Signals of Adverse Drug Reactions of Paliperidone Compared to Other Atypical Antipsychotics Using the Korean Adverse Event Reporting System Database.

Abstract:

BACKGROUND AND OBJECTIVES:Schizophrenia is a severe public health problem and one of the top ten causes of disability, affecting about 1.1% of the world's population. Paliperidone is a new atypical antipsychotic used to treat schizophrenia. Several case reports about unexpected adverse drug reactions of paliperidone have been consistently reported around the world. The purpose of this study was to detect signals of adverse events (AEs) after paliperidone treatment using the Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System database (KIDS-KD). METHODS:We applied data-mining techniques based on a disproportionality analysis to KIDS-KD consisting of spontaneously reported AE reports related to atypical antipsychotics between January 2009 and December 2018. We calculated three data-mining indices of paliperidone compared to all other atypical antipsychotics. We defined signals that satisfied all three criteria of the indices. We checked if the signals identified were included in the drug labels for South Korea, the USA, the UK, Japan, Germany, and France. RESULTS:The total number of suspected AE reports related to all atypical antipsychotics in the KIDS-KD from January 2009 to December 2018 was 43,970. Among those, the number of AE reports related to paliperidone was 9453. Overall, 13 signals such as seborrhea, hallucination, obesity, gingivitis, and intervertebral disorder were classified into newly detected meaningful signals. CONCLUSION:We detected new AE signals of paliperidone that were not listed on the drug labels of six countries, and many that were related to psychotic symptoms, metabolic problems, and endocrine disorders.

journal_name

Clin Drug Investig

authors

Seo DE,Kim S,Park BJ

doi

10.1007/s40261-020-00945-z

subject

Has Abstract

pub_date

2020-09-01 00:00:00

pages

873-881

issue

9

eissn

1173-2563

issn

1179-1918

pii

10.1007/s40261-020-00945-z

journal_volume

40

pub_type

杂志文章
  • Intranasal Fluticasone Once Daily Compared with Once-Daily Cetirizine in the Treatment of Seasonal Allergic Rhinitis : Results of a Multicentre, Double-Blind Study.

    abstract::The efficacy and tolerability of fluticasone aqueous nasal spray, 200µg once daily for 21 days, was compared with cetirizine, 10mg once daily for 21 days, in a multicentre, randomised, double-blind, double-dummy, parallel group study. 237 evaluable patients aged 12 years and above, with seasonal allergic rhinitis (def...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.2165/00044011-199713060-00001

    authors: Vervloet D,Charpin D,Desfougeres JL

    更新日期:1997-06-01 00:00:00

  • Pharmacokinetic Bioequivalence of Two Inhaled Tiotropium Bromide Formulations in Healthy Volunteers.

    abstract:BACKGROUND AND OBJECTIVE:A novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the sam...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s40261-016-0441-8

    authors: Algorta J,Andrade L,Medina M,Kirkov V,Arsova S,Li F,Chi J

    更新日期:2016-09-01 00:00:00

  • Randomised, double-blind study of the effects of oxybutynin, tolterodine, trospium chloride and placebo on sleep in healthy young volunteers.

    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

    authors: Diefenbach K,Donath F,Maurer A,Quispe Bravo S,Wernecke KD,Schwantes U,Haselmann J,Roots I

    更新日期:2003-01-01 00:00:00

  • Hypokalaemia in healthy volunteers after single and multiple doses of formoterol or salbutamol.

    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

    authors: van den Berg BT,Louwerse RT,Luiken GJ,Jonkers RE,van Boxtel CJ

    更新日期:1998-01-01 00:00:00

  • Long-Term Cost Effectiveness of Interferon-beta-1a in the Treatment of Relapsing-Remitting Multiple Sclerosis : An Econometric Model.

    abstract:OBJECTIVE:To evaluate the cost effectiveness of subcutaneous interferon-beta-1a (IFNbeta-1a) 44mug three times weekly in relapsing-remitting multiple sclerosis (RRMS) using an econometric model. METHODS:Data on RRMS patients treated with IFNbeta-1a 22 or 44mug subcutaneously three times weekly or placebo for up to 4 y...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.2165/00044011-200323090-00003

    authors: Lepen C,Coyle P,Vollmer T,Blumhardt L,Lilliu H,Beresniak A

    更新日期:2003-01-01 00:00:00

  • Switching patients with stable schizophrenia or schizoaffective disorder from olanzapine to risperidone long-acting injectable.

    abstract:BACKGROUND:Patients with schizophrenia or related disorders often switch antipsychotic therapy, most commonly due to lack of efficacy and side effects. The differences in anticipated efficacy and tolerability among atypical antipsychotics may drive switching behaviours. Switching to long-acting antipsychotics may impro...

