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PubMed2005

A medication screening trial evaluation of reserpine, gabapentin and lamotrigine pharmacotherapy of cocaine dependence.

AIMS: To conduct a preliminary evaluation of the safety and efficacy of reserpine, gabapentin or lamotrigine versus an unmatched placebo control as a treatment for cocaine dependence. DESIGN: A 10-week out-patient study using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design. SETTING: The study was conducted at the Cincinnati Medication Development Research Unit (MDRU). PARTICIPANTS: Participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence. Sixty participants were enrolled, with 50 participants completing the final study measures. INTERVENTION: The targeted daily doses of medication were reserpine 0.5 mg, gabapentin 1800 mg and lamotrigine 150 mg. All participants received 1 hour of manualized individual cognitive behavioral therapy on a weekly basis. MEASUREMENTS: Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression scale--observer and self-report of cocaine use. Safety measures included adverse events, electrocardiograms (ECGs), vital signs and laboratory tests. FINDINGS: Subjective measures of cocaine dependence indicated significant improvement for all study groups. Urine BE results indicated a significant improvement for the reserpine group (P < 0.05) and non-significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures. The medications appeared to be tolerated well. CONCLUSIONS: The present findings suggest that reserpine may be worthy of further study as a cocaine dependence treatment.

Adult↗
PubMed2003

Lidocaine patch 5% with systemic analgesics such as gabapentin: a rational polypharmacy approach for the treatment of chronic pain.

OBJECTIVE: To assess the effectiveness and safety of the lidocaine patch 5%, a targeted peripheral analgesic, in the treatment of postherpetic neuralgia, painful diabetic neuropathy, and low back pain patients with incomplete responses to their current analgesic treatment regimen containing gabapentin. DESIGN: This was a 2-week, open-label, nonrandomized, multicenter pilot trial in the clinical setting. Patients with postherpetic neuralgia, painful diabetic neuropathy, or low back pain with partial responses (average daily pain intensity >4/10) to their current analgesic treatment regimen were included. Treatment consisted of daily application of up to four lidocaine patches to areas of maximal peripheral pain. Effectiveness was evaluated using the Brief Pain Inventory (BPI). Safety was assessed by adverse events, physical and neurologic examinations, vital signs, and clinical laboratory tests. RESULTS: Significant improvements in BPI measures of pain intensity and pain relief were reported for all groups of patients after 2 weeks of lidocaine patch 5% treatment. Significant improvements in BPI measures of pain interference with general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life were noted. The lidocaine patch 5% was found to be safe and well tolerated. CONCLUSIONS: Results of this study highlight the potential advantages achieved with rational polypharmacy using a targeted peripheral analgesic, the lidocaine patch 5%, with centrally acting agents such as the anticonvulsant gabapentin. Controlled trials are warranted to further define the impact of such combination therapy.

Acetates↗
PubMedDate not supplied

Efficacy and tolerance of long-term, high-dose gabapentin: additional observations.

Gabapentin (GBP) has shown antiepileptic efficacy and good tolerance in clinical trials. Much remains to be learned about its clinical use. As a participating center in the US Gabapentin Study Group, we report observations that have practical implications for patient management. Twenty-three patients with intractable partial-onset seizures initiated open-label treatment after a blinded placebo-controlled add-on dose efficacy study. In the titration phase, GBP and concurrent antiepileptic drugs (AEDs) were adjusted to achieve optimal efficacy on maximally tolerated GBP doses. Nine patients had no significant improvement in seizure control and discontinued GBP. The remaining 14 patients were observed while treated long-term with stable-dose GBP and concurrent AEDs. Improvement was maintained as long as patients were followed: < or = 4 years. The protocol-allowed upper dose limit, 2,400 mg/day, was well tolerated by 16 of 23 patients, indicating that higher doses may be tolerated. GBP discontinuation did not cause rebound increases in seizure frequency. The most common adverse events (AEs) (in 14 of 23) were similar to those induced by concurrent AEDs and responded to reduction of concurrent AEDs. Many patients reported positive psychostimulatory effects. These observations extend previous findings indicating that GBP is an effective and well-tolerated drug for treatment of partial-onset seizures.

Acetates↗
PubMed1998

Conversion to high dose gabapentin monotherapy in patients with medically refractory partial epilepsy.

