Cardiovascular Toxicities with Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors in Cancer Patients: A Meta-Analysis of 77 Randomized Controlled Trials
ConclusionsThe available data suggest that the use of VEGFR-TKIs is associated with a significantly increased risk of cardiovascular toxicities in cancer patients. Clinicians should be aware of this risk and perform regular cardiovascular monitoring. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 16, 2018 Category: Drugs & Pharmacology Source Type: research

Physicians ’ and Pharmacists’ Clinical Considerations for Elderly Patients with Type 2 Diabetes Mellitus: The IMPLICA2 Study
AbstractBackgroundManagement of elderly patients with type 2 diabetes mellitus (T2DM) is complex due to their age-related conditions. Several clinical guidelines provide specific recommendations for management of these patients  but little is known about their implementation in clinical practice.ObjectiveTo describe physician and community pharmacist perceptions and routine clinical practice in the management of elderly T2DM patients.MethodsCross-sectional study.ResultsA total of 993 physicians and 999 community pharmacists completed the questionnaire. More physicians than pharmacists agreed on the need to establish m...
Source: Clinical Drug Investigation - October 12, 2018 Category: Drugs & Pharmacology Source Type: research

The Association between Polypharmacy and Hip Fracture in Osteoporotic Women: A Nested Case –Control Study in South Korea
AbstractBackground and ObjectivePolypharmacy, regarded as an indicator of potentially inappropriate medications (PIMs), may lead to a higher risk of serious health consequences in elderly patients with osteoporosis. Thus, this study aimed to analyze the association between polypharmacy and hip fracture in patients with osteoporosis because only a limited number of studies have reported on this association, with inconsistent results to date.MethodsIn this nested case –control study using a population-based sample cohort, the target cases were female patients with hip fracture diagnosed with osteoporosis and aged&thins...
Source: Clinical Drug Investigation - October 10, 2018 Category: Drugs & Pharmacology Source Type: research

Impaired Renal Function May Not Negate the Efficacy of Tolvaptan in the Treatment of Cirrhotic Patients with Refractory Ascites
The objective of this study was to investigate the efficacy and safety of tolvaptan in patients with decompensated cirrhosis and severe chronic kidney disease (s-CKD).MethodsWe studied 43 patients with liver cirrhosis who received tolvaptan (7.5  mg/day) for refractory ascites. s-CKD was defined as an estimated glomerular filtration rate (eGFR) 
Source: Clinical Drug Investigation - October 4, 2018 Category: Drugs & Pharmacology Source Type: research

Safety, Tolerability, and Pharmacokinetics of the Novel Anti-influenza Agent Baloxavir Marboxil in Healthy Adults: Phase I Study Findings
ConclusionSingle-dose oral baloxavir marboxil was well tolerated, had a favorable safety profile, and had favorable pharmacokinetic characteristics, including a long half-life, supporting single oral dosing. The baloxavir acid area under the plasma concentration-time curve decreased with food intake by approximately 40%. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 4, 2018 Category: Drugs & Pharmacology Source Type: research

Safety and Plasma Concentrations of a Cyclin-dependent Kinase 9 (CDK9) Inhibitor, FIT039, Administered by a Single Adhesive Skin Patch Applied on Normal Skin and Cutaneous Warts
ConclusionThe FIT039 patch showed no topical or systemic adverse reactions when applied on normal skin or cutaneous warts. The safety and good adherence of the FIT039 patch are encouraging and support further studies to evaluate the efficacy of FIT039 in patients with cutaneous warts. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 4, 2018 Category: Drugs & Pharmacology Source Type: research

Impaired Renal Function May Not Negate the Efficacy of Tolvaptan in the Treatment of Cirrhotic Patients with Refractory Ascites
The objective of this study was to investigate the efficacy and safety of tolvaptan in patients with decompensated cirrhosis and severe chronic kidney disease (s-CKD).MethodsWe studied 43 patients with liver cirrhosis who received tolvaptan (7.5  mg/day) for refractory ascites. s-CKD was defined as an estimated glomerular filtration rate (eGFR) 
Source: Clinical Drug Investigation - October 4, 2018 Category: Drugs & Pharmacology Source Type: research

