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 trials of lamotrigine monotherapy compared with carbamazepine and phenytoin, respectively, and one open randomised trial comparing lamotrigine with carbamazepine. The results of the three trials were pooled for comparison of tolerability. SETTING:Multicentre in Europe. PATIENTS:Adult patients (>12 years of age) with newly diagnosed partial seizures (with or without secondary generalisation) and primary generalised tonic-clonic seizures (n = 443 patients on lamotrigine, n = 246 on carbamazepine, n = 95 on phenytoin). RESULTS:Comparable efficacy was demonstrated between lamotrigine and both carbamazepine or phenytoin. The time to withdrawal survival analysis supported a significant difference in favour of lamotrigine [hazard ratio 1.57 (95% CI 1.07 to 2.31)] in the double-blind trial. Overall, twice the proportion of patients withdrew from carbamazepine or phenytoin because of adverse events (19.1 and 18.9%, respectively) compared with lamotrigine (9.5%). Lamotrigine was particularly well tolerated with regard to adverse effects affecting the central nervous system. Rash was the most common adverse event necessitating discontinuation of each drug, the rates being very similar across treatment groups (6.1% on lamotrigine, 8.9% on carbamazepine, 5.3% on phenytoin). The rate of rash resulting in withdrawal of lamotrigine was clearly related to the dose escalation employed in the different trials during the first month of therapy. CONCLUSIONS:Lamotrigine is an effective monotherapy treatment for adult patients with newly diagnosed epilepsy, and is better tolerated than either carbamazepine or phenytoin monotherapy. The incidence of rash requiring withdrawal of lamotrigine is related to dose escalation (2.2% of patients withdrawing when the recommended escalation was followed).
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Mullens ELdoi
10.2165/00044011-199816020-00005subject
Has Abstractpub_date
1998-01-01 00:00:00pages
125-33issue
2eissn
1173-2563issn
1179-1918pii
160205journal_volume
16pub_type
杂志文章abstract:BACKGROUND AND OBJECTIVES:Oxycodone tamper resistant (OTR) is a new extended-release abuse-deterrent formulation providing improvements in the tamper resistant characteristics. This study aimed to investigate the pharmacokinetic properties of the new OTR tablets and evaluate the bioequivalence of oxycodone from OTR and...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-019-00870-w
更新日期:2020-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This study was performed in healthy Chinese subjects to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of a novel injection formulation of dexlansoprazole in the context of single and multiple administration, compared with the original lansoprazole injection. METHODS:H...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-019-00824-2
更新日期:2019-10-01 00:00:00
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
更新日期:2005-01-01 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:BACKGROUND AND OBJECTIVE:Clinicians must choose between an increasing number of medications for the treatment of pulmonary arterial hypertension (PAH) with different routes of administration, adverse effects, costs and efficacies. We constructed a decision analysis to help inform treatment choices in PAH. METHODS:We c...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11317820-000000000-00000
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Recent data suggest that P-glycoprotein may be involved in cellular transport of lacosamide. OBJECTIVE:To investigate potential drug-drug interactions (DDIs) between lacosamide and digoxin, this phase I, multiple-dose, randomised, double-blind, placebo-controlled, crossover trial assessed the pharmacokineti...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-014-0180-7
更新日期:2014-05-01 00:00:00
abstract::The Editor-in-Chief has retracted this article because two of the three studies [1, 2] included in the meta-analysis (cited as references 11 and 12) have been retracted due to fabrication of the data, which has rendered the results of this meta-analysis invalid. ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,撤回出版物
doi:10.1007/s40261-018-0643-3
更新日期:2018-05-01 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
pub_type: 杂志文章
doi:10.2165/00044011-200525100-00004
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-generation tyrosine kinase inhibitor (TKI) imatinib or the second-generation TKIs dasatinib or nilotinib. Thanks to the efficacy of TKIs, CML has switched from a fatal to a 'chronic' pathology, and ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0676-7
更新日期:2018-09-01 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::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
更新日期:1998-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the effectiveness and safety of amlodipine in two cohorts of hypertensive patients, one newly diagnosed and the other previously diagnosed but not controlled with drug therapy, and to assess the risk factors for the entire sample at the outset of the study. PATIENTS AND DESIGN:We designed a postm...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323120-00001
更新日期:2003-01-01 00:00:00
abstract::Epilepsy is common in children and adolescents where its prevalence is 3.2-5.5/1000. About one-third of patients also have attention deficit hyperactivity/impulsivity disorder (ADHD). The possible relationship between epilepsy and ADHD is still unclear, and ADHD symptoms (such as inattention, hyperactivity, behavioral...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-017-0585-1
