New research commissioned by the National Institute for Health Research's Health Technology Assessment (NIHR HTA) programme suggests that a newer drug for treatment of partial epilepsy is clinically superior to the existing drug of first choice for the condition, while an older drug is better than new for treatment of generalised seizures. A ground breaking clinical trial involving more than 2,000 patients has compared newer drugs for epilepsy with carbamazepine and valproate, which have been widely accepted as the drugs of first choice for patients with partial onset and generalised seizures respectively for the last 20 years. Researchers found that a newer drug, lamotrigine, is clinically superior and is a cost-effective alternative to carbamazepine for the majority of patients diagnosed with partial seizures. However valproate remains the most clinically effective drug for patients with generalised epilepsy.
Epilepsy is the most common neurological condition in the UK affecting up to 1% of the population. It impacts significantly upon the quality of life of patients, but as many as 70% of patients enter long term remission shortly after starting drug therapy. "The last 15 years have seen the licensing of a number of new antiepileptic drugs, but for several reasons previous trials have failed to inform clinical practice or policy," says lead researcher Professor David Chadwick. "Given that the majority of patients who develop epilepsy are treated with single drugs and may continue to take them for many years, it was essential that research was conducted to compare standard and new antiepileptic drugs, to establish which is the best first line treatment."
The multi-centre SANAD trial, conducted by researchers from the University of Liverpool, was the largest trial of its kind. It comprised two arms. In patients with partial epilepsy, carbamazepine was compared to newer drugs gabapentin, lamotrigine and oxcarbazepine and topiramate. In generalised epilepsy, valproate was compared with lamotrigine and topiramate. The study involved patients (both children above the age of five and adults) who had had two or more clinically definite unprovoked epileptic seizures within the past year, and for whom treatment with a single antiepileptic drug was the best option.
Researchers investigated the effect of the different drugs on seizure recurrence, quality of life of patients, and chronic epilepsy, as well as cost-effectiveness. In partial onset seizures, lamotrigine controlled epilepsy for longer than carbamazepine, gabapentin, and topiramate. Lamotrigine was also a cost-effective alternative to carbamazepine for patients with partial seizures.
In patients with idiopathic generalised epilepsy or difficult to classify epilepsy, valproate remains the most clinically effective drug, though topiramate may be a cost-effective alternative for some patients.
"Despite the lack of research evidence there has been a steady rise in the prescribing of newer antiepileptic drugs in recent years. In 2002 new drugs accounted for 69% of the total costs of antiepileptic drugs to the NHS (£99 million of £142 million) so it was vital that research was conducted to allow doctors to make informed decisions about the best first line treatment to use before newer, more expensive drugs became the first choice by default," says Professor Chadwick.
"Its size and its NHS setting mean that the results of SANAD are highly relevant to clinical practice, allowing doctors to make an informed decision about what drugs to prescribe and translating directly into benefit for patients."
The results of the SANAD trial are published in this week's issue of The Lancet. The full report will shortly be published in the acclaimed Health Technology Assessment journal. To register to be alerted by email when the project publishes in full visit http://www.hta.ac.uk/project/1031.asp?src=sanad
1.Twelve per cent and 8% fewer patients experienced treatment failure on lamotrigine than carbazepine, the standard drug, at one and two years after remission respectively.
2.A randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of standard and new antiepileptic drugs (SANAD) is due to be published in full in the Health Technology Assessment journal this autumn.
3.The HTA programme is a programme of the National Institute for Health Research (NIHR) and produces high quality research information about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest of the NIHR programmes, with 360 projects published since its inception in 1993. About 50 are published each year, all available for download free of charge from the website. It is coordinated by the National Coordinating Centre for Health Technology Assessment (NCCHTA), based at the University of Southampton. Visit www.hta.ac.uk for more information.
Epilepsy is the most common neurological condition in the UK affecting up to 1% of the population. It impacts significantly upon the quality of life of patients, but as many as 70% of patients enter long term remission shortly after starting drug therapy. "The last 15 years have seen the licensing of a number of new antiepileptic drugs, but for several reasons previous trials have failed to inform clinical practice or policy," says lead researcher Professor David Chadwick. "Given that the majority of patients who develop epilepsy are treated with single drugs and may continue to take them for many years, it was essential that research was conducted to compare standard and new antiepileptic drugs, to establish which is the best first line treatment."
The multi-centre SANAD trial, conducted by researchers from the University of Liverpool, was the largest trial of its kind. It comprised two arms. In patients with partial epilepsy, carbamazepine was compared to newer drugs gabapentin, lamotrigine and oxcarbazepine and topiramate. In generalised epilepsy, valproate was compared with lamotrigine and topiramate. The study involved patients (both children above the age of five and adults) who had had two or more clinically definite unprovoked epileptic seizures within the past year, and for whom treatment with a single antiepileptic drug was the best option.
Researchers investigated the effect of the different drugs on seizure recurrence, quality of life of patients, and chronic epilepsy, as well as cost-effectiveness. In partial onset seizures, lamotrigine controlled epilepsy for longer than carbamazepine, gabapentin, and topiramate. Lamotrigine was also a cost-effective alternative to carbamazepine for patients with partial seizures.
In patients with idiopathic generalised epilepsy or difficult to classify epilepsy, valproate remains the most clinically effective drug, though topiramate may be a cost-effective alternative for some patients.
"Despite the lack of research evidence there has been a steady rise in the prescribing of newer antiepileptic drugs in recent years. In 2002 new drugs accounted for 69% of the total costs of antiepileptic drugs to the NHS (£99 million of £142 million) so it was vital that research was conducted to allow doctors to make informed decisions about the best first line treatment to use before newer, more expensive drugs became the first choice by default," says Professor Chadwick.
"Its size and its NHS setting mean that the results of SANAD are highly relevant to clinical practice, allowing doctors to make an informed decision about what drugs to prescribe and translating directly into benefit for patients."
The results of the SANAD trial are published in this week's issue of The Lancet. The full report will shortly be published in the acclaimed Health Technology Assessment journal. To register to be alerted by email when the project publishes in full visit http://www.hta.ac.uk/project/1031.asp?src=sanad
1.Twelve per cent and 8% fewer patients experienced treatment failure on lamotrigine than carbazepine, the standard drug, at one and two years after remission respectively.
2.A randomised controlled trial of longer-term clinical outcomes and cost-effectiveness of standard and new antiepileptic drugs (SANAD) is due to be published in full in the Health Technology Assessment journal this autumn.
3.The HTA programme is a programme of the National Institute for Health Research (NIHR) and produces high quality research information about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest of the NIHR programmes, with 360 projects published since its inception in 1993. About 50 are published each year, all available for download free of charge from the website. It is coordinated by the National Coordinating Centre for Health Technology Assessment (NCCHTA), based at the University of Southampton. Visit www.hta.ac.uk for more information.
