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PubMed1996

A cost minimization study comparing vigabatrin, lamotrigine and gabapentin for the treatment of intractable partial epilepsy.

Epilepsy is one of the commonest of the serious neurological disorders. The total economic burden of epilepsy in the United Kingdom has been estimated to be 1930 m pounds, with around 32 m pounds spent on antiepileptic drug therapy alone. Despite the high level of expenditure on drug therapy for epilepsy there is very little information regarding the relative cost-effectiveness of the different drugs available. It is important to establish the relative cost-effectiveness of therapies to provide decision makers with the information necessary to allocate resources in a rational manner and thus achieve the highest benefit for available resources. In this study the cost-effectiveness of lamotrigine, vigabatrin and gabapentin was estimated by a cost minimization analysis for the first year of drug therapy using data based on published studies. In general, there was little difference between the initial direct costs of treatment, however, the fewer side-effects associated with gabapentin is reflected in the lower total costs of treatment in the first year resulting in savings of 18.52 pounds per patient compared with lamotrigine and 47.18 pounds compared with vigabatrin. Based on incidence data estimates this translates to estimated direct cost savings to the UK of between 166,680 pounds and 424,620 pounds per annum.

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PubMed1997

A naturalistic study of the use of vigabatrin, lamotrigine and gabapentin in adults with learning disabilities.

Epilepsy is a common condition in people with learning disabilities with many patients continuing to suffer from seizures despite antiepileptic drug (AED) treatment. Although the advent of newer AEDs offers hope for better treatment, there is a need to compare the efficacy of each new AED in adults with both drug-resistant epilepsy and learning disabilities. This retrospective casenote study involves the analysis of the outcome for those adults with learning disabilities treated with either vigabatrin, lamotrigine or gabapentin. The information obtained from the casenote analysis was used to both compare the efficacies of the three drugs and also the side-effects and drop-out rates, including reasons for drop-out. The total number of patients involved was 51 who underwent 71 treatment episodes. All three AEDs had similar efficacies. Although vigabatrin was found to be associated with a higher incidence of behaviour problems, behaviour problems occurred with the other drugs as well. Lamotrigine caused increased seizures in 24% of patients, especially when prescribed at a higher dose. Gabapentin appeared to be associated with fewer serious side-effects.

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PubMed2003

Use of gabapentin to reduce chronic neuropathic pain in Fabry disease.

The effect of the anticonvulsant gabapentin on neuropathic pain was studied in six male patients with Fabry disease, aged 15-45 years. After 4 weeks of treatment, pain, as measured using the Brief Pain Inventory, was decreased compared with baseline. Treatment was generally well tolerated. This study indicates that gabapentin should be considered as a treatment option for the neuropathic pain of Fabry disease.

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PubMed2004

Pilot study using gabapentin for tamoxifen-induced hot flashes in women with breast cancer.

In this pilot study, 22 women with breast cancer on tamoxifen therapy with at least two hot flashes a day took oral gabapentin at 300 mg three times a day for 4 weeks. The 16 women who completed the study had a mean decrease in hot flash duration of 73.6% (P = 0.027), frequency of 44.2% (P < 0.001), and severity of 52.6% (P < 0.001), with a complete response in 8/16 women. Side effects reported by four women who did not complete 4 weeks of the study were nausea (1/4), rash (1/4) and excessive sleepiness (3/4). Two additional patients did not provide complete data. Gabapentin is a promising new agent in the treatment of tamoxifen induced hot flashes, and should be studied further.

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PubMed2001

Adjunctive gabapentin in patients with intellectual disability and bipolar spectrum disorders.

