Risk of heart failure and edema associated with the use of pregabalin: a systematic review

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• 作者：Joanne M Ho (1) (2)
  Andrea C Tricco (2)
  Laure Perrier (2) (8)
  Maggie Chen (2)
  David N Juurlink (1) (3) (4) (5) (6)
  Sharon E Straus (1) (2) (6) (7)
  
• 关键词：Edema ; Heart failure ; Observational studies ; Pregabalin ; Randomized controlled trials ; Systematic review
• 刊名：Systematic Reviews
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：2
• 期：1
• 全文大小：171KB
• 参考文献：1. Bockbrader HN, Wesche D, Miller R, Chapel S, Janiczek N, Burger P: A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. / Clin Pharmacokinet 2010,49(10):661-69. CrossRef
  2. Salinsky M, Storzbach D, Munoz S: Cognitive effects of pregabalin in healthy volunteers: a double-blind, placebo-controlled trial. / Neurology 2010,74(9):755-61. CrossRef
  3. Murphy N, Mockler M, Ryder M, Ledwidge M, McDonald K: Decompensation of chronic heart failure associated with pregabalin in patients with neuropathic pain. / J Card Fail 2007,13(3):227-29. CrossRef
  4. Page RL, Cantu M, Lindenfeld J, Hergott LJ, Lowes BD 2nd: Possible heart failure exacerbation associated with pregabalin: case discussion and literature review. / J Cardiovasc Med 2008,9(9):922-25. CrossRef
  5. De Smedt RH, Jaarsma T, van den Broek SA, Haaijer-Ruskamp FM: Decompensation of chronic heart failure associated with pregabalin in a 73-year-old patient with postherpetic neuralgia: a case report. / Br J Clin Pharmacol 2008,66(2):327-28. CrossRef
  6. MedEffect Canada: Canadian Vigilance Adverse Reaction. / Pregabalin and Pulmonary Edema1965-011.
  7. Zaccara G, Gangemi P, Perucca P, Specchio L: The adverse event profile of pregabalin: A systematic review and meta?analysis of randomized controlled trials. / Epilepsia 2011,52(4):826-36. CrossRef
  8. Grundy SM, Benjamin IJ, Burke GL, Chait A, Eckel RH, Howard BV, Mitch W, Smith SC Jr, Sowers JR: Diabetes and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. / Circulation 1999,100(10):1134-146. CrossRef
  9. Sampson M: / Canadian Agency for Drugs and Technologies in Health. Peer Review of Electronic Search Strategies. Canadian Agency for Drugs and Technologies in Health: PRESS; 2008.
  10. Landis JR, Koch GG: The measurement of observer agreement for categorical data. / Biometrics 1977,33(1):159-74. CrossRef
  11. Chou R, Aronson N, Atkins D, Ismaila AS, Santaguida P, Smith DH, Whitlock E, Wilt TJ, Moher D: AHRQ series paper 4: assessing harms when comparing medical interventions. / J Clin Epidemiol 2010,63(5):502-12. CrossRef
  12. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR: Systematic review of the empirical evidence of study publication bias and outcome reporting bias. / PLoS One 2008,3(8):e3081. CrossRef
  13. Higgins JPT, Altman DG, G?tzsche PC, Jüni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA, Cochrane Bias Methods Group; Cochrane Statistical Methods Group: The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. / BMJ 2011, 343:d5928. CrossRef
  14. Sanderson S, Tatt ID, Higgins JPT: Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. / Int J Epidemiol 2007,36(3):666-76. CrossRef
  15. Bero L, Grilli R, Grimshaw J, Mowatt G, Oxman A, Zwarenstein M, Cochrane Effective Practice and Organisation of Care Group: / The Cochrane Library. Centre for Practice Changing Research: Ottawa; 2002.
  16. Wells GA, Shea B, O’connell D, Peterson J, Welch V, Losos M, Tugwell P: / The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. 3rd Symp Syst Rev Beyond Basics. OHRI: Ottawa; 2000.
  17. Santaguida P, Raina P, Ismaila A: / The development of the McHarm quality assessment scale for adverse events. Hamilton, Canada; Available from http://hiru.mcmaster.ca/epc/mcharm.pdf
  18. Knodel LC: Comparison of three algorithms used to evaluate adverse drug reactions. / Am J Hosp Pharm 1986 Jul,43(7):1709-714.
  19. Higgins JPT, Green S: / Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. Oxford: UK: The Cochrane Collaboration; 2011. Available from http://www.cochrane-handbook.org
  20. Higgins JP, Thompson SG: Quantifying heterogeneity in a meta-analysis. / Stat Med 2002 Jun 15,21(11):1539-558. CrossRef
  21. DerSimonian R, Laird N: Meta-analysis in clinical trials. / Control Clin Trials 1986,7(3):177-88. CrossRef
  22. Egger M, Smith GD, Schneider M, Minder C: Bias in meta-analysis detected by a simple, graphical test. / BMJ 1997,315(7109):629-34. CrossRef
  
• 作者单位：Joanne M Ho (1) (2)
  Andrea C Tricco (2)
  Laure Perrier (2) (8)
  Maggie Chen (2)
  David N Juurlink (1) (3) (4) (5) (6)
  Sharon E Straus (1) (2) (6) (7)
  
  1. Department of Medicine, University of Toronto, Suite RFE 3-805, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada
  2. Li Ka Shing Knowledge Institute, St. Michael’s Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
  8. Office of Continuing Education and Professional Development, Faculty of Medicine, University of Toronto, 500 University Avenue, Suite 650, Toronto, Ontario, M5G 1V7, Canada
  3. The Institute for Clinical Evaluative Sciences, G1 06, 2075 Bayview Avenue, Toronto, Ontario, M4N 3M5, Canada
  4. The Sunnybrook Research Institute, 2075 Bayview Avenue, Toronto, Ontario, M4N 3M5, Canada
  5. Department of Pediatrics, University of Toronto, The Hospital for Sick Children, Room 1436D, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada
  6. Institute of Health Policy, Management and Evaluation, University of Toronto, Health Sciences Building, 155 College Street, Suite 425, Toronto, Ontario, M5T 3M6, Canada
  7. Division of Geriatric Medicine, University of Toronto, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
  
• ISSN：2046-4053

文摘

Background Pregabalin is used in the treatment of postherpetic neuralgia, diabetic neuropathic pain, partial seizures, anxiety disorders and fibromyalgia. Recognized adverse effects associated with its use include cognitive impairment, somnolence and dizziness. Heart failure associated with pregabalin has been described, however the strength of this association has not been well characterized. To examine this further, we will conduct a systematic review of the risk of heart failure and edema associated with use of pregabalin. Methods/design We will include all studies (experimental, quasi-experimental, observational, case series/reports, drug regulatory reports) that examine the use of pregabalin compared to placebo, gabapentin or conventional care. Our primary outcome is heart failure and the secondary outcomes include edema and weight gain. We will search electronic databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials), and grey literature sources (trial registries, conference abstracts) to identify relevant studies. To ensure literature saturation, we will contact drug manufacturers, conduct forward citation searching, and scan the reference lists of key articles and included studies. We will not restrict inclusion by language or publication status. Two reviewers will screen citations (titles and abstracts) and full-text articles, conduct data abstraction, and appraise risk of bias. Random-effects meta-analysis will be conducted if the studies are deemed heterogeneous in terms of clinical, statistical and methodological factors but still suitable for meta-analysis. Conclusions The results of this review will assist physicians to better appreciate pregabalin’s risk for edema or congestive heart failure and will be pertinent to the thousands of patients worldwide who are administered this medication. Our protocol was registered in the PROSPERO database (CRD42012002948).