Safety, Tolerability, and Pharmacokinetics of the Novel Anti-influenza Agent Baloxavir Marboxil in Healthy Adults: Phase I Study Findings
ConclusionSingle-dose oral baloxavir marboxil was well tolerated, had a favorable safety profile, and had favorable pharmacokinetic characteristics, including a long half-life, supporting single oral dosing. The baloxavir acid area under the plasma concentration-time curve decreased with food intake by approximately 40%. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 4, 2018 Category: Drugs & Pharmacology Source Type: research

Safety and Plasma Concentrations of a Cyclin-dependent Kinase 9 (CDK9) Inhibitor, FIT039, Administered by a Single Adhesive Skin Patch Applied on Normal Skin and Cutaneous Warts
ConclusionThe FIT039 patch showed no topical or systemic adverse reactions when applied on normal skin or cutaneous warts. The safety and good adherence of the FIT039 patch are encouraging and support further studies to evaluate the efficacy of FIT039 in patients with cutaneous warts. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 4, 2018 Category: Drugs & Pharmacology Source Type: research

Signal Detection Between Fluoroquinolone Use and the Risk of Rhegmatogenous Retinal Detachment: Sequence Symmetry Analysis Using Nationwide South Korean Healthcare Database Between 2004 and 2015
ConclusionsOur detection suggests a possible association between fluoroquinolone use and RRD. However, possible overestimation and reverse causality bias may have influenced our findings due to the limitation of an SSA design. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

A Review on Imiquimod Therapy and Discussion on Optimal Management of Basal Cell Carcinomas
AbstractBasal cell carcinoma (BCC) is the most common type of skin cancer with an increasing incidence. However, it is still poorly researched compared to many other human diseases. Today, cutaneous neoplasms are a frequent, major problem faced by medical professionals. BCC tumors can cause extensive cosmetic distress as well as disfigurement to patients especially when on the face. Treatment options include surgery, systemic agents, and topical agents. Over the past few decades more studies have been performed to evaluate the utility of topical imiquimod therapy for treatment of BCC. Imiquimod is a toll-like receptor that...
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics, Pharmacodynamics, and Safety of the Novel Calcimimetic Agent Evocalcet in Healthy Japanese Subjects: First-in-Human Phase I Study
ConclusionsThese results suggest that evocalcet may have a comparable efficacy and better safety profile than that of cinacalcet, one of the current treatments for secondary hyperparathyroidism in patients with chronic kidney disease. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

