1.Lamotrigine monotherapy in children with epilepsy: a systematic review.
Yan-Tao LIU ; Ling-Li ZHANG ; Liang HUANG ; Li-Nan ZENG
Chinese Journal of Contemporary Pediatrics 2016;18(7):582-588
OBJECTIVETo investigate the efficacy and safety of lamotrigine monotherapy in children with epilepsy via a systematic review.
METHODSPubMed, Cochrane, CNKI, VIP, CBM, Wanfang Data were searched for randomized controlled trials (RCTs) of lamotrigine monotherapy in children with epilepsy. Literature screening, data extraction, and quality assessment were performed according to the method recommended by Cochrane Collaboration. RevMan 5.2 software was used to conduct the Meta analysis.
RESULTSA total of 9 RCTs involving 1 016 participants were included. Lamotrigine yielded a significantly lower complete control rate of seizure than ethosuximide, but the complete control rate of seizure showed no significant differences between lamotrigine and carbamazepine/sodium valproate. Patients treated with lamotrigine had a significantly lower incidence rate of adverse events than those treated with carbamazepine, but the incidence rate of adverse events showed no significant differences between patients treated with lamotrigine and sodium valproate/carbamazepine. The drop-out rate showed no significant differences between the three treatment groups.
CONCLUSIONSLamotrigine is an ideal alternative drug for children who do not respond to traditional antiepileptic medication or experience significant adverse reactions; however, more high-quality RCTs with a large sample size and a long follow-up time are needed to confirm these conclusions.
Anticonvulsants ; therapeutic use ; Epilepsy ; drug therapy ; Humans ; Randomized Controlled Trials as Topic ; Triazines ; adverse effects ; therapeutic use
2.Safety and tolerability of Vardenafil.
National Journal of Andrology 2006;12(9):857-860
This paper reviewed the safety and tolerability of vardenafil in the treatment of erectile dysfunction (ED), including the general, cardiovascular and ocular safety. Results from clinical trials and practice experience demonstrated that vadenafil had good safety and tolerability, whether for general ED population or for difficult-to-treat ED patients, whether as short-term treatment or as long-term therapy.
Drug Tolerance
;
Erectile Dysfunction
;
drug therapy
;
Humans
;
Imidazoles
;
adverse effects
;
therapeutic use
;
Male
;
Middle Aged
;
Phosphodiesterase Inhibitors
;
adverse effects
;
therapeutic use
;
Piperazines
;
adverse effects
;
therapeutic use
;
Sulfones
;
adverse effects
;
therapeutic use
;
Treatment Outcome
;
Triazines
;
adverse effects
;
therapeutic use
;
Vardenafil Dihydrochloride
3.Valproic acid versus lamotrigine as a monotherapy for absence epilepsy in children.
Tie-Shuan HUANG ; Jin-Lan ZHU ; Bing LI ; Yan HU ; Li CHEN ; Jian-Xiang LIAO
Chinese Journal of Contemporary Pediatrics 2009;11(8):653-655
OBJECTIVETo compare the efficacy of valproic acid (VPA) and lamotrigine as a monotherapy for absence epilepsy in children.
METHODSA randomized, open-label design was used. Childhood absence epilepsy was diagnosed based on the presence of typical seizures and video-EEG findings. Eligible patients were randomly treated with VPA or lamotrigine. All patients were followed up for 12 months.
RESULTSForty-five out of 48 eligible children completed the study. There were 23 children in the VPA group and 22 children in the lamotrigine group. Seventeen children were seizure-free in the VPA group 12 months after treatment. Fifteen out of the 17 children showed normal EEG (no epileptic-formed discharge). Twelve children were seizure-free in the lamotrigine group 12 months after treatment. The proportion showing normal EEG in the lamotrigine group (6/22, 27.3%) was significantly lower than that in the VPA group (15/23, 65.2%) (P<0.05). Severe adverse effects were not found in both groups.
CONCLUSIONSBoth VPA and lamotrigine are safe and efficacious for treatment of absence seizures in children. VPA appears to be better than lamotrigine in tapering epileptic-formed discharge.
Anticonvulsants ; therapeutic use ; Child ; Child, Preschool ; Electroencephalography ; Epilepsy, Absence ; drug therapy ; physiopathology ; Female ; Humans ; Male ; Triazines ; adverse effects ; therapeutic use ; Valproic Acid ; adverse effects ; therapeutic use
4.Lamotrigine in pregnancy: safety profile and the risk of malformations.