    journal_title:Clinical drug investigation

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.2165/11599080-000000000-00000

    authors: Rosa F,Schreiner A,Thomas P,Sherif T

    更新日期:2012-04-01 00:00:00

  • Treatment of Major Depressive Disorder in Japanese Patients with Cancer: A Matched Cohort Study Using Employer-Based Health Insurance Claims Data.

    abstract:BACKGROUND AND OBJECTIVE:Patients with cancer are at high risk of major depressive disorder (MDD), but little is known about their MDD treatment. We investigated the use of antidepressants and other drugs for MDD after cancer diagnosis, and patient characteristics associated with their use. METHODS:Adults with a new c...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-020-00976-6

    authors: Akechi T,Fujimoto S,Mishiro I,Murase K

    更新日期:2020-12-01 00:00:00

  • CYP3A4 polymorphism and lopinavir toxicity in an HIV-infected pregnant woman.

    abstract::Cytochrome P450 (CYP) 3A4 has been considered to be the most important enzyme system for metabolism of lopinavir/ritonavir (LPV/r), a widely used HIV protease inhibitor (PI) recommended during pregnancy. Herein we present a clinical case of a pregnant HIV-infected woman who was taking standard doses of LPV/r, 400/100 ...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-014-0245-7

    authors: López Aspiroz E,Cabrera Figueroa SE,Iglesias Gómez A,Valverde Merino MP,Domínguez-Gil Hurlé A

    更新日期:2015-01-01 00:00:00

  • The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in Coronary Artery Disease Patients with Type 2 Diabetes Mellitus: Rationale and Design of RosCal Study.

    abstract:INTRODUCTION:More and more evidence suggests that the density of calcification plays an important role in the plaque stability. However, few studies have investigated the statin treatment on the density of plaque calcification in patients with both coronary artery disease (CAD) and type 2 diabetes mellitus. METHODS:On...

    journal_title:Clinical drug investigation

    pub_type: 临床试验,杂志文章

    doi:10.1007/s40261-016-0445-4

    authors: Zhang W,Luan Y,Jin C,Xu S,Bi X,Zhao Y,Qiu F,Fu G,Wang M

    更新日期:2016-12-01 00:00:00

  • Levetiracetam in idiopathic generalised epilepsy and porphyria cutanea tarda.

    abstract::We report the case of a 50-year-old male patient with idiopathic generalised epilepsy and porphyria cutanea tarda. Valproic acid and phenobarbital monotherapy controlled seizures but exacerbated porphyric symptomatology, while clobazam, clonazepam and lamotrigine monotherapy were well tolerated as regards porphyric di...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.2165/00044011-200626060-00007

    authors: Bilo L,Meo R,Fulvia de Leva M

    更新日期:2006-01-01 00:00:00

  • Amlexanox for the treatment of recurrent aphthous ulcers.

    abstract::Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population. The minor manifestation of the condition is the most common and is characterised by small, shallow, round or oval lesions that are surrounded by a raised erythematous h...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.2165/00044011-200525090-00001

    authors: Bell J

    更新日期:2005-01-01 00:00:00

  • Vedolizumab Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability Following Administration of a Single, Ascending, Intravenous Dose to Healthy Volunteers.

    abstract:BACKGROUND AND OBJECTIVES:Vedolizumab, a humanized monoclonal antibody against the α4β7 integrin, is indicated for treatment of moderately to severely active ulcerative colitis or Crohn's disease. In this placebo-controlled, double-blind, randomized, single ascending-dose study, the pharmacokinetics, pharmacodynamics, ...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s40261-016-0437-4

    authors: Rosario M,Wyant T,Leach T,Sankoh S,Scholz C,Parikh A,Fox I,Feagan BG

    更新日期:2016-11-01 00:00:00

  • Cost effectiveness of fesoterodine and tolterodine for the treatment of overactive bladder with urge urinary incontinence in Spain and Finland.

    abstract:BACKGROUND:Overactive bladder is a prevalent condition worldwide that is associated with a considerable burden, both on the patient and on society. OBJECTIVE:Our objective was to assess the economic value of fesoterodine compared with tolterodine extended release (ER) for the treatment of overactive bladder (OAB) with...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,评审

    doi:10.1007/s40261-014-0178-1

    authors: Angulo JC,Valpas A,Rejas J,Linden K,Kvasz M,Snedecor SJ

    更新日期:2014-05-01 00:00:00

  • Proton pump inhibitors in acute treatment of reflux oesophagitis : a cost-effectiveness analysis.

