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Trial of Pregabalin for Acute and Chronic Sciatica. Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica.We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted (...) underwent randomization, of whom 108 received pregabalin and 101 received placebo; after randomization, 2 patients in the pregabalin group were determined to be ineligible and were excluded from the analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 95% confidence interval [CI], -0.2 to 1.2; P=0.19). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0
Pregabalin for Acute Pain: A Review of the Clinical Effectiveness Pregabalin for Acute Pain: A Review of the Clinical Effectiveness | CADTH.ca Find the information you need Pregabalin for Acute Pain: A Review of the Clinical Effectiveness Pregabalin for Acute Pain: A Review of the Clinical Effectiveness Published on: January 24, 2017 Project Number: RC0843-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical (...) effectiveness of pregabalin for acute pain? What is the comparative effectiveness of concurrent pregabalin and opioid use versus opioids alone for the management of acute or post-operative pain? Key Message One randomized controlled trial (RCT) demonstrated that compared to opioids alone, a single pre-operative dose of pregabalin in combination with post-operative opioids significantly reduced post-operative opioid consumption, pain scores and use of breakthrough analgesia at 48 hours. A second RCT
Pregabalin for essential tremor. Essential tremor is one of the most common movement disorders. Treatment primarily consists of pharmacological agents. While primidone and propranolol are well-established treatments in clinical practice, they may be ineffective in 25% to 55% of patients and can produce serious adverse events in a large percentage of them. For these reasons, it is worth evaluating the treatment alternatives for essential tremor. Some specialists have suggested that pregabalin (...) could be a potentially useful agent, but there is uncertainty about its efficacy and safety.To assess the effects of pregabalin versus placebo or other treatment for essential tremor in adults.We performed a systematic search without language restrictions to identify all relevant trials up to December 2015. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, NICE, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry
Adjunctive pregabalin vs gabapentin for focal seizures: Interpretation of comparative outcomes To evaluate the comparative safety and adjunctive efficacy of pregabalin and gabapentin in reducing seizure frequency in patients with partial-onset seizures based on prestudy modeling showing superior efficacy for pregabalin.The design of this comparative efficacy and safety study of pregabalin and gabapentin as adjunctive treatment in adults with refractory partial-onset seizures was randomized (...) , flexible dose, double blind, and parallel group. The study included a 6-week baseline and a 21-week treatment phase. The primary endpoint was the percentage change from baseline in 28-day seizure rate to the treatment phase.A total of 484 patients were randomized to pregabalin (n = 242) or gabapentin (n = 242). Of these, 359 patients (187 pregabalin, 172 gabapentin) completed the treatment phase. The observed median and mean in percentage change from baseline was -58.65 and -47.7 (SD 48.3
Pregabalin for pain in fibromyalgia in adults. This review updates part of an earlier Cochrane review on 'Pregabalin for acute and chronic pain in adults' (Moore 2009), and considers only fibromyalgia pain.Antiepileptic drugs have been used in pain management since the 1960s. Pregabalin is an antiepileptic drug also used in management of chronic pain conditions, including fibromyalgia. Pain response with pregabalin is associated with major benefits for other symptoms, and improved quality (...) of life and function in people with chronic painful conditions.To assess the analgesic efficacy and adverse events of pregabalin for pain in fibromyalgia in adults, compared with placebo or any active comparator.We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE for randomised controlled trials from inception to May 2009 for the original review and to 16 March 2016 for this update. We also searched the reference lists of retrieved studies and reviews
Prior Opioid Use Does Not Impact the Response to Pregabalin in Patients With Fibromyalgia Fibromyalgia (FM) is a chronic pain disorder for which pregabalin is an approved treatment in the United States. Although opioids are not a recommended treatment option, they continue to be used by many FM patients. The impact of patients' prior opioid use on their subsequent response to pregabalin has not been assessed.This was a pooled analysis of 4 clinical trials to assess the efficacy of pregabalin (...) in FM patients both with and without prior opioid use. Patients were divided into those using opioids prior to the trial and those who were not. The change in least squares mean pain score (assessed by 0 to 10 numeric rating scale) with pregabalin compared with placebo was assessed together with FM symptoms, anxiety, and depression.There were 2062 patients in the analysis set, including 371 patients with prior opioid use. Equal numbers of patients were treated with placebo, pregabalin 300 mg/d
