메뉴 건너뛰기




Volumn 17, Issue 1, 2016, Pages

Reporting of harms outcomes: A comparison of journal publications with unpublished clinical study reports of orlistat trials

Author keywords

Adverse effect; Adverse event; Evidence based healthcare; HarmsOrlistatClinical study report; Obesit; Randomised controlled trial; Systematic review

Indexed keywords

PLACEBO; TETRAHYDROLIPSTATIN; ANTIOBESITY AGENT; LACTONE;

EID: 84977545013     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1327-z     Document Type: Article
Times cited : (29)

References (34)
  • 2
    • 84873847876 scopus 로고    scopus 로고
    • Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin
    • Vedula SS, Tianjing L, Dickersin K. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS Med. 2013;10(1):1-13.
    • (2013) PLoS Med , vol.10 , Issue.1 , pp. 1-13
    • Vedula, S.S.1    Tianjing, L.2    Dickersin, K.3
  • 3
    • 72849132173 scopus 로고    scopus 로고
    • Dissemination and publication of research findings: an updated review of related biases
    • Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010;14(8):iii. doi:10.3310/hta14080. ix-xi, 1-193.
    • (2010) Health Technol Assess , vol.14 , Issue.8 , pp. 3
    • Song, F.1    Parekh, S.2    Hooper, L.3    Loke, Y.K.4    Ryder, J.5    Sutton, A.J.6
  • 4
    • 84886614481 scopus 로고    scopus 로고
    • Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data
    • Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med. 2013;10(10):e1001526. doi:10.1371/journal.pmed.1001526.
    • (2013) PLoS Med , vol.10 , Issue.10
    • Wieseler, B.1    Wolfram, N.2    McGauran, N.3    Kerekes, M.F.4    Vervölgyi, V.5    Kohlepp, P.6
  • 5
    • 0035906286 scopus 로고    scopus 로고
    • CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation
    • Moher D, Jones A, Lepage L. CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285(15):1992-5.
    • (2001) JAMA , vol.285 , Issue.15 , pp. 1992-1995
    • Moher, D.1    Jones, A.2    Lepage, L.3
  • 6
    • 84859005251 scopus 로고    scopus 로고
    • Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study
    • Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373. doi:10.1136/bmj.d7373.
    • (2012) BMJ. , vol.344
    • Prayle, A.P.1    Hurley, M.N.2    Smyth, A.R.3
  • 7
    • 84860213443 scopus 로고    scopus 로고
    • The imperative to share clinical study reports: recommendations from the Tamiflu experience
    • Doshi P, Jefferson T, del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Med. 2012;9(4):e1001201. doi:10.1371/journal.pmed.1001201.
    • (2012) PLoS Med , vol.9 , Issue.4
    • Doshi, P.1    Jefferson, T.2    Mar, C.3
  • 8
    • 70349992632 scopus 로고    scopus 로고
    • Possible harms of oseltamivir--a call for urgent action
    • Jefferson T, Jones M, Doshi P, Del Mar C. Possible harms of oseltamivir--a call for urgent action. Lancet. 2009;374(9698):1312-3.
    • (2009) Lancet , vol.374 , Issue.9698 , pp. 1312-1313
    • Jefferson, T.1    Jones, M.2    Doshi, P.3    Mar, C.4
  • 9
    • 42149090567 scopus 로고    scopus 로고
    • Clinical trials and drug promotion: selective reporting of study 329
    • Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Saf Med. 2008;20(1):73-81.
    • (2008) Int J Risk Saf Med , vol.20 , Issue.1 , pp. 73-81
    • Jureidini, J.N.1    McHenry, L.B.2    Mansfield, P.R.3
  • 10
    • 77958142340 scopus 로고    scopus 로고
    • Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials
    • Eyding D, Lelgemann M, Grouven U, Härter M, Kromp M, Kaiser T. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737. doi:10.1136/bmj.c4737.
    • (2010) BMJ. , vol.341
    • Eyding, D.1    Lelgemann, M.2    Grouven, U.3    Härter, M.4    Kromp, M.5    Kaiser, T.6
  • 11
    • 84855701883 scopus 로고    scopus 로고
    • Opening up data at the European Medicines Agency
    • Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ. 2011;342:d2686. doi:10.1136/bmj.d2686.
    • (2011) BMJ. , vol.342
    • Gøtzsche, P.C.1    Jørgensen, A.W.2
  • 12
    • 84880936131 scopus 로고    scopus 로고
    • European drug agency's attempts to improve transparency stalled by legal action from two US drug companies