    abstract:BACKGROUND AND AIM:Gastro-oesophageal reflux disease is a common medical problem that places a significant financial burden on outpatient pharmaceutical expenditure. A substantial proportion of this expenditure can be attributed to the use of proton pump inhibitors (PPIs). The aim of this analysis was to evaluate the c...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.2165/00044011-200525050-00005

    authors: Lucioni C,Mazzi S,Rossi C

    更新日期:2005-01-01 00:00:00

  • Cost-Utility Analysis of Three Iron Chelators Used in Monotherapy for the Treatment of Chronic Iron Overload in β-Thalassaemia Major Patients: An Italian Perspective.

    abstract:PURPOSE:Deferiprone (DFP), deferasirox (DFX) and deferoxamine (DFO) are used in thalassaemia major (TM) patients to treat chronic iron overload. We evaluated the cost-effectiveness of DFP, compared with DFX and DFO monotherapy, from an Italian healthcare system perspective. METHODS:A Markov model was used over a time ...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-017-0496-1

    authors: Pepe A,Rossi G,Bentley A,Putti MC,Frizziero L,D'Ascola DG,Cuccia L,Spasiano A,Filosa A,Caruso V,Hanif A,Meloni A

    更新日期:2017-05-01 00:00:00

  • Ivabradine in Patients with Stable Coronary Artery Disease: A Rationale for Use in Addition to and Beyond Percutaneous Coronary Intervention.

    abstract::Heart rate is an established prognostic marker for longevity and is an important contributor in the pathophysiology of various cardiovascular diseases, including ischemic heart disease and heart failure. Most ischemic episodes are triggered by an increase in heart rate, which causes an imbalance between myocardial oxy...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,评审

    doi:10.1007/s40261-016-0472-1

    authors: Godino C,Colombo A,Margonato A

    更新日期:2017-02-01 00:00:00

  • Pharmacokinetics, safety and tolerability of DA-6034, an anti-inflammatory agent, after single and multiple oral administrations in healthy volunteers.

    abstract:BACKGROUND AND OBJECTIVES:Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract. DA-6034 has been shown to be effective in an IBD model and has demonstrated a good toxicological profile in preclinical studies. This study evaluated the tolerability, safety and pharmacokinetics...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s40261-013-0147-0

    authors: Lee J,Shin KH,Kim JR,Lim KS,Jang IJ,Chung JY

    更新日期:2014-01-01 00:00:00

  • Cost Effectiveness of Exenatide Once Weekly Versus Insulin Glargine and Liraglutide for the Treatment of Type 2 Diabetes Mellitus in Greece.

    abstract:OBJECTIVE:The objective of this study was to evaluate the long-term cost effectiveness of exenatide once weekly (ExQW) versus insulin glargine (IG) or liraglutide 1.2 mg (Lira1.2mg) for the treatment of adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on oral antidiabetic drug (OAD) therapy...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s40261-017-0586-0

    authors: Tzanetakos C,Bargiota A,Kourlaba G,Gourzoulidis G,Maniadakis N

    更新日期:2018-01-01 00:00:00

  • 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.

    abstract:BACKGROUND:Cutaneous warts are caused by human papilloma virus (HPV) infection. FIT039, a specific inhibitor of CDK9, suppresses the proliferation of DNA viruses in vitro. PURPOSE:We evaluated the safety, plasma concentrations, and efficacy of FIT039 delivered by single application of an adhesive skin patch on normal ...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-018-0712-7

    authors: Sumi E,Nomura T,Asada R,Uozumi R,Tada H,Amino Y,Sawada T,Yonezawa A,Hagiwara M,Kabashima K

    更新日期:2019-01-01 00:00:00

  • Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis.

    abstract:BACKGROUND AND OBJECTIVES:The new oral anticoagulants (NOACs) are used for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF) and those at risk of deep venous thrombosis. Their rapid onset of action and predictable pharmacokinetic and pharmacodynamic profiles make them...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-016-0436-5

    authors: Acanfora D,Acanfora C,Scicchitano P,Longobardi M,Furgi G,Casucci G,Lanzillo B,Dentamaro I,Zito A,Incalzi RA,Ciccone MM

    更新日期:2016-10-01 00:00:00

  • Safety of Overnight Switch from Brand-Name to Generic Levetiracetam.

    abstract:BACKGROUND AND OBJECTIVE:Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. The objective of this study was to evaluate the safety and tolerability of the brand-to-generic levetiracetam switch in patients with focal or generalized epilepsy. METHODS:A prosp...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-015-0351-1

    authors: Vari MS,Pinto F,Mencaroni E,Giudizioso G,Minetti C,La Neve A,Francavilla T,Piccioli M,Striano S,del Gaudio L,Tovo P,Striano P,Verrotti A

    更新日期:2016-01-01 00:00:00

  • Nimesulide versus Ibuprofen for Postoperative Tonsillectomy Pain : A Double-Blind, Randomised, Active Comparator-Controlled Clinical Trial.

