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 epilepsy in patients over 16 years old with a 5-year time horizon in the Valencia Community, a Spanish region with a population of 5 million. METHODS:The BI model compares the pharmaceutical expenditure on antiepileptics in two scenarios: with and without brivaracetam. It assumes that the introduction and increased use of brivaracetam will lead to a proportional decrease in consumption of coexisting adjunctive antiepileptics and calculates the evolution of the consumption of brivaracetam over 5 years (2016-2020). The model was designed from the perspective of the Spanish National Health System. Data on the candidate population, consumption of antiepileptics, market share and pharmaceutical expenditure were obtained from real-world data. Finally, a sensitivity analysis was carried out on the set of variables involved in the evolution of costs using a Monte-Carlo simulation. RESULTS:The model estimates that the target population eligible for adjunctive antiepileptics will hold at around 2352 between 2016 and 2020. Annual expenditure on antiepileptics is approximately €3.6 million. The number of patients eligible for treatment with brivaracetam would increase from 42 to 179 and annual savings of 0.09-0.37% would be created, representing €41,873 over 5 years (0.23% of the total budget). The sensitivity analysis corroborates that the probability of achieving savings with brivaracetam is around 84%. CONCLUSIONS:Brivaracetam is a therapeutic alternative that allows savings for the health system in patients with non-controlled epilepsy in monotherapy, having a fixed, predictable annual cost (independent of dose) from the first day of treatment as the lack of need for titration means the patient is within a range of therapeutic doses from the first dose.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Barrachina-Martínez I,Vivas-Consuelo D,Piera-Balbastre Adoi
10.1007/s40261-017-0615-zsubject
Has Abstractpub_date
2018-04-01 00:00:00pages
353-363issue
4eissn
1173-2563issn
1179-1918pii
10.1007/s40261-017-0615-zjournal_volume
38pub_type
杂志文章abstract:BACKGROUND AND OBJECTIVE:Tendon rupture can result from fluoroquinolone exposure. The objective of this study was to quantify relative and absolute risk and determine how risk is affected by timing of exposure. METHODS:The UK Health Improvement Network primary care database was used to perform a nested case-control st...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0729-y
更新日期:2019-02-01 00:00:00
abstract::Page 806, column 1, line 3: The text, which previously read. ...
journal_title:Clinical drug investigation
pub_type: 已发布勘误
doi:10.1007/s40261-020-00892-9
更新日期:2020-03-01 00:00:00
abstract::Early initiation of rational and effective combination therapy consisting of antihypertensive drugs with two different and complementary mechanisms of actions is increasingly becoming accepted in clinical practice and by guidelines as a first-line approach to control blood pressure (BP) and prevent cardiovascular outc...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/11538440-000000000-00000
更新日期:2010-01-01 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: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
更新日期:2020-12-01 00:00:00
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
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and safety of the natural platelet-activating factor receptor antagonist, BN 52021 (ginkgolide B) in the treatment of patients with severe sepsis related to Gram-negative and mixed bacterial infection. DESIGN AND SETTING:Prospective, randomised, double-blind, placebo-controlled, mult...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424030-00002
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combinations are the preferred maintenance therapy for adult asthma patients uncontrolled by ICS alone. Supporting data are largely from mixed populations of adolescents and adults, although ICS/LABA combinations are not approved f...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533420-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::Despite the availability of effective pain treatments, there are numerous barriers to effective management resulting in a large proportion of patients not achieving optimal pain control. Chronic pain is inadequately treated because of a combination of cultural, societal, educational, political and religious constraint...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/11630040-000000000-00000
更新日期:2012-02-22 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Little is known about the effects of the calcium channel antagonist manidipine when it is added as a third drug in non-controlled hypertensive patients with diabetes mellitus receiving dual antihypertensive therapy. The aim of this study was to evaluate the response in terms of blood pressure (...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11587400-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:Weight gain during insulin therapy can be a challenging problem in already overweight type 2 diabetes mellitus patients, affecting treatment compliance and long-term prognosis. The analogue insulin detemir has been reported to have a weight-sparing effect compared with other basal insulins. This pooled analys...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200727040-00007
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Ramucirumab is a fully immunoglobulin G (lgG) monoclonal antibody targeting vascular endothelial growth factor receptor type 2 (VEGFR2). Previous clinical trials suggested ramucirumab could improve the survival and increase the risk of adverse effects. Here, we aimed to assess the efficacy and...
