The Experts below are selected from a list of 17553 Experts worldwide ranked by ideXlab platform
James P Young - One of the best experts on this subject based on the ideXlab platform.
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a 14 week randomized double blinded placebo controlled monotherapy trial of Pregabalin in patients with fibromyalgia
The Journal of Pain, 2008Co-Authors: Lesley M Arnold, James P Young, Susan A Martin, Uma Sharma, Jon I Russell, E W Diri, Rachel W Duan, Jeannette A Barrett, G. HaigAbstract:Abstract The purpose of the study was to assess the efficacy and safety of Pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to Pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the Pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in Pregabalin-treated patients were significantly greater ( P P P = .004) and the 600 mg/d ( P = .003) doses. Compared with placebo, all 3 doses of Pregabalin were associated with significant improvement in sleep. The most commonly reported Pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related. Perspective This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of Pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that Pregabalin is an important treatment option for patients with fibromyalgia.
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fibromyalgia relapse evaluation and efficacy for durability of meaningful relief freedom a 6 month double blind placebo controlled trial with Pregabalin
Pain, 2008Co-Authors: Leslie J Crofford, G. Haig, Philip J Mease, Susan L Simpson, James P Young, Susan A Martin, Uma SharmaAbstract:This was a multicenter, double-blind (DB), placebo-controlled, randomized discontinuation trial to evaluate the efficacy of Pregabalin monotherapy for durability of effect on fibromyalgia (FM) pain. The trial included a 6-week open-label (OL) Pregabalintreatment period followed by 26-week DB treatment with placebo or Pregabalin. Adults with FM and P40-mm score on 100-mm pain visual analog scale (VAS) were eligible. During OL weeks 1–3, patients received escalating dosages of Pregabalin to determine their optimal dosages. During OL weeks 4–6, patients received their optimal fixed dosages (300, 450, 600 mg/d). To be randomized, patients must have had P50% decrease in pain VAS and a self-rating of ‘‘much” or ‘‘very much” improved on Patient Global Impression of Change (PGIC) at the end of OL. Double-blind treatment was with placebo or the patient’s optimal fixed dosage of Pregabalin. Primary outcome was time to loss of therapeutic response (LTR), defined as <30% reduction in pain (from OL baseline) or worsening of FM. A total of 1051 patients entered OL; 287 were randomized to placebo, 279 to Pregabalin. Time to LTR was longer for Pregabalin versus placebo (P < .0001). Kaplan–Meier estimates of time-to-event showed half the placebo group had LTR by Day 19; half the Pregabalin group still had not lost response by trial end. At the end of DB, 174 (61%) placebo patients met LTR criteria versus 90 (32%) Pregabalin patients. Pregabalin was well tolerated, though 178 (17%) discontinued during OL for treatment-related adverse events (AE), and more Pregabalin than placebo patients discontinued for AEs during DB. In those who respond, Pregabalin demonstrated durability of effect for relieving FM pain. 2008 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
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a randomized double blind placebo controlled phase iii trial of Pregabalin in the treatment of patients with fibromyalgia
The Journal of Rheumatology, 2008Co-Authors: Philip J Mease, James P Young, Susan A Martin, Jon I Russell, Lesley M Arnold, Hana Florian, Uma SharmaAbstract:OBJECTIVE: To evaluate the efficacy and safety of Pregabalin for symptomatic relief of pain associated with fibromyalgia (FM) and for management of FM. METHODS: This multicenter, double-blind, placebo-controlled trial randomly assigned 748 patients with FM to receive placebo or Pregabalin 300, 450, or 600 mg/day (dosed twice daily) for 13 weeks. The primary outcome variable for study objective 1, symptomatic relief of pain associated with FM, was comparison of endpoint mean pain scores between each Pregabalin group and placebo. The outcome variable for study objective 2, management of FM, included endpoint mean pain scores, Patient Global Impression of Change (PGIC), and Fibromyalgia Impact Questionnaire (FIQ)-Total Score. Secondary outcomes included assessments of sleep, fatigue, and mood disturbance. RESULTS: Patients in all Pregabalin groups showed statistically significant improvement in endpoint mean pain score and in PGIC response compared with placebo. Improvements in FIQ-Total Score for the Pregabalin groups were numerically but not significantly greater than those for the placebo group. Compared with placebo, all Pregabalin treatment groups showed statistically significant improvement in assessments of sleep and in patients9 impressions of their global improvement. Dizziness and somnolence were the most frequently reported adverse events. CONCLUSION: Pregabalin at 300, 450, and 600 mg/day was efficacious and safe for treatment of pain associated with FM. Pregabalin monotherapy provides clinically meaningful benefit to patients with FM.