    • Dyer C. European drug agency's attempts to improve transparency stalled by legal action from two US drug companies. BMJ. 2013;346:f3588. doi:10.1136/bmj.f3588.
    • (2013) BMJ. , vol.346
    • Dyer, C.1
  • 13
    • 84977594512 scopus 로고    scopus 로고
    • 2nd October 2014 EMA/240810/2013. Policy/0070. Accessed 23 Apr 2015.
    • European Medicines Agency (EMA) policy on publication of clinical data for medicinal products for human use. 2nd October 2014 EMA/240810/2013. Policy/0070. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf. Accessed 23 Apr 2015.
  • 14
    • 0030952712 scopus 로고    scopus 로고
    • Mode of action of orlistat
    • Guerciolini R. Mode of action of orlistat. Int J Obes (Lond). 1997;21 Suppl 3:S12-23.
    • (1997) Int J Obes (Lond) , vol.21 , pp. S12-23
    • Guerciolini, R.1
  • 15
    • 69449091278 scopus 로고    scopus 로고
    • Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis
    • Johansson K, Neovius K, DeSantis SM, Rössner S, Neovius M. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Obes Rev. 2009;10(5):564-75.
    • (2009) Obes Rev , vol.10 , Issue.5 , pp. 564-575
    • Johansson, K.1    Neovius, K.2    DeSantis, S.M.3    Rössner, S.4    Neovius, M.5
  • 17
    • 84877624422 scopus 로고    scopus 로고
    • Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink
    • Douglas IJ, Langham J, Bhaskaran K, Brauer R, Smeeth L. Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink. BMJ. 2013;346:f1936.
    • (2013) BMJ. , vol.346
    • Douglas, I.J.1    Langham, J.2    Bhaskaran, K.3    Brauer, R.4    Smeeth, L.5
  • 18
    • 84977512722 scopus 로고    scopus 로고
    • Software for word counting for PDF file. Accessed 18 Nov 2014.
    • Any Count Software. Software for word counting for PDF file. Available at: http://www.anycount.com/. Accessed 18 Nov 2014.
  • 20
    • 84977522116 scopus 로고    scopus 로고
    • A community Site for R - sponsored by Revolution Analytics
    • R packages: metabin meta-analysis of binary outcome data. Last Accessed 16 June 2015
    • Inside-R. A community Site for R - sponsored by Revolution Analytics. R packages: metabin meta-analysis of binary outcome data. Last Accessed 16 June 2015. Available at: http://www.inside-r.org/packages/cran/meta/docs/metabin.
  • 22
    • 20444446770 scopus 로고    scopus 로고
    • Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial
    • Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J. Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial. JAMA. 2005;293(23):2873-83. Erratum in: JAMA. 2005;294(12):1491.
    • (2005) JAMA , vol.293 , Issue.23 , pp. 2873-2883
    • Chanoine, J.P.1    Hampl, S.2    Jensen, C.3    Boldrin, M.4    Hauptman, J.5
  • 23
    • 0037406461 scopus 로고    scopus 로고
    • Latin-American trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients
    • Halpern A, Mancini MC, Suplicy H, Zanella MT, Repetto G, Gross J, et al. Latin-American trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients. Diabetes Obes Metab. 2003;5(3):180-8.
    • (2003) Diabetes Obes Metab , vol.5 , Issue.3 , pp. 180-188
    • Halpern, A.1    Mancini, M.C.2    Suplicy, H.3    Zanella, M.T.4    Repetto, G.5    Gross, J.6
  • 24
    • 1042303480 scopus 로고    scopus 로고
    • XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients
    • Torgerson JS, Hauptman J, Boldrin MN, Sjöström L. XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care. 2004;27(1):155-61.
    • (2004) Diabetes Care , vol.27 , Issue.1 , pp. 155-161
    • Torgerson, J.S.1    Hauptman, J.2    Boldrin, M.N.3    Sjöström, L.4
  • 25
    • 0036845652 scopus 로고    scopus 로고
    • The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial
    • Hanefeld M, Sachse G. The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2002;4(6):415-23.
    • (2002) Diabetes Obes Metab , vol.4 , Issue.6 , pp. 415-423
    • Hanefeld, M.1    Sachse, G.2
  • 26
    • 0036598137 scopus 로고    scopus 로고
    • Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: a 1-year randomized controlled trial
    • Kelley DE, Bray GA, Pi-Sunyer FX, Klein S, Hill J, Miles J, Hollander P. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care. 2002;25(6):1033-41.
    • (2002) Diabetes Care , vol.25 , Issue.6 , pp. 1033-1041
    • Kelley, D.E.1    Bray, G.A.2    Pi-Sunyer, F.X.3    Klein, S.4    Hