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PubMed2001

Gabapentin treatment for bipolar disorders.

OBJECTIVE: [corrected] To review the effectiveness data on the use of gabapentin in bipolar disorders. DATA SOURCES: Clinical literature was accessed through MEDLINE (January 1985-November 2000). Key search terms included gabapentin, mood stabilizer, and bipolar disorder. DATA SYNTHESIS: Bipolar disorder is a complex condition that can be difficult to treat effectively. Mood stabilizers are increasingly being used to manage bipolar disorder. Studies that used gabapentin in bipolar disorders are evaluated. CONCLUSIONS: From the data presented, gabapentin cannot be recommended for treatment of bipolar disorder. Further studies are required to determine whether gabapentin has any role in the management of bipolar disorder.

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PubMed2002

Gabapentin for hot flashes in prostate cancer.

OBJECTIVE: To report a case of successful treatment of refractory hot flashes with gabapentin in a patient with prostate cancer who was receiving combination antiandrogen and gonadotropin hormone-releasing hormone (GnRH) analog therapy. CASE SUMMARY: A 70-year-old white man with a history of advancing prostate cancer experienced disabling hot flashes from combination therapy with the antiandrogen bicalutamide and the GnRH analog goserelin acetate. He failed to respond to clonidine 0.1 mg twice daily, megestrol acetate 40 mg/d, diethylstilbestrol 1 mg/d, and venlafaxine 25 mg twice daily. The patient was then treated with gabapentin 600 mg once daily, at which time he experienced near-complete resolution of his symptoms. DISCUSSION: This case supports a previous report of the marked improvement in severity and duration of hot flashes associated with antiandrogen or GnRH analog therapy in prostate cancer. The mechanism by which gabapentin reduces hot flashes is unknown. CONCLUSIONS: Hot flashes resulting from antiandrogen or GnRH analog therapy are often difficult to treat and leave many patients disabled. Gabapentin has been shown to markedly reduce the severity, frequency, and duration of these hot flashes. Controlled trials are necessary to evaluate gabapentin against other therapeutic modalities.

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PubMedDate not supplied

Gabapentin for overactive bladder and nocturia after anticholinergic failure.

INTRODUCTION: We reviewed our experience with the use of gabapentin to treat symptoms of overactive bladder (OAB) and nocturia in patients who have failed conventional anticholinergic therapy. METHODS: Thirty-one patients referred to us with refractory (OAB) and/or nocturia were treated with oral gabapentin. All the patients had tried or remained on antimuscarinic drugs during treatment. Twenty-four of 31 complained of bothersome symptoms during day and night and the other seven had primary complaints of nocturia. Initial gabapentin doses ranged from 100-300 mg at bedtime. Dose was slowly titrated up to 3,000 mg based on patients' symptomatology and tolerability. RESULTS: The mean age was 51 years old (range 27-78). There were 13 men and 18 women. The median steady state dose chosen by the patient after initial titration was 600 mg/day. Fourteen of 31 patients reported subjective improvement of their frequency and 8 have been on the medication for over 12 months with persistent efficacy. For the 14 improved patients, mean frequency/24 hours decreased from 14.1 +/- 2.2 to 10.0 +/- 2.1. Three patients with primary nocturia reported improvement from a mean of 4.0 +/- 1.3 to 1.0 +/- 0.3 episodes/night. Six patients stopped taking the drug within one month due to side effects mostly described as drowsiness or lethargy. CONCLUSIONS: Fourteen of 31 patients with refractory (OAB) and nocturia improved with oral gabapentin. Gabapentin was generally well tolerated and can be considered in selective patients when conventional modalities have failed.

Adult↗
PubMedDate not supplied

Efficacy of gabapentin in treating chronic phantom limb and residual limb pain.

Twenty-four adults with phantom limb pain (PLP) and/or residual limb pain (RLP) participated in a double-blind crossover trial. Participants were randomly assigned to receive gabapentin or placebo and later crossed over to the other treatment, with a 5-week washout interval in which they did not receive medication. Gabapentin was titrated from 300 mg to the maximum dose of 3,600 mg. Measures of pain intensity, pain interference, depression, life satisfaction, and functioning were collected throughout the study. Analyses revealed no significant group differences in pre- to posttreatment change scores on any of the outcome measures. More than half of the participants reported a meaningful decrease in pain during the gabapentin phase compared with about one-fifth who reported a meaningful decrease in pain during the placebo phase. In this trial, gabapentin did not substantially affect pain. More research on the efficacy of gabapentin to treat chronic PLP and RLP is needed.