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Pregabalin for relief of neuropathic pain associated with diabetic neuropathy a randomized double blind study
European Journal of Pain, 2008Co-Authors: T R Tolle, Rainer Freynhagen, Mark Versavel, Uwe Trostmann, James P YoungAbstract:Abstract Seven published, randomized, placebo-controlled clinical trials with Pregabalin have shown robust efficacy for relief of neuropathic pain from DPN and PHN. An investigation of the efficacy and safety of twice daily Pregabalin enrolled 395 adults with painful DPN for ⩾1 year in a 12-week, double-blind, placebo-controlled trial. Patients were randomized to placebo, 150, 300, or 600 mg/day Pregabalin ( n = 96, 99, 99, and 101). Primary efficacy measure was change from baseline in endpoint mean pain score from patients’ daily pain diaries. Secondary efficacy measures included pain-related sleep-interference scores, Patient and Clinical Global Impressions of Change (PGIC, CGIC), and the EuroQOL Health Utilities Index (EQ-5D). Statistically significant reduction in pain was observed in patients receiving Pregabalin 600 mg/day, and 46% of patients treated with 600 mg/day Pregabalin reported ⩾50% improvement in mean pain scores from baseline (vs 30% of placebo patients, p = 0.036). Number needed to treat to achieve such response was 6.3. Pregabalin 600 mg/day was significantly superior to placebo in improving pain-related sleep-interference scores ( p = 0.003), PGIC ( p = 0.021), and CGIC ( p = 0.009). (Neither Pregabalin 150 nor 300 mg/day separated from placebo on these measures, largely because of an atypically large placebo response in one country representing 42% of patients.) All Pregabalin dosages were superior to placebo in improving EQ-5D utility scores (all p ⩾ 0.0263 vs placebo). Pregabalin was well tolerated at all dosages; adverse events were generally mild to moderate. Number needed to harm (discontinuation because of adverse events) was 10.3 for Pregabalin 600 mg/day.
Uma Sharma - One of the best experts on this subject based on the ideXlab platform.
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a 14 week randomized double blinded placebo controlled monotherapy trial of Pregabalin in patients with fibromyalgia
The Journal of Pain, 2008Co-Authors: Lesley M Arnold, James P Young, Susan A Martin, Uma Sharma, Jon I Russell, E W Diri, Rachel W Duan, Jeannette A Barrett, G. HaigAbstract:Abstract The purpose of the study was to assess the efficacy and safety of Pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to Pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the Pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in Pregabalin-treated patients were significantly greater ( P P P = .004) and the 600 mg/d ( P = .003) doses. Compared with placebo, all 3 doses of Pregabalin were associated with significant improvement in sleep. The most commonly reported Pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related. Perspective This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of Pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that Pregabalin is an important treatment option for patients with fibromyalgia.
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fibromyalgia relapse evaluation and efficacy for durability of meaningful relief freedom a 6 month double blind placebo controlled trial with Pregabalin
Pain, 2008Co-Authors: Leslie J Crofford, G. Haig, Philip J Mease, Susan L Simpson, James P Young, Susan A Martin, Uma SharmaAbstract:This was a multicenter, double-blind (DB), placebo-controlled, randomized discontinuation trial to evaluate the efficacy of Pregabalin monotherapy for durability of effect on fibromyalgia (FM) pain. The trial included a 6-week open-label (OL) Pregabalintreatment period followed by 26-week DB treatment with placebo or Pregabalin. Adults with FM and P40-mm score on 100-mm pain visual analog scale (VAS) were eligible. During OL weeks 1–3, patients received escalating dosages of Pregabalin to determine their optimal dosages. During OL weeks 4–6, patients received their optimal fixed dosages (300, 450, 600 mg/d). To be randomized, patients must have had P50% decrease in pain VAS and a self-rating of ‘‘much” or ‘‘very much” improved on Patient Global Impression of Change (PGIC) at the end of OL. Double-blind treatment was with placebo or the patient’s optimal fixed dosage of Pregabalin. Primary outcome was time to loss of therapeutic response (LTR), defined as <30% reduction in pain (from OL baseline) or worsening of FM. A total of 1051 patients entered OL; 287 were randomized to placebo, 279 to Pregabalin. Time to LTR was longer for Pregabalin versus placebo (P < .0001). Kaplan–Meier estimates of time-to-event showed half the placebo group had LTR by Day 19; half the Pregabalin group still had not lost response by trial end. At the end of DB, 174 (61%) placebo patients met LTR criteria versus 90 (32%) Pregabalin patients. Pregabalin was well tolerated, though 178 (17%) discontinued during OL for treatment-related adverse events (AE), and more Pregabalin than placebo patients discontinued for AEs during DB. In those who respond, Pregabalin demonstrated durability of effect for relieving FM pain. 2008 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