    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

    authors: Aho M,Kokki H,Nikanne E

    更新日期:2003-01-01 00:00:00

  • Effect of rifampicin on the pharmacokinetics of lenvatinib in healthy adults.

    abstract:BACKGROUND AND OBJECTIVES:Lenvatinib is an oral, multitargeted tyrosine kinase inhibitor under clinical investigation in solid tumours. This study evaluated the influence of P-glycoprotein (P-gp) inhibition (single-dose rifampicin) and simultaneous cytochrome P450 3A4 (CYP3A4)/P-gp induction (multiple-dose rifampicin) ...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-014-0217-y

    authors: Shumaker RC,Aluri J,Fan J,Martinez G,Thompson GA,Ren M

    更新日期:2014-09-01 00:00:00

  • Lack of bioequivalence between two aciclovir tablets in healthy subjects.

    abstract:OBJECTIVE:This study aimed to compare the systemic bioavailability of two aciclovir tablets, Rouz-Aciclovir (test) and Zovirax (reference), in 12 healthy volunteers. METHODS:In a crossover design, each subject received a single oral dose of aciclovir 400 mg followed by a 7-day washout period. Plasma concentrations of ...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,随机对照试验

    doi:10.2165/00044011-200828010-00006

    authors: Amini H,Javan M,Gazerani P,Ghaffari A,Ahmadiani A

    更新日期:2008-01-01 00:00:00

  • Salmeterol/Fluticasone Propionate in a Single Inhaler is Superior to Budesonide Alone in Control of Chinese Asthmatic Adults : An Open-Label, Randomised, 6-Week Study.

    abstract:OBJECTIVE AND DESIGN:There is comparatively little information on asthma management in China. A multicentre, randomised, open-label, parallel-group, 6-week treatment study was conducted to evaluate the efficacy and safety of salmeterol/fluticasone propionate combination treatment in Chinese adult asthmatic patients. S...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.2165/00044011-200424100-00004

    authors: Zhong NS,Ping ZJ,Humphries MJ,Xin D

    更新日期:2004-01-01 00:00:00

  • Management of cognitive determinants in senile dementia of Alzheimer's type: therapeutic potential of a novel polyherbal drug product.

    abstract:BACKGROUND AND OBJECTIVE:The enigmatic etiology of neurodegenerative diseases poses a challenge for the development of novel and efficient drugs. The objective of the present study was to evaluate the efficacy of a polyherbal (test) formulation on cognitive functions, inflammatory markers and oxidative stress in health...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s40261-014-0235-9

    authors: Sadhu A,Upadhyay P,Agrawal A,Ilango K,Karmakar D,Singh GP,Dubey GP

    更新日期:2014-12-01 00:00:00

  • Clinical experience with lamotrigine monotherapy in adults with newly diagnosed epilepsy: a review of published randomised clinical trials.

    abstract:OBJECTIVES:This paper aimed to provide an overview from published randomised clinical trials of the efficacy and tolerability of lamotrigine monotherapy compared with carbamazepine and phenytoin when initiated in adult patients with newly diagnosed epilepsy. DESIGN:The review included two double-blind, randomised tria...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.2165/00044011-199816020-00005

    authors: Mullens EL

    更新日期:1998-01-01 00:00:00

  • Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database.

    abstract:BACKGROUND AND OBJECTIVE:Golimumab is a fully human anti-tumor necrosis factor monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This study estimated rates of prespecified outcomes in patients with RA, PsA or AS initiating golimumab ...

    journal_title:Clinical drug investigation

    pub_type: 杂志文章

    doi:10.1007/s40261-020-00959-7

    authors: Ziyadeh NJ,Geldhof A,Noël W,Otero-Lobato M,Esslinger S,Chakravarty SD,Wang Y,Seeger JD

    更新日期:2020-11-01 00:00:00

  • Effects of a Novel Aldose Reductase Inhibitor, Fidarestat (SNK-860), on Vibration Perception Threshold and Subjective Symptoms in Patients with Diabetic Polyneuropathy : An Open-Label Pilot Study.

    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

    authors: Hotta N,Yasuda K,Sumita Y,Sano T,Kakuta H,Nagashima M,Hayashi Y,Yamamoto M,Wakao T,Okuyama M,Kobayashi M,Mori K

    更新日期:2004-01-01 00:00:00

  • Retrospective comparison of the effectiveness of a fenofibrate 145 mg formulation compared with the standard 160 mg tablet.

    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

    authors: Davidson MH,Jones PH

    更新日期:2008-01-01 00:00:00