A Network Pharmacology-Based Analysis of Multi-Target, Multi-Pathway, Multi-Compound Treatment for Ovarian Serous Cystadenocarcinoma
ConclusionIn summary, latent drugs against ovarian serous cystadenocarcinoma were acquired and their target actions and pathways were determined by the network pharmacology strategy, which provides a new prospect for medicamentous therapy for ovarian serous cystadenocarcinoma. However, further in-depth studies are indispensable to increase the validity of this study. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Direct and Indirect Costs of Immunoglobulin Replacement Therapy in Patients with Common Variable Immunodeficiency (CVID) and X-Linked Agammaglobulinemia (XLA) in Italy
ConclusionsThis information provides a comprehensive perspective of the economic issues, and facilitates better-informed public health decision making, in the management of CVID and XLA in Italy. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Non-Compartmental Pharmacokinetics and Safety of Single-Dose Eldecalcitol (ED-71) in Healthy Chinese Adult Males
ConclusionPharmacokinetic exposure (Cmax and partial AUCs) was dose-proportional over the tested dose range of 0.5 –0.75 µg in healthy Chinese adult males. The pharmacokinetic character of eldecalcitol in Chinese subjects was similar to historical data from Japanese subjects. Eldecalcitol was well tolerated at doses ranging from 0.5 to 0.75 µg, with no new safety signals identified.Clinical Trial RegistrationThis study was registered at the China Food and Drug Administration (Registration number: 2014L02212 and 2014L02213), and also registered athttp://www.chinadrugtrials.org.cn (No. CTR20160430...
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Successful Response to Osimertinib Rechallenge after Intervening Chemotherapy in an EGFR T790M-Positive Lung Cancer Patient
AbstractOsimertinib is the best treatment choice for patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small-cell lung cancer (NSCLC) whose disease progresses on a first- or second-generation EGFR-tyrosine kinase inhibitor due to acquired T790M mutation. On the other hand, there is a lack of therapeutic strategies with proven efficacy at the time of progression on osimertinib. If not administered previously, platinum-based chemotherapy can provide some clinical benefit, while immunotherapy does not seem to work in this setting. Here, we report on a unique case of response to osimertinib rechallenge...
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Indications for Systemic Fluoroquinolone Therapy in Europe and Prevalence of Primary-Care Prescribing in France, Germany and the UK: Descriptive Population-Based Study
ConclusionLarge numbers of fluoroquinolone products in Europe are listed for the treatment of milder infections such as acute bronchitis, acute sinusitis and uUTIs. Among the countries assessed, fluoroquinolones were commonly prescribed for these conditions and potentially should lead to a review of therapeutic guidelines. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Potential for Cost Saving with Iclaprim Owing to Avoidance of Vancomycin-Associated Acute Kidney Injury in Hospitalized Patients with Acute Bacterial Skin and Skin Structure Infections
ConclusionsIclaprim has the potential to reduce the economic burden of acute bacterial skin and skin structure infections in hospitalized patients at risk for vancomycin-associated acute kidney injury when iclaprim acquisition is US$300/day or less. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Cost Estimate of Immune-Related Adverse Reactions Associated with Innovative Treatments of Metastatic Melanoma
ConclusionThis study may represent a useful tool to understand the economic burden associated with the management of irAEs associated with patients affected by metastatic melanoma. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Identification of Somatic Disorders Related to Psychoactive Drug Use from an Inpatient Database in a French University Hospital
ConclusionsCombining extraction of ICD-10 codes and a focused review of a preselection of relevant hospitalisations appears to be efficient and time-saving. This method should be applied in other hospital settings before considering the exploration of inpatient data on a wider scale. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Signal Detection Between Fluoroquinolone Use and the Risk of Rhegmatogenous Retinal Detachment: Sequence Symmetry Analysis Using Nationwide South Korean Healthcare Database Between 2004 and 2015
ConclusionsOur detection suggests a possible association between fluoroquinolone use and RRD. However, possible overestimation and reverse causality bias may have influenced our findings due to the limitation of an SSA design. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Correction to: Gadobutrol: A Review in Contrast-Enhanced MRI and MRA
The article Gadobutrol: A Review in Contrast-Enhanced MRI and M (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - October 1, 2018 Category: Drugs & Pharmacology Source Type: research

Cost-utility of Sunitinib Versus Pazopanib in Metastatic Renal Cell Carcinoma in Canada using Real-world Evidence
ConclusionWhen using real-world evidence, sunitinib is found to be a cost-effective treatment compared to pazopanib in mRCC patients in Canada. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 28, 2018 Category: Drugs & Pharmacology Source Type: research

Highly Purified Human Menopausal Gonadotropin (Menopur ® ): A Profile of Its Use in Infertility
AbstractMenopur® is a highly purified, urine-derived, human menopausal gonadotropin containing both follicle stimulating hormone (FSH) and luteinizing hormone (LH) activity. It is an effective option for controlled ovarian stimulation (COS) in assisted reproductive technology protocols and for ovulation induction (OI) in anovulatory infertility, and is associated with a different endocrine profile from that of recombinant (r) FSH in these settings (in terms of serum levels of FSH, androgens and/or estradiol). When used for COS in women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), Men...
Source: Clinical Drug Investigation - September 28, 2018 Category: Drugs & Pharmacology Source Type: research