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a randomized double blind placebo controlled phase iii trial of Pregabalin in the treatment of patients with fibromyalgia
The Journal of Rheumatology, 2008Co-Authors: Philip J Mease, James P Young, Susan A Martin, Jon I Russell, Lesley M Arnold, Hana Florian, Uma SharmaAbstract:OBJECTIVE: To evaluate the efficacy and safety of Pregabalin for symptomatic relief of pain associated with fibromyalgia (FM) and for management of FM. METHODS: This multicenter, double-blind, placebo-controlled trial randomly assigned 748 patients with FM to receive placebo or Pregabalin 300, 450, or 600 mg/day (dosed twice daily) for 13 weeks. The primary outcome variable for study objective 1, symptomatic relief of pain associated with FM, was comparison of endpoint mean pain scores between each Pregabalin group and placebo. The outcome variable for study objective 2, management of FM, included endpoint mean pain scores, Patient Global Impression of Change (PGIC), and Fibromyalgia Impact Questionnaire (FIQ)-Total Score. Secondary outcomes included assessments of sleep, fatigue, and mood disturbance. RESULTS: Patients in all Pregabalin groups showed statistically significant improvement in endpoint mean pain score and in PGIC response compared with placebo. Improvements in FIQ-Total Score for the Pregabalin groups were numerically but not significantly greater than those for the placebo group. Compared with placebo, all Pregabalin treatment groups showed statistically significant improvement in assessments of sleep and in patients9 impressions of their global improvement. Dizziness and somnolence were the most frequently reported adverse events. CONCLUSION: Pregabalin at 300, 450, and 600 mg/day was efficacious and safe for treatment of pain associated with FM. Pregabalin monotherapy provides clinically meaningful benefit to patients with FM.
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Pregabalin for the treatment of postherpetic neuralgia a randomized placebo controlled trial
Neurology, 2003Co-Authors: Robert H Dworkin, Uma Sharma, Ann E Corbin, J P Young, L Lamoreaux, H Bockbrader, E A Garofalo, R M PooleAbstract:Objective: To evaluate the efficacy and safety of Pregabalin in the treatment of postherpetic neuralgia (PHN). Methods: The authors conducted a multicenter, parallel-group, double-blind, placebo-controlled, 8-week, randomized clinical trial in PHN, defined as pain for 3 or more months following herpes zoster rash healing. Patients (n = 173) were randomized to treatment with Pregabalin or placebo. Patients randomized to Pregabalin received either 600 mg/day (creatinine clearance > 60 mL/min) or 300 mg/day (creatinine clearance 30 to 60 mL/min). The primary efficacy measure was the mean of the last seven daily pain ratings. Secondary endpoints included additional pain ratings, sleep interference, quality of life, mood, and patient and clinician ratings of global improvement. Results: Pregabalin-treated patients had greater decreases in pain than patients treated with placebo (endpoint mean scores 3.60 vs 5.29, p = 0.0001). Pain was significantly reduced in the Pregabalin-treated patients after the first full day of treatment and throughout the study, and significant improvement on the McGill Pain Questionnaire total, sensory, and affective pain scores was also found. The proportions of patients with ≥30% and ≥50% decreases in mean pain scores were greater in the Pregabalin than in the placebo group (63% vs 25% and 50% vs 20%, p = 0.001). Sleep also improved in patients treated with Pregabalin compared to placebo ( p = 0.0001). Both patients and clinicians were more likely to report global improvement with Pregabalin than placebo ( p = 0.001). Given the maximal dosage studied, Pregabalin had acceptable tolerability compared to placebo despite a greater incidence of side effects, which were generally mild to moderate in intensity. Conclusions: Treatment of PHN with Pregabalin is safe, efficacious in relieving pain and sleep interference, and associated with greater global improvement than treatment with placebo.
Nicholas A Buckley - One of the best experts on this subject based on the ideXlab platform.