Pregnancy outcome following maternal exposure to pregabalin may call for concern To investigate pregnancy outcomes following maternal use of pregabalin.This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to pregabalin with those of matched controls (not exposed to any medications known to be teratogenic or to any antiepileptic drugs). Teratology Information Services systematically collected data between 2004 and 2013.Data were collected from 164 (...) exposed pregnancies and 656 controls. A significantly higher major birth defect rate in the pregabalin group was observed after exclusion of chromosomal aberration syndromes, and when cases with exposure during first trimester of pregnancy were analyzed separately (7/116 [6.0%] vs 12/580 [2.1%]; odds ratio 3.0, 95% confidence interval 1.2-7.9, p = 0.03). The rate of live births was lower in the pregabalin group (71.9% vs 85.2%, p < 0.001), primarily due to a higher rate of both elective (9.8% vs 5.0
Pregabalin and Speech Pathology Combination Therapy for Refractory Chronic Cough: A Randomized Controlled Trial Chronic refractory cough (CRC) is a difficult problem to treat. Speech pathology treatment (SPT) improves symptoms but resolution is incomplete. Centrally acting neuromodulators also improve cough symptoms, but not cough reflex sensitivity, and the effect is short-lived. We hypothesized that combined SPT and centrally acting neuromodulators would have a superior outcome than SPT alone (...) . Our goal was to determine whether combined pregabalin and SPT is more effective than SPT alone.Randomized placebo controlled trial. Forty patients with CRC were randomly assigned to receive either combined SPT and pregabalin 300 mg daily or combined SPT and placebo. Outcome measures were collected at baseline, end of treatment, and 4 weeks after the end of treatment. Primary outcome measures were cough frequency using the Leicester Cough Monitor, cough severity using a visual analog scale
Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study To evaluate pregabalin's efficacy and safety versus placebo to reduce pain in patients with diabetic peripheral neuropathy (DPN) using a concomitant nonsteroidal anti-inflammatory drug.In a randomized, double-masked, 14-week, 2-period, crossover study, patients with painful DPN using a nonsteroidal anti-inflammatory drug for non-DPN-related pain received (...) 150 to 300 mg/d pregabalin or placebo (period 1); 14-day washout; then, the opposite therapy (period 2). Endpoints included weekly change in DPN pain score, sleep interference, adverse events, and patient-reported outcomes.Patients with similar baseline characteristics were randomized (period 1) to 1 of the 2 following possible sequences: pregabalin→placebo (n=154) or placebo→pregabalin (n=147). Results of the primary efficacy measure, mean weekly DPN pain at endpoint, showed no significant
Pregabalin for decreasing pancreatic pain in chronic pancreatitis. Chronic abdominal pain is one of the major symptoms in people with chronic pancreatitis. The role of pregabalin in people with chronic pancreatic pain due to chronic pancreatitis is uncertain.To assess the benefits and harms of pregabalin in people with chronic abdominal pain due to chronic pancreatitis.We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2015, issue 6, and MEDLINE (...) difference (MD) with 95% confidence intervals (CI) with RevMan 5, based on intention-to-treat analysis.Only one study, funded by Pfizer, met the inclusion criteria for the review. A total of 64 participants (with chronic pain due to chronic pancreatitis) were randomly assigned to receive escalating doses of pregabalin (150 mg per day to 600 mg per day; 34 participants) or matching placebo (30 participants). Participants received pregabalin or placebo for three weeks on an outpatient basis; the outcomes
Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking This randomized, double-blind, placebo-controlled, multicenter, 2-period crossover study (two 6-week treatment periods separated by a 2-week washout period) evaluated the efficacy and safety of pregabalin (150 to 300 mg/d) for treatment of pain and pain on walking in patients with painful diabetic peripheral neuropathy (DPN) who experienced pain while walking.Co-primary (...) efficacy endpoints were: (1) mean pain score (last 7 daily pain diary scores, 0 to 10 numeric rating scale at end of each treatment period) and (2) DPN pain on walking (0 to 10 numeric rating scale immediately after walking 50 feet [15.2 m] on flat surface). Secondary endpoints included other pain parameters, patient-reported sleep, health-related quality of life, and safety measures.Two hundred three patients were treated (pregabalin, n=198; placebo, n=186), with no statistically significant treatment
Perioperative use of pregabalin for acute pain-a systematic review and meta-analysis Evidence supporting postoperative pain management using pregabalin as an adjunct intervention across various surgical pain models is lacking. The objective of this systematic review was to evaluate "model-specific" comparative effectiveness and harms of pregabalin following a previously published systematic review protocol. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched (...) from inception through August 2013. Data were screened and single extraction with independent verification and dual risk of bias assessment was performed. Quality of evidence (QoE) was rated using the GRADE approach. Primary outcomes were pain relief at rest and on movement and reduction in postoperative analgesic consumption. A total of 1423 records were screened, and 43 studies were included. Perioperative pregabalin resulted in: 16% (95% confidence interval [CI], 9%-21%) reduction in analgesic