PURPOSE: To evaluate the safety and efficacy of high dose gabapentin (GBP) monotherapy (3,000-4,800 mg/day) in patients with medically refractory partial epilepsy. METHODS: GBP monotherapy at daily doses up to 4,800 mg was attempted in patients participating in the open-label phase of a double-blind, dose-controlled, GBP monotherapy trial. For those who achieved monotherapy, the types and severity of adverse events were assessed and the average seizure frequency per 28 days while maintained on the highest daily GBP dose was compared to the seizure frequency during the baseline phase of the double blind trial. Correlation analysis between GBP serum level, total daily dose, and percentage of seizure change from baseline was performed. RESULTS: A total of 45 patients participated in the open-label phase of the trial and 23 (51%) were converted successfully to GBP monotherapy. In those patients, the average daily gabapentin dose was 3,900 mg and the mean length of follow-up was 252 days. Compared to baseline, there was a mean reduction of 54%, 43%, and 14% for simple partial, complex partial and secondarily generalized seizures respectively, while maintained on high-dose GBP monotherapy. A significant linear correlation between daily GBP dosage (2,400-4,800 mg) and resultant mean serum levels was found (r = 0.51; p < 0.01). There was no significant correlation between seizure frequency and total daily GBP dose or with serum levels. High-dose GBP monotherapy was well tolerated; only one patient exited the trial because of adverse events. The most common adverse event was tiredness/sleepiness and was not dose-related. CONCLUSIONS: GBP monotherapy is well tolerated in daily doses of up to 4,800 mg and is effective in a subgroup of patients with medically refractory partial epilepsy.

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PubMed1999

Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study.

PURPOSE: To evaluate the tolerability and safety of gabapentin (GBP) as add-on therapy for seizure control. METHODS: Conducted in an outpatient setting and reflecting usual practice, this study compared tolerability of GBP dosages < or = 1,800 versus >1,800 mg/day, when these doses were required to achieve the most effective seizure control. Two analyses of adverse events are presented: tolerability and safety. In the tolerability analysis, each patient served as his or her own control to compare the occurrence of adverse events at GBP < or =1,800 versus >1,800 mg/day. The safety analysis required patients to receive at least one dose of GBP and have a follow-up contact. RESULTS: A total of 2,216 patients enrolled in this open-label, 16-week study and were evaluable for safety. Of these, 74.0% completed the 16-week study, and 281 met the tolerability criteria. Within these 281 patients, two mutually exclusive groups were compared (a) those reporting adverse events at only < or =1,800 mg/day (low dose); and (b) those reporting adverse events at only >1,800 mg/day (high dose). Three adverse events (asthenia, headache, and dizziness) were observed in a statistically significantly larger number of patients at only the low dose than in the group reporting these same adverse events at only the high dose, suggesting that patients who tolerated GBP at < or = 1,800 mg/day did not experience a significant increase in adverse events with dosages >1,800 mg/day. Overall, 10.6% of the 2,216 patients in the safety population prematurely withdrew because of adverse events, and 3.5% discontinued because of lack of efficacy. Safety and tolerability of GBP was rated as excellent or good for 78.5% of all patients. CONCLUSIONS: Gabapentin doses >1,800 mg/day were as well tolerated as doses < or =1,800 mg/day and were not associated with more adverse events.

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PubMed1999

Monotherapy trials with gabapentin for partial epilepsy.

The efficacy and safety of gabapentin as monotherapy for treatment of partial onset seizures were evaluated in three large multicenter, double-blind, parallel-group, dose-controlled trials. In the first trial, 275 outpatients with refractory partial epilepsy maintained on stable doses of one or two antiepileptic drugs (AEDs) were switched to gabapentin (GBP) monotherapy at 600 mg, 1200 mg, or 2400 mg daily. Patients were required to exit the 26-week double-blind phase of the study if they experienced worsening of seizure frequency. With respect to time to exit, there was no statistically significant difference among the three groups; only 3% of patients withdrew from the trial because of adverse events. In the second study, 82 hospitalized patients with medically refractory epilepsy were tapered off baseline AEDs and randomly assigned to GBP monotherapy at 300 mg/day or 3600 mg/day. Patients remained in the trial for a maximum of 8 days but had to exit the trial if they experienced one or more exit events. Time to exit was significantly longer in patients in the 3600-mg group (151 h) compared with those in the 300-mg group (85 h) (p = 0.0001). None of the patients withdrew from the trial because of side effects. In the third study, 292 patients with newly diagnosed partial seizures were randomized to GBP 300, 900, or 1800 mg/day or to carbamazepine (CBZ) 600 mg/day. Patients remained in the trial for up to 6 months or until they experienced an exit event. Mean time to exit was significantly longer for patients who received GBP 900 mg/day (p = 0.02) or 1800 mg/day (p = 0.04) compared with those who received 300 mg/day. The completion rate for the CBZ group (37%) was similar to that of the GBP 900-mg (39%) and 1800-mg (38%) groups. Patients receiving CBZ had a higher withdrawal rate because of adverse events compared with the GBP 900-mg and 1800-mg groups. The results of these trials provide good evidence of the efficacy and safety of GBP as monotherapy for the treatment of partial-onset seizures.