Cost-utility of Sunitinib Versus Pazopanib in Metastatic Renal Cell Carcinoma in Canada using Real-world Evidence
ConclusionWhen using real-world evidence, sunitinib is found to be a cost-effective treatment compared to pazopanib in mRCC patients in Canada. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 28, 2018 Category: Drugs & Pharmacology Source Type: research

Highly Purified Human Menopausal Gonadotropin (Menopur ® ): A Profile of Its Use in Infertility
AbstractMenopur® is a highly purified, urine-derived, human menopausal gonadotropin containing both follicle stimulating hormone (FSH) and luteinizing hormone (LH) activity. It is an effective option for controlled ovarian stimulation (COS) in assisted reproductive technology protocols and for ovulation induction (OI) in anovulatory infertility, and is associated with a different endocrine profile from that of recombinant (r) FSH in these settings (in terms of serum levels of FSH, androgens and/or estradiol). When used for COS in women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), Men...
Source: Clinical Drug Investigation - September 28, 2018 Category: Drugs & Pharmacology Source Type: research

The Effects of Novel Antidiabetic Drugs on Albuminuria in Type 2 Diabetes  Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials
AbstractBackground and ObjectiveThe effects of novel antidiabetic drugs, including sodium-glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 (GLP-1) receptor agonists, and dipeptidyl peptidase 4 (DPP-4) inhibitors, on albuminuria in patients with type 2 diabetes mellitus (T2DM) are still controversial. Therefore, we performed a meta-analysis to evaluate the effects of novel antidiabetic drugs on albuminuria in patients with T2DM.MethodsWe conducted a random-effects meta-analysis of randomized controlled trials (RCTs) by searching the MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials datab...
Source: Clinical Drug Investigation - September 25, 2018 Category: Drugs & Pharmacology Source Type: research

Effects of Cilostazol-Based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy After Coronary Drug-Eluting Stent Implantation: An Updated Meta-Analysis of the Randomized Controlled Trials
AbstractBackground and ObjectiveThe results of studies on cilostazol-based triple antiplatelet therapy (TAT) after drug-eluting stent (DES) implantation were inconsistent. To assess the effects of TAT compared with dual antiplatelet therapy (DAT) after DES/second-generation DES implantation, we performed a meta-analysis of randomized controlled trials (RCTs).MethodsAll relevant studies evaluated were identified by searching the  PubMed, EMBASE, Cochrane Library, and ISI Web of Science databases without time and language limitation. Subgroup analyses were performed to evaluate the efficacy and safety of TAT after ...
Source: Clinical Drug Investigation - September 24, 2018 Category: Drugs & Pharmacology Source Type: research

Riociguat for the Treatment of Raynaud ’s Phenomenon: A Single-Dose, Double-Blind, Randomized, Placebo-Controlled Cross-Over Pilot Study (DIGIT)
ConclusionIn this pilot study, single-dose riociguat was well tolerated in patients with RP and resulted in improved digital blood flow in some patient subsets, with high inter-individual variability. Long-term evaluation is warranted. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 20, 2018 Category: Drugs & Pharmacology Source Type: research

Economic Evaluations of Tyrosine Kinase Inhibitors for Patients with Chronic Myeloid Leukemia in Middle- and High-Income Countries: A Systematic Review
ConclusionsDespite high costs, the included studies indicate that imatinib regimens are cost effective in newly diagnosed patients with CP-CML. For people with CML who are resistant or intolerant to standard-dose imatinib, dasatinib is likely to be a more cost-effective strategy in middle-income countries. More studies are necessary to assess the long-term efficacy and cost effectiveness of novel treatment options. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 19, 2018 Category: Drugs & Pharmacology Source Type: research

