta-analysis suggests that study location, patient population, and a background DMARD treatment influence placebo ACR20. These along with placebo response temporal profiles have important implications for designing and interpreting RA clinical trials. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - January 17, 2020 Category: Drugs & Pharmacology Source Type: research

Clinical Pharmacokinetics, Safety and Exploratory Efficacy Study of a Topical Bactericidal VB-1953: Analysis of Single and Multiple Doses in a Phase I Trial in Acne Vulgaris Subjects
ConclusionVB-1953 topical gel appears to be safe for use in adults with facial acne vulgaris and may offer new advances as a topical antibiotic agent for the disease. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - January 11, 2020 Category: Drugs & Pharmacology Source Type: research

Comparison of the Efficacy and Safety of Pregabalin and Duloxetine in Taxane-Induced Sensory Neuropathy: A Randomized Controlled Trial
This study aimed to compare the efficacy and safety of pregabalin (150  mg daily) and duloxetine (60 mg daily) for managing TIPN in breast cancer patients.MethodsThis randomized, double-blind, Phase II clinical trial was carried out at a chemotherapy center affiliated to Mazandaran University of Medical Sciences. Patients with breast cancer who received paclitaxel or docetaxel and had a grade 1 or more neuropathy (based on the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI-CTCAE v4.03), and who had score 4 or higher neuropathic pain severity [based on the visual analog scale...
Source: Clinical Drug Investigation - January 10, 2020 Category: Drugs & Pharmacology Source Type: research

Expression of Concern to: Fetal Safety of Dydrogesterone Exposure in the First Trimester of Pregnancy
The Editor-in-Chief of Clinical Drug Investigation has become aware that the original article contains a number of errors and inconsistencies. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - January 8, 2020 Category: Drugs & Pharmacology Source Type: research

Practical Considerations for Treatment of Relapsed/Refractory FLT3-ITD Acute Myeloid Leukaemia with Quizartinib: Illustrative Case Reports
AbstractQuizartinib is a tyrosine kinase inhibitor selectively targeting the FMS-like tyrosine kinase 3 (FLT3) receptor that has been developed for the treatment of acute myeloid leukaemia (AML). The Phase 3 QuANTUM-R study investigated the efficacy of quizartinib monotherapy in patients with relapsed/refractoryFLT3-ITD mutation-positive AML. The clinical course of four QuANTUM-R participants exemplifies issues specific to quizartinib treatment and is described here. Patient 1 wasFLT3-ITD mutation-negative at AML diagnosis, but becameFLT3-ITD mutation-positive during treatment that included several lines of chemotherapy an...
Source: Clinical Drug Investigation - January 7, 2020 Category: Drugs & Pharmacology Source Type: research

Cost Effectiveness of Ceritinib and Alectinib Versus Crizotinib in First-Line Anaplastic Lymphoma Kinase-Positive Advanced Non-small-cell Lung Cancer
ConclusionsOur results indicate that compared with crizotinib and alectinib, ceritinib is a cost-effective option for treatment-na ïve patients with ALK-positive advanced NSCLC. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - December 9, 2019 Category: Drugs & Pharmacology Source Type: research

PCSK9 Inhibitors ’ New Users: Analysis of Prescription Patterns and Patients’ Characteristics from an Italian Real-world Study
ConclusionsDuring the first year of availability, the rate of prescription of PCSK9 inhibitors appears below expectations. Patients were mainly in secondary prevention and had been slightly persistent to previous LLTs. During follow-up, the PCSK9 inhibitor monotherapy showed high levels of adherence and persistence. This real-world study sets the stage for future longer-term investigations useful to improve our knowledge on the appropriateness, drug access and public healthcare sustainability of PCSK9 inhibitors. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - December 3, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use
The original article has been corrected. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 28, 2019 Category: Drugs & Pharmacology Source Type: research

