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 schizophrenia symptoms and clinical benefits were maintained also in the long-term treatments. Paliperidone ER and PP are generally well tolerated with a predictable adverse event profile. Areas covered: Data from studies evaluating safety and tolerability in the acute and maintenance treatment of schizophrenia with paliperidone are reviewed. The reported treatment-emergent adverse events of these formulations are discussed. Expert opinion: In the treatment of schizophrenia and schizoaffective disorders the safety profile has a central role because it can enhance patient compliance. In fact treatment-emergent adverse events are one of the main causes of discontinuation in these patients. In particular the main limitation in the administration of paliperidone could be represented by the onset of hyperprolactinemia (especially in women) and of mild parkinsonism. Paliperidone has a high impact on current long-term drug strategies, especially given the new 3 month long-acting injectable formulation of PP.

journal_name

Expert Opin Drug Saf

authors

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

doi

10.1080/14740338.2017.1288716

subject

Has Abstract

pub_date

2017-03-01 00:00:00

pages

365-379

issue

3

eissn

1474-0338

issn

1744-764X

journal_volume

16

pub_type

杂志文章,评审
  • Adverse events associated with somatostatin analogs in acromegaly.

    abstract:INTRODUCTION:In patients with acromegaly, somatostatin analogs (SSA) represent the first choice medical treatment. The long-acting SSA have been found to be effective in controlling growth hormone and IGF-I levels in a high percentage of patients, resulting in an improvement in the quality of life; moreover, these pept...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2015.1059817

    authors: Grasso LF,Auriemma RS,Pivonello R,Colao A

    更新日期:2015-08-01 00:00:00

  • Safety and efficacy of paracetamol and NSAIDs in osteoarthritis: which drug to recommend?

    abstract:INTRODUCTION:Osteoarthritis (OA) is the most common form of arthritis and is a major cause of disability, especially in people ≥ 45 years old. Several international societies recommend the use of both acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) to alleviate OA pain. However, patients with OA often ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2015.1056776

    authors: Richette P,Latourte A,Frazier A

    更新日期:2015-08-01 00:00:00

  • 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 rand...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,meta分析,评审

    doi:10.1517/14740338.2015.1053457

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

    更新日期:2015-08-01 00:00:00

  • The safety of apatinib for the treatment of gastric cancer.

    abstract:INTRODUCTION:Apatinib is an orally administered small-molecule vascular endothelial growth factor receptor 2 inhibitor. It has been approved and indicated for advanced gastric cancer after the failure of two or more lines of systemic therapy in China. Areas covered: This review summarizes the mechanisms, clinical appli...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2018.1535592

    authors: Geng R,Song L,Li J,Zhao L

    更新日期:2018-11-01 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

  • Pegylated-interferon-α(2a) in clinical practice: how to manage patients suffering from side effects.

    abstract:INTRODUCTION:The goal of antiviral therapy in patients with chronic hepatitis C is to slow or halt the progression of fibrosis and prevent the development of cirrhosis. Accordingly, antiviral treatment is proposed for a large population of patients with chronic hepatitis. AREAS COVERED:The standard-of-care for chronic...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2011.559161

    authors: Calvaruso V,Mazza M,Almasio PL

    更新日期:2011-05-01 00:00:00

  • The risks associated with prenatal antidepressant exposure: time for a precision medicine approach.

    abstract:INTRODUCTION:The prevalence of depression in pregnancy is over 10% and a significant proportion of pregnant women use antidepressant medication. The safety of antidepressants in pregnancy is controversial, partly due to methodological challenges. The conflicting results in the literature may, however, also be due to di...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2017.1341872

    authors: Pedersen LH

    更新日期:2017-08-01 00:00:00

  • The safety of treatment options for acute bacterial skin and skin structure infections.

    abstract:INTRODUCTION:Acute bacterial skin and skin-structure infections (ABSSSI) may develop in both in-patients and out-patients, possibly with a severe clinical presentation. Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2019.1621288

    authors: Bassetti M,Peghin M,Castaldo N,Giacobbe DR

    更新日期:2019-08-01 00:00:00

  • Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety.

    abstract::This review aims to give an updated overview of the worldwide situation of off-label and unlicensed drug use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.5.5.703

    authors: Cuzzolin L,Atzei A,Fanos V

    更新日期:2006-09-01 00:00:00

  • Disproportionality analysis of bullous pemphigoid adverse events with PD-1 inhibitors in the FDA adverse event reporting system.

