Abstract:
BACKGROUND AND OBJECTIVE:Schizophrenia treatment has been shifting to resocialization by efficacious antipsychotic drugs. However, even some of the pivotal studies of approved new antipsychotic drugs with proven efficacy had failed due to high placebo response. The aim of this study was to identify the potential factors affecting placebo response by meta-analysis for randomized clinical trials for antipsychotic drugs using Positive and Negative Syndrome Scale (PANSS) focusing on the current methodological change in the handling of missing data [from last observation carried forward (LOCF) to mixed-effect models for repeated measures (MMRM)] for successful future clinical trials. METHODS:Recent trends in the degree of placebo response were investigated between publication year (1993 to 2016) and the mean change of PANSS total score in the placebo arm. The potential factors affecting the degree of placebo response, such as study design and operational factors, were analyzed separately by meta-regression for LOCF- and MMRM-based data. RESULTS:There was no correlation between publication year and the mean change of PANSS score in the placebo arm in schizophrenia studies of 10 years applying MMRM. The number of countries and treatment setting in MMRM-based data and study duration in LOCF-based data were significantly associated with placebo response. CONCLUSION:Placebo response in schizophrenia clinical trials published between 2007 and 2016 has not increased over time. Differences in the healthcare environment among countries were suggested to affect the evaluation of antipsychotic drugs. Further analyses on the potential factors of placebo response for MMRM-based data are required.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Matsusaki A,Kaneko M,Narukawa Mdoi
10.1007/s40261-018-0661-1subject
Has Abstractpub_date
2018-08-01 00:00:00pages
751-761issue
8eissn
1173-2563issn
1179-1918pii
10.1007/s40261-018-0661-1journal_volume
38pub_type
杂志文章,meta分析abstract::We performed a prospective, randomised, investigator-masked and parallel-group study to compare topical lomefloxacin 0.3% instilled twice daily with topical chloramphenicol instilled five times daily in the treatment of acute bacterial conjunctivitis. 191 patients (lomefloxacin 96, chloramphenicol 95) were enrolled in...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815040-00001
更新日期:1998-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 h...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/0044011-200828120-00004
更新日期:2008-01-01 00:00:00
abstract::Mecapegfilgrastim (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 inf...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-019-00836-y
更新日期:2019-10-01 00:00:00
abstract:OBJECTIVE:To characterise the pharmacokinetics of indinavir during different phases of the menstrual cycle in HIV-infected women. DESIGN:Open-label study. SETTING:The immunodeficiency clinic at Erie County Medical Center, Buffalo, New York. PATIENTS:Ten HIV-infected women were enrolled in the study. Eligibility crit...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200222020-00007
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Nonsteroidal anti-inflammatory drugs are effective analgesics but their use during tonsillectomy is controversial because of the risk of postoperative bleeding. The aim of this study was to compare the analgesic efficacy and safety of nimesulide, a preferential cyclo-oxygenase type-2 inhibitor,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323100-00004
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The management of patients on vitamin K antagonist therapy who require an invasive procedure is problematic. A randomised, controlled, double-blind clinical trial was designed to compare the efficacy and safety of bemiparin, a low molecular weight heparin (LMWH), with unfractionated heparin (UF...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0141-6
更新日期:2013-12-01 00:00:00
abstract:OBJECTIVE:To compare changes in lipid levels (total cholesterol [total-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG], and high-density lipoprotein cholesterol [HDL-C]) for patients who switched from standard fenofibrate 160 mg (requiring dosing with food) to fenofibrate 145 mg with no food effect ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200828100-00002
更新日期:2008-01-01 00:00:00
abstract::Oral teneligliptin [Teneglucon® (Argentina)], a dipeptidyl peptidase-4 inhibitor, is indicated for the treatment of adults with type 2 diabetes (T2DM). This article reviews the pharmacology, therapeutic efficacy and tolerability of teneligliptin in the treatment of adults with T2DM. In 12- or 16-week, placebo-controll...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-015-0348-9
更新日期:2015-11-01 00:00:00
abstract::Currently three different inactivated influenza vaccine types are available: whole virus (WV), split (SPL) and subunit (SU) vaccines. Physicians and patients at risk for influenza complications may wonder whether there are important differences between the vaccine types with respect to antibody induction (serology) an...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815010-00001
更新日期:1998-01-01 00:00:00
abstract::The superior vena cava (SVC) syndrome occurs when obstruction of this vessel interrupts venous return of blood from the head, upper extremities and thorax to the right atrium. Most cases of SVC syndrome result from neoplasia, especially from lung cancer, but other non-cancer-associated causes may include fibrosis caus...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200727070-00007
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The optimal choice for first- and second-line antiseizure medications for pediatric patients with convulsive status epilepticus remains ambiguous. The present study aimed to estimate the comparative effect on the efficacy and safety of different antiseizure medications in pediatric patients wit...
