This study identified variables associated with discontinuation of LEV due to behavioral abnormalities. Slower titration of LEV should be considered in those patients at higher risk of discontinuing LEV for behavioral reasons.
Summary:Purpose: The objective of this study was to compare the pharmacokinetics and cognitive effects of a new diazepam (DZP) rectal gel (Diastatn) with intravenously administered DZP.Methods: Twenty healthy volunteers were enrolled in a single-blind, randomized, double-dummy, two-period, crossover study. Subjects received either 15 mg of DZP rectal gel or 7.5 mg of DZP by intravenous infusion. Blood samples for DZP and desmethyldiazepam analysis were obtained before the dose and from 3 min to 240 h after the dose. Heart rate and blood pressure were measured over the first 24-h period. Subjects also completed five repetitions of a neuropsychological test battery over the first 8-h period.Results: Diazepam rapidly appeared in plasma after rectal administration, exceeding 200 ng/mL within 15 min and reaching an initial maximum of 373 ng/ml at 45 min and a second maximum of 447 * 91.1 ng/ml at -70 min. The absolute bioavailability of DZP rectal gel was 90.4%. Subjects receiving intravenous DZP were less alert and performed less efficiently on the WAIS Digit Symbol test 6 min after the dose. Subjects receiving DZP rectal gel performed less well on the WAIS Digit Span test 1 h after the dose and required more time to complete the Letter Cancellation and Grooved Pegboard tests 1 and 2 h after drug administration.Conclusions: Diastat@ displayed rapid, consistent absorption and was well tolerated. Alterations in cognition were mild and dissipated within 4 h of drug administration. This new rectal drug-delivery system offers an easy, safe, and bioavailable method to administer DZP.
We have identified clinically relevant risk factors associated with the discontinuation of ZNS. Our findings support the concept that selected patients are relatively more vulnerable to CNS adverse events when exposed to ZNS.
We studied 95 patients who underwent standard anterior temporal lobectomy (ATL) without stimulation mapping of language areas, using neuropsychological parameters of language function preoperatively and 1 year postoperatively [Boston Naming Test and Verbal Fluency, and the Information, Comprehension, Arithmetic, Similarities, Digit Span, and Vocabulary subtests of the Wechsler Adult Intelligence Scale (WAIS)]. Verbal IQ (VIQ), Performance IQ (PIQ), Full-Scale IQ (FSIQ), and Verbal Deviation Quotient were also evaluated, as were parameters of memory function. All patients had hemisphere dominance for language assessed by an intracarotid amytal test. Fifty-three patients had a left dominant (LHDL) ATL with a mean extent of lateral resection of 4.8 cm, and 10 had a left ATL with right or mixed hemisphere dominance (RHDL, MDL). Thirty-two patients had a right nondominant ATL. Seizure outcome was 57 and 59% seizure-free for LHDH and right nondominant group, respectively, 1 year after operation. Comparison of preoperative scores showed the LHDL group to have significantly lower scores than the right nondominant group for several parameters of language function and memory. The group undergoing left dominant ATL showed no significant loss of language function postoperatively and actually showed gains in many parameters. Standard ATL without stimulation mapping of language areas and with conservative lateral resection is safe for long-term language function. In addition, evidence shows preexisting language dysfunction in patients undergoing left dominant ATL.
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