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PubMed2006

Gabapentin-induced coma in a patient with renal failure.

We describe a 60-year-old woman who became comatose after a single dose of gabapentin for right-sided sciatalgia. The patient was improved by hemodialysis. Gabapentin toxicity should be considered when mental status changes develop in patients with renal failure after even a single dose.

Administration, Oral↗
PubMed1999

Gabapentin: a new tool in the treatment of neuropathic pain.

Human neuropathic pain remains a prevalent and pervasive problem in our society. Pharmacologically there is also no single, uniformly well-tolerated drug that is reliably helpful. Gabapentin has emerged as a useful new tool based on the results of two large multicenter trials in models of human neuropathy. Gabapentin proved to be a significantly better analgesic than placebo, was well tolerated in the elderly population, and had a significant positive impact on several subjective and objective outcome measures. A discussion of the standard treatments and the studies supporting this new tool is the purpose of this review.

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PubMed1998

Gabapentin. Antiepileptic mechanism of action.

Gabapentin is an antiepileptic drug used in the treatment of partial and generalized tonic-clonic seizures. Its antiepileptic mechanism of action is not known. The transport of gabapentin across membranes and its demonstrated effects on voltage-gated ion channels (sodium, calcium), presynaptic mechanisms that can enhance GABAergic inhibition, and ligand-gated ion channels (GABA receptors and glutamate receptors) are reviewed.

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PubMed1998

Renal impairment as a possible side effect of gabapentin. A single case report.

A bipolar I manic patient was treated successfully by adding gabapentin to perazine and clonazepam. Also initially tolerated well, an increase of creatinine after several weeks of GP (2000 mg) was observed which was reversible after discontinuation of GP. It is suggested that the possibility of renal dysfunction should be kept in mind with the usage of gabapentin.

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PubMed2002

Gabapentin for relief of neuropathic pain related to anticancer treatment: a preliminary study.

The aim of our study was to explore a potential analgesic effect of gabapentin in patients with neuropathic pain caused by anticancer treatment. A total of 23 outpatients without active disease and with chronic, treatment-related pain were included in this single-center, open-label, exploratory, non-controlled study. The primary end-points were pain intensity and pain relief following a 4-week treatment period. A total of 15 patients (65%) completed the study, 5 (22%) discontinued the study due to treatment failure and 3 (13%) due to toxicity. More than 50% reduction in pain intensity was obtained in 11 of 23 patients (48%, 95% CI 30-66%). Pain relief increased from 8.33% (+/- 13.64) to 66.58% (+/- 18.35) (p <0.01). Somnolence, mental clouding, and headache were the most frequently reported adverse events. We concluded that gabapentin should be accepted for further investigation in this important setting of supportive care.

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PubMed2002

Gabapentin in late-onset poststroke seizures.

Stroke is a frequent cause of epileptic seizures (ES) in adults. The authors evaluated the long-term efficacy and tolerability of gabapentin (900 to 1,800 mg/day) in 71 patients with a first poststroke late ES during a mean follow-up time of 30 months. ES recurred in 18.3% of the patients and side effects were noted in 27 cases (38%), but only two (2.8%) required discontinuation or early withdrawal. Gabapentin monotherapy was useful and safe for late poststroke ES.

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PubMed2005

Effects of topiramate and gabapentin on cognitive abilities in healthy volunteers.

OBJECTIVE: To evaluate the cognitive effects of topiramate (TPM) and gabapentin (GBP). METHODS: Forty healthy volunteers were randomized to a 12-week course of TPM, GBP, or placebo. Doses were gradually escalated over 10 weeks to a maximum of 400 mg/day of TPM or 3,600 mg/day of GBP or to the highest tolerated dose. Subjects were interviewed and examined biweekly. Cognitive testing was performed prior to initiating the drug and again 12 weeks later, at least 2 weeks after achieving plateau dosing. For each subject and cognitive measure, test-retest Z scores were calculated based on regression equations derived from 73 healthy volunteers. Group comparisons utilized the Wilcoxon test. RESULTS: There were significant TPM vs GBP and TPM vs placebo differences in test-retest Z scores for four of six target cognitive measures (Digit Symbol, Story Recall, Selective Reminding, Controlled Oral Word Association), always indicating worse retest performance for subjects receiving TPM. Overall, 12 of 24 cognitive measures were similarly affected. TPM effects were large, and several target measures averaged >2 SD of negative change. One measure was significantly affected by GBP. CONCLUSIONS: Topiramate (TPM) impaired cognitive test performance, whereas gabapentin had minimal effects. The effects of TPM were of sufficient magnitude potentially to affect daily and occupational function.