A Caprini Risk Score-Based Cost-Effectiveness Analysis of Enoxaparin for the Thromboprophylaxis of Patients After Nonorthopedic Surgery in a Chinese Healthcare Setting
ConclusionsAs the first analysis evaluating the economic outcomes of enoxaparin in patients undergoing general non-orthopedic surgery, this study suggests that thromboprophylaxis with enoxaparin is highly cost-effective compared with no prevention in patients with Caprini risk score  ≥ 3. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 26, 2019 Category: Drugs & Pharmacology Source Type: research

Early and Late Switch from Ranibizumab to an Intravitreal Dexamethasone Implant in Patients with Diabetic Macular Edema in the Event of a Poor Anatomical Response
ConclusionsAlthough both early switching and late switching are similar in terms of providing functional and morphological improvement, early switching appeared better for ensuring patient well-being in the early period and improving patient adherence. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 25, 2019 Category: Drugs & Pharmacology Source Type: research

Bleeding Risk of Therapeutic Unfractionated Heparin and Low Molecular Weight Heparin in Patients with Cirrhosis
ConclusionsLow molecular weight heparin may be a safer option in patients with cirrhosis treated for acute venous thromboembolism, but future studies should confirm these findings. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 21, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function
ConclusionsPeficitinib exposure and TEAEs were similar in subjects with and without renal impairment after a single oral 150  mg dose. Based on these findings, it is not expected that peficitinib dose adjustment will be required in clinical practice, according to the degree of renal impairment.ClinicalTrials.gov identifierNCT02603497. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 15, 2019 Category: Drugs & Pharmacology Source Type: research

Safety, Tolerability, and Effects of Sodium Bicarbonate Inhalation in Cystic Fibrosis
ConclusionNebulized NaHCO3 inhalation appears to be a safe and well tolerated potential therapeutic agent in the management of CF. Nebulized NaHCO3 inhalation temporarily elevates airway liquid pH and reduces sputum viscosity and viscoelasticity. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 13, 2019 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 5, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics and Bioequivalence Evaluation of a New Oxycodone Tamper-Resistant Tablet Administered with an Opioid Antagonist in Patients with Chronic Pain
ConclusionsThe new OTR formulation could provide a new choice in the treatment of chronic pain and reduce the potential for oxycodone abuse.Chictr.org identifier: ChiCTR1800017253. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 2, 2019 Category: Drugs & Pharmacology Source Type: research

Nivolumab Versus Docetaxel for Previously Treated Advanced Non-Small Cell Lung Cancer in China: A Cost-Effectiveness Analysis
ConclusionsNivolumab is unlikely to be cost-effective compared with docetaxel for patients with previously treated advanced NSCLC in China. Ensuring that nivolumab is included in the National Reimbursement Drug List (NRDL) may be a valid mean of meeting extensive treatment demands in China. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 2, 2019 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to “The Challenges of Studying Peripheral Vestibular Vertigo”
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 2, 2019 Category: Drugs & Pharmacology Source Type: research

The Challenges of Studying Peripheral Vestibular Vertigo
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 1, 2019 Category: Drugs & Pharmacology Source Type: research

Immediate Resolution of Hemispatial Neglect and Central Post-Stroke Pain After Perispinal Etanercept: Case Report
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 22, 2019 Category: Drugs & Pharmacology Source Type: research

Influence of Prevalent Vertebral Fracture on the Correlation between Change in Lumbar Spine Bone Mineral Density and Risk of New Vertebral Fracture: A Meta-Analysis of Randomized Clinical Trials
ConclusionsThe change in lumbar spine BMD, not BMD T-score at one timepoint, had a significant correlation with the incidence of vertebral fracture. The prediction of the fracture risk by change in lumbar spine BMD was improved by adjusting the proportion of subjects with prevalent vertebral fracture in the study population. The difference of prevalence of vertebral fracture among populations should be considered when the association between change in lumbar spine BMD and incidence of vertebral fracture is examined. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 19, 2019 Category: Drugs & Pharmacology Source Type: research