更新日期:2018-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Cerebral vasospasm is a common and serious complication of aneurysmal subarachnoid haemorrhage (SAH). Many studies have revealed a role of inflammation in the development of cerebral vasospasm. This study aimed to investigate whether topically administered dexamethasone could attenuate vasospas...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/00044011-200727120-00004
更新日期:2007-01-01 00:00:00
abstract:OBJECTIVE:To estimate the cost effectiveness of venlafaxine compared with generic fluoxetine and generic amitriptyline used in major depressive disorder in primary care in the UK. METHODS:A decision-tree model for the treatment of major depressive disorder was constructed using a Delphi panel. The tree was populated w...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200929030-00004
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Ultra-long-acting insulin degludec (DEG) has a longer duration of action and less daily variability relative to other basal insulin (BI), and thus may benefit patients with type 1 diabetes mellitus (T1DM). We examined the impact of switching BI to DEG on glycemic control and insulin dose in T1...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0541-0
更新日期:2017-09-01 00:00:00
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
更新日期:1997-06-01 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::None of the available antiemetics is entirely effective, perhaps because most of them act through the blockade of one receptor. There is a possibility that a combination of antiemetics with different sites of activity would be more effective than one drug alone for prophylaxis against postoperative nausea and vomiting...
journal_title:Clinical drug investigation
pub_type: 杂志文章,收录出版,评审
doi:10.2165/00044011-200222090-00001
更新日期:2002-09-01 00:00:00
abstract:BACKGROUND:Warfarin is a commonly used oral anticoagulant and its interaction with other drugs can result in serious thrombotic or bleeding events. Currently, there is no definitive evidence on the possibility of an interaction between warfarin and oseltamivir. OBJECTIVE:The objective of this study was to investigate ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11595860-000000000-00000
更新日期:2012-02-01 00:00:00
abstract:BACKGROUND:Although some evidence suggests that women may be at greater risk for hypoglycemia, no conclusion has been reached, and female sex has not been taken into account in antidiabetic drug-induced hypoglycemia. This study aimed to determine whether females are at a higher risk of sulfonylurea (SU)-associated hypo...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0314-6
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Oral contraceptives (OCs) are one of the most commonly used classes of drugs worldwide. A case of neutropenia and associated infections in a young woman using OCs that settled after discontinuation and reappeared upon re-challenge, has led us to investigate a potential association between oral contraceptives...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-019-00818-0
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0556-6
更新日期:2017-10-01 00:00:00
abstract:BACKGROUND:α(1)-Antitrypsin deficiency (α-ATD) is a disorder inherited in an autosomal recessive pattern, with co-dominant alleles known as the protease inhibitor system (Pi). The main function of α(1)-antitrypsin (α-AT) is to protect the lungs against a powerful elastase released from neutrophil leucocytes. α-ATD typi...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11631920-000000000-00000
更新日期:2012-05-01 00:00:00
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
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Statin-induced changes in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) are unrelated. Many patients initiated on statins experience a paradoxical decrease in HDL-C. The aim of this study was to evaluate the association between a decrease in HDL-C...
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:BACKGROUND AND OBJECTIVES:Tegoprazan is one of the potassium-competitive acid blockers (P-CABs). It exhibits its anti-secretory effects by competitively and reversibly blocking the availability of K+ of the H+, K+-ATPase. This study was designed to investigate the safety and pharmacokinetics of tegoprazan in healthy Ch...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00986-4
更新日期:2021-01-01 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:Cancer pain affects patients at all stages of the disease and there are clear guidelines for its management. Morphine is considered the first-choice strong opioid in the treatment of moderate-to-severe pain; however, numerous studies have shown that oxycodone controlled-release (CR) has a simi...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200828070-00001
更新日期:2008-01-01 00:00:00
abstract::Androgenetic alopecia (AGA) is characterized by non-scarring follicle miniaturization. Despite the success of approved therapies, commonly reported side effects and the need for continual use has led to the investigation of alternative therapies. The aim of this paper is to critically review the success of off-label, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-00743-8
更新日期:2019-03-01 00:00:00