Bioequivalence and Pharmacokinetics of Bisoprolol –Amlodipine 5 mg/5 mg Combination Tablet versus Bisoprolol 5 mg Tablet and Amlodipine 5 mg Tablet: An Open-Label, Randomized, Two-Sequence Crossover Study in Healthy Chinese Subjects
ConclusionsBioequivalence was achieved for bisoprolol and amlodipine FDC under both fasting and fed conditions, and all treatments were safe and well tolerated by all study subjects.Trial RegistrationClinicalTrials.gov: NCT03226275. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 19, 2018 Category: Drugs & Pharmacology Source Type: research

Multicenter, Open-Label Study of Long-Term Topiroxostat (FYX-051) Administration in Japanese Hyperuricemic Patients with or Without Gout
ConclusionsWe verified the efficacy and safety of 58-week oral topiroxostat administration at stepwise increments to up to 240  mg/day.Study RegistrationJAPIC CTI-101068. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 15, 2018 Category: Drugs & Pharmacology Source Type: research

Replacement Effects and Budget Impacts of Insurance Coverage for Sodium-Glucose Co-Transporter-2 Inhibitors on Oral Antidiabetic Drug Utilization
ConclusionsBoth the prescription rates and expenditure rates for SGLT-2 inhibitors have increased since they have been covered by national health insurance in Taiwan, which significantly reduced usage of DPP-4 inhibitors but caused the positive growth of overall antidiabetic drug expenditures. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 15, 2018 Category: Drugs & Pharmacology Source Type: research

Safety Profile of High-Dose Botulinum Toxin Type A in Post-Stroke Spasticity Treatment
AbstractBotulinum toxin type A (BoNT-A) is considered the gold standard for the treatment of focal post-stroke spasticity (PSS). However, a recently published study estimated that a significant percentage of patients affected by PSS could benefit from higher doses of BoNT-A than those permitted by current directives in the countries studied. Several studies have reported the use of high doses of BoNT-A in the management of patients affected by severe PSS; however, the most important adverse effect of this drug might be systemic diffusion of the toxin, which could potentially be related to its dose. Even if systemic toxicit...
Source: Clinical Drug Investigation - September 12, 2018 Category: Drugs & Pharmacology Source Type: research

Evaluation of Drug –Drug Interaction Potential between Baloxavir Marboxil and Oseltamivir in Healthy Subjects
ConclusionThe lack of a clinically meaningful drug –drug interaction between baloxavir marboxil and oseltamivir has been established. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 10, 2018 Category: Drugs & Pharmacology Source Type: research

Correction to: Gadobutrol: A Review in Contrast-Enhanced MRI and MRA
The article Gadobutrol: A Review in Contrast-Enhanced MRI and M (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 10, 2018 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics and Safety After a Single Dose of Imarikiren in Subjects with Renal or Hepatic Impairment
ConclusionsRI and HI are associated with limited changes in imarikiren pharmacokinetics. Imarikiren was safe and well-tolerated, regardless of the severity of RI or HI.Clinical Trial RegistrationClinicalTrials.gov Identifier: NCT02367872. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 7, 2018 Category: Drugs & Pharmacology Source Type: research

Cost-Effectiveness of Elbasvir/Grazoprevir Versus Daclatasvir Plus Asunaprevir in Patients with Chronic Hepatitis C Virus Genotype 1b Infection in China
ConclusionsTreatment with EBR/GZR was the cost-effective option for patients with chronic HCV GT1b infection in China, regardless of cirrhosis status or treatment history. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 7, 2018 Category: Drugs & Pharmacology Source Type: research

Safety of Edoxaban 30  mg in Elderly Patients with Severe Renal Impairment
ConclusionIn this explorative study analyzing patients with severe CKD treated with edoxaban 30  mg once daily, no major bleeding or thrombotic events were observed. Some minor bleedings were observed. While additional studies are necessary to confirm the results of this exploratory study, edoxaban 30 mg once daily appears to be safe in patients with severe CKD. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 6, 2018 Category: Drugs & Pharmacology Source Type: research

Direct and Indirect Costs of Immunoglobulin Replacement Therapy in Patients with Common Variable Immunodeficiency (CVID) and X-Linked Agammaglobulinemia (XLA) in Italy
ConclusionsThis information provides a comprehensive perspective of the economic issues, and facilitates better-informed public health decision making, in the management of CVID and XLA in Italy. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 6, 2018 Category: Drugs & Pharmacology Source Type: research

