PURPOSE To evaluate the activity of CPT-11, which is a new derivative camptothecin, against refractory or relapsed small-cell lung cancer (SCLC). PATIENTS AND METHODS Sixteen patients with SCLC were entered onto prospective, non-randomized, single-institution phase II trial. All 16 had been pretreated heavily some form cisplatin-based combination chemotherapy. Five received previous chemotherapy cisplatin, vincristine, doxorubicin, and etoposide (CODE) as an induction therapy. Six treated...

What is known and objective Amiodarone (AMD) treatment associated with a number of significant adverse effects including thyroid dysfunction. However, the relationship between development dysfunction dosage duration AMD remains unclear. The purpose this study was to examine onset profiles amiodarone-associated using spontaneous drug reaction (ADR) reporting database. Methods Data were obtained from US Food Drug Administration Adverse Event Reporting System (FAERS). For signal detection ADRs,...

Purpose: Some studies have suggested that the use of benzodiazepines in elderly is associated with an increased risk dementia.However, this association might be due to confounding by indication and reverse causation.To examine between benzodiazepine anxiolytic drug dementia, we conducted data mining a spontaneous reporting database large organized prescriptions.Methods: Data from US Food Drug Administration Adverse Event Reporting System (FAERS) first quarter 2004 through end 2013 Canada...

In recent years, the potential risk of cancer associated with statin use has been a focus much interest. However, it remains uncertain whether therapy is risk. To examine association between and cancer, we conducted data mining using US Food Drug Administration (FDA) Adverse Event Reporting System (FAERS) large organized database claims constructed by vendor (The Japan Medical Data Center Co., Ltd, Tokyo, [JMDC]).Relevant reports in FAERS, which included from first quarter 2004 through end...

Voltage-gated sodium channels (VGSCs) are drug targets for the treatment of epilepsy. Recently, a decreased risk cancer associated with channel-blocking antiepileptic drugs (AEDs) has become research focus interest. The purpose this study was to test hypothesis that use AEDs inversely cancer, using different methodologies, algorithms, and databases.A total 65,146,507 drug-reaction pairs from first quarter 2004 through end 2013 were downloaded US Food Drug Administration Adverse Event...

Amiodarone is associated with a number of significant adverse effects, including elevated transaminase levels, pulmonary fibrosis, arrhythmia, and thyroid dysfunction. Although dysfunction considered to be common potentially serious effect amiodarone therapy, the exact pathogenesis remains unknown because its complex manifestations. Therefore, prevalence of, risk factors for, amiodarone-induced in Japanese patients were investigated present study.A retrospective analysis treated between...

What is known and objective Polypharmacy associated with an increased risk of adverse drug reactions (ADRs) interactions, decreased adherence to medication medical cost. Recently, polypharmacy has become a major problem in care Japan as result the increase ageing population. The purpose this study was investigate current situation association between events. Methods A retrospective data analysis performed using two different real-world from 2007 2015 Japan. Japanese Adverse Drug Event Report...

Despite extensive research on pharmacokinetic interactions between hydroxymethylglutaryl-CoA reductase inhibitors (statins) and fibrates, the underlying pharmacodynamic mechanisms contributing to increased risk of rhabdomyolysis remain unclear. This study aimed determine differences among statins or fibrates in terms their susceptibility rhabdomyolysis. The data mining FDA Adverse Event Reporting System (FAERS) suggested association both with add-on effect combinations. In rats,...

A historical cohort analysis of the Japan medical data center (JMDC) claims databases was performed to compare incidence rates bleeding events with warfarin (WF) versus direct oral anticoagulant (DOAC) treatment in patients non-valvular atrial fibrillation.The aim this study is clarify risk factors for younger newly treated WF or DOAC clinical practice setting.Patients who initiated from April 2012 March 2015 were selected JMDC database.A 1:1 propensity score matching used new users...

This study was aimed at investigating the risk of malignancies in rheumatoid arthritis patients treated with methotrexate (MTX), and whether addition biological disease-modifying antirheumatic drugs (bDMARDs) further increases receiving MTX therapy, by using data from a spontaneous adverse reaction database.Patient U.S. Food Drug Administration's Adverse Event Reporting System (FAERS) first quarter 2004 to end 2015 were analyzed.A subset analysis performed investigate use bDMARDs increased...

Introduction: Warfarin and direct oral anticoagulants (DOACs) have been widely used in antithrombotic therapy.Although warfarin use has suspected to be associated with osteoporosis risk, several studies shown otherwise.Conversely, a few reports found an association between DOACs osteoporosis.This study therefore clarifies the by analyzing real-world data using different methodologies, algorithms, databases.Methods: Real-world from US Food Drug Administration Adverse Event Reporting System...