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rising Pregabalin use and misuse in australia trends in utilization and intentional poisonings
Addiction, 2019Co-Authors: Sallie-anne Pearson, Rose Cairns, Andrea L Schaffer, Nicholas A Buckley, Nicole M RyanAbstract:BACKGROUND AND AIMS Pregabalin is a gamma-aminobutyric acid (GABA) analogue, used to treat neuropathic pain and epilepsy. Pregabalin was registered in Australia in 2005, and subsidized publically in 2013. We aimed to describe Australian patterns of Pregabalin use and intentional poisoning, and identify people potentially at high risk of misuse. DESIGN AND SETTING Population-based retrospective cohort study of dispensings in the 10% sample of Australian Pharmaceutical Benefits Scheme (July 2012-February 2017); intentional poisoning calls to New South Wales Poisons Information Centre (NSWPIC) (2004-2016); intentional poisonings in two Australian toxicology service databases; and poisoning fatalities in NSW coronial records (2005-2016). PARTICIPANTS A total of 122 572 people dispensed Pregabalin, people with intentional Pregabalin overdoses managed by NSWPIC and the toxicology services and Pregabalin-associated deaths referred to the NSW coroner. MEASUREMENTS Trends in dispensing, poisoning, death; demographics and patient characteristics, proportion of users at high risk of misuse (latent class analysis, LCA) and characteristics of high-risk users. FINDINGS Pregabalin dispensing increased by 73 424 per year [95% confidence interval (CI) = 61726-85 121 P < 0.001] between 2013 and 2016. NSWPIC received 1158 reports of intentional Pregabalin poisonings, with a 53.8% increase per year, 2005-2016 (95% CI = 44.0-64.2%, P < 0.001). We identified 88 Pregabalin-associated deaths, 57.8% yearly increase (95% CI = 30.0-91.6%, P < 0.001). Patients overdosing on Pregabalin commonly co-ingested opioids, benzodiazepines and illicit drugs, and had high rates of psychiatric and substance use comorbidities; 14.7% of Pregabalin users were classed by the LCA as at high risk of misuse, and were more likely to be younger, male, co-prescribed benzodiazepines or opioids, have more individual prescribers and higher Pregabalin strengths dispensed. CONCLUSIONS There has been a dramatic increase in Pregabalin use, poisonings and deaths in Australia since it became subsidized publicly in 2013. One in seven Australians dispensed Pregabalin appears to be at high risk of misuse.
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Rising Pregabalin use and misuse in Australia: trends in utilization and intentional poisonings
Addiction, 2018Co-Authors: Rose Cairns, Sallie-anne Pearson, Andrea L Schaffer, Nicole M Ryan, Nicholas A BuckleyAbstract:Pregabalin is a gamma-aminobutyric acid (GABA) analogue, used to treat neuropathic pain and epilepsy. Pregabalin was registered in Australia in 2005, and subsidized publically in 2013. We aimed to describe Australian patterns of Pregabalin use and intentional poisoning, and identify people potentially at high risk of misuse. Population-based retrospective cohort study of dispensings in the 10% sample of Australian Pharmaceutical Benefits Scheme (July 2012-February 2017); intentional poisoning calls to New South Wales Poisons Information Centre (NSWPIC) (2004-2016); intentional poisonings in two Australian toxicology service databases; and poisoning fatalities in NSW coronial records (2005-2016). A total of 122 572 people dispensed Pregabalin, people with intentional Pregabalin overdoses managed by NSWPIC and the toxicology services and Pregabalin-associated deaths referred to the NSW coroner. Trends in dispensing, poisoning, death; demographics and patient characteristics, proportion of users at high risk of misuse (latent class analysis, LCA) and characteristics of high-risk users. Pregabalin dispensing increased by 73 424 per year [95% confidence interval (CI) = 61726-85 121 P < 0.001] between 2013 and 2016. NSWPIC received 1158 reports of intentional Pregabalin poisonings, with a 53.8% increase per year, 2005-2016 (95% CI = 44.0-64.2%, P < 0.001). We identified 88 Pregabalin-associated deaths, 57.8% yearly increase (95% CI = 30.0-91.6%, P < 0.001). Patients overdosing on Pregabalin commonly co-ingested opioids, benzodiazepines and illicit drugs, and had high rates of psychiatric and substance use comorbidities; 14.7% of Pregabalin users were classed by the LCA as at high risk of misuse, and were more likely to be younger, male, co-prescribed benzodiazepines or opioids, have more individual prescribers and higher Pregabalin strengths dispensed. There has been a dramatic increase in Pregabalin use, poisonings and deaths in Australia since it became subsidized publicly in 2013. One in seven Australians dispensed Pregabalin appears to be at high risk of misuse. © 2018 Society for the Study of Addiction.