Collagenase Clostridium Histolyticum: A Review in Peyronie ’s Disease
AbstractCollagenase Clostridium Histolyticum (hereafter referred to as CCH) [Xiaflex®; Xiapex®] is a mixture of twoClostridium histolyticum collagenases [AUX-I (a Class I clostridial collagenase) and AUX-II (a Class II clostridial collagenase)]. Administered by intralesional injection, it is available in various countries for the treatment of adult men with Peyronie ’s disease (PD). In two double-blind, multinational, phase III studies, CCH improved the physical (penile curvature) and psychological (patient-reported bother) aspects of PD in adult men. Such beneficial effects were also seen in two open-label, ...
Source: Clinical Drug Investigation - October 18, 2019 Category: Drugs & Pharmacology Source Type: research

Stratifying Therapeutic Enoxaparin Dose in Morbidly Obese Patients by BMI Class: A Retrospective Cohort Study
ConclusionStandard dosing of enoxaparin in morbidly obese patients will most likely lead to supratherapeutic anti-Xa levels and thus further investigation is warranted to better determine appropriate dosing. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 17, 2019 Category: Drugs & Pharmacology Source Type: research

Targeting Hormones for Improving Cognition in Major Mood Disorders and Schizophrenia: Thyroid Hormones and Prolactin
AbstractCognitive deficits are a core feature of serious mental illnesses such as major depression, bipolar disorder and schizophrenia and are a common cause of functional disability. However, the efficacy of pharmacological interventions for improving the cognitive deficits in these disorders is limited. As pro-cognitive pharmacological treatments are lacking, we aimed to review whether thyroid hormones or drugs that target prolactin may become potential candidates for ‘repurposing’ trials aiming to improve cognition. We conducted a narrative review focused on thyroid hormones and prolactin as potential target...
Source: Clinical Drug Investigation - October 14, 2019 Category: Drugs & Pharmacology Source Type: research

Assessing Barriers to Adherence with the Use of Dimethyl Fumarate in Multiple Sclerosis
AbstractBackgroundMultiple sclerosis (MS) is a chronic, inflammatory, central nervous system demyelinating disease that requires long-term use of disease-modifying therapies (DMT). Patient adherence to DMT is key in reducing the inflammation that leads to relapses and neurodegeneration. Dimethyl fumarate (DMF) poses unique challenges to adherence including being the only twice-daily dosing DMT. Previous research suggests there are direct roles that providers play on improving their patients ’ adherence rates, such as focusing on the patient-provider relationship, helping put the patient at ease so that they feel unde...
Source: Clinical Drug Investigation - October 10, 2019 Category: Drugs & Pharmacology Source Type: research

Comparative Efficacy and Safety of Peficitinib 25, 50, 100, and 150 mg in Patients with Active Rheumatoid Arthritis: A Bayesian Network Meta-Analysis of Randomized Controlled Trials
ConclusionsPeficitinib 50, 100, and 150 mg once daily was effective in treating active RA, without causing a significant risk for AEs. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 10, 2019 Category: Drugs & Pharmacology Source Type: research

The Prediction Model of Warfarin Individual Maintenance Dose for Patients Undergoing Heart Valve Replacement, Based on the Back Propagation Neural Network
ConclusionThe BPNN model shows promise for predicting the warfarin maintenance dose after heart valve replacement. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 4, 2019 Category: Drugs & Pharmacology Source Type: research

Combination of Olanzapine and Samidorphan Has No Clinically Significant Effect on the Pharmacokinetics of Lithium or Valproate
ConclusionsConsistent with previously reported findings on olanzapine, administration of multiple doses of OLZ/SAM did not have a clinically significant effect on the pharmacokinetics of lithium or valproate. Co-administration of OLZ/SAM and lithium or valproate was generally well tolerated; the safety profile of OLZ/SAM was consistent with that observed in previous clinical studies. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 4, 2019 Category: Drugs & Pharmacology Source Type: research

Fetal Safety of Dydrogesterone Exposure in the First Trimester of Pregnancy
ConclusionsDYD confers teratogenic effects after exposure to the recommended doses in pregnant women. The risks of hypospadias and cryptorchidism have biological plausibility by the known effects on male genitalia, as is the risk for spina bifida, by the proven decrease in folic acid levels. Some of these adverse fetal effects appear to be further augmented by concomitant use of IVF and ART. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 3, 2019 Category: Drugs & Pharmacology Source Type: research