journal_title:Clinical drug investigation
pub_type:
doi:10.1007/s40261-020-00975-7
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The skeletal muscle relaxant tizanidine is approved by the US FDA and the European Medicines Agency for treating spasticity and is supplied as tablets for oral administration. However, tizanidine has a poor bioavailability, due to extensive first-pass metabolism. Therefore, the nasal route of a...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0137-2
更新日期:2013-12-01 00:00:00
abstract::The role of postprandial hyperglycaemia in contributing to the risk of both micro- and macrovascular complications in patients with diabetes mellitus is being increasingly recognized. In type 2 diabetes, there is a progressive shift in the relative contributions of postprandial and fasting hyperglycaemia to the overal...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/00044011-200828040-00001
更新日期:2008-01-01 00:00:00
abstract::A specific beta(2)-adrenoceptor-mediated effect, hypokalaemia, was studied in healthy volunteers after single as well as multiple dosages of the long-acting agonist formoterol and the short-acting agent salbutamol. The purpose of the study was to test with simple methodologies if rapidly induced tachyphylaxis for this...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815060-00009
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Recurrent aphthous ulceration is the most common oral mucosal disease known. It presents as three types: minor (most prevalent), major and herpetiform. However, there are no well established effective and reliable treatments of this condition. Alchemilla vulgaris (Lady's Mantle) has traditional...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626100-00003
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:European guidelines do not recommend the use of carbamazepine, levetiracetam, phenobarbital, phenytoin, topiramate and valproic acid in patients taking direct oral anticoagulants (DOACs). Little is known regarding the clinical relevance of the interaction between DOACs and antiepileptic drugs. OBJECTIVES:To...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00982-8
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Characteristics of nucleoside reverse transcriptase inhibitors (NRTIs) make the drug class susceptible to elimination via continuous veno-venous hemofiltration (CVVH), potentially leading to suboptimal drug concentrations if given at the recommended anephric doses during CVVH. The objective of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0275-9
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Little is known about the effects of the calcium channel antagonist manidipine when it is added as a third drug in non-controlled hypertensive patients with diabetes mellitus receiving dual antihypertensive therapy. The aim of this study was to evaluate the response in terms of blood pressure (...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11587400-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND:Warfarin is a commonly used oral anticoagulant and its interaction with other drugs can result in serious thrombotic or bleeding events. Currently, there is no definitive evidence on the possibility of an interaction between warfarin and oseltamivir. OBJECTIVE:The objective of this study was to investigate ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11595860-000000000-00000
更新日期:2012-02-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and safety of the natural platelet-activating factor receptor antagonist, BN 52021 (ginkgolide B) in the treatment of patients with severe sepsis related to Gram-negative and mixed bacterial infection. DESIGN AND SETTING:Prospective, randomised, double-blind, placebo-controlled, mult...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424030-00002
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:For patients with hypertension, effective 24-hour blood pressure (BP) control is vital to ensure protection against the early morning surge in BP and the associated increased risk of cardiovascular events. The aim of this analysis was to assess the 24-hour antihypertensive efficacy of olmesartan medoxomil (2...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626040-00002
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Status epilepticus (SE) is an important emergency situation associated with high morbidity and mortality. The goal of pharmacological therapy-rapid seizure termination-is only achieved in just over half of patients with first-line anti-epileptic drug (AED) therapy and many patients require sec...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0295-5
更新日期:2015-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Following oral administration of abiraterone acetate, the parent compound abiraterone acetate is rapidly metabolized to abiraterone. To our knowledge, bioanalytical methods to date have not been able to detect the parent compound in human plasma, and bioassay was only performed on the metabolit...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-019-00752-1
更新日期:2019-03-01 00:00:00
abstract::Lung infections caused by invasive filamentous fungi are very rare conditions in AIDS, but must be considered in patients with profound immune suppression especially in the presence of additional risk factors, such as hematologic malignancies, corticosteroid therapy, neutropenia, and chemotherapy. The authors report a...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0017-1
更新日期:2013-02-01 00:00:00
abstract:OBJECTIVE:To evaluate the effects of fidarestat (SNK-860) on vibration perception threshold, as measured by C64 quantitative tuning fork (64Hz) analysis, as well as its effects on subjective symptoms in patients with diabetic polyneuro-pathy. DESIGN AND SETTING:Open-label, prospective study conducted at 12 hospitals i...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424110-00006
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Clinical studies have reported that zonisamide is effective for a wide range of seizure types, including refractory partial-onset seizures. However, there have been no reported studies of the efficacy of zonisamide in the Chinese population to date. The aim of the present study was to evaluate ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11539750-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Icosapent ethyl is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved as an adjunct to diet to reduce triglyceride levels in adult patients with triglyceride levels ≥500 mg/dL (≥5.65 mmol/L). The objective of this open-label, drug-drug interaction study was to examine...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0252-8
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Dutasteride is currently marketed by GlaxoSmithKline (GSK), either as monotherapy or as a fixed-dose combination with tamsulosin. As part of the project to develop the fixed-dose combination product, alternative formulations of dutasteride were prepared by GSK, and their pharmacokinetic proper...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0419-6
更新日期:2016-09-01 00:00:00
abstract:OBJECTIVE:Central nervous effects of oral anticholinergics may limit the success of incontinence therapy and patient compliance. Only a few studies investigating this topic are available. This study was conducted to determine whether oral anticholinergics alter sleep and psychometric test parameters. DESIGN:Randomised...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323060-00003
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Recent data suggest that P-glycoprotein may be involved in cellular transport of lacosamide. OBJECTIVE:To investigate potential drug-drug interactions (DDIs) between lacosamide and digoxin, this phase I, multiple-dose, randomised, double-blind, placebo-controlled, crossover trial assessed the pharmacokineti...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-014-0180-7
更新日期:2014-05-01 00:00:00