    abstract::Objectives: Bullous pemphigoid, an autoimmune dermatological disease, may be associated with the use of a relatively new anti-cancer drug class, PD-1 inhibitors, which includes pembrolizumab and nivolumab. This paper analyzes the signals between PD-1 inhibitors and bullous pemphigoid based upon the reported real-world...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章

    doi:10.1080/14740338.2019.1619693

    authors: Aggarwal P

    更新日期:2019-07-01 00:00:00

  • Overview and safety of fingolimod hydrochloride use in patients with multiple sclerosis.

    abstract:INTRODUCTION:Fingolimod (Gilenya®, FTY720) is an oral sphingosine-1-phosphate analogue that was approved by the FDA in 2010 for the treatment of relapsing forms of multiple sclerosis (MS). Fingolimod's mechanism of action is primarily related to lymphocyte sequestration in primary and secondary lymphoid tissues. Phase ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2014.920820

    authors: Ward MD,Jones DE,Goldman MD

    更新日期:2014-07-01 00:00:00

  • Strategies to counter antipsychotic-associated weight gain in patients with schizophrenia.

    abstract::Introduction: Patients living with schizophrenia have a marked risk of clinically significant weight gain and obesity compared to the general population. The risks have been highlighted following the introduction of second-generation antipsychotics. In turn, obesity is associated with a higher prevalence of cardiovasc...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2019.1674809

    authors: Marteene W,Winckel K,Hollingworth S,Kisely S,Gallagher E,Hahn M,Ebdrup BH,Firth J,Siskind D

    更新日期:2019-12-01 00:00:00

  • A drug safety evaluation of mogamulizumab for the treatment of cutaneous T-Cell lymphoma.

    abstract::Introduction: Cutaneous T-cell lymphomas (CTCL) are rare non-Hodgkin lymphomas of skin-homing T-cells that initially or mainly manifest cutaneously. Treatment of CTCL is challenging given the disease states' varying presentation and prognosis. Systemic treatment options often lack comparative evidence and have relativ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2019.1643837

    authors: Afifi S,Mohamed S,Zhao J,Foss F

    更新日期:2019-09-01 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

  • Safety of secukinumab in the treatment of psoriasis.

    abstract:INTRODUCTION:Secukinumab is a human monoclonal antibody that selectively targets and neutralizes interleukin (IL)-17A, a cytokine that is normally involved in mucocutaneous defense against extracellular organisms and is abnormally expressed in psoriasis. In 2015, secukinumab was the first IL-17A inhibitor approved for ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2016.1221923

    authors: Blauvelt A

    更新日期:2016-10-01 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

  • The effect of anticholinergic agents on gastro-oesophageal reflux and related disorders.

    abstract::The most important risk factor of oesophageal adenocarcinoma is gastro-oesophageal reflux disease. Gastro-oesophageal reflux disease is in itself a common disorder, giving bothersome symptoms. In daily clinical practice, anticholinergic drugs are believed to increase the risk of gastro-oesophageal reflux through effec...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.7.2.173

    authors: van Soest EM,Dieleman JP,Kuipers EJ

    更新日期:2008-03-01 00:00:00

  • Bleeding complications of unfractionated heparin.

    abstract:INTRODUCTION:Unfractionated heparin is an anticoagulant used in the treatment of myocardial infarction, pulmonary embolism and other thrombotic disorders. However, with anticoagulation comes the risk of bleeding and adverse events. These risks increase with supratherapeutic dosing. AREAS COVERED:In this review, we dis...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2011.521150

    authors: Krishnaswamy A,Lincoff AM,Cannon CP

    更新日期:2011-01-01 00:00:00

  • Basiliximab: efficacy and safety evaluation in kidney transplantation.

    abstract:INTRODUCTION:Basiliximab is a chimeric monoclonal antibody directed against the alpha chain of interleukin-2 receptor (IL-2R). When administered intravenously at a dosage of 20 mg at the time of transplantation and 4 days later, basiliximab saturates the alpha chain of IL-2R for 4 weeks. AREAS COVERED:This review eval...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.1517/14740338.2014.861816

    authors: Ponticelli C

    更新日期:2014-03-01 00:00:00

  • Diabetes and fracture healing: the skeletal effects of diabetic drugs.

