Latest & greatest articles for pregabalin

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Top results for pregabalin

41. Pregabalin Zentiva

Pregabalin Zentiva 26 May 2015 EMA/CHMP/408316/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Zentiva International non-proprietary name: PREGABALIN Procedure No. EMEA/H/C/003900/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 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 (...) . Pharmacovigilance 18 2.6. Risk management plan 18 2.7. PSUR submission 22 2.8. Product information 22 2.8.1. User consultation 22 3. Benefit-risk balance 22 4. Recommendation 23 Pregabalin Zentiva Assessment report EMA/CHMP/408316/2015 Page 2/24 List of abbreviations AE adverse event API Active Pharmaceutical Ingredient AR Assessment Report ASM Active Substance Manufacturer ASMF Active Substance Master File = Drug Master File AUC Area Under the plasma Concentration AUC0-inf Area Under the plasma Concentration

2015 European Medicines Agency - EPARs

42. Pregabalin Accord

Pregabalin Accord 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 25 June 2015 EMA/CHMP/282380/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Accord International non-proprietary name: pregabalin Procedure No. EMEA/H/C/004024/0000 Note Assessment report as adopted by the CHMP with all (...) (EMA) for Pregabalin Accord, through the centralised procedure under Article 3 (3) of Regulation (EC) No. 726/2004– ‘Generic of a Centrally authorised product’. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 22 May 2014. The application concerns a generic medicinal product as defined in Article 10(2)(b) of Directive 2001/83/EC and refers to a reference product for which a Marketing Authorisation is or has been granted in the Union on the basis of a complete dossier

2015 European Medicines Agency - EPARs

43. Gabapentin and pregabalin: major adverse effects

Gabapentin and pregabalin: major adverse effects Prescrire IN ENGLISH - Spotlight ''Gabapentin and pregabalin: major adverse effects'', 1 November 2014 {1} {1} {1} | | > > > Gabapentin and pregabalin: major adverse effects Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight Gabapentin and pregabalin: major adverse effects To reduce the consequences (...) of some severe adverse effects associated with gabapentin or pregabalin, it is advisable not to expose patients to them other than in situations where these drugs have proved to be highly effective. Gabapentin and pregabalin are used in certain epilepsies and for pain in neurological diseases. Pregabalin is also used to treat anxiety disorders. According to a review of French pharmacovigilance data published in 2013, between 1995 and 2009, 2415 adverse effects linked to gabapentin or pregabalin were

2014 Prescrire

44. Comparison of pregabalin with pramipexole for restless legs syndrome. (PubMed)

Comparison of pregabalin with pramipexole for restless legs syndrome. Dopaminergic medications relieve symptoms of the restless legs syndrome (RLS) but have the potential to cause iatrogenic worsening (augmentation) of RLS with long-term treatment. Pregabalin may be an effective alternative.In this 52-week, randomized, double-blind trial, we assessed efficacy and augmentation in patients with RLS who were treated with pregabalin as compared with placebo and pramipexole. Patients were randomly (...) assigned to receive 52 weeks of treatment with pregabalin at a dose of 300 mg per day or pramipexole at a dose of 0.25 mg or 0.5 mg per day or 12 weeks of placebo followed by 40 weeks of randomly assigned active treatment. The primary analyses involved a comparison of pregabalin and placebo over a period of 12 weeks with use of the International RLS (IRLS) Study Group Rating Scale (on which the score ranges from 0 to 40, with a higher score indicating more severe symptoms), the Clinical Global

2014 NEJM

45. Pregabalin

Pregabalin USE OF PREGABALIN IN PREGNANCY 0344 892 0909 USE OF PREGABALIN IN PREGNANCY (Date of issue: June 2016 , Version: 3.1 ) This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a . Please encourage all women to complete an . A corresponding patient information leaflet on is available at . Summary Pregabalin is an anticonvulsant used as adjunctive therapy in adults (...) with partial seizures, with or without secondary generalisation, and in the treatment of neuropathic pain and generalised anxiety disorder. There is limited information on the use of pregabalin in pregnancy, with less than 200 exposures in the published literature. Fetal toxicity has been reported in animal studies. A prospective cohort study found a significant increased risk of major malformation in comparison with unexposed controls, however these findings are limited by the small number of exposed

