Latest & greatest articles for pregabalin

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Top results for pregabalin

21. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study (PubMed)

Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study 25968451 2016 02 06 2016 10 27 2016 12 30 1536-5409 32 3 2016 Mar The Clinical journal of pain Clin J Pain Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. 203-10 10.1097/AJP.0000000000000254 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

2016 EvidenceUpdates

22. Pregabalin for decreasing pancreatic pain in chronic pancreatitis. (PubMed)

Pregabalin for decreasing pancreatic pain in chronic pancreatitis. BACKGROUND: 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. OBJECTIVES: To assess the benefits and harms of pregabalin in people with chronic abdominal pain due to chronic pancreatitis. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL (...) identified trials and independently extracted data. We calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) with RevMan 5, based on intention-to-treat analysis. MAIN RESULTS: 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

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2016 Cochrane

23. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking (PubMed)

Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking 25565583 2015 10 02 2016 07 01 2015 10 02 1536-5409 31 11 2015 Nov The Clinical journal of pain Clin J Pain Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. 946-58 10.1097/AJP.0000000000000198 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

2015 EvidenceUpdates

24. Imipramine and pregabalin combination for painful polyneuropathy: a randomized controlled trial (PubMed)

Imipramine and pregabalin combination for painful polyneuropathy: a randomized controlled trial 25719617 2015 04 18 2016 01 26 2015 04 18 1872-6623 156 5 2015 May Pain Pain Imipramine and pregabalin combination for painful polyneuropathy: a randomized controlled trial. 958-66 10.1097/j.pain.0000000000000143 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

2015 EvidenceUpdates

25. Pregabalin Sandoz

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

2015 European Medicines Agency - EPARs

26. 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

27. 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

28. Pregabalin Mylan

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

2015 European Medicines Agency - EPARs

29. Pregabalin Sandoz GmbH

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

2015 European Medicines Agency - EPARs

30. Pregabalin Mylan Pharma

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

2015 European Medicines Agency - EPARs

31. Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication (PubMed)

Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication 25503625 2015 01 20 2015 05 04 2016 12 15 1526-632X 84 3 2015 Jan 20 Neurology Neurology Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication. 265-72 10.1212/WNL.0000000000001168 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 were separated by a 10-day washout period, including a 3-day taper phase after the first period. The primary outcome variable was the time to first moderate pain symptom (Numeric Rating Scale score ≥4) during a 15-minute treadmill test (Tfirst). Secondary outcome measures

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2015 EvidenceUpdates

32. 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

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

Comparison of pregabalin with pramipexole for restless legs syndrome. BACKGROUND: 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. METHODS: 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

2014 NEJM

34. 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

35. 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

36. 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 23887339 2014 04 08 2014 11 26 2015 11 19 1536-5409 30 5 2014 May The Clinical journal of pain Clin J Pain Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. 379-90 10.1097/AJP.0b013e31829ea1a1 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

2013 EvidenceUpdates

37. 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 22751028 2012 12 05 2013 06 05 2015 11 19 1536-5409 29 1 2013 Jan The Clinical journal of pain Clin J Pain Combination of pregabalin and dexamethasone for postoperative pain and functional outcome in patients undergoing lumbar spinal surgery: a randomized placebo-controlled trial. 9-14 10.1097/AJP.0b013e318246d1a9 (...) 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

2013 EvidenceUpdates

38. 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.

39. 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.

40. 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.