Prakash ; L V PRABHU ; M A NASAR ; R RAI ; S MADHYASTHA ; G SINGH
Singapore medical journal 2007;48(10):880-883
The use of antiepileptic drugs in pregnancy always presents challenges to doctors and their patients as it may have deleterious effects on the developing embryo. Lamotrigine is most commonly-prescribed drug among the newer antiepileptic drugs; hence, it has been selected for the present review. A number of studies pertaining to the safety of lamotrigine use during pregnancy have been reported, with differing results. Contradictory results have been reported in animals regarding lamotrigine teratogenicity, and human studies have also proven inconclusive. In many countries, human pregnancy registries are maintained to establish the safety of antiepileptic drugs during pregnancy, as all the different suggestions favour some over others, with specific antiepileptic combinations still being questioned. It is our hope that the present work may integrate the available disparate relevant facts into a directed effort towards minimising the risk of foetal compromise.
Abnormalities, Drug-Induced
;
Animals
;
Anticonvulsants
;
adverse effects
;
therapeutic use
;
Epilepsy
;
drug therapy
;
Female
;
Folic Acid Deficiency
;
chemically induced
;
Humans
;
Pregnancy
;
Teratogens
;
pharmacokinetics
;
pharmacology
;
Triazines
;
adverse effects
;
therapeutic use
5.Treatment of erectile dysfunction after radical retropubic prostatectomy with PDE5 inhibitor.
National Journal of Andrology 2005;11(9):708-712
The rate of erectile dysfunction after radical retropubic prostatectomy is from 10% to 100%. The prevalence of erectile dysfunction after nerve-sparing radical prostatectomy is more than one third. In the patients who had undergone bilateral NS, 72% responded to sildenafil, 71.7% and 59.7% responded to 20 mg and 10 mg of vardenafil respectively. For all randomized patients who received tadalafil, the mean percentage of successful penetration attempts was 54% and the mean percentage of successful intercourse attempts was 41%. For the subgroup with evidence of postoperative tumescence these values were 69% and 52%, respectively. No head-to-head trials have been performed with sildenafil, vardenafil and tadalafil in treatment of erectile dysfunction after radical prostatectomy.
Carbolines
;
therapeutic use
;
Erectile Dysfunction
;
drug therapy
;
etiology
;
Humans
;
Imidazoles
;
therapeutic use
;
Male
;
Phosphodiesterase Inhibitors
;
therapeutic use
;
Piperazines
;
therapeutic use
;
Prostatectomy
;
adverse effects
;
Purines
;
therapeutic use
;
Sildenafil Citrate
;
Sulfones
;
therapeutic use
;
Tadalafil
;
Triazines
;
therapeutic use
;
Vardenafil Dihydrochloride
6.Cardiovascular safety of vardenafil.
National Journal of Andrology 2004;10(10):790-793
Vardenafil is a new type of PDE5 inhibitor (PDE5I) with great inhibiting potential on PDE5 (IC50: 0.01 nmol/L) for enhancing erectile function. International and domestic clinical studies showed it to be safe and effective in treating ED with mild temporary side effects such as headache, dizziness, flushing and rhinitis. In this paper we reviewed the cardiovascular safety of vardenafil. Studies showed that clinical dosage of vardenafil could decrease the systematic arterial blood pressure mildly (< 10 mmHg) , however, it did not interact in a potentially hazardous way with antihypertensive or antianginal therapy, with the exception of organic nitrates. Vardenafil slightly prolonged the QT interval (QTc) in cardiac repolarization, but with no evidence to prove that it could cause arrhythmia in clinical studies. The rates and categories of cardiovascular adverse events of vardenafil therapy were not significantly different from placebo in 5 clinical trials. Present studies demonstrated that clinical dosage of vardenafil appeared generally well tolerated in most patients with chronic and stable cardiovascular disease and it was an ideal drug for the first line treatment of ED.
Adult
;
Blood Pressure
;
drug effects
;
Erectile Dysfunction
;
drug therapy
;
Heart
;
drug effects
;
Humans
;
Imidazoles
;
adverse effects
;
therapeutic use
;
Male
;
Middle Aged
;
Phosphodiesterase Inhibitors
;
adverse effects
;
therapeutic use
;
Piperazines
;
adverse effects
;
therapeutic use
;
Safety
;
Sulfones
;
adverse effects
;
therapeutic use
;
Triazines
;
adverse effects
;
therapeutic use
;
Vardenafil Dihydrochloride
7.Efficacy and safety of vardenafil in the treatment of erectile dysfunction in men with hypertension.