Imipramine and pregabalin combination for painful polyneuropathy: a randomized controlled trial Monotherapy with first-line drugs for neuropathic pain often fails to provide sufficient pain relief or has unacceptable side effects because of the need for high doses. The aim of this trial was to test whether the combination of imipramine and pregabalin in moderate doses would relieve pain more effectively than monotherapy with either of the drugs. This was a randomized, double-blind, placebo (...) -controlled, crossover, multicenter trial consisting of four 5-week treatment periods in patients with painful polyneuropathy. Treatment arms were imipramine 75 mg/d vs pregabalin 300 mg/d vs combination therapy vs placebo. Patients with polyneuropathy and symptoms for more than 6 months, age 20 to 85 years, pain intensity ≥4 on a 0- to 10-point numeric rating scale (NRS) and pain at least 4 days a week were included in the trial. A total of 262 patients were screened for participation, 73 patients were
Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication To test the effects of pregabalin on the induction of neurogenic claudication.This study was a randomized, double-blind, active placebo-controlled, 2-period, crossover trial. Twenty-nine subjects were randomized to receive pregabalin followed by active placebo (i.e., diphenhydramine) or active placebo followed by pregabalin. Each treatment period lasted 10 days, including a 2-step titration. Periods (...) Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom (difference in median Tfirst = -1.08 [95% confidence interval -2.25 to 0.08], p = 0.61). In addition, none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo.Pregabalin was not more effective than
Pregabalin Sandoz 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 23 April 2015 EMA/CHMP/102862/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Sandoz International non-proprietary name: pregabalin Procedure No. EMEA/H/C/004010 Note Assessment report as adopted by the CHMP with all (...) information of a commercially confidential nature deleted. Pregabalin Sandoz Assessment report EMA/CHMP/102862/2015 Page 2/23 Table of contents 1. Background information on the procedure 4 1.1. Submission of the dossier 4 1.2. Manufacturers 5 1.3. Steps taken for the assessment of the product 6 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 7 2.2.1. Introduction 7 2.2.2. Active substance 7 2.2.3. Finished medicinal product 9 2.2.4. Discussion on chemical, and pharmaceutical aspects 11
Pregabalin Sandoz GmbH 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 26 May 2015 EMA/CHMP/102870/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Sandoz GmbH International non-proprietary name: pregabalin Procedure No. EMEA/H/C/004070 Note Assessment report as adopted by the CHMP (...) with all information of a commercially confidential nature deleted. Pregabalin Sandoz GmbH Assessment report EMA/CHMP/102870/2015 Page 2/23 Table of contents 1. Background information on the procedure 4 1.1. Submission of the dossier 4 1.2. Manufacturers 5 1.3. Steps taken for the assessment of the product 6 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 7 2.2.1. Introduction 7 2.2.2. Active substance 7 2.2.3. Finished medicinal product 9 Adventitious agents 11 2.2.4. Discussion
Pregabalin Mylan 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 23 April 2015 EMA/CHMP/90129/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Mylan International non-proprietary name: pregabalin Procedure No. EMEA/H/C/004078/0000 Note Assessment report as adopted by the CHMP with all (...) information of a commercially confidential nature deleted. Assessment report EMA/CHMP/90129/2015 Page 2/29 Administrative information Name of the medicinal product: Pregabalin Mylan Applicant: Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL UNITED KINGDOM Active substance: pregabalin International Nonproprietary Name/Common Name: pregabalin Pharmaco-therapeutic group (ATC Code): Pregabalin (N03AX16) Therapeutic indications: Epilepsy Pregabalin Mylan is indicated as adjunctive therapy
Pregabalin Mylan Pharma 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 23 April 2015 EMA/CHMP/90102/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Mylan Pharma International non-proprietary name: pregabalin Procedure No. EMEA/H/C/003962/0000 Note Assessment report as adopted by the CHMP (...) with all information of a commercially confidential nature deleted. Assessment Report EMA/CHMP/90102/2015 Page 2/29 Administrative information Name of the medicinal product: Pregabalin Mylan Pharma Applicant: Generics UK Limited Station Close Potters Bar Hertfordshire EN6 1TL UNITED KINGDOM Active substance: pregabalin International Nonproprietary Name/Common Name: pregabalin Pharmaco-therapeutic group (ATC Code): Pregabalin (N03AX16) Therapeutic indications: Neuropathic pain Pregabalin Mylan Pharma