Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0012833 (dizziness)
 9,689 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A brief review of epilepsy as a disease, anti-epileptic drugs (AEDs) and methods of evaluation of AEDs are presented as a background for the assessment of levetiracetam which has been approved by the FDA as add-on therapy for the treatment of partial seizures with or without secondary generalisation in adults. The exact mechanism of action of levetiracetam is not known but its action differs from that of other anti-epileptic drugs. A specific binding site for levetiracetam has been identified and is possibly related to anticonvulsant activity. Levetiracetam offers an effective and broad spectrum treatment of epileptic seizures, partial as well as generalised epilepsy. Levetiracetam has been shown to be effective in genetic and kindled animal models of epilepsy and against chemoconvulsant-induced partial epileptic seizures. Levetiracetam has a near perfect pharmacokinetic profile, with rapid absorption following oral administration, excellent bioavailability, quick attainment of steady-state concentrations, linear kinetics and minimal plasma protein binding. Levetiracetam does not interact with commonly used drugs and other AEDs. In recent Phase III clinical trials, the responder rate was 39.4 - 42.1% on 3000 mg dose, compared with placebo rates of 10.9 - 16.7%. Levetiracetam has a favourable safety profile and the most frequently reported adverse events were somnolence, asthenia and dizziness. Overall, levetiracetam is considered to have several advantages over current AEDs.
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PMID:An assessment of levetiracetam as an anti-epileptic drug. 1106 Jul 65

The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of levetiracetam are reviewed. Levetiracetam is an adjunctive treatment for partial-onset epileptic seizures. This drug inhibits seizure activity via a mechanism that does not involve excitatory or inhibitory neuronal pathways. Oral bioavailability is about 100%, and food does not alter absorption. Levetiracetam is minimally plasma protein bound (10%). Peak time to absorption after oral administration is one hour, and steady state is achieved in two days with twice-daily administration. Three clinical studies have demonstrated levetiracetam's ability to reduce seizure frequency in patients with partial-onset epilepsy. The most commonly reported adverse effects in clinical trials were somnolence, dizziness, infection, and asthenia. The potential for interactions with medications that are hepatically metabolized is minimal. The starting dosage is 500 mg twice a day; the maximum dosage is 3000 mg/day within four weeks. Levetiracetam is effective as an adjunctive treatment of partial-onset epilepsy with or without secondary generalization.
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PMID:Levetiracetam. 1144 76

Levetiracetam is a new antiepileptic drug, structurally and mechanistically dissimilar to other marketed antiepileptic drugs. It is effective in reducing partial seizures in patients with epilepsy, both as adjunctive treatment and as monotherapy. Levetiracetam has many therapeutic advantages for patients with epilepsy. It has favorable pharmacokinetic characteristics (good bioavailability, linear pharmacokinetics, insignificant protein binding, lack of hepatic metabolism, and rapid achievement of steady-state concentrations) and a low potential for drug interactions. Recommended starting dosages are considered to be clinically effective; therefore, patients can have some protection from seizures soon after they begin levetiracetam. The most common adverse effects observed with levetiracetam are mild and include somnolence, asthenia, and dizziness. Clinical experience and data from meta-analyses indicate that levetiracetam is well tolerated, with efficacy comparable or slightly better than that observed with other new antiepileptic drugs. Levetiracetam may be particularly useful in patients who are unresponsive to other antiepileptic drugs, patients receiving drugs with increased potential for drug interactions, or those with hepatic impairment.
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PMID:Levetiracetam: a novel antiepileptic drug. 1171 11

Levetiracetam has recently been licensed in Europe and the U.S.A. for use as an adjunctive agent in partial epilepsy with or without secondary generalization. The mode of action has yet to be elucidated, but may involve a new brain-specific binding site, the ligand for which is unknown. Levetiracetam has a favorable pharmacokinetic profile, with rapid and almost complete oral absorption, almost 100% bioavailability, linear, dose-dependent maximum plasma concentrations and minimal plasma protein binding. Excretion is mainly renal, with most of the drug being eliminated unchanged. Levetiracetam does not have an effect on the major drug-metabolizing hepatic enzymes, and thus is associated with a low incidence of interactions with other antiepileptic drugs (AEDs). These properties make it a well-tolerated drug, with the most common reported side effects being asthenia, somnolence, headache and dizziness. Antiepileptic properties of levetiracetam demonstrated in animal studies have been borne out by large double-blind, placebo-controlled clinical trials, with significantly improved responder rates (>/= 50% reduction in seizure frequency from baseline) and number of seizure- free patients versus placebo. In addition, efficacy appears to be maintained over the long term and no evidence for the development of tolerance to the effects of levetiracetam has been seen. (c) 2001 Prous Science. All rights reserved.
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PMID:Levetiracetam: A new antiepileptic drug for the adjunctive therapy of chronic epilepsy. 1273 64

The Safety of Keppra as Adjunctive Therapy in Epilepsy (SKATE) study is a continuing phase IV open-label evaluation of the antiepileptic drug levetiracetam (Keppra) as an adjunctive therapy in adult patients with uncontrolled partial seizures. The study, which began in April 2000, is scheduled to include 1400 patients from 300 centres in 16 countries. An interim analysis of the first 731 patients from 117 centres in nine countries treated over a 16-week period showed that seizure frequency was reduced by half or more in 49% of patients across all seizure types. A substantial 17.2% of patients achieved complete freedom from seizures. Levetiracetam was well tolerated overall. Adverse events were predominantly mild to moderate and rarely led to discontinuation. The most commonly reported symptoms were asthenia, somnolence, headache and dizziness.
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PMID:The SKATE study: interim analysis. 1291 96