journal_title:Clinical drug investigation
pub_type: 杂志文章,meta分析,评审
doi:10.1007/s40261-015-0355-x
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 h...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/0044011-200828120-00004
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:TZP-101 is a selective, small molecule ghrelin receptor agonist in clinical development for the treatment of gastric motility disorders. The objectives of this study was to assess pharmacokinetic parameters of TZP-101 after multiple- and single-dose administration to healthy subjects and patien...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200929060-00004
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Characteristics of nucleoside reverse transcriptase inhibitors (NRTIs) make the drug class susceptible to elimination via continuous veno-venous hemofiltration (CVVH), potentially leading to suboptimal drug concentrations if given at the recommended anephric doses during CVVH. The objective of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0275-9
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Gemigliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes mellitus. This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability. METHODS:A randomized, open-la...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-014-0184-3
更新日期:2014-06-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The possible adverse or positive effects of levothyroxine treatment among patients with atrial fibrillation have been debated. Atrial fibrillation, levothyroxine treatment, and dementia are common among older adults, yet little is known about the effects of levothyroxine on the development of d...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0740-3
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND:NSAIDs are widely used for patients presenting with low back pain. A quick-release formulation of lornoxicam, a potent NSAID from the chemical class of oxicams, offers a faster onset of pain relief compared with the standard tablet formulation. METHODS:Time to onset of pain relief with lornoxicam was compar...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626050-00004
更新日期:2006-01-01 00:00:00
abstract::This article discusses current practice in the treatment of conjunctivitis and how the use of topical moxifloxacin can increase therapeutic effectiveness, reduce treatment failures and, consequently, be cost effective and reduce the societal burden of the disorder. Current practice and effectiveness data were derived ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11589020-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:This study aimed to investigate the relative bioavailability and bioequivalence of two omeprazole enteric-coated formulations following repeated doses (steady state) in healthy male and female adult volunteers. DESIGN AND STUDY PARTICIPANTS:The study formulation (Ompranyt® 20mg capsules, Bial-Industrial Farm...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200121030-00006
更新日期:2001-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Several drugs may interact with levothyroxine and reduce its bioavailability. The aim of this study was to analyse the Italian general practice patients with hypothyroidism from 2002-2011, in terms of variation of thyroid-stimulating hormone (TSH) levels, number of levothyroxine prescriptions ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0271-0
更新日期:2015-03-01 00:00:00
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
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Interferon-alpha treatment is associated with a large number of adverse effects. Depressive symptoms are not unexpected, and potentially dangerous psychiatric adverse effects can induce life-threatening conditions. We compared the incidence of depressive symptoms in patients with chronic hepati...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200626110-00005
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a risk that disturbances of activities of daily living (ADL) due to rheumatoid arthritis (RA) are increased by the occurrence of fractures, including vertebral compression fractures and femoral neck fractures, in RA patients receiving oral corticosteroid therapy. Bisphosphonates are mo...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200828030-00002
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and tolerability of alendronic acid 70mg once weekly for the treatment of male osteoporosis. PATIENTS AND METHODS:This randomised, double-blind, placebo-controlled, 12-month trial compared the effect of alendronic acid 70mg once weekly or placebo (randomised 2 : 1) on bone mineral de...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424060-00003
更新日期:2004-01-01 00:00:00
abstract:OBJECTIVE:To compare the efficacy and safety of single doses of quinfamide and secnidazole in the treatment of amoebic non-dysenteric colitis in children. DESIGN:This was a prospective, longitudinal, double-blind, randomised, comparative study. SETTING:The participants were students or relatives of students at two ur...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200020020-00003
更新日期:2000-01-01 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:BACKGROUND AND OBJECTIVES:Dyslipidaemia is a major cardiovascular risk factor associated with type 2 diabetes mellitus. Saroglitazar (ZYH1) is a novel peroxisome proliferator-activated receptor (PPAR) agonist with predominant PPARα and moderate PPARγ activity. It has been developed for the treatment of dyslipidaemia an...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0128-3
更新日期:2013-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The management of patients on vitamin K antagonist therapy who require an invasive procedure is problematic. A randomised, controlled, double-blind clinical trial was designed to compare the efficacy and safety of bemiparin, a low molecular weight heparin (LMWH), with unfractionated heparin (UF...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0141-6
更新日期:2013-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:A new oral antidiabetic drug class, sodium-glucose co-transporter-2 inhibitors (SGLT-2 inhibitors), has been covered by national health insurance in Taiwan since May 2016. This study estimated the impacts of insurance coverage for SGLT-2 inhibitors on the replacement effects of antidiabetic dr...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0689-2
更新日期:2018-12-01 00:00:00