National Journal of Andrology 2006;12(10):953-956
The prevalence of erectile dysfunction (ED) is higher in hypertension patients than in non-hypertension men. Because doctors worry about the severe adverse events of drug combination, they tend to be reluctant to prescribe ED medicines for patients. Vardenafil, as a novel and highly selective phosphodiesterase 5 inhibitor, has been proved by many clinical trials to be quite safe for the cardiovascular system. A recent large-scale clinical trial showed that vardenafil could improve erectile function in ED men with hypertension, with sure safety and no significant clinical changes in the index of hypertension or heart rate.
Adult
;
Aged
;
Erectile Dysfunction
;
complications
;
drug therapy
;
Humans
;
Hypertension
;
complications
;
Imidazoles
;
adverse effects
;
therapeutic use
;
Male
;
Middle Aged
;
Phosphodiesterase Inhibitors
;
adverse effects
;
therapeutic use
;
Piperazines
;
adverse effects
;
therapeutic use
;
Sulfones
;
adverse effects
;
therapeutic use
;
Treatment Outcome
;
Triazines
;
adverse effects
;
therapeutic use
;
Vardenafil Dihydrochloride
8.Efficacy and safety of oral vardenafil in the treatment of erectile dysfunction.
Tianming PAN ; Shenrong ZHUANG ; Hongming MA ; Kai HONG ; Wenhao TANG
National Journal of Andrology 2004;10(12):955-959
OBJECTIVETo evaluate the efficacy and safety of vardenafil on men with erectile dysfunction (ED) of various etiologies.
METHODSA total of 88 men with mild to severe erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, fixed-dose trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil.
RESULTSThis study indicated that vardenafil dosages of 5, 10 and 20 mg were significantly superior to placebo for the treatment of ED, on the basis of the primary study endpoints of the EF domain score of the IIEF, diary-recorded success rates for penetration and maintenance of erection during the intercourse and the GAQ. Vardenafil was well tolerated. The incidence of adverse events was higher for vardenafil than for placebo.
CONCLUSIONOral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies.
Administration, Oral ; Adult ; Aged ; Double-Blind Method ; Erectile Dysfunction ; drug therapy ; Humans ; Imidazoles ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Piperazines ; adverse effects ; therapeutic use ; Sulfones ; adverse effects ; therapeutic use ; Triazines ; adverse effects ; therapeutic use ; Vardenafil Dihydrochloride
9.Efficacy and safety of vardenafil in men with erectile dysfunction and depression.
National Journal of Andrology 2004;10(11):876-879
Erectile dysfunction (ED) usually exists in combination with depression in men. The comorbidity of the two diseases may bring more troubles to patients, so it is important to find an effective treatment. Recently, DRIVER (Depression Related Improvement with Vardenafil for Erectile Response) trials showed that, phosphodiesterase 5 (PDE 5) inhibitor vardenafil could improve not only erectile function but also depressive symptoms and quality of life in men with ED and depression. Vardenafil was generally safe and well tolerated.
Adult
;
Aged
;
Aged, 80 and over
;
Depressive Disorder
;
complications
;
drug therapy
;
Erectile Dysfunction
;
complications
;
drug therapy
;
Humans
;
Imidazoles
;
adverse effects
;
therapeutic use
;
Male
;
Middle Aged
;
Phosphodiesterase Inhibitors
;
adverse effects
;
therapeutic use
;
Piperazines
;
adverse effects
;
therapeutic use
;
Quality of Life
;
Sulfones
;
adverse effects
;
therapeutic use
;
Treatment Outcome
;
Triazines
;
adverse effects
;
therapeutic use
;
Vardenafil Dihydrochloride
10.Efficacy and safety of vardenafil for men with erectile dysfunction.
National Journal of Andrology 2004;10(9):704-710
Vardenafil is an oral, potent, highly selective phosphodiesterase 5 (PDE5) inhibitor. It improves erectile function significantly regardless of the etiology and severity of erectile dysfunction (ED) or the age of the patients. Its onset time leading to successful intercourse is as short as 10 minutes after administered orally, and in most patients it works persistently. Adverse reactions are generally transient and mild to moderate in nature. So vardenafil is both effective and safe for men with ED.
Double-Blind Method
;
Erectile Dysfunction
;
drug therapy
;
Humans
;
Imidazoles
;
adverse effects
;
therapeutic use
;
Male
;
Middle Aged
;
Phosphodiesterase Inhibitors
;
adverse effects
;
therapeutic use
;
Piperazines
;
adverse effects
;
therapeutic use
;
Sulfones
;
adverse effects
;
therapeutic use
;
Treatment Outcome
;
Triazines
;
adverse effects
;
therapeutic use
;
Vardenafil Dihydrochloride