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 prospective study in patients with primary, cryptogenic or symptomatic epilepsy, who were taking branded levetiracetam and were switched to generic levetiracetam. Patients were consecutively recruited from January 2013 to January 2015. We evaluated efficacy, tolerability and compliance before switching (T0) and after 6 months of therapy (T1). Evaluations were scheduled as follows: baseline, 7 and 15 days, 1, 3 and 6 months. At each visit clinical diary seizures, physical and neurological examination, laboratory parameters and electroencephalogram were evaluated. RESULTS:Fifty-nine patients, equally mixed by sex, were included in the study. Mean age was 26.1 years. Forty-seven per cent of the patients enrolled received levetiracetam as monotherapy. One patient was lost during the follow-up: so at T1 we had 58 patients (28 monotherapy and 30 polytherapy). At T0 and at T1, there was no statistically significant difference in terms of seizure frequency and intensity, occurrence of adverse events, laboratory parameters and electroencephalographic features. Two patients stopped treatment with the generic (both at 3 months after the switch) and restarted therapy with brand levetiracetam because of seizure increase. At the end of the study, the switchback rate was 3.4%. CONCLUSIONS:No increase of seizures and adverse effects were observed when branded levetiracetam was interchanged to a generic equivalent. More studies should be conducted with a larger series of patients to confirm these results.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
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 Adoi
10.1007/s40261-015-0351-1subject
Has Abstractpub_date
2016-01-01 00:00:00pages
87-91issue
1eissn
1173-2563issn
1179-1918pii
10.1007/s40261-015-0351-1journal_volume
36pub_type
杂志文章abstract:INTRODUCTION:The management of advanced gastrointestinal stromal tumors (GISTs) has been modified considerably by the availability of costly tyrosine kinase inhibitors (TKIs); however, the best therapeutic sequence in terms of cost and effectiveness remains unknown. OBJECTIVE:The aim of this study was to compare four ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0463-2
更新日期:2017-01-01 00:00:00
abstract::Appropriate and successful management of pain with opioid analgesics is based on tailoring pharmacologic treatment to the individual and identifying the minimal effective dose at which pain is controlled with minimal adverse effects. Morphine and morphine-like-agonists exhibit similar pharmacodynamic profiles, but sub...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/0044011-200929001-00002
更新日期:2009-01-01 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
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abstract:BACKGROUND AND OBJECTIVES:CKD-712, a candidate treatment for septic shock, acts by increasing cardiac output. This study investigated changes in the pharmacodynamics, pharmacokinetics, and tolerability of CKD-712 after a single intravenous administration. METHODS:A dose-block-randomized, double-blind, placebo-controll...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
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更新日期:2017-04-01 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
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更新日期:2013-02-01 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
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更新日期:2019-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:More than 30% of patients with epilepsy have inadequate control of seizures with drug therapy. The goal of this study is to determine the budget impact (BI) of the introduction of brivaracetam to the portfolio of approved drugs in Spain as adjunctive therapy for the treatment of partial-onset e...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0615-z
更新日期:2018-04-01 00:00:00
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
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND:Muscle wasting is common and insidious in end-stage renal disease (ESRD). Loss of muscle quantity and quality reduces quality of life and increases mortality in ESRD patients. Additionally, secondary hyperparathyroidism (SHPT) causes muscle atrophy. Meanwhile, vitamin D, which is used for SHPT treatment, pla...
journal_title:Clinical drug investigation
pub_type: 杂志文章
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abstract:OBJECTIVES:To determine the efficacy of L-carnitine in reducing hyperammonaemia and improving neuropsychological performance in patients with hepatic cirrhosis and subclinical hepatic encephalopathy (SHE). DESIGN:Randomised, parallel group, controlled trial. PATIENTS AND METHODS:The study enrolled 31 patients with he...
