Abstract:
INTRODUCTION:Mood stabilizer (MS) plus antipsychotic (AP) co-treatment is common in patients with acute bipolar disorder (BD), but adverse effects (AEs) of this strategy have not been systematically reviewed. AREAS COVERED:We conducted a systematic review searching PubMed/MEDLINE and PsycINFO on April 1, 2015 for randomized trials in ≥ 20 adults with acute manic/mixed or depressed BD comparing MS or AP monotherapy with their combination that reported quantitative AE data. Pooled together, MS+AP versus MS monotherapy (studies = 18, n = 4419) was associated with significantly higher burden regarding 21/53 (39.6%) individual AEs, particularly weight gain-related (5/5 = 100%), extrapyramidal (5/12 = 41.7%) and glucose/lipid-related AEs (3/8 = 37.5%). AP+MS versus AP monotherapy (studies = 3, n = 397) was associated with significantly higher burden regarding 4/21 (19.0%) individual AEs (≥ 1 AE, tremor, sedation/somnolence, vomiting). EXPERT OPINION:Efficacy advantages of AP+MS co-treatment versus monotherapy should be balanced with its greater AE burden. AE risk is higher for adding AP to MS (17 additional AEs) than adding MS to an AP, including the particularly concerning cardiometabolic AEs. More data are needed, as only one or two studies provided data for 21/21 (100%) AEs of MS augmentation of AP, and 13/53 (24.5%) AEs of AP augmentation of MS, and as sparse data suggest clinically relevant AE differences across individual AP+MS combinations.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Galling B,Garcia MA,Osuchukwu U,Hagi K,Correll CUdoi
10.1517/14740338.2015.1053457subject
Has Abstractpub_date
2015-08-01 00:00:00pages
1181-99issue
8eissn
1474-0338issn
1744-764Xjournal_volume
14pub_type
杂志文章,meta分析,评审abstract:BACKGROUND:The nasal cavity is a vulnerable zone which may be damaged by vascular disorders. We systematically assessed the frequency and severity of nasal cavity alterations during bevacizumab treatment, to determine its clinical relevance and factors contributing to its onset. PATIENTS AND METHODS:We conducted a hos...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2014.960388
更新日期:2014-11-01 00:00:00
abstract:INTRODUCTION:Carbonic anhydrase (CA) inhibitors have an impressive safety record despite the multiple functions that CA isozymes serve because they are not fully inhibited with most dosing. While reducing the targeted CA-dependent process sufficiently for disease control, residual activity and uncatalyzed rates in comb...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.897328
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:Paliperidone, the major active metabolite of risperidone, is a second-generation antipsychotic that has been developed as an extended-release (ER) oral formulation and a long-acting injectable paliperidone palmitate (PP) formulation. Paliperidone has demonstrated efficacy in the reduction of acute schizoph...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1288716
更新日期:2017-03-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Despite the beneficial effect of imatinib treatment in chronic myeloid leukemia patients, some patients develop resistance and/or intolerance and need a switch to second-generation tyrosine kinase inhibitors. Dasatinib is indicated for chronic myeloid leukemia patients with resistance or intoler...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740331003742935
更新日期:2010-09-01 00:00:00
abstract:INTRODUCTION:In the past two decades, the number of women with autoimmune and inflammatory diseases experiencing a pregnancy has significantly increased in parallel with the enormous advances in the diagnosis and management of these disorders. However, information regarding the safety of immunosuppressive agents comes ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.951326
更新日期:2014-12-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Trastuzumab has become a mainstay in the treatment of women with human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer in the metastatic and adjuvant settings. Although trastuzumab is generally well tolerated, cardiac toxicity has emerged as a rare but potentially serious ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740331003627441
更新日期:2010-03-01 00:00:00
abstract:OBJECTIVES:Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying wheth...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1248942
更新日期:2016-12-01 00:00:00
abstract::An unprecedented interest in biomarker development has arisen from the increasing use of genomic information and high-throughput technologies in the field of drug development. Monitoring global cellular responses to perturbation due to disease, drug treatment or toxicity is achieved using molecular profiling methods s...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/eods.3.2.137.27344
更新日期:2004-03-01 00:00:00
abstract::Most regulatory agencies and pharmaceutical companies focus the majority of their pharmacovigilance on safety signal identification in large databases. GlaxoSmithKline (GSK) has > 100 drugs marketed worldwide. In order to determine which database has the highest statistical power to detect safety signals in three larg...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.6.713
更新日期:2007-11-01 00:00:00
abstract::The non-nucleoside analogue inhibitor of the reverse transcriptase, efavirenz (EFV), has become commonly used in highly active antiretroviral combination therapy in the treatment of HIV infection. Although being effective in suppressing plasma viral load, neuropsychiatric side effects have been reported in individuals...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.2.147
更新日期:2007-03-01 00:00:00
abstract::Bone morphogenetic proteins (BMPs) have been extensively studied since the discovery of agents within bone that could induce bone formation at ectopic sites by Urist in the 1960s. Extensive preclinical research has been carried out showing the efficacy of these products in promoting bone healing. Clinical trials are e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.1.75
更新日期:2005-01-01 00:00:00
abstract::Aerosolized delivery of a number of antimicrobial agents has been studied. Despite a theoretical soundness behind this strategy, full consideration of the potential toxicities associated with this mode of administration is imperative. Aerosolized amphotericin B, as both deoxycholate and lipid formulations, has been st...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.5.523
更新日期:2007-09-01 00:00:00
abstract:INTRODUCTION:The polycystic ovary syndrome (PCOS) is a very prevalent disorder in premenopausal women. Cardiovascular risk factors cluster in these patients, raising concern about the safety of the drugs commonly used to ameliorate symptoms of androgen excess in in this population at risk of cardiovascular morbidity. ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1839409
更新日期:2020-12-01 00:00:00
abstract::Objectives: This study aimed to develop a procedure to explore the adverse drug reaction signals of drug-induced neutropenia (DIN) or drug-induced agranulocytosis (DIA) in children using an electronic health records (EHRs) database. Methods: A two-stage design was presented. First, the suspected drugs to induce DIN or...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1604682
更新日期:2019-05-01 00:00:00
abstract:BACKGROUND:Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. OBJECTIVES:The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. METHODS:This was a retrospective study conducted at the Departmen...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1226279
更新日期:2016-11-01 00:00:00
abstract::Objectives: To examine the signals of bullous pemphigoid (BP) with dipeptidyl peptidase-4 inhibitors (DPP-4i) in VigiBase® and the potential role of their pharmacodynamic/pharmacokinetic parameters in the occurrence of BP. Methods: Case/non-case analyses were performed in VigiBase® to examine the signal of BP [reporti...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1668373
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND:Ximelagatran, the first oral agent in the new class of direct thrombin inhibitors, was withdrawn from the market due to increased rates of liver enzyme elevations in long-term treatments. Despite intensive pre clinical investigations the cellular mechanisms behind the observed hepatic effects remain unknown....