Adult↗
PubMed2003

Gabapentin for the treatment of behavioural alterations in dementia: preliminary 15-month investigation.

BACKGROUND: Although the core feature of dementia is progressive cognitive disruption, non-cognitive behavioural problems are expressed in most patients with dementia during the course of their illness. While psychotropic drugs are frequently used to control behavioural symptoms, comorbidities, which are very common in the geriatric population, could often limit their use. Gabapentin may be a potential treatment in such situations. METHODS: In this open, baseline comparison study 20 patients with probable Alzheimer's disease with behavioural alterations and serious comorbidities (paralytic ileus, open-angle glaucoma, ischaemic cardiopathy, hepatic failure or severe prostatic hyperplasia) received gabapentin for 15 months. Patients were allowed to continue any previous therapy for concurrent diseases. However, concomitant antipsychotic or benzodiazepine intake was not permitted. RESULTS: Gabapentin appeared to be efficacious and well tolerated in this patient population, and did not appear to interact with other drugs. General benefit is reflected by a reduction of caregiver stress. No patients withdrew before the end of the study and no serious adverse events were reported. CONCLUSION: The results of this study in patients with probable Alzheimer's disease with behavioural alterations and serious comorbidities indicate that gabapentin provides significant and sustained efficacy in terms of behaviour, with associated reductions in caregiver burden. The results of an ongoing larger, randomised, double-blind study of gabapentin are keenly awaited and may help to provide a safer and more efficacious treatment option for this group of patients.

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PubMed2002

Pilot evaluation of gabapentin for treating hot flashes.

OBJECTIVE: To obtain pilot prospective data regarding the efficacy and tolerability of gabapentin for alleviating hot flashes. PATIENTS AND METHODS: This prospective single-arm clinical trial was conducted between July 26, 2001, and November 30, 2001. Patients underwent a baseline week and then 4 weeks of gabapentin treatment, with increasing doses during the first 3 weeks, from 300 to 600 to 900 mg/d. Data were obtained primarily from patient-completed questionnaires. RESULTS: Data from 20 evaluable women (of 24 entered in the trial) were available. Four patients discontinued use of gabapentin for perceived drug-related untoward symptoms, primarily related to light-headedness and dizziness. The 16 patients who completed this clinical trial had a mean reduction in hot flash frequency, in the fourth treatment week compared to the baseline week, of 66%. Their corresponding hot flash score (frequency times average severity) reduction was 70%. Additionally, patients who completed the 4 treatment weeks had a strong tendency to report an improvement in several other symptoms. CONCLUSION: Although a double-blind placebo-controlled clinical trial should be conducted to better elucidate the efficacy and toxicity of gabapentin in patients with hot flashes, the available data suggest that gabapentin is a reasonable treatment to consider in patients with hot flashes if they do not wish to use hormonal therapy.

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PubMed1999

Clinical experience with gabapentin in patients with bipolar or schizoaffective disorder: results of an open-label study.

BACKGROUND: This study was carried out to evaluate the efficacy, tolerability, and safety of gabapentin as an adjunctive treatment in patients with bipolar or schizoaffective disorder with manic or hypomanic symptoms. METHOD: Twenty-five patients fulfilling DSM-IV diagnostic criteria for bipolar I disorder or schizoaffective disorder underwent a 16-week, open-trial treatment with gabapentin. Symptom severity was measured using the Clinical Global Impressions scale (CGI) and the Brief Psychiatric Rating Scale (BPRS). Baseline scores and final scores were compared by using the Student t test and the Friedman range variance analysis. RESULTS: Twenty-two patients (88%) completed the 16 weeks of treatment with gabapentin; 19 (76%) had a positive response as measured by changes in CGI and BPRS scores. The mean dose was 1440 mg/day. The only side effect observed was oversedation, which decreased with continuing treatment. CONCLUSION: Gabapentin was effective in the treatment of mania and hypomania in patients with bipolar and schizoaffective disorders. If confirmed in controlled studies, these findings suggest that gabapentin represents a well-tolerated, rapidly acting antimanic agent.

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PubMed2000

Low doses of gabapentin may be helpful in the management of chronic daily headache.