Minoru Kawamura - One of the best experts on this subject based on the ideXlab platform.
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Combined antiallodynic effect of Neurotropin® and Pregabalin in rats with L5-spinal nerve ligation.
Life sciences, 2013Co-Authors: Ryohei Okazaki, Hisashi Okai, Hiroyuki Yoshida, Hiroyoshi Namba, Kazuki Taguchi, Minoru KawamuraAbstract:In this study, we investigated the combined effect of Neurotropin® and Pregabalin for L5-spinal nerve ligation (L5-SNL) model in rats and thiopental-induced sleep in mice. The left fifth lumbar nerve of rats was tightly ligated with silk sutures under pentobarbital anesthesia. The hindpaw withdrawal threshold was measured by application of von Frey filaments. Thiopental sodium was intravenously administered in mice and sleeping time was measured. In L5-SNL rats, an isobolographic analysis was performed to clarify the combined antiallodynic effect of Neurotropin and Pregabalin 14 days after ligation in rats. In isobolographic analysis and thiopental-induced sleep test, Neurotropin and Pregabalin were orally administered to coincide with the timing of the peak effect of each drug. Neurotropin (50-200 NU/kg) and Pregabalin (2.5-10mg/kg) showed a dose-dependent antiallodynic action in L5-SNL rats. The antiallodynic effect of Pregabalin was reversed by intrathecal injection of yohimbine or ondansetron. Isobolographic analysis suggested that the combined antiallodynic effect of Neurotropin and Pregabalin in L5-SNL rats may have been more than a mere additive effect. Neurotropin (50-400 NU/kg) had no effect on thiopental-induced sleeping time whereas Pregabalin (30-100mg/kg) significantly prolonged it. When the dose of Pregabalin was 30 mg/kg, Neurotropin (50-400 NU/kg) did not further exacerbate the prolongation effect of Pregabalin on thiopental-induced sleep. It was suggested that when Neurotropin was administered in combination with Pregabalin, it might provide more effective pain relief than that obtained with each agent alone in neuropathic pain without aggravating adverse effects of Pregabalin. Copyright © 2013 Elsevier Inc. All rights reserved.
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Combined antiallodynic effect of Neurotropin® and Pregabalin in rats with L5-spinal nerve ligation.
Life Sciences, 2013Co-Authors: Ryohei Okazaki, Hisashi Okai, Hiroyuki Yoshida, Hiroyoshi Namba, Kazuki Taguchi, Minoru KawamuraAbstract:Abstract Aims In this study, we investigated the combined effect of Neurotropin® and Pregabalin for L5-spinal nerve ligation (L5-SNL) model in rats and thiopental-induced sleep in mice. Main methods The left fifth lumbar nerve of rats was tightly ligated with silk sutures under pentobarbital anesthesia. The hindpaw withdrawal threshold was measured by application of von Frey filaments. Thiopental sodium was intravenously administered in mice and sleeping time was measured. In L5-SNL rats, an isobolographic analysis was performed to clarify the combined antiallodynic effect of Neurotropin and Pregabalin 14 days after ligation in rats. In isobolographic analysis and thiopental-induced sleep test, Neurotropin and Pregabalin were orally administered to coincide with the timing of the peak effect of each drug. Key findings Neurotropin (50–200 NU/kg) and Pregabalin (2.5–10 mg/kg) showed a dose-dependent antiallodynic action in L5-SNL rats. The antiallodynic effect of Pregabalin was reversed by intrathecal injection of yohimbine or ondansetron. Isobolographic analysis suggested that the combined antiallodynic effect of Neurotropin and Pregabalin in L5-SNL rats may have been more than a mere additive effect. Neurotropin (50–400 NU/kg) had no effect on thiopental-induced sleeping time whereas Pregabalin (30–100 mg/kg) significantly prolonged it. When the dose of Pregabalin was 30 mg/kg, Neurotropin (50–400 NU/kg) did not further exacerbate the prolongation effect of Pregabalin on thiopental-induced sleep. Significance It was suggested that when Neurotropin was administered in combination with Pregabalin, it might provide more effective pain relief than that obtained with each agent alone in neuropathic pain without aggravating adverse effects of Pregabalin.