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.7.4.351
更新日期:2008-07-01 00:00:00
abstract::Treating bipolar disorder in women during reproduction presents a significant challenge to the physician. The pharmaceutical agents most commonly used for treating bipolar disorder have been associated with adverse effects when used during pregnancy and breastfeeding. Of particular concern has been the association of ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/eods.3.3.221.31074
更新日期:2004-05-01 00:00:00
abstract:BACKGROUND:To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost. METHODS:Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2015.1017467
更新日期:2015-05-01 00:00:00
abstract:INTRODUCTION:Clozapine was first introduced as an antipsychotic in the 1970's but a cluster of deaths, later linked to the drug's risk of agranulocytosis, led to its withdrawal in most countries. However, work in the 1980's established its unique efficacy in treatment resistant schizophrenia (TRS), which constitutes as...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1191468
更新日期:2016-09-01 00:00:00
abstract::It is estimated that over three-quarters of a million people are injured or die in hospitals each year from adverse drug events (ADEs). The majority of medical errors result from poorly designed healthcare systems rather than from negligence on the part of healthcare providers. In general, healthcare systems rely on v...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.3.5.449
更新日期:2004-09-01 00:00:00
abstract::Many diseases are now treatable with modern drugs. Elderly people, because they suffer from age-related illnesses, stand to gain the most, but they are also at risk from adverse drug reactions (ADRs). There are complex reasons for the increased frequency of ADRs, including poor prescribing, polypharmacy, altered drug ...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.2.3.211
更新日期:2003-05-01 00:00:00
abstract:INTRODUCTION:Adult onset Still disease (AOSD) is a rare systemic inflammatory condition. The clinical spectrum of this disease ranges from self-limiting forms with mild symptoms to life-threatening cases. Glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) represent the first line of therapy for AOSD, wi...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1839411
更新日期:2020-12-01 00:00:00
abstract:INTRODUCTION:Since calcitonin gene-related peptide (CGRP) plays an important role in the pathophysiology of migraine via the activation of the trigeminovascular system, the newest prophylactic treatments directly block CGRP or its receptor. However, the safety of these novel antimigraine drugs is not yet sufficiently e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1811229
更新日期:2020-10-01 00:00:00
abstract:INTRODUCTION:Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC). AREA COVERED:Pembrolizumab was appr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1805428
更新日期:2020-09-01 00:00:00
abstract:INTRODUCTION:Patients with end-stage renal disease (ESRD) are considered at higher risk of influenza-related complications and are listed worldwide among the subjects for whom yearly influenza vaccination is strongly recommended. However, influenza vaccination coverage of patients with ESRD is significantly lower than ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.1053459
更新日期:2015-08-01 00:00:00
abstract:INTRODUCTION:ACE inhibitors are first-line therapy in patients with chronic kidney disease (CKD). The main adverse effects of ACE inhibitors are hypotension, renal function impairment and hyperkalemia. AREAS COVERED:This paper reviews evidence from clinical studies regarding adverse effects of ACE inhibitors in patien...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.951328
更新日期:2014-10-01 00:00:00
abstract::Millions of women worldwide use the combined oral contraceptive pill as an effective form of contraception. However, the focus on its side effects to date has mainly been on physical aspects, even though the most commonly stated reason for discontinuation is depression. There are surprisingly few large studies investi...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.4.371
更新日期:2007-07-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to investigate whether the use of statins was associated with a decreased risk of gallstone disease. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all patients who were aged 50 years and older and had a first-time diagnosis of gallstone dis...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2012.653560
更新日期:2012-05-01 00:00:00
abstract:INTRODUCTION:Gestational diabetes mellitus (GDM), the most frequent medical complication of pregnancy, is associated with several adverse outcomes over the short- and long-term for both mother and offspring. Standard treatment for GDM consists of insulin injections. Oral hypoglycemic agents (OHAs), on the other hand, a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.521740
更新日期:2011-03-01 00:00:00