CONTEXT: The difficult management of chronic daily headache and the lack of clinical trials for this medical condition led the authors to perform this study. Gabapentin has been successfully used for a variety of chronic pain conditions and therefore may be of use in the treatment of chronic headache. OBJECTIVE: To assess the efficacy and safety of low doses of gabapentin in cases of chronic daily headache. DESIGN: Open-label study on a series of cases of chronic daily headache. PATIENTS: Twenty-one consecutive patients with primary headache lasting 4 or more hours a day, at least 15 days per month, were invited to participate in this open trial. They were treated with low doses of gabapentin for sufficient time to lead to a headache-free period of at least 7 consecutive days. A minimum of 1 follow-up visit and 1 phone call were made in the subsequent 6-9 months. MEASUREMENTS: A simple "Patient Impression of Change" was used to evaluate the results. Patients were also invited to compare this treatment to previous ones, whenever possible. RESULTS: The efficacy of the treatment with gabapentin was rated as "excellent" by 19% of the patients, "good" by 47.6%, "fair" by 19%, and "poor" by 14.4%. CONCLUSIONS: Despite the inherent limitations of such a small open trial, the authors concluded that ratings of excellent and good by two thirds of this population of patients with chronic daily headache should encourage the setup of a large double-blind, multicentric, placebo-controlled trial of low doses of gabapentin for chronic daily headache.

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PubMedDate not supplied

[Efficacy and tolerance of gabapentin in dystonia and hemifacial spasm: a pilot study].

INTRODUCTION: The pharmacological management of dystonia is suboptimal. Focal dystonia and hemifacial spasm can be successfully managed with botulinum toxin injections. The physiopathology of dystonia remains a mystery. The gabaergic transmission may be involved in the origin of dystonia. Gabapentin is a gabaergic agent and therefore it can be useful in dystonia. PATIENTS AND METHODS: 28 patients with different forms of dystonia and hemifacial spasm were included in this open study. They received gabapentin (mean dose 1885 mg/d). RESULTS: Gabapentin was not efficacious but a subgroup of 6 patients (3 with hemifacial spasm, 2 with posttraumatic dystonia and 1 with spasmodic torticollis) significantly improved. Gabapentin was well tolerated. Somnolence was the most commonly reported side effect. CONCLUSION: Gabapentin may be useful in some patients with dystonia and hemifacial spasm. Double blind studies are clearly needed.

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PubMed2002

Gabapentin. Pfizer.

Gabapentin has been approved for the treatment of neuropathic pain in six European countries, New Zealand and Australia, and numerous countries in Latin America. By January 2001, Pfizer was preparing to file an NDA in the US for this indication; by October 2001, this NDA had been filed with the FDA. The drug is a GABA analog, but is not a GABA mimetic, although some neurons that respond to gabapentin are GABAergic. Gabapentin, at relevant concentrations, binds to an auxiliary protein of voltage-gated calcium channels (a2/3) and apparently, as a result, modulates the action of calcium channels and neurotransmitter release. This may account for many of its pharmacological actions. Gabapentin is also a substrate for the large neutral amino acid transporter, and this may be the major route allowing gabapentin access to the CNS. Modulation of synaptic transmission between primary afferents and substantia gelatinosa neurons, and blockade of signal transduction, are two potential mechanisms of action, in addition to inhibition of glutamate release by voltage-sensitive calcium channels. In September 2001, Morgan Stanley predicted sales of US $1871 million in 2002 falling to US $413 million in 2006.

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PubMedDate not supplied

[Effectiveness and safety of gabapentin in the preventive treatment of migraine].

INTRODUCTION: Migraine is a frequent and disabling pathological condition with important socioeconomic repercussions. Recent studies have explored the use of antiepileptic drugs in the prophylactic treatment of migraine. Preliminary studies have shown that gabapentin is a drug that is effective and well tolerated by patients. AIM. To evaluate the effectiveness and safety of gabapentin in the prophylactic treatment of migraine. PATIENTS AND METHODS: A prospective, open, multicentre, random clinical study, carried out according to IHS criteria, which compares the effectiveness and safety of gabapentin in 1,200 mg/day and 2,000 mg/day doses as a preventive treatment for migraine over a 16 week period. RESULTS: Significant differences were found in patients treated with gabapentin, as compared with their basal state, in the following: a lower number of attacks (reduction in weeks 4, 10 and 16: 2.4 2.8, 2.9 2.9 and 3.1 2.9 attacks/month on a basal rate of 5.3 3.5 attacks/month), lower intensity (on a scale of 0 3 of increasing pain intensity: basal rate: 2.7 0.4, week 4: 1.8 0.9, week 10: 1.7 0.9, week 16: 1.4 1.0) and how long the pain lasts (basal rate 390 hours/month, week 4: 180 hours/month, week 10: 180 hours/month, week 16: 120 hours/month). No statistically significant differences were found between doses of 1,200 or 2,000 mg/day. Mild adverse effects were seen in 62 patients (37.8%): drowsiness (22.6%), asthenia (7.9%), dizziness (4.9%), abdominal pain (3.7%) and dazedness (3.7%). No serious adverse events occurred. CONCLUSIONS: Gabapentin can be considered an effective and safe drug in the preventive treatment of migraine.