The aim of the present study was to assess the efficacy of adjunctive gabapentin (GBP) in the treatment of patients with intellectual disability (ID) and bipolar spectrum disorders. Ten affected subjects with demonstrable increases in symptomatology during 'significant' life events which had interfered with or induced the interruption of their rehabilitation programmes were chosen for this study. The meaning of 'significant' was defined for each patient as a frequently repeated life event which had elicited a marked increase in symptoms on at least two occasions. Gabapentin (300-900 mg day-1) was added to the standard therapy. The subjects' psychopathological conditions during the significant life event were assessed by means of standardized tools both before and after adjunctive therapy with GBP. A positive response to therapy was observed, with subsequent improvement of psychopathological conditions, particularly for anxiety and depressive symptoms. The promising results obtained with GBP suggest the need for further trials. Adjunctive GBP may become an alternative treatment approach for patients with ID in whom traditional mood-stabilizing agents have frequent contraindications.

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PubMed1998

Role of branched-chain aminotransferase isoenzymes and gabapentin in neurotransmitter metabolism.

Because it is well known that excess branched-chain amino acids (BCAAs) have a profound influence on neurological function, studies were conducted to determine the impact of BCAAs on neuronal and astrocytic metabolism and on trafficking between neurons and astrocytes. The first step in the metabolism of BCAAs is transamination with alpha-ketoglutarate to form the branched-chain alpha-keto acids (BCKAs). The brain is unique in that it expresses two separate branched-chain aminotransferase (BCAT) isoenzymes. One is the common peripheral form [mitochondrial (BCATm)], and the other [cytosolic (BCATc)] is unique to cerebral tissue, placenta, and ovaries. Therefore, attempts were made to define the isoenzymes' spatial distribution and whether they might play separate metabolic roles. Studies were conducted on primary rat brain cell cultures enriched in either astroglia or neurons. The data show that over time BCATm becomes the predominant isoenzyme in astrocyte cultures and that BCATc is prominent in early neuronal cultures. The data also show that gabapentin, a structural analogue of leucine with anticonvulsant properties, is a competitive inhibitor of BCATc but that it does not inhibit BCATm. Metabolic studies indicated that BCAAs promote the efflux of glutamine from astrocytes and that gabapentin can replace leucine as an exchange substrate. Studying astrocyte-enriched cultures in the presence of [U-14C]glutamate we found that BCKAs, but not BCAAs, stimulate glutamate transamination to alpha-ketoglutarate and thus irreversible decarboxylation of glutamate to pyruvate and lactate, thereby promoting glutamate oxidative breakdown. Oxidation of glutamate appeared to be largely dependent on the presence of an alpha-keto acid acceptor for transamination in astrocyte cultures and independent of astrocytic glutamate dehydrogenase activity. The data are discussed in terms of a putative BCAA/BCKA shuttle, where BCATs and BCAAs provide the amino group for glutamate synthesis from alpha-ketoglutarate via BCATm in astrocytes and thereby promote glutamine transfer to neurons, whereas BCATc reaminates the amino acids in neurons for another cycle.

3-Methyl-2-Oxobutanoate Dehydrogenase (Lipoamide)↗
PubMed2002

A postmarketing surveillance study of gabapentin as add-on therapy for 3,100 patients in England.

PURPOSE: Our aim was to monitor the use of gabapentin (GBP) by patients prescribed this drug by primary care physicians in England soon after it was marketed in the United Kingdom. METHODS: A noninterventional observational cohort study was conducted by using the technique of prescription-event monitoring. Patients were identified from dispensed National Health Service prescriptions. Outcome data were obtained from questionnaires sent to the doctor approximately 6 months after the initial prescription. These data included demographic information, events reported since starting GBP, and reason for stopping the drug, if it was stopped. Incidence rates were calculated for given periods for all events reported. Additional information was requested for selected events of medical interest, including pregnancies. Standardised mortality ratio (SMR) was calculated. RESULTS: The cohort comprised 3,100 patients, of whom 136 (4%) were children. The median duration of treatment was 8.1 months. The most frequently reported adverse events reported during the first month of treatment, drowsiness/sedation, dizziness, and malaise/lassitude, also were the commonest reasons for discontinuing GBP and reported as suspected adverse drug reactions (ADRs). There were no congenital anomalies in the 11 babies born to women who used GBP during the first trimester of pregnancy. Crude mortality rate was 5 times that in general population but similar to that in other published studies. CONCLUSIONS: Neurologic-related events were the most frequently reported adverse events. They also were the commonest reasons for discontinuing treatment and reported as suspected ADRs. No previously unrecognised adverse events were detected in this large cohort of patients who were among the first treated with gabapentin in England.