Unexpected Benefit from Alpelisib and Fulvestrant in a Woman with Highly Pre-treated ER-Positive, HER2-Negative PIK3CA Mutant Metastatic Breast Cancer
We present the case of a postmenopausal patient with a secondary metastatic ER-positive, HER2-negative breast cancer who was successfully treated with fulvestrant and alpelisib following six lines of therapy. The tumour showed two uncommonPIK3CA mutations, and with the combination of alpelisib and fulvestrant the patient went from ECOG grade 3, before the start of this therapy, to ECOG grade 1 during treatment until progressive disease after 6  months. This unexpected benefit emphasizes the importance of performing a Next Generation Sequencing (NGS)-based assay to screen for several cancer genes in the metastatic sett...
Source: Clinical Drug Investigation - September 5, 2018 Category: Drugs & Pharmacology Source Type: research

Regression and Genomic Analyses on the Association Between Dose-Normalized Mycophenolic Acid Exposure and Absolute Neutrophil Count in Steroid-Free, De Novo Kidney Transplant Recipients
ConclusionThese findings support the clinical strategy for conducting MPA therapeutic drug monitoring in adult kidney transplant patients on steroid-free immunosuppressant therapy. The novel population genomic analysis data warrant further epidemiological investigations in a larger study sample. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - September 3, 2018 Category: Drugs & Pharmacology Source Type: research

Open-Label Single-Dose Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of Mirogabalin
ConclusionsMild hepatic impairment resulted in lower A200-700 and A204-4455 exposure, while moderate hepatic impairment did not affect A200-700 exposure. Overall, mild-to-moderate hepatic impairment did not have a significant effect on mirogabalin exposure. A single 15-mg dose of mirogabalin was well tolerated by subjects with mild or moderate hepatic impairment. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 31, 2018 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics, Pharmacodynamics, and Safety of the Novel Calcimimetic Agent Evocalcet in Healthy Japanese Subjects: First-in-Human Phase I Study
ConclusionsThese results suggest that evocalcet may have a comparable efficacy and better safety profile than that of cinacalcet, one of the current treatments for secondary hyperparathyroidism in patients with chronic kidney disease. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 30, 2018 Category: Drugs & Pharmacology Source Type: research

Successful Response to Osimertinib Rechallenge after Intervening Chemotherapy in an EGFR T790M-Positive Lung Cancer Patient
AbstractOsimertinib is the best treatment choice for patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small-cell lung cancer (NSCLC) whose disease progresses on a first- or second-generation EGFR-tyrosine kinase inhibitor due to acquired T790M mutation. On the other hand, there is a lack of therapeutic strategies with proven efficacy at the time of progression on osimertinib. If not administered previously, platinum-based chemotherapy can provide some clinical benefit, while immunotherapy does not seem to work in this setting. Here, we report on a unique case of response to osimertinib rechallenge...
Source: Clinical Drug Investigation - August 27, 2018 Category: Drugs & Pharmacology Source Type: research

Indications for Systemic Fluoroquinolone Therapy in Europe and Prevalence of Primary-Care Prescribing in France, Germany and the UK: Descriptive Population-Based Study
ConclusionLarge numbers of fluoroquinolone products in Europe are listed for the treatment of milder infections such as acute bronchitis, acute sinusitis and uUTIs. Among the countries assessed, fluoroquinolones were commonly prescribed for these conditions and potentially should lead to a review of therapeutic guidelines. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 24, 2018 Category: Drugs & Pharmacology Source Type: research

Cost Estimate of Immune-Related Adverse Reactions Associated with Innovative Treatments of Metastatic Melanoma
ConclusionThis study may represent a useful tool to understand the economic burden associated with the management of irAEs associated with patients affected by metastatic melanoma. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 24, 2018 Category: Drugs & Pharmacology Source Type: research