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doi:10.2165/00044011-200222001-00002
更新日期:2002-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a general concern about the use of multisource (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modified-release formulations of clarithromycin (i.e. the originator Klacid XL and the generic Kl...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Herpes zoster (HZ) and its most frequent complication, post-herpetic neuralgia (PHN), have been shown to considerably impact quality of life (QoL). This has not yet been demonstrated in Japan. METHODS:QoL in HZ and PHN patients was evaluated using the Zoster Brief Pain Inventory (ZBPI), EuroQ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-017-0581-5
更新日期:2018-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
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更新日期:2013-03-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0372-9
更新日期:2016-03-01 00:00:00
abstract::Psychotropic medications and alcohol are potential risk factors for falls in older adults. However, there has been no appraisal of the literature on whether these medications, both singly and in combination with alcohol, are associated with falls in community dwelling older adults (those aged 60 years and older living...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-0721-6
更新日期:2019-02-01 00:00:00
abstract:OBJECTIVE:To compare the bioavailability of two 15mg ambroxol lozenges with a commercial 30mg ambroxol tablet. DESIGN:Open-label, two-way crossover study. METHOD:Each formulation was randomly administered to 20 healthy Thai volunteers (ten male and ten female) with a 1-week washout period between formulations. After ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323040-00007
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVE:The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 27 803 patients with diabetes mellitus (26 044 were diagnosed as having type 2 diabetes) over a 12-week treatment period. PATIENTS AND M ethods: Overall efficacy data were reported for type 1 and type 2 diabetes, ...
journal_title:Clinical drug investigation
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doi:10.2165/00044011-200525100-00004
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journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11534480-000000000-00000
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更新日期:2020-12-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
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更新日期:2018-01-01 00:00:00
abstract:BACKGROUND:As an increasing number of elderly are undergoing orthopaedic procedures, it is important to understand and evaluate postoperative pain management in this population, especially in regard to opioid use. Data in the literature pertaining to the very elderly remains scarce. OBJECTIVES:This study was conducted...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-00744-7
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Several antiviral therapies are now available for patients with chronic hepatitis B (CHB), but the most cost-effective strategy for Chinese patients is unclear. The aim of this study was to estimate the long-term cost effectiveness of the antiviral treatments (lamivudine, adefovir, telbivudine ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0273-y
更新日期:2015-03-01 00:00:00
abstract:OBJECTIVES:This study investigated the pharmacokinetics and pharmacodynamics of a fixed-dose combination (FDC) tablet of olmesartan medoxomil 20 mg and amlodipine 5 mg (CS-8663) in healthy Chinese subjects. METHODS:This single-centre, open-label study was conducted in five healthy males and five females aged 18-45 yea...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0026-0
更新日期:2012-12-01 00:00:00
abstract:OBJECTIVE:In this study, we evaluated the effectiveness of amlodipine in patients with severe ischaemic left ventricular dysfunction (LVD) and mild to moderate heart failure, but not current angina, assessing the effects of the drug on symptoms, left ventricular function and exercise capacity. PATIENTS AND METHODS:We ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199816040-00003
更新日期:1998-01-01 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: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 factor...
journal_title:Clinical drug investigation
pub_type: 杂志文章,meta分析
doi:10.1007/s40261-018-0661-1
更新日期:2018-08-01 00:00:00
abstract:OBJECTIVE:Addressing the needs of migraineurs by actively seeking patient feedback on disease-related disability and treatment satisfaction may lead to improved management and treatment outcomes. Patient feedback can be collected in postmarketing surveillance (PMS) studies. The objective of this PMS study was to evalua...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200727010-00005
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Mirabegron, a selective β3-adrenoceptor agonist for the treatment of overactive bladder (OAB), is eliminated by renal and metabolic routes. The potential influence of renal or hepatic impairment on the pharmacokinetics of mirabegron was evaluated. METHODS:Two separate open-label, single-dose,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0031-3
更新日期:2013-01-01 00:00:00
abstract:OBJECTIVE:The efficacy and tolerability of a new combination inhaler containing both salmeterol 50mg and fluticasone 100mg in a single device was compared with the delivery of the two drugs via two separate inhalers in a multicentre, double-blind, double-dummy study. PATIENTS:244 symptomatic asthma patients (age range...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199816030-00003
更新日期:1998-01-01 00:00:00