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PubMed2000

Gabapentin for chronic pain in spinal cord injury: a case report.

A 30-year-old white woman with an L1 complete spinal cord injury (SCI) secondary to a gunshot wound in 1985, presented to a chronic pain service for evaluation. She had a 13-year history of chronic lower extremity pain. She described her discomfort as "throbbing, aching, and stabbing." She had tried many different medications, including opioids, Tegretol, and tricyclic antidepressants, without success. During the evaluation process, she admitted to being "angry, frustrated, and anxious." She was diagnosed with central pain after SCI. She was placed on gabapentin 300 mg 3 times daily; within 1 week, her visual analog pain scale fell from 95 mm to 27 mm, and her McGill Short Form pain score fell from 13 to 3. Her mood also vastly improved. This case report suggests that gabapentin should be studied as a therapeutic option for treating central pain post-SCI and should be considered as a viable, well-tolerated, low-toxicity tool.

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PubMed1999

Successful treatment with gabapentin in the presence of hypersensitivity syndrome to phenytoin and carbamazepine: a report of three cases.

We report three consecutive patients with hypersensitivity syndrome (HSS) due to phenytoin and carbamazepine and successful treatment with gabapentin. HSS is a rare but potentially fatal reaction to multiple drugs including several anticonvulsants. Cross-reactivity among drugs may occur. Immediate withdrawal of the offending drug is the most important step in treatment. Benzodiazepines acutely and, after resolution of the hepatitis, valproic acid have been successfully used for seizure control in patients with HSS. Our cases indicate that gabapentin is also a safe anticonvulsant in HSS.

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PubMed1999

Gabapentin leads to remission of somatoform pain disorder with major depression.

Gabapentin, a novel antiepileptic drug, is effective in the treatment of partial seizures with and without secondary generalization. Evidence suggests that it may have mood-stabilizing and possibly antidepressant properties in bipolar depression. We report on a 48-year-old woman who had recurrent major depressive disorder. Following inguinal herniorrhaphy, she developed severe stabbing pain in the lower abdomen and inguinal area that progressed to constant pain in her whole body. She was depressive, hopeless, and had given up her social activities. A diagnosis of major depressive disorder and somatoform pain disorder was made. Antidepressants and carbamazepine were ineffective, and she had attempted suicide. Gabapentin resulted in remission of both the pain and the depressive mood at a dose of 1.800 mg/day.

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PubMed2003

Treatment of neuropathic orbital pain with gabapentin.

We report and discuss a case of severe neuropathic orbital pain refractory to standard analgesics that responded well to treatment with the anticonvulsant gabapentin. Gabapentin may be a useful adjuvant analgesic in the treatment of neuropathic pain.

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PubMed2000

Rodent model of chronic central pain after spinal cord contusion injury and effects of gabapentin.

Spinal cord injury (SCI) often results in abnormal pain syndromes in patients. We present a recently developed SCI mammalian model of chronic central pain in which the spinal cord is contused at T8 using the NYU impactor device (10-g rod, 2.0-mm diameter, 12.5-mm drop height), an injury which is characterized behaviorally as moderate. Recovery of locomotor function was assessed with an open field test and scored using the open field test scale (BBB scale). Somatosensory tests of paw withdrawal responses accompanied by supraspinal responses to both mechanical punctate (von Frey hairs) and nonpunctate (4 mm diameter blunt probe) as well as thermal (radiant heat) peripheral stimuli were performed. Comparisons at the level of the individual animal between precontusion and postcontusion responses indicated significant increases in reactions to low threshold punctate mechanical stimuli, non-punctate stimuli and thermal stimuli (p < 0.05). To demonstrate the validity of this model as a central pain model, gabapentin, an agent used clinically for central pain, was given i.p. at 10 or 30 mg/kg. Gabapentin treatment significantly and reversibly changed the responses, consistent with the attenuation of the abnormal sensory behavior, and the attenuated responses lasted for the duration of the drug effect (up to 6 h). These results support the use of the spinal contusion model in the study of chronic central pain after SCI.