Different computational approaches are employed to efficiently identify novel repositioning possibilities utilizing different sources of information and algorithms. It is critical propose high-valued candidate-repositioning before conducting lengthy in vivo validation studies that consume significant resources. Here we report a multi-methodological approach opportunities for drug repositioning. We performed analyses real-world data (RWD) acquired from the United States Food Drug...

We aimed to investigate the relationship between voriconazole (VRCZ) trough concentrations and hepatotoxicity evaluate whether recommended concentration is adequate in our clinical setting.A retrospective study was performed serum VRCZ development of at Kindai University Nara Hospital. Patients treated with from March 2010 January 2018 were identified medical records. A total 42 patients (mean age 61.9 ± 16.9 years; 33 males 9 females) enrolled this study.Hepatotoxicity developed 28.6%...

To examine the association between statin use and risk of lower urinary tract symptoms (LUTS) in reports submitted to US Food Drug Administration (FDA) Adverse Event Reporting System (FAERS) 2004 2011.Relevant FAERS were identified analyzed. The reporting odds ratio (ROR) was used detect spontaneous report signals, calculated using case/non-case method. Cases by presence an adverse drug reaction (ADR) which statins suspected drug. Non-cases all same reactions induced drugs other than...

Difference in the risk of gastrointestinal (GI) complications between users enteric-coated and buffered low-dose aspirin (LDA) is unclear. The purpose study to examine difference GI damage LDA products.A large chronologically organized receipt database constructed by a vendor was utilized. Prescription event sequence symmetry analysis used identify LDA-induced over period from January 2005 July 2011. use combination with H2-receptor antagonists (H2RAs) proton pump inhibitors (PPIs) examined...

Atrial fibrillation (AF) is a major risk factor for the development of stroke and silent cerebral infarct (SCI). Additionally, AF independently associated with neurological disorders, including cognitive impairment dementia. Although oral anticoagulants (OACs) are used to reduce SCI in patients AF, it unclear whether OACs

Background The purpose of the study was to characterize pharmacokinetics mycophenolic acid (MPA) in Japanese heart transplant recipients and find time point that has best correlation with MPA area under plasma concentration curve (AUC). Methods Results Twenty-two treated mycophenolate mofetil were evaluated study. Approximately 9 months after transplantation, serum concentration-time from 0 12 h (AUC0-12 h) evaluated. AUC0-12 values cyclosporine (CsA) tacrolimus (FK) groups ranged 13.11...

We tested whether genetic deletion of Cav3.2 T-type Ca2+ channels abolishes hydrogen sulfide (H2S)-mediated pain signals in mice. In Cav3.2-expressing HEK293 cells, Na2S, an H2S donor, at 100 μM clearly increased Ba2+ currents, as assessed by whole-cell patch-clamp recordings. wild-type C57BL/6 mice, intraplantar and intracolonic administration Na2S evoked mechanical allodynia visceral nociceptive behavior, respectively, which were abolished TTA-A2, a channel blocker. Cav3.2-knockout mice...

The efficacy and safety of statins have been studied in a number clinical trials epidemiological studies. In recent years, the Medicine Healthcare Products Regulatory Agency (MHRA) has assessed evidence available on following adverse reactions associated with use statins: sleep disturbances, memory loss, micturition disorders (problems urination), sexual depression, interstitial pneumopathy. However, association between statin risk these remains unclear. To examine lower urinary tract...

Background: Osteoporosis, which is a major public health concern, has been known to reduce health-related quality of life. Some studies have suggested that antipsychotics could perhaps cause osteoporosis by increasing serum prolactin levels. However, the association between and risk for developing controversial. Objective: The present study aimed assess antipsychotic use onset in real-world settings. Methods: A multimethod data-mining approach using different algorithms databases was used....

In general, drugs are used in accordance with an approved dosage regimen expectation of appropriate balance between efficacy and toxicity. However, dose control a narrow therapeutic range marked intersubject variability pharmacokinetics should be established through individualization dosing based on drug monitoring (TDM). The purpose this study was to examine differences the doses antiarrhythmic digoxin clinical practice influence TDM dosing.Prescription research performed at five national...

Hospitalized patients unable to ingest anything by mouth require nutritional support enteral feeding and administration of drugs through a nasogastric tube inserted into the digestive tract. Nasogastric amiodarone may not always be equivalent oral amiodarone.We collected 162 observations serum desethylamiodarone metabolite concentrations from 93 within 60 days starting treatment with amiodarone. Eight were given drug nasogastrically 85 patients, orally. The two groups, compared in terms...

On the basis of two case reports it is suggested that serious convulsions may occur in patients treated with flucoazole when serum trough concentrations exceed 80 μg/mL. The authors recommend monitoring fluconazole during high-dose therapy poor kidney function.