2014 UK Teratology Information Service

46. Pregabalin Pfizer

Pregabalin Pfizer 20 February 2014 EMA/174304/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Pfizer International non-proprietary name: Pregabalin Procedure No. EMEA/H/C/003880/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E (...) ) to the European Medicines Agency (EMA) for Pregabalin Pfizer, through the centralised procedure. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 24 October 2013. The applicant applied for the following indications: • Neuropathic pain Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults. • Epilepsy Pregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation

2014 European Medicines Agency - EPARs

47. Gabapentin and pregabalin in the management of postoperative pain after lumbar spinal surgery: a systematic review and meta-analysis (PubMed)

Gabapentin and pregabalin in the management of postoperative pain after lumbar spinal surgery: a systematic review and meta-analysis Systematic review and meta-analysis.To review the literature systematically and make a comprehensive understanding of the efficacy of these 2 drugs in the management of postoperative pain after lumbar spinal surgery.Several trials that evaluated the efficacy of gabapentin and pregabalin in the management of postoperative pain after lumbar spinal surgery have been (...) published.PubMed (1980 to present), adapted for EMBASE (1980 to present), and Cochrane databases were searched for randomized placebo-controlled trials. Random effect model was used in our meta-analysis, and standard mean difference (SMD) was chosen as the pooled estimate.Seven trials were included in our study. All included studies could be considered to be of high quality in methodology. The pooled results from meta-analysis demonstrated that compared with placebo, both gabapentin and pregabalin could

2013 EvidenceUpdates

48. Pregabalin in Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy: A Randomized Withdrawal Trial (PubMed)

Pregabalin in Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy: A Randomized Withdrawal Trial This study used a randomized withdrawal design to evaluate the efficacy of pregabalin versus placebo for pain relief in patients with painful diabetic peripheral neuropathy inadequately treated by other therapies.A total of 665 patients received pregabalin in a 6-week single-blind phase. Two hundred ninety-four patients who achieved a ≥ 30% pain response were randomized (...) to receive pregabalin or placebo in a double-blind phase for a further 13 weeks. The primary endpoint was the change in mean pain score from single-blind baseline to double-blind endpoint for pregabalin versus placebo (last observation carried forward [LOCF]). Secondary endpoints included a baseline observation carried forward (BOCF) analysis of mean pain score; time to loss of pain response; and other assessments of pain, sleep, function, and quality of life (QOL).Pregabalin numerically improved all

2013 EvidenceUpdates

49. Antiepileptics other than gabapentin, pregabalin, topiramate, and valproate for the prophylaxis of episodic migraine in adults. (PubMed)

Antiepileptics other than gabapentin, pregabalin, topiramate, and valproate for the prophylaxis of episodic migraine in adults. Some antiepileptic drugs but not others are useful in clinical practice for the prophylaxis of migraine. This might be explained by the variety of actions of these drugs in the central nervous system. The present review is part of an update of a Cochrane review first published in 2004, and previously updated (conclusions not changed) in 2007.To describe and assess (...) the evidence from controlled trials on the efficacy and tolerability of antiepileptic drugs other than gabapentin, pregabalin, topiramate, and valproate (which are the subjects of separate Cochrane reviews) for preventing migraine attacks in adult patients with episodic migraine.We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2012, Issue 12), PubMed/MEDLINE (1966 to 15 January 2013), MEDLINE In-Process (current week, 15 January 2013), and EMBASE (1974 to 15

Full Text available with Trip Pro

2013 Cochrane

50. Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults. (PubMed)

Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults. Some antiepileptic drugs but not others are useful in clinical practice for the prophylaxis of migraine. This might be explained by the variety of actions of these drugs in the central nervous system. The present review is part of an update of a Cochrane review first published in 2004, and previously updated (conclusions not changed) in 2007.To describe and assess the evidence from controlled trials on the efficacy (...) and tolerability of gabapentin/gabapentin enacarbil or pregabalin for preventing migraine attacks in adult patients with episodic migraine.We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2012, Issue 12), PubMed/MEDLINE (1966 to 15 January 2013), MEDLINE In-Process (current week, 15 January 2013), and EMBASE (1974 to 15 January 2013) and handsearched Headache and Cephalalgia through January 2013.Studies were required to be prospective, controlled trials

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2013 Cochrane

51. Combination of Pregabalin and Dexamethasone for Postoperative Pain and Functional Outcome in Patients Undergoing Lumbar Spinal Surgery: A Randomized Placebo-controlled Trial (PubMed)

Combination of Pregabalin and Dexamethasone for Postoperative Pain and Functional Outcome in Patients Undergoing Lumbar Spinal Surgery: A Randomized Placebo-controlled Trial In this randomized-controlled study, we investigated the effects of combined administration of pregabalin and dexamethasone on postoperative pain and analgesic requirements, and functional outcome in patients who underwent lumbar spinal surgery.One hundred eight patients were randomized to group C (placebo+placebo), group P (...) (pregabalin + placebo), or group PD (pregabalin+dexamethasone). According to their allocated group, patients received placebo or pregabalin 150 mg every 12 hours starting 1 hour before anesthetic induction for a total of 8 doses. Dexamethasone 16 mg or normal saline was injected before the induction of anesthesia. The pain intensity, analgesic requirements, and side effects were assessed in the postoperative period: postanesthesia care unit, 12, 24, 48, and 72 hours. Pain intensity and daily activity

2013 EvidenceUpdates

52. Pregabalin monotherapy for epilepsy. (PubMed)

Pregabalin monotherapy for epilepsy. Many people with epilepsy suffer from poorly controlled seizures, despite current antiepileptic treatments. Due to high rates of treatment resistance, there is interest in new pharmacological treatment options such as pregabalin. However, it remains unclear whether existing evidence of pregabalin is rigorous enough to support its monotherapy.To determine the efficacy and tolerability of pregabalin in people with epilepsy.We searched the Cochrane Epilepsy (...) Group's Specialized Register (August 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7 ), MEDLINE (1946 to August week 1, 2012), EMBASE (1974 to August 2012) and the Chinese Biomedical Literature Database (CBM) (1978 to August 2012). No language restrictions were imposed.Randomised controlled trials (RCTs) comparing pregabalin with placebo or another antiepileptic drug monotherapy for epilepsy.Two review authors (QZ and LY) independently extracted

2012 Cochrane

53. A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain

A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain Gordon J, Lister S, Prettyjohns M, McEwan P, Tetlow A, Gabriel Z Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods (...) , the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The objective was to assess the cost-effectiveness of pregabalin for patients with refractory neuropathic pain. The authors concluded that it was a cost-effective alternative to usual care. On the whole, the methods were well reported and the authors' conclusions seem valid for pregabalin in addition to usual care, rather than as an alternative. Type of economic

2012 NHS Economic Evaluation Database.

54. Abuse and misuse potential of pregabalin: a review of the clinical evidence

Abuse and misuse potential of pregabalin: a review of the clinical evidence Abuse and misuse potential of pregabalin: a review of the clinical evidence Abuse and misuse potential of pregabalin: a review of the clinical evidence CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Abuse and misuse potential of pregabalin: a review (...) of the clinical evidence. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). 2012 Authors' conclusions There is a limited volume of evidence regarding the abuse and misuse potential of pregabalin. Existing evidence is generally of low quality and suggests that certain populations with a history of substance abuse may be at increased risk to abuse pregabalin. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Analgesics; Anticonvulsants; Drug and Narcotic Controls