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PubMedDate not supplied

Analysis of gabapentin in serum and plasma by solid-phase extraction and gas chromatography-mass spectrometry for therapeutic drug monitoring.

A simple method for the determination of gabapentin (Neurontin) is described. The method uses solid-phase extraction by disk column and derivatization followed by gas chromatographic-mass spectrometric analysis. The single-step derivatization with MTBSTFA produces a t-BDMS derivative of both the carboxylic and amine moieties of the molecule. Each step of the procedure was optimized to assure reliable performance of the method. The assay limit of detection was 0.1 microg/mL with a linear range from 1.0 to 35 microg/mL. Within-run (n = 3) and between-run (n = 40) coefficients of variation were less than 8.2 and 15.9%, respectively. The method has proven reliable in routine production for more than a year, producing clean chromatography with unique ion fragments, consistent ion mass ratios, and no interferences. Statistical analysis of the gabapentin concentrations measured in 1020 random specimens over a 2-month period showed a mean concentration of 6.07 microg/mL with a standard deviation of 5.28.

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PubMed2001

Effects of Gabapentin and Topiramate in primary rat astrocyte cultures.

We studied in vitro the effects of anticonvulsant drugs Gabapentin and Topiramate on the production of reactive oxygen species and nitric oxide (NO), the activity of glutamine synthetase (GS), and cell viability in primary cultures of rat cortical astrocytes which are intimately involved in the normal functioning of neurons. We investigated the effects of these drugs at concentrations within the therapeutic range (1, 10 and 50 microg/ml). We observed that, in cultured astrocytes, Gabapentin induced a weak increase in the biosynthesis of NO, a mild decrease in GS activity and cell viability, and minor induction of a stress condition. Topiramate was observed to induce even greater stressor effects on these cells.

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PubMed1997

Treatment of restless legs syndrome with gabapentin.

Gabapentin is a well tolerated anticonvulsant, structurally related to gamma-aminobutyric acid, with an unknown mechanism of action. Restless legs syndrome (RLS) is a disorder characterized by sensory and motor symptoms in the legs that is best treated with dopaminergic drugs and opiates. In this open-label study, eight patients with RLS were treated with gabapentin. Four of the eight had a beneficial response, three with almost complete resolution of symptoms for up to 6 months. For a disorder that is often difficult to treat, these results are encouraging, and they suggest that a placebo-controlled trial is warranted.

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PubMed2000

Increased seizures after discontinuing carbamazepine: results from the gabapentin monotherapy trial.

Studies in patients with epilepsy undergoing telemetry evaluation for surgery have suggested that discontinuation of carbamazepine (CBZ) is associated with increased seizures. The period of observation in that setting, however, was limited to a few days. The authors reviewed the occurrence of seizures in patients with epilepsy who had all their antiepileptic medications discontinued during an 8-week period, converted to gabapentin monotherapy, and observed for 26 weeks as part of the gabapentin trial #945-082. Two hundred and seventy-five patients were enrolled. Kaplan-Meier estimates of time to exit for all patients showed that 18% of patients previously treated with CBZ completed the study as compared with 30% of the patients receiving other antiepileptic medications. Increase in the frequency of seizures was maximal in the 2 weeks following CBZ discontinuation. Seizures increased both in frequency and severity but no new seizure types were observed. The findings in this study show that removal of CBZ is associated with increased frequency of seizures in patients with a previous history of epilepsy with incompletely controlled seizures. The period of maximal increase was the first 2 weeks after CBZ discontinuation.

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PubMed2004

Association between patient age and gabapentin serum concentration-to-dose ratio: a preliminary multivariate analysis.

OBJECTIVES: To evaluate the association between patient age and gabapentin (GBP) concentration-to-dose ratio by a multivariate analysis. METHODS: The association between patient age and the trough steady-state serum concentration of gabapentin (GBP) normalized to 1 mg/kg body weight or concentration-to-dose ratio (CDR) was retrospectively assessed by analysis of covariance. Potential confounding factors considered were GBP dosage, the number of GBP doses per day, and the presence of concomitant antiepileptic drugs (AEDs). Concentrations that had been measured in predose "trough" samples collected from 66 patients, aged 5-84 years, with partial seizures or neuropathic pain chronically receiving GBP BID (n = 21) or TID (n = 45), alone (n = 15) or in combination with other AEDs (n = 51) were used in this retrospective analysis. RESULTS: Average GBP CDR was 0.23 +/- 0.18 (mean +/- SD). The GBP CDR increased with age (r2 = 0.46, P < 0.001), and the correlation was improved when only samples from patients taking GBP BID were separately considered (r2 = 0.68, P < 0.001). The ratio was lower in the 10 children younger than 11 years of age (0.07 +/- 0.05) than in 8 adolescents aged 12 to 18 years (0.14 +/- 0.04), lower than in 35 adults aged 19 to 65 years (0.22 +/- 0.13), and lower than in 13 patients older than 65 years of age (0.45 +/- 0.20) by 1-way analysis of variance (F = 19.4, P < 0.001). Analysis of covariance showed a significant influence on GBP CDR of patient age (P < 0.001) and the number of GBP daily doses (P < 0.01), but GBP daily dosage or concomitant AEDs had no significant influence on the ratio. CONCLUSIONS: In this retrospective study of a small, select group of patients, (1) the GBP CDR increased significantly with age when potential confounding factors such as GBP dosage, number of GBP doses per day, and concomitant AEDs were considered by analysis of covariance, and (2) patients older than 65 years, even without any known renal disease, may have double GBP CDR than younger adults and, therefore, may need half of the GBP dose per body weight to achieve a similar concentration.

Adolescent↗
PubMedDate not supplied

Gabapentin treatment of neurogenic overactive bladder.

OBJECTIVE: Detrusor overactivity is a well-recognized and distressing medical condition affecting both men and women, with a significant prevalence in the population and with a higher incidence rate in people older than 70 years. This pathological condition is characterized by irritative symptoms: urinary urgency, with or without incontinence, and urinary frequency, often seriously compromising the quality of life of the people who have it. The complaint of these symptoms is defined by the International Continence Society (www.continet.org) as "overactive bladder." Many neurological patients experience irritative symptoms of the lower urinary tract related to their disease, and this condition drastically limits their social life. Various drugs have been introduced in therapy protocols to treat neurogenic detrusor overactivity; however, in many cases, the outcomes of these treatments have proven to be unsatisfactory. This fact is probably related to the incomplete understanding of the pathophysiological aspects of detrusor overactivity. Recent studies suggest the possible role in the detrusor overactivity pathogenesis of bladder receptors, afferent pathways, and spinal cord interneurons; consequently, the modulation of bladder receptor and/or spinal cord centers activity has been proposed as a possible approach to control involuntary detrusor contractions, using drugs capable of acting on bladder afferent pathways. The aim of this study was to evaluate the efficacy of gabapentin, an anticonvulsive agent used by neurologists in the treatment of epilepsy and neurogenic pain, in the treatment of detrusor overactivity of neurogenic origin. METHODS: Sixteen patients affected by neurogenic overactive bladder were enrolled in the study. The clinical outcomes were assessed by symptomatic score evaluations, voiding diary, and urodynamic test before and after 31 days of gabapentin treatment. RESULTS: The preliminary results showed significant modifications of urodynamic indexes, particularly of the detrusor overactivity, whereas the symptomatic score evaluation and the voiding diary data demonstrated a significant lowering of the irritative symptoms. Furthermore, we did not record significant adverse effects and no patient interrupted the drug treatment. CONCLUSIONS: These data support the rationale that detrusor overactivity may be controlled by modulating the afferent input from the bladder and the excitability of the sacral reflex center and suggest a novel method to treat overactive bladder patients.

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