NEWS HIGHLIGHTS
Published Studies Related to Phenytoin
Safety and feasibility of switching from phenytoin to levetiracetam monotherapy for glioma-related seizure control following craniotomy: a randomized phase II pilot study. [2009.07]
Seizures are common in patients with gliomas, and phenytoin (PHT) is frequently used to control tumor-related seizures. PHT, however, has many undesirable side effects (SEs) and drug interactions with glioma chemotherapy...
Lorazepam versus diazepam-phenytoin combination in the treatment of convulsive status epilepticus in children: A randomized controlled trial. [2009.03.16]
BACKGROUND: Convulsive status epilepticus demands urgent and appropriate management with anticonvulsants. Intravenous diazepam is an established drug in the management of convulsive status epilepticus in adults as well as in children. The efficacy of intravenous lorazepam has not been well established in children. OBJECTIVE: To determine whether intravenous lorazepam is as efficacious as diazepam-phenytoin combination in the treatment of convulsive status epilepticus in children. STUDY DESIGN: Randomized controlled trial... CONCLUSION: Lorazepam is as efficacious and safe as diazepam-phenytoin combination. We recommend use of lorazepam as a single drug to replace the two drug combination of diazepam-phenytoin combination to control the initial seizure in pediatric convulsive status epilepticus.
Ineffectiveness of folic acid supplementation against phenytoin-induced decrease in salivary immunoglobulin A concentration of epileptic patients. [2008]
CONCLUSIONS: According to these results, folic acid supplementation does not seem to have the efficacy to ameliorate phenytoin-induced salivary IgA hyposecretion. (c) 2008 S. Karger AG, Basel
Topical phenytoin solution for treating pressure ulcers: a prospective, randomized, double-blind clinical trial. [2007.11]
STUDY DESIGN: Prospective, randomized, double-blind clinical trial.Objectives:To evaluate the efficacy of topical phenytoin solution in treating pressure ulcers among patients with spinal cord disorders and to evaluate the systemic absorption of topical phenytoin. SETTING: Physical Medicine and Rehabilitation Unit, Christian Medical College, Vellore, India... CONCLUSIONS: Phenytoin solution is a safe topical agent that accelerates healing of pressure ulcers. However, its efficacy is only slightly more than normal saline treatment.
Phenytoin as an augmentation for SSRI failures: a small controlled study. [2006.11]
BACKGROUND: Lithium augmentation of antidepressant effects in patients unimproved on antidepressants is well documented. We hypothesized that phenytoin, reported to have antimanic, antidepressant and prophylactic effects on affective disorder, might also augment in SSRI failures... CONCLUSIONS: Lithium's ability to augment in antidepressant failures may not be shared with the anticonvulsant mood stabilizers.
Clinical Trials Related to Phenytoin
Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin� Kapseals� 100 mg [Completed]
The objective of this study was to investigate the steady-state bioequivalence of Mylan's
extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg
(3x100mg), under both fasting and fed conditions.
Phenytoin as an Augmentation for SSRI Failures [Completed]
About two-thirds of depressed patients respond to a standard course of serotonin specific
reuptake inhibitor (SSRI's) within 3-4 weeks. While some clinicians advise continued
watchful waiting after this time or switch to a different reuptake-blocker based
antidepressant, result of such conservative strategies are usually disappointing. For severe
depression electroconvulsive therapy (ECT) is an option and for atypical depressions
monoamine oxide inhibitors (MAO) inhibitors often give relief at this point. A unique
strategy with both theoretical and practical implications is lithium augmentation (Fava et
al, 1994). Addition of lithium to SSRI failures at 3-4 weeks is consistently and sometimes
dramatically found to be helpful. This is considered true even by those authors who advocate
use of lithium under usual circumstances only in bipolar patients.
Lithium in recent years has been joined as a mood stabilizer by carbamazepine and valproate.
Phenytoin, ignored for many years as a possible anticonvulsant mood stabilizer, has been
recently reported in double-blind controlled trials to be anti-manic (Mishory et al, 2000)
and also prophylactic in BP disorder (Mishory et al, 2003).
Data on mood stabilizers other than lithium as augmentors in SSRI failures are sparse.
Carbamazepine (Steinacher et al, 2002) and valproate (Barbee et al, 2002) have been used.
Given our recent preliminary results of phenytoin's efficacy in unipolar depression (Nemets
et al, 2005) and its analogy to lithium as a mood stabilizer, it seems important to study
phenytoin as a possible augmentation of SSRI failures.
We have published a negative study previously of inositol as an augmentation of SSRI
failures, enrolling forty-two patients over two years (Nemets et al, 1999). Antidepressant
failures are easier to recruit from referring physicians in our center than are untreated
patients, whom clinicians are reluctant to refer for new drug studies given the adequacy of
standard treatment in 2/3 of them. Thus we estimate that we could enroll 20 patients per
year in such a study. Survey of the literature of Li augmentation suggests that 40 phenytoin
vs. 40 placebo should give adequate power to detect a significant phenytoin effect if the
phenytoin effect is similar to that of lithium.
An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy. [Completed]
The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and
chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb
34714 administration on the steady-state plasma levels of phenytoin.
Dilantin Levels With Continuous Delivery of Enteral Feedings - A Pilot Study [Terminated]
It is unclear how enteral nutrition via a feeding tube should be given when a patient is
receiving enteral Dilantin. Some caregivers hold the feedings for one hour before and one
hour after the Dilantin dose to insure adequate absorption of the medication and some
caregivers think that the feedings do not need to be interrupted.
Hypothesis: Dilantin levels will remain therapeutic when enteral nutrition is given
continuously during the administration of enteral Dilantin.
The objective of this study is to determine Dilantin levels when enteral feedings are given
by the continuous method. Thirty patients will be studied. When Dilantin levels are in the
therapeutic range for 2 consecutive days on interrupted feedings (baseline), the patient will
be switched to continuous feedings uninterrupted for the medication, for 7 days. Dilantin
levels will be checked daily and if the levels become subtherapeutic an intravenous (IV)
bolus of Dilantin will be given and the enteral dose will be increased (doses determined by
primary caregiver). Serum albumin will be measured at baseline and at the beginning and end
of each week, in order to calculate free Dilantin.
Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma [Completed]
The purpose of this study was to determine whether antiepileptic drug phenytoin is effective
in the treatment of chronic asthma in children.
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