Activities of Daily Living↗
PubMed2005

New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine.

OBJECTIVE: To determine the relative tolerability and efficacy of two newer antiepileptic drugs, lamotrigine (LTG) and gabapentin (GBP), as compared to carbamazepine (CBZ) in older patients with epilepsy. METHODS: This was an 18-center, randomized, double-blind, double dummy, parallel study of 593 elderly subjects with newly diagnosed seizures. Patients were randomly assigned to one of three treatment groups: GBP 1,500 mg/day, LTG 150 mg/day, CBZ 600 mg/day. The primary outcome measure was retention in trial for 12 months. RESULTS: Mean age was 72 years. The most common etiology was cerebral infarction. Patients had multiple medical conditions and took an average of seven comedications. Mean plasma levels at 6 weeks were as follows: GBP 8.67 +/- 4.83 microg/mL, LTG 2.87 +/- 1.60 microg/mL, CBZ 6.79 +/- 2.92 microg/mL. They remained stable throughout the trial. Early terminations: LTG 44.2%, GBP 51%, CBZ 64.5% (p = 0.0002). Significant paired comparisons: LTG vs CBZ: p < 0.0001; GBP vs CBZ: p = 0.008. Terminations for adverse events: LTG 12.1%, GBP 21.6%, CBZ 31% (p = 0.001). Significant paired comparisons: LTG vs CBZ: p < 0.0001; LTG vs GBP: p = 0.015. There were no significant differences in seizure free rate at 12 months. CONCLUSIONS: The main limiting factor in patient retention was adverse drug reactions. Patients taking lamotrigine (LTG) or gabapentin (GBP) did better than those taking carbamazepine. Seizure control was similar among groups. LTG and GBP should be considered as initial therapy for older patients with newly diagnosed seizures.

Aged↗
PubMed1995

Gabapentin treatment of seizures in acute intermittent porphyria.

Most antiepileptic drugs (AEDs) available have demonstrated porphyrogenicity in hepatic porphyrias. Gabapentin is a new AED not appreciably metabolized by the liver in humans. We report two patients with acute intermittent porphyria successfully treated with gabapentin without its inducing porphyric crisis.

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PubMed1998

Gabapentin in orthostatic tremor: results of a double-blind crossover with placebo in four patients.

We treated four patients affected by orthostatic tremor (OT) with gabapentin in increasing doses (300 to 2,400 mg/d). OT was evaluated with patients' self-monitoring scales, tremor rating scales, electromyography (EMG) showing the 14- to 18-Hz frequencies, and EMG frequency analysis. All patients had transitory responses to clonazepam. Gabapentin induced disappearance of OT in three patients and consistent reduction in one. Crossover to placebo induced reappearance of tremor.

Acetates↗
PubMed1999

Cognitive effects of topiramate, gabapentin, and lamotrigine in healthy young adults.

OBJECTIVE: To study the acute and steady-state cognitive effects of three new antiepileptic drugs (AEDs): gabapentin, lamotrigine, and topiramate. BACKGROUND: Several newer antiepileptic medications approved recently by the Food and Drug Administration are gaining attention as efficacious alternatives to established AEDs. Greater tolerability with fewer side effects are reported in some. However, the potential cognitive effects of these newer AEDs have received limited attention. METHODS: Healthy young adults randomized to either of the three drugs were administered tests of attention, psychomotor speed, language, memory, and mood at baseline (predrug), acute single-dose period, and after 2 and 4 weeks on the drug. RESULTS: Compared with baseline, the topiramate group had selective, statistically significant declines on measures of attention and word fluency at acute doses, whereas the other two AED groups had no performance changes. At the 2- and 4-week test periods, only the topiramate subjects continued to display neurocognitive effects from drug administration. CONCLUSIONS: Results demonstrate potential acute and steady-state adverse cognitive effects for topiramate, whereas minimal effects were displayed for either gabapentin or lamotrigine in young healthy adults.

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PubMed2001

Treatment of idiopathic restless legs syndrome (RLS) with gabapentin.

Nine patients with idiopathic restless legs syndrome (RLS) were treated with 300 mg of gabapentin as an initial dose and an up-titration until relief of symptoms for 4 weeks. Subjective symptoms improved significantly. Polysomnographic data showed a reduction of periodic leg movements during sleep (PLMS) (p = 0.003) and PLMS index (p = 0.001). The authors conclude that gabapentin provides a well-tolerated and effective treatment of idiopathic RLS.

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