A Systematic Review of Economic Evaluations Assessing the Cost-Effectiveness of Licensed Drugs Used for Previously Treated Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Negative Advanced/Metastatic Non-Small Cell Lung Cancer
ConclusionsThere are a wide range of approaches in the modelling of treatments for advanced NSCLC; however, the model structures are consistent. There is variation in the exploration of sensitivity analyses, with considerable uncertainty remaining in most evaluations. Improved reporting is necessary to ensure transparency in future analyses. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 3, 2019 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of a Fixed Combination of Cinnarizine 20  mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial
ConclusionThe fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg was found to be not only non-inferior, but superior to betahistine 16 mg in the improvement of peripheral vestibular vertigo. Furthermore, taking into account a good and slightly favorable safety profile, the present study provides evidence that the fixed-combination preparation is a potent and even superior alternative to betahistine in the treatment of vertigo related to peripheral vestibular disorders.Study RegistrationEudraCT No. 2011-004025-27. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 30, 2019 Category: Drugs & Pharmacology Source Type: research

Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use
AbstractGlycopyrronium tosylate (Qbrexza™) is available as single-use, pre-moistened cloths and has been approved in the USA for the topical treatment of primary axillary hyperhidrosis in adults and children  ≥ 9 years of age. Glycopyrronium tosylate is effective in reducing patient-reported severity of disease and gravimetrically measured sweat production in this patient population; improvements have been shown to be maintained throughout long-term treatment (up to 48 weeks). Glycopyrronium tos ylate is generally well tolerated, with most adverse events being mild to moderate in severity. ...
Source: Clinical Drug Investigation - September 30, 2019 Category: Drugs & Pharmacology Source Type: research

Cost-effectiveness Analysis of CYP2D6*10 Pharmacogenetic Testing to Guide the Adjuvant Endocrine Therapy for Postmenopausal Women with Estrogen Receptor Positive Early Breast Cancer in China
ConclusionFrom the perspective of the Chinese healthcare system,CYP2D6*10 pharmacogenetic testing was cost effective for postmenopausal women with ER-positive early breast cancer. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 26, 2019 Category: Drugs & Pharmacology Source Type: research

Effect of Macitentan on the Pharmacokinetics of the Breast Cancer Resistance Protein Substrates, Rosuvastatin and Riociguat, in Healthy Male Subjects
ConclusionsMacitentan 10  mg did not affect the pharmacokinetics of BCRP substrates, rosuvastatin or riociguat in healthy male subjects.EudraCT numbers: 2017 –003095–31 and 2017–003502–41. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 24, 2019 Category: Drugs & Pharmacology Source Type: research

Open-Label Study to Assess the Efficacy of Ipragliflozin for Reducing Insulin Dose in Patients with Type 2 Diabetes Mellitus Receiving Insulin Therapy
In this study, therefore, we examined insulin dose reduction by ipragliflozin add-on therapy in Japanese patients with type 2 diabetes mellitus treated with long-acting basal insulin.MethodsIn this multicenter, open-label study, patients received one ipragliflozin 50-mg tablet once daily in combination with basal insulin for 24  weeks. The primary efficacy endpoint was the change and percent change in insulin dose from baseline to Week 24. Secondary efficacy endpoints included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), glycoalbumin, cholesterol, leptin, adiponectin, C-peptide, glucagon,...
Source: Clinical Drug Investigation - September 24, 2019 Category: Drugs & Pharmacology Source Type: research

Evaluation of the Feasibility of a Web-Based Survey to Assess Patient-Reported Symptom Improvement and Treatment Satisfaction Among Patients with Psoriatic Arthritis Receiving Secukinumab
ConclusionsPatient-reported perspectives may be feasibly collected to provide insights into treatment experience and satisfaction of secukinumab. Most patients with psoriatic arthritis in our real-world study experienced symptom improvement after initiating secukinumab;>  50% of patients reported symptom improvement within 4 weeks. Additionally, almost all patients reported satisfaction with secukinumab treatment. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 23, 2019 Category: Drugs & Pharmacology Source Type: research