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PubMed2002

Nifedipine potentiates gabapentin antinociception in rats.

To evaluate the involvement of Ca++ channels in Gabapentin antinociception. In healthy male albino rats formalin (50 microliters, 5%) was injected at the planter surface of the paw. Pain score was calculated. Antinociceptive effect of (10, 30 mg/kg) gabapentin and (3, 10 mg/kg) nifedipine alone and on co-administration of sub analgesic doses was studied 30 minutes after formalin injection and reduction in pain scores was calculated. Gabapentin (30 mg/kg) and nifedipine (10 mg/kg) reduced the pain score in formalin injected rats. Gabapentin (10 mg/kg) and nifedipine (3 mg/kg) given alone did not modify pain score, however, on co-administration they significantly reduced the pain score. Study provides evidence of involvement of Ca++ channels in gabapentin antinociception.

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PubMed2003

A case of cutaneous leukocytoclastic vasculitis associated with gabapentin.

Gabapentin was approved for use in the USA in 1994 as an add-on drug in adults who have partial seizures either alone or with secondary generalised seizures. Its use has been expanded to include treatment for other conditions such as neuropathic pain and paraesthesiae. Gabapentin was prescribed for our patient who had persistent left-sided hemi-paraesthesiae consequential of a previous thalamic infarct. One week after commencement of gabapentin, she developed an adverse reaction in the form of a purpuric rash over bilateral lower limbs. Skin biopsy revealed histological features of cutaneous leukocytoclastic vasculitis. This rash completely resolved with withdrawal of gabapentin and steroidal treatment. This cutaneous adverse reaction to gabapentin has not been reported in the medical literature.

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PubMed2003

Gabapentin in the management of pentazocine dependence: a potent analgesic--anticraving agent.

OBJECTIVES: To evaluate the role of Gabapentin in the management of Pentazocine dependence for suppressing muscle aching and craving during its withdrawal. MATERIAL AND METHODS: Patients of Pentazocine dependence were divided in two groups GpA and GpB (n = 10 in each) and were administered Clonidine (P.O.) in first seven days (acute detoxification phase) and later Naltrexone (P.O.) from seventh day onwards (stabilisation-maintenance phase). Gabapentin (1200 mg/day) was additionally added in group B. Muscle pain and craving were rated on 100 mm visual-analogue scale. Psychological dependence was assessed on four step categorical scale. RESULTS: Group B (Gabapentin group) scored significantly lower (p < 0.001) than group A on both the parameters. Psychological dependence was significantly low (p < 0.01) in Gabapentin group. CONCLUSION: Gabapentin is an important adjuvant to the management of opiate dependence both in acute detoxification as well as stabilisation phase.

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PubMedDate not supplied

Gabapentin in the treatment of uremic itch: an index case and a pilot evaluation.

BACKGROUND: The prevalence of renal itch in patients on dialysis is approximately 30%, but its treatment is often ineffective. We describe an index case of a hemodialysis (HD) patient suffering from painful diabetic neuropathy (PDN) treated with gabapentin; the first administration of the drug led to the complete remission of the concomitant uremic pruritus. Subsequently, we report the results of a pilot evaluation aimed at testing the effectiveness and safety of low gabapentin doses in HD patients with uremic pruritus. METHODS: Five consecutive HD patients unresponsive to antihistamines received 4-week gabapentin treatment at a starting dose of 100 mg after every thrice-weekly HD, which was subsequently adjusted based on clinical response. Puritus severity was evaluated by means of a visual analogue scale (VAS) before each HD session on days 0, 2, 4, 7, 14, 21, 28 and 35. Safety was assessed using adverse event data. RESULTS: All patients experienced a rapid subjective improvement in pruritus, with the mean VAS score decreasing from 8.4-1.6 after the first drug administration. Three patients required a dose increase to 100 mg four times a week to obtain better itch control. Two patients experienced complete itch remission. CONCLUSION: Although a double-blind placebo-controlled clinical trial should be conducted to better elucidate the efficacy and toxicity of gabapentin in patients with uremic itch, our data suggest that gabapentin could be considered an effective and safe alternative treatment for uremic pruritus.

Aged↗
PubMed2005

Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin?

