Old versus new antiepileptic drugs: the SANAD study

Perucca, Emilio; Alexandre, Veriano; Tomson, Torbjörn

doi:10.1016/s0140-6736(07)61149-0

Cited by 19 publications

(7 citation statements)

References 5 publications

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“…The trial reported lamotrigine to be most effective when compared with carbamazepine and other new AEDs in focal seizures and valproate to be more effective than topiramate and lamotrigine in generalized and unclassified epilepsies. It is also now known that new AEDs are not completely free of severe adverse effects, particularly the cognitive and psychiatric adverse effects associated with topiramate and levetiracetam, but have similar efficacy as older AEDs in newly diagnosed patients [32]. To our knowledge, this is the first study in India that evaluated the impact of specific pharmacotherapy characteristics on QOL in PWE as well as the tolerability profile of AED therapy in a naturalistic setting.…”

Section: Qol In Pwementioning

confidence: 97%

Antiepileptic Drugs and Quality of Life in Patients with Epilepsy: A Tertiary Care Hospital-Based Study

George¹,

Kulkarni²,

Sarma

2015

Value in Health Regional Issues

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Section: Qol In Pwementioning

confidence: 97%

Antiepileptic Drugs and Quality of Life in Patients with Epilepsy: A Tertiary Care Hospital-Based Study

George¹,

Kulkarni²,

Sarma

2015

Value in Health Regional Issues

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“…In this trial, choice of AED, choice of doses, and duration of treatment were dependent on the clinician's usual practice, and the trial simply determined which of the 2 management policies (immediate treatment or deferred treatment) had the best outcomes in a setting that mimicked routine care. A pragmatic approach was also applied in the Standard versus New Antiepileptic Drugs studies, even though these studies had shortcomings in trial design that may have adversely affected generalizability . Because clinical management in pragmatic trials resembles routine care, these trials tend to be easily accepted by physicians and patients alike, thereby facilitating enrolment of large sample sizes .…”

Section: Nonregulatory Trialsmentioning

confidence: 99%

“…A pragmatic approach was also applied in the Standard versus New Antiepileptic Drugs studies, 49,50 even though these studies had shortcomings in trial design that may have adversely affected generalizability. 51 Because clinical management in pragmatic trials resembles routine care, these trials tend to be easily accepted by physicians and patients alike, thereby facilitating enrolment of large sample sizes. [48][49][50] However, for open-label studies, lack of masking can introduce bias in the assessment of outcomes.…”

Section: Comparative Effectiveness Trialsmentioning

confidence: 99%

From clinical trials of antiepileptic drugs to treatment

Perucca

2018

Epilepsia Open

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SummaryRational prescribing should be based on the assessment of high‐quality evidence about the benefits and risks of available treatment options. Because clinical trials, particularly randomized controlled trials (RCTs), provide the best source of evidence, their design and results need to be carefully scrutinized. The majority of RCTs of antiepileptic drugs (AEDs) have been designed to address regulatory requirements, and generally they involve restrictive eligibility criteria, rigid dosing schemes, short duration of follow‐up, and comparison with placebo rather than standard treatments. Although these studies have high internal validity, they are conducted in a setting that is distant from routine clinical practice and therefore their usefulness in guiding treatment decisions is limited. Information more directly applicable to clinical practice can be derived from a relatively small number of comparative effectiveness monotherapy RCTs, although the design of some of these studies was probably biased in favor of the sponsor's product. Alarmingly, there is a paucity of well‐designed trials in epilepsy syndromes other than focal epilepsies, and no RCTs at all in most of the less common epileptic syndromes of infancy and childhood. In the light of these shortcomings, there is scope for re‐assessing regulatory requirements to facilitate generation of data more directly applicable to the routine clinical setting. Likewise, research‐funding organizations should be sensitized about the lack of adequate evidence to guide therapeutic practice in epilepsy, and the need to promote high‐quality comparative effectiveness trials. Future prospective pragmatic trials may benefit from the increasingly widespread availability of electronic health records.

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“…In fact, even large cohort studies often present data on mix of newly diagnosed and chronic patients that are obviously representative of the general population but bring limited information on outcomes of newly diagnosed patients. The SANAD trial represented a first attempt to identify pragmatic algorithms of treatment in newly diagnosed patients [15] but it was heavily criticised in terms of methodology and significance of their results [16][17][18].…”

Section: Discussionmentioning

confidence: 99%

Third generation antiepileptic drug monotherapies in adults with epilepsy

Mula

2016

Expert Review of Neurotherapeutics

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Introduction: Drugs marketed during the last few years (i.e. Lacosamide, Ruifinamide, Eslicarbazepine acetate, Brivaracetam and Perampanel) are increasingly regarded as third generation AEDs. This paper presents available data about monotherapy with third generation drugs and on-going clinical trials with special attention to the existing debate about monotherapy license in epilepsy.Areas covered: References were identified by searches of Medline/PubMed. In addition, currently active studies for these AEDs were identified in the ClinicalTrials.gov database. Expert commentary:Results of studies on Eslicarbazepine acetate and Lacosamide clearly suggest good efficacy and tolerability. The selective pharmacological profile, the lack of interactions, the good tolerability with low propensity for cognitive side effects and the availability of different pharmacological formulations represent evident advantages. Although third generation monotherapies are quite promising, long-term safety data is needed in order to understand how these compounds will place in the current armamentarium.

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Old versus new antiepileptic drugs: the SANAD study

Cited by 19 publications

References 5 publications

Antiepileptic Drugs and Quality of Life in Patients with Epilepsy: A Tertiary Care Hospital-Based Study

Antiepileptic Drugs and Quality of Life in Patients with Epilepsy: A Tertiary Care Hospital-Based Study

From clinical trials of antiepileptic drugs to treatment

Third generation antiepileptic drug monotherapies in adults with epilepsy

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