Gut Microbiome in Psoriasis is Perturbed Differently During Secukinumab and Ustekinumab Therapy and Associated with Response to Treatment
ConclusionThese results indicate that gut microbiome is altered differently after anti-IL17 and anti-IL12/23 treatment. Secukinumab (anti-IL17) therapy is associated with distinct and more profound gut microbiome shifts than ustekinumab therapy (anti-IL 12/23) in patients with psoriasis. Moreover, gut microbiome would serve as potential biomarkers of response to secukinumab treatment. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 23, 2019 Category: Drugs & Pharmacology Source Type: research

Reduction of Immune Activation and Partial Recovery of Staphylococcal Enterotoxin B-Induced Cytokine Production After Switching to an Integrase Strand Transfer Inhibitor-Containing Regimen: Results from an Observational Cohort Study
ConclusionsOur data show a favorable effect of EVG/c/FTC/TDF switch to preserve immune activation-driven damage to T cell homeostasis, restore the multifunctional properties of effector T cells, and possibly contain cell-associated HIV viral burden in already virologically suppressed patients. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 17, 2019 Category: Drugs & Pharmacology Source Type: research

Efficacy of the Topical Calcineurin Inhibitors Tacrolimus and Pimecrolimus in the Treatment of Vitiligo in Infants Under 2  Years of Age: A Randomized, Open-Label Pilot Study
ConclusionsTopical tacrolimus ointment 0.03% or pimecrolimus cream 1% have efficacy for vitiligo in infants, which serves to achieve an appropriate level of safety and tolerability during the 6-month period of applications. Thus, TCIs proved to be a therapeutic option for vitiligo in infants under 2  years of age. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 14, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Glucagon-Like Peptide-1 Receptor Agonists in Type 2 Diabetes: Their Use and Differential Features
The articleGlucagon-Like Peptide-1 Receptor Agonists in Type 2 Diabetes: Their Use and Differential Features, written byKA Lyseng-Williamson, was originally published Online First without open access. After publication involume 39, issue 8, pages 805-819, Springer Healthcare IME requested that the article be Open Choice to make the article an open access publication. Post-publication open access was funded by an independent educational grant fromNovo Nordisk A/S . The article is forthwith distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/lice...
Source: Clinical Drug Investigation - September 12, 2019 Category: Drugs & Pharmacology Source Type: research

Randomized Comparison Study of Novel Recombinant Human Antithrombin Gamma and Plasma-Derived Antithrombin in Healthy Volunteers
ConclusionsAs 90% confidence intervals forCmax,day3 and AUC48 –t ratios for rhAT-gamma:pAT were within the acceptability range for bioequivalence, rhAT-gamma (72  IU/kg) and pAT (60 IU/kg) are considered bioequivalent. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 6, 2019 Category: Drugs & Pharmacology Source Type: research

Mecapegfilgrastim in Chemotherapy-Induced Neutropenia: A Profile of Its Use in China
AbstractMecapegfilgrastim (HHPG-19K) is a long-acting pegylated recombinant human granulocyte-colony stimulating factor (rhG-CSF) that is administered subcutaneously as prophylaxis once per chemotherapy cycle as a weight-adjusted dose of 100  µg/kg or as a 6 mg fixed dose. It is approved in China to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy associated with a clinically significant incidence of febrile neutropenia. I n phase III trials, once per cycle prophylaxis with mecapegfilgrastim was ...
Source: Clinical Drug Investigation - September 5, 2019 Category: Drugs & Pharmacology Source Type: research

Non-Vitamin K Antagonist Oral Anticoagulant Treatment in Centenarians: A Series of Four Cases
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 3, 2019 Category: Drugs & Pharmacology Source Type: research