OBJECTIVE: This article reviews the available information on pregabalin, a new anticonvulsant for peripheral neuropathic pain. Pregabalin was provisionally approved by the US Food and Drug Administration in December 2004 and was granted final approval after controlled substance scheduling (Schedule V) by the US Drug Enforcement Agency in August 2005. METHODS: A MEDLINE search (1986-August 2005) was conducted to identify pertinent studies in the English language. The search terms included pregabalin, PD144723, CI-1008, gabapentin, and neuropathic pain. Additional references were obtained from the bibliographies of identified articles. All studies that evaluated any aspect of pregabalin in vitro or in vivo in animals or humans were included, with a focus on data relevant to older adults. RESULTS: In preclinical studies, pregabalin, a structural congener of gabapentin, exhibited antinociceptive activity in animal models of neuropathic and inflammatory pain. Unlike gabapentin, pregabalin was well absorbed (> 90%), and its absorption was dose independent. Like gabapentin, pregabalin was predominantly excreted unchanged in the urine (> or = 98%). Dosed at 50 to 200 mg TID, pregabalin was superior to placebo in relieving pain and improving sleep and health-related quality of life in patients with diabetic peripheral neuropathy and postherpetic neuralgia (P < 0.001-P < 0.049). No active-controlled trials were available. The most problematic adverse events associated with pregabalin were dizziness and somnolence (21%-26%). CONCLUSIONS: In the absence of active-controlled clinical trials and geriatric-specific efficacy/tolerability data, the place of pregabalin in the analgesic armamentarium for the elderly is unclear. Because pregabalin is a Schedule V controlled substance, its utility is not compromised by substantial limitation of access or the need for extra steps in prescribing. However, abuse potential is a consideration, and utilization should be carefully monitored, particularly in patients with a past or current history of substance abuse. The improved pharmacokinetic profile of pregabalin relative to gabapentin is manifested in linear and dose-independent absorption and a narrow therapeutic dosing range. However, pregabalin still requires multiple administrations per day, and daily doses > 150 mg/d require dose titration. The relatively high frequency of central nervous system adverse events, particularly dizziness and somnolence, is a concern in the elderly. Time and further experience should clarify the role of this agent.

Aged↗
PubMed2006

[Comparison of efficacy of gabapentin and amitriptyline in the management of peripheral neuropathic pain].

In this single center, double blind and randomized trial gabapentin as a new anticonvulsant was compared in efficacy and safety with amitriptyline which is a classic agent in neuropathic pain treatment. Fourty six patients with neuropathic pain which was burning, stabbing and shooting in quality were allocated to take gabapentin (group GBP) and amitriptyline (group AMI) monotherapy. The assesment variables were burning, stabbing, shooting pain on visual analog scale (VAS; 0: no pain, 10: worst pain imaginable), allodynia as present or not by lightly touching the skin with cotton. Primary efficacy variable was the degree of burning, stabbing and shooting pain improvement that was accepted as the difference of beginning and 4th week's VAS of all pain qualities. The secondary efficacy variable was the patient satisfaction scale determined as whether possible side effects of study drugs affect the patients' daily life. The degree of pain improvement was only seen in shooting pain and was statistically significantly high in group GBP. The patient satisfaction scale was also high in group GBP. Both gabapentin and amitriptyline provided effective pain control in peripheral neuropathic pain. Additionally gabapentin was more effective especially in paroxysmal shooting pain than other pain qualities. And also gabapentin was tolerated well.

Amines↗
PubMed1994

Clinical pharmacokinetics of gabapentin.

Pharmacokinetic properties are important to consider in evaluating the usefulness of new antiepileptic drugs (AEDs). Gabapentin is a new, water-soluble, antiepileptic agent with properties of an amino acid. This drug is rapidly absorbed and exhibits dose-dependent bioavailability as a result of a saturable transport mechanism. Plasma concentrations are essentially proportional to dosages up to 1,800 mg daily, which is the highest dosage used in double-blind, placebo-controlled clinical trials. Gabapentin is not protein-bound. A high volume of distribution indicates greater concentration in tissue than in plasma. It is not metabolized and does not induce hepatic enzymes or inhibit metabolism of other antiepileptic drugs. As a result, metabolism-related factors do not necessitate dosage alterations of gabapentin and concomitant AEDs after prolonged therapy. The drug is excreted unchanged in urine; plasma clearance is linearly related to creatinine clearance; and dosage is readily adjusted based on renal function. The elimination half-life is approximately 5 to 9 hours. Consequently, three divided doses are usually required per day, but steady state is rapidly achieved. No significant interactions between gabapentin and standard antiepileptic drugs or oral contraceptives have been observed. These and other pharmacokinetic properties make gabapentin unique among available AEDs.

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