    abstract:INTRODUCTION:Over 39,000 diabetic patients are surgically treated for trauma and orthopaedic injuries annually in the UK, yet the effects of diabetic medications on the skeletal system is an under researched and under acknowledged field. AREAS COVERED:This review covers all English language novel experimental data rep...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2012.639359

    authors: Simpson CM,Calori GM,Giannoudis PV

    更新日期:2012-03-01 00:00:00

  • Drug safety evaluation of alemtuzumab for multiple sclerosis.

    abstract:INTRODUCTION:Alemtuzumab is a humanised anti-CD52 mAb which has recently been licensed for the treatment of relapsing multiple sclerosis in Europe. AREAS COVERED:The efficacy and safety of alemtuzumab from open label, Phase II and Phase III trials is reported. EXPERT OPINION:Alemtuzumab causes rapid and profound comp...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2014.928691

    authors: Willis M,Robertson NP

    更新日期:2014-08-01 00:00:00

  • Efficacy and safety of adalimumab treatment in patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

    abstract:INTRODUCTION:In the last couple of years, the number of patients with chronic inflammatory rheumatic diseases being treated with TNF α antagonist has increased dramatically. Adalimumab, a fully human monoclonal antibody against TNF α, is one of the most frequently administered TNF α antagonists. Yet, unresolved issues ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2011.581661

    authors: Poddubnyy D,Rudwaleit M

    更新日期:2011-07-01 00:00:00

  • Rationale for administering beta-blocker therapy to patients undergoing coronary artery bypass surgery: a systematic review.

    abstract:INTRODUCTION:Secondary preventative therapies are essential for patients undergoing coronary artery bypass graft (CABG) surgery to optimize perioperative and long-term outcomes. Beta-blockers are commonly used to treat patients with coronary artery disease and congestive heart failure (CHF), but their role for CABG pat...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2018.1504019

    authors: Thaper A,Kulik A

    更新日期:2018-08-01 00:00:00

  • The risks of warfarin use in the elderly.

    abstract::The use of warfarin in the elderly, particularly for stroke prevention in chronic atrial fibrillation, is steadily increasing. Although the benefits of warfarin are greatest in the elderly, so are the risk of adverse outcomes and the difficulties of anticoagulant management. Clinical systems need to improve to counter...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.5.3.417

    authors: Bereznicki LR,Peterson GM,Jackson SL,Jeffrey EC

    更新日期:2006-05-01 00:00:00

  • Policies to mitigate nonmedical use of prescription medications: how should emerging evidence of gabapentin misuse be addressed?

    abstract:INTRODUCTION:Over the past decade, increased prescription supply has facilitated an epidemic of nonmedical use of controlled substances, including predominantly opioids, as well as benzodiazepines, z-hypnotics, and stimulants. Areas covered: More recently, misuse of noncontrolled prescriptions, such as gabapentin, has ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章

    doi:10.1080/14740338.2017.1390081

    authors: Peckham AM,Fairman KA,Sclar DA

    更新日期:2018-05-01 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

  • High-dose interleukin-2 (IL-2) for the treatment of melanoma: safety considerations and future directions.

    abstract:INTRODUCTION:In 1998, high-dose interleukin-2 (IL-2) was the first immunotherapy approved for the treatment of metastatic melanoma based on durable objective responses documented in a subset of patients but widespread utilization was limited by significant toxicity. Advances in targeted therapy and the emergence of T c...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2017.1382472

    authors: Marabondo S,Kaufman HL

    更新日期:2017-12-01 00:00:00

  • Phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a comparison of safety profiles.

    abstract:INTRODUCTION:Hyperphosphatemia is common in the late stages of chronic kidney disease (CKD) and is associated with elevated parathormone levels, abnormal bone mineralization, extraosseous calcification and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2014.907791

    authors: Locatelli F,Del Vecchio L,Violo L,Pontoriero G

    更新日期:2014-05-01 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

  • The safety of pomalidomide for the treatment of multiple myeloma.

    abstract:INTRODUCTION:Pomalidomide, a derivative of thalidomide and member of the immunomodulatory drugs is licenced for use in relapsed and refractory multiple myeloma (RRMM) in Europe, USA, Canada and Japan. AREAS COVERED:This review details all published trials in which pomalidomide has been used in the treatment of myeloma...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2016.1154039

    authors: Jones JR,Pawlyn C,Davies FE,Morgan GJ

    更新日期:2016-01-01 00:00:00