Tropicamide/Phenylephrine/Lidocaine Intracameral Injection: A Review in Cataract Surgery
AbstractTropicamide 0.02%/phenylephrine 0.31%/lidocaine 1% injectable solution (Mydrane®) is the first fixed-dose mydriatic/anaesthetic combination approved for intracameral use in adults undergoing cataract surgery. In a phase 3 trial in this setting, intracameral tropicamide/phenylephrine/lidocaine was at least as effective as a standard topical regimen of tropicamide plus phenylephrine in enabling successful capsulorhexis without the use of additional mydriatics. The intracameral preparation, which is administered via a single injection, provides rapid and sustained mydriasis through to the end of surgery, with reci...
Source: Clinical Drug Investigation - August 31, 2019 Category: Drugs & Pharmacology Source Type: research

Nivolumab-Induced Recurrence of Rheumatoid Arthritis in a Patient with Metastatic Gastric Adenocarcinoma
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 29, 2019 Category: Drugs & Pharmacology Source Type: research

Investigation of the Association Between Total and Free Plasma and Saliva Mycophenolic Acid Concentrations Following Administration of Enteric-Coated Mycophenolate Sodium in Adult Kidney Transplant Recipients
ConclusionsMeasurement of MPA concentration in saliva cannot currently replace plasma measurement for therapeutic drug monitoring of MPA following EC-MS administration. Additional studies are required to examine the relationship between MPA saliva concentrations and patient outcomes. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 23, 2019 Category: Drugs & Pharmacology Source Type: research

Single-Dose Pharmacokinetics and Tolerability of Aprocitentan, a Dual Endothelin Receptor Antagonist, in Subjects with Severe Renal Function Impairment
ConclusionsBased on these single-dose results, subjects with mild, moderate, or severe renal function can be included in clinical studies without the need for dose adjustment. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 21, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics and Safety of Posaconazole Administered by Intravenous Solution and Oral Tablet in Healthy Chinese Subjects and Effect of Food on Tablet Bioavailability
ConclusionsPosaconazole was generally well tolerated in healthy Chinese male and female subjects. The safety and the high-fat breakfast and fasted pharmacokinetics of posaconazole in healthy Chinese subjects are within exposures demonstrated to be generally well tolerated and efficacious and compare reasonably well with the overall posaconazole data across Western countries. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 20, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Glucagon-Like Peptide-1 Receptor Agonists in Type 2 Diabetes: Their Use and Differential Features
The original version of this article unfortunately contained some mistakes. The corrected details are provided below: (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 17, 2019 Category: Drugs & Pharmacology Source Type: research

Effect of Combination Therapy of Endothelin Receptor Antagonist and Phosphodiesterase-5 Inhibitor on Clinical Outcome and Pulmonary Haemodynamics in Patients with Pulmonary Arterial Hypertension: A Meta-Analysis
The objective of this meta-analysis was to evaluate the effect of an endothelin receptor antagonist and phosphodiesterase-5 inhibitor combination in pulmonary arterial hypertension.MethodsAfter performing a comprehensive literature search in MEDLINE, Cochrane and the International Clinical Trial Registry Platform, reviewers assessed eligibility and extracted data from seven relevant articles (publications till December 2018). PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed in the selection, analysis and reporting of findings. The odds ratio and mean difference were calcu...
Source: Clinical Drug Investigation - August 16, 2019 Category: Drugs & Pharmacology Source Type: research

Prophylactic Sildenafil in Preterm Infants at Risk of Bronchopulmonary Dysplasia: A Pilot Randomized, Double-Blinded, Placebo-Controlled Trial
AbstractBackgroundBronchopulmonary dysplasia (BPD) is the need for oxygen therapy at 36  weeks postmenstrual age (PMA). Sildenafil has been shown to enhance the lung alveolarization and vascularization in newborn animal models after lung injury and has possible therapeutic potential for the prevention of BPD.ObjectiveTo perform a proof-of-concept, Phase II, pilot randomized, double-blind, clinical trial to study the efficacy of sildenafil in preventing BPD, in postnatal (
Source: Clinical Drug Investigation - August 14, 2019 Category: Drugs & Pharmacology Source Type: research