Levetiracetam (LEV) is the most recently licensed antiepileptic drug (AED) for adjunctive therapy of partial seizures. Its mechanism of action is uncertain but it exhibits a unique profile of anticonvulsant activity in models of chronic epilepsy. Three randomised, double-blind, placebo-controlled trials enrolling 904 patients with refractory partial epilepsy have demonstrated the efficacy of LEV as adjunctive therapy, with a responder rate (> or = 50% reduction in seizure frequency) of 28-41%. Long-term efficacy studies suggest retention rates of 60% after one year, with 13% of patients seizure-free for six months of the study and 8% seizure-free for one year. Adverse effects of LEV, including somnolence, lethargy and dizziness, were generally mild and the frequency of incidents was not significantly different between the active treatment and placebo groups in clinical trials. LEV has no clinically significant pharmacokinetic interactions (PKI) with other AEDs, or with commonly prescribed medications. Preliminary data suggest that LEV has efficacy in primary generalised epilepsy and further randomised trials are under way. The combination of potent antiepileptic properties with a relatively mild adverse effect profile makes LEV an attractive adjunctive therapy for partial seizures.
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PMID:Levetiracetam: a new therapeutic option for refractory epilepsy. 1452 64

Levetiracetam (Keppra) was evaluated in a subset of patients aged >/=65 years (n=78) enrolled in a large (n=1030) open-label, phase IV trial (the KEEPER trial). A 4-week dose adjustment was followed by a 12-week evaluation period. An overall median reduction in partial seizures of 80.1% (n=65) was observed. Overall, 76.9% of patients were >/=50% responders, 56.9% were >/=75% responders, and 40.0% were 100% responders. Levetiracetam was well tolerated, with 42.3% of patients reporting one or more adverse events. A total of 15 patients (19.2%) experienced an adverse event that led to discontinuation. Somnolence (n=13,16.7%) and dizziness (n=7,9.0%) were the most commonly reported adverse events. Despite the limitations of the open-label study design, these data provide information regarding the use of levetiracetam as add-on therapy for the treatment of partial-onset seizures in patients >/=65 years of age, including those requiring concomitant medications.
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PMID:Use of levetiracetam in a population of patients aged 65 years and older: a subset analysis of the KEEPER trial. 1469 4

This review discusses the safety and tolerability of levetiracetam, as presented by the available literature, with attention paid to special populations. In Phase II/III trials, the adverse effects occurring more commonly in the treatment groups versus the placebo group were; somnolence (14.8 versus 8.4%), asthenia (14.7 versus 9.1%), infection (primarily common cold) (13.4 versus 7.5%), and dizziness (8.8 versus 4.1%). Adverse events usually appear within the first month after treatment initiation, are not dose-dependent, are mostly mild-to-moderate, generally resolve without medication withdrawal, and are transient when the medication is stopped. No significant changes in haematology and chemistry profiles or weight occurred. Hypersensitivity reactions were rare and no idiosyncratic event has been reported. Open-label studies have added patient data with other epileptic syndromes and from a wider patient pool, such as children and patients with prior psychiatric history. These studies have supported initial safety findings, but have reported increased behavioural adverse events in children and patients with a history of prior behavioural problems. Levetiracetam is proving to be safe and well-tolerated. So far, it appears to have a favourable safety profile in special populations, such as children, the elderly, and patients with hepatic dysfunction. Preliminary data in pregnancy are promising, but more data are needed on the impact of levetiracetam on the developing fetus and pharmacokinetic alterations caused in pregnancy. Adjustments in dosing are required for decreases in renal clearance.
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PMID:Levetiracetam safety profiles and tolerability in epilepsy patients. 1533 97

The objective of this study was to determine whether levetiracetam warrants further investigation as a treatment of essential tremor (ET). The authors conducted a 4 -week, open label trial of levetiracetam (Keppra, UCB Pharmaceuticals) in 10 patients diagnosed with ET. Patients were assessed with the complete Tremor Rating Scale (TRS), global impression measures, and adverse events at baseline, after 2 weeks low-dose 500 mg bid and at 4 weeks high-dose 1500 mg bid. All 10 subjects (mean age, 68.6 +/- 7.4 years; seven men, 9 with a positive family history of ET) completed the trial. The TRS observed tremor section modestly improved in 8 subjects (P <0.01). The TRS writing section, water pouring section, and activities of daily living section did not change, and visual analog scores did not change. Subjects rated themselves as "much improved" (n=3), moderately improved (n=1), unchanged (n=1), and mildly worse (n=5). Adverse events included dizziness (n=2), sedation (n=1), and nervousness (n=1). Levetiracetam was well tolerated but failed to improve tremor consistently in this small trial.
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PMID:An open-label pilot study of levetiracetam for essential tremor. 1561 31

Levetiracetam (LEV) is increasingly used as adjunctive anticonvulsant therapy because of apparent low toxicity. Somnolence, asthenia, headache, dizziness, and nervousness are the most frequently reported side effects (1). We describe a patient, predisposed to the development of the syndrome of inappropriate antidiuretic hormone secretion (SIADH), in whom hyponatremia developed after two challenges of LEV.
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PMID:Hyponatremia associated with repeated use of levetiracetam. 1594 44


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