G. Haig - One of the best experts on this subject based on the ideXlab platform.
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Clinical pharmacokinetics of Pregabalin in healthy volunteers.
Journal of clinical pharmacology, 2010Co-Authors: Howard Norman Bockbrader, Louis L. Radulovic, Edward L. Posvar, James C. Strand, Christine Alvey, Janice A. Busch, Edward J. Randinitis, Brian Corrigan, G. Haig, Rebecca A. BoydAbstract:Pregabalin has shown clinical efficacy for treatment of neuropathic pain syndromes, partial seizures, and anxiety disorders. Five studies in healthy volunteers are performed to investigate single- and multiple-dose pharmacokinetics of Pregabalin. Pregabalin is rapidly absorbed following oral administration, with peak plasma concentrations occurring between 0.7 and 1.3 hours. Pregabalin oral bioavailability is approximately 90% and is independent of dose and frequency of administration. Food reduces the rate of Pregabalin absorption, resulting in lower and delayed maximum plasma concentrations, yet the extent of drug absorption is unaffected, suggesting that Pregabalin may be administered without regard to meals. Pregabalin elimination half-life is approximately 6 hours and steady state is achieved within 1 to 2 days of repeated administration. Corrected for oral bioavailability, Pregabalin plasma clearance is essentially equivalent to renal clearance, indicating that Pregabalin undergoes negligible nonrenal elimination. Pregabalin demonstrates desirable, predictable pharmacokinetic properties that suggest ease of use. Because Pregabalin is eliminated renally, renal function affects its pharmacokinetics.
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a 14 week randomized double blinded placebo controlled monotherapy trial of Pregabalin in patients with fibromyalgia
The Journal of Pain, 2008Co-Authors: Lesley M Arnold, James P Young, Susan A Martin, Uma Sharma, Jon I Russell, E W Diri, Rachel W Duan, Jeannette A Barrett, G. HaigAbstract:Abstract The purpose of the study was to assess the efficacy and safety of Pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to Pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the Pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in Pregabalin-treated patients were significantly greater ( P P P = .004) and the 600 mg/d ( P = .003) doses. Compared with placebo, all 3 doses of Pregabalin were associated with significant improvement in sleep. The most commonly reported Pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related. Perspective This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of Pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that Pregabalin is an important treatment option for patients with fibromyalgia.
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fibromyalgia relapse evaluation and efficacy for durability of meaningful relief freedom a 6 month double blind placebo controlled trial with Pregabalin
Pain, 2008Co-Authors: Leslie J Crofford, G. Haig, Philip J Mease, Susan L Simpson, James P Young, Susan A Martin, Uma SharmaAbstract:This was a multicenter, double-blind (DB), placebo-controlled, randomized discontinuation trial to evaluate the efficacy of Pregabalin monotherapy for durability of effect on fibromyalgia (FM) pain. The trial included a 6-week open-label (OL) Pregabalintreatment period followed by 26-week DB treatment with placebo or Pregabalin. Adults with FM and P40-mm score on 100-mm pain visual analog scale (VAS) were eligible. During OL weeks 1–3, patients received escalating dosages of Pregabalin to determine their optimal dosages. During OL weeks 4–6, patients received their optimal fixed dosages (300, 450, 600 mg/d). To be randomized, patients must have had P50% decrease in pain VAS and a self-rating of ‘‘much” or ‘‘very much” improved on Patient Global Impression of Change (PGIC) at the end of OL. Double-blind treatment was with placebo or the patient’s optimal fixed dosage of Pregabalin. Primary outcome was time to loss of therapeutic response (LTR), defined as <30% reduction in pain (from OL baseline) or worsening of FM. A total of 1051 patients entered OL; 287 were randomized to placebo, 279 to Pregabalin. Time to LTR was longer for Pregabalin versus placebo (P < .0001). Kaplan–Meier estimates of time-to-event showed half the placebo group had LTR by Day 19; half the Pregabalin group still had not lost response by trial end. At the end of DB, 174 (61%) placebo patients met LTR criteria versus 90 (32%) Pregabalin patients. Pregabalin was well tolerated, though 178 (17%) discontinued during OL for treatment-related adverse events (AE), and more Pregabalin than placebo patients discontinued for AEs during DB. In those who respond, Pregabalin demonstrated durability of effect for relieving FM pain. 2008 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