2012 Health Technology Assessment (HTA) Database.

55. The cost-effectiveness of pregabalin in the treatment of fibromyalgia: US perspective

The cost-effectiveness of pregabalin in the treatment of fibromyalgia: US perspective The cost-effectiveness of pregabalin in the treatment of fibromyalgia: US perspective The cost-effectiveness of pregabalin in the treatment of fibromyalgia: US perspective Lloyd A, Boomershine CS, Choy EH, Chandran A, Zlateva G Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results (...) and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The study examined the cost-effectiveness of pregabalin for treatment of severe fibromyalgia compared with placebo, duloxetine, milnacipran, gabapentin, tramadol and amitriptyline. The authors concluded that pregabalin was more beneficial and less expensive than the other available treatments for severe fibromyalgia, except when compared to amitriptyline. The study used valid

2012 NHS Economic Evaluation Database.

56. Pregabalin for chronic prostatitis. (PubMed)

Pregabalin for chronic prostatitis. Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a condition that is detrimental to the quality of life of men. Evidence suggests that it may have a neuropathic origin and therefore medications such as pregabalin might have a role in the controlling of symptoms.The primary objective was to compare pregabalin to other modalities of pain relief to alleviate men's symptoms of CP/CPPS.The secondary objective was to assess the safety and effectiveness (...) of pregabalin to improve various individual symptoms consistent with CP/CPPS.We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to May 2012), EMBASE (1980 to May 2012), CINAHL, clinicaltrials.gov, Google Scholar, and reference lists of articles and abstracts from conference proceedings, without language restriction for pregabalin treatment of Class III prostatitis and CP/CPPS.Randomized controlled trials (RCTs) comparing pregabalin to placebo or other types of analgesics

2012 Cochrane

57. Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study (PubMed)

Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients.We performed a randomized, double-blind, placebo-controlled, 2-period crossover PSG study. Patients ages ≥18 years with fibromyalgia satisfied subjective and objective sleep (...) disturbance criteria prior to randomization. Eligible patients were randomized (1:1) to pregabalin (300-450 mg/day) or placebo for crossover period 1, and vice versa for period 2. Each crossover period comprised a dose-adjustment and dose-maintenance phase, with a 2-week taper/washout between periods. In-laboratory PSGs were recorded during 2 consecutive nights at screening and at the end of each crossover period. The primary end point was the difference in sleep maintenance defined by PSG-recorded wake

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2012 EvidenceUpdates

58. Abuse and Misuse Potential of Pregabalin: A Review of the Clinical Evidence

Abuse and Misuse Potential of Pregabalin: A Review of the Clinical Evidence Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses (...) : This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. TITLE: Abuse and Misuse Potential of Pregabalin: A Review of the Clinical Evidence DATE: 24 April 2012 CONTEXT AND POLICY ISSUES Pregabalin (Lyrica) is an anticonvulsant approved in Canada and the United States (US) since 2005 to treat neuropathic pain

2012 Canadian Agency for Drugs and Technologies in Health - Rapid Review

59. Can pregabalin effectively diminish acute herpetic pain and reduce the incidence of post-herpetic neuralgia in patients who present with acute herpes zoster?

Can pregabalin effectively diminish acute herpetic pain and reduce the incidence of post-herpetic neuralgia in patients who present with acute herpes zoster? BestBets: Can pregabalin effectively diminish acute herpetic pain and reduce the incidence of post-herpetic neuralgia in patients who present with acute herpes zoster? Can pregabalin effectively diminish acute herpetic pain and reduce the incidence of post-herpetic neuralgia in patients who present with acute herpes zoster? Report (...) By: Eliane Raymond-Dufresne - PGY-3, Emergency Medicine Search checked by Katharine Wylie - Senior Informatacist Institution: Laval University, Québec, Canada Date Submitted: 23rd November 2011 Date Completed: 13th February 2012 Last Modified: 20th February 2012 Status: Green (complete) Three Part Question In [patients with new onset of herpes zoster infection], can [pregabalin] be used to [decrease the incidence of post-herpetic neuralgia and to decrease the intensity of acute herpetic pain]? Clinical

2012 BestBETS

60. The adverse event profile of pregabalin: a systematic review and meta-analysis of randomized controlled trials

The adverse event profile of pregabalin: a systematic review and meta-analysis of randomized controlled trials Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.

2012 DARE.