Safety and tolerability of antipsychotic-mood stabilizer co-treatment in the management of acute bipolar disorder: results from a systematic review and exploratory meta-analysis.

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 Saf

authors

Galling B,Garcia MA,Osuchukwu U,Hagi K,Correll CU

doi

10.1517/14740338.2015.1053457

subject

Has Abstract

pub_date

2015-08-01 00:00:00

pages

1181-99

issue

8

eissn

1474-0338

issn

1744-764X

journal_volume

14

pub_type

杂志文章,meta分析,评审
  • An observational study of nasal cavity toxicity in cancer patients treated with bevacizumab.

    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

    authors: D'Amico M,Pagano M,Pasa A,Puntoni M,Clavarezza M,Gennari A,Gozza A,Zanardi S,Defferrari C,Provinciali N,Campazzi E,Campora S,Paleari L,Marra D,Petrera M,DeCensi A

    更新日期:2014-11-01 00:00:00

  • Safety of carbonic anhydrase inhibitors.

    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

    authors: Swenson ER

    更新日期:2014-04-01 00:00:00

  • Paliperidone for the treatment of schizophrenia and schizoaffective disorders - a drug safety evaluation.

    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

    authors: Mauri MC,Reggiori A,Paletta S,Di Pace C,Altamura AC

    更新日期:2017-03-01 00:00:00

  • Pleural/pericardic effusions during dasatinib treatment: incidence, management and risk factors associated to their development.

    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

    authors: Breccia M,Alimena G

    更新日期:2010-09-01 00:00:00

  • Safety considerations when prescribing immunosuppression medication to pregnant women.

    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

    authors: Gerosa M,Meroni PL,Cimaz R

    更新日期:2014-12-01 00:00:00

  • The cardiac safety of trastuzumab in the treatment of breast cancer.

    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

    authors: Chien AJ,Rugo HS

    更新日期:2010-03-01 00:00:00

  • Italian monitoring registries: a tool for a safer use of innovative drugs? Data from the national pharmacovigilance system.

    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

    authors: Magro L,Arzenton E,Moretti U,Sottosanti L,Potenza S,Leone R

    更新日期:2016-12-01 00:00:00

  • Molecular profiling approaches for identifying novel biomarkers.

    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

    authors: Bailey WJ,Ulrich R

    更新日期:2004-03-01 00:00:00

  • Database size and power to detect safety signals in pharmacovigilance.

    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

    authors: Hammond IW,Gibbs TG,Seifert HA,Rich DS

    更新日期:2007-11-01 00:00:00

  • Neuropsychiatric side effects of efavirenz therapy.

    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

    authors: Arendt G,de Nocker D,von Giesen HJ,Nolting T

    更新日期:2007-03-01 00:00:00

  • Application of bone morphogenetic proteins in orthopaedic practice: their efficacy and side effects.

    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

    authors: Harwood PJ,Giannoudis PV

    更新日期:2005-01-01 00:00:00

  • Safety of aerosolized amphotericin B.

    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

    authors: Knechtel SA,Klepser ME

    更新日期:2007-09-01 00:00:00

  • A safety evaluation of current medications for adult women with the polycystic ovarian syndrome not pursuing pregnancy.

    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

    authors: Luque-Ramírez M,Ortiz-Flores AE,Nattero-Chávez L,Escobar-Morreale HF

    更新日期:2020-12-01 00:00:00

  • Pediatric drug safety signal detection of non-chemotherapy drug-induced neutropenia and agranulocytosis using electronic healthcare records.

    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

    authors: Wei R,Jia LL,Yu YC,Nie XL,Song ZY,Fan DF,Xie YF,Peng XX,Zhao ZG,Wang XL

    更新日期:2019-05-01 00:00:00

  • Efficacy and safety of infliximab in psoriatic patients over the age of 65.

    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

    authors: Chiricozzi A,Pavlidis A,Dattola A,Bianchi L,Chimenti MS,Fida M,Saraceno R

    更新日期:2016-11-01 00:00:00

  • Bullous pemphigoid induced by dipeptidyl peptidase-4 (DPP-4) inhibitors: a pharmacovigilance-pharmacodynamic/pharmacokinetic assessment through an analysis of the vigibase®.

    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

    authors: Carnovale C,Mazhar F,Arzenton E,Moretti U,Pozzi M,Mosini G,Leoni O,Scatigna M,Clementi E,Radice S

    更新日期:2019-11-01 00:00:00

  • Investigations into the liver effects of ximelagatran using high content screening of primary human hepatocyte cultures.

    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

    authors: Ainscow EK,Pilling JE,Brown NM,Orme AT,Sullivan M,Hargreaves AC,Cooke EL,Sullivan E,Carlsson S,Andersson TB

    更新日期:2008-07-01 00:00:00

  • The pharmacology of bipolar disorder during pregnancy and breastfeeding.

    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

    authors: Dodd S,Berk M

    更新日期:2004-05-01 00:00:00

  • From benzalkonium chloride-preserved Latanoprost to Polyquad-preserved Travoprost: a 6-month study on ocular surface safety and tolerability.

    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

    authors: Rossi GC,Scudeller L,Rolle T,Pasinetti GM,Bianchi PE

    更新日期:2015-05-01 00:00:00

  • Clozapine's critical role in treatment resistant schizophrenia: ensuring both safety and use.

    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

    authors: Remington G,Lee J,Agid O,Takeuchi H,Foussias G,Hahn M,Fervaha G,Burton L,Powell V

    更新日期:2016-09-01 00:00:00

  • Information technology for detecting medication errors and adverse drug events.

    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

    authors: Anderson JG

    更新日期:2004-09-01 00:00:00

  • Are drugs really toxic for older people?

    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

    authors: Beard K

    更新日期:2003-05-01 00:00:00

  • Current treatment options and safety considerations when treating adult-onset Still's disease.

    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

    authors: Cavalli G,Farina N,Campochiaro C,Baldissera E,Dagna L

    更新日期:2020-12-01 00:00:00

  • CGRP inhibitors for migraine prophylaxis: a safety review.

    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

    authors: Rivera-Mancilla E,Villalón CM,MaassenVanDenBrink A

    更新日期:2020-10-01 00:00:00

  • Safety of pembrolizumab in recurrent or advanced gastric cancer expressing PD-L1 refractory to platinum and fluoropyrimidine.

    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

    authors: Mishima S,Kawazoe A,Shitara K

    更新日期:2020-09-01 00:00:00

  • Influenza vaccination in patients with end-stage renal disease.

    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

    authors: Principi N,Esposito S,ESCMID Vaccine Study Group (EVASG).

    更新日期:2015-08-01 00:00:00

  • Safety of ACE inhibitor therapies in patients with chronic kidney disease.

    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

    authors: Sidorenkov G,Navis G

    更新日期:2014-10-01 00:00:00

  • Depression as a side effect of the contraceptive pill.

    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

    authors: Kulkarni J

    更新日期:2007-07-01 00:00:00

  • Statin use and the risk of gallstone disease: a population-based case-control study.

    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

    authors: Chiu HF,Chen CC,Kuo HW,Lee IM,Wu TN,Yang CY

    更新日期:2012-05-01 00:00:00

  • Oral hypoglycemic agents for gestational diabetes mellitus?

    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

    authors: Maymone AC,Baillargeon JP,Ménard J,Ardilouze JL

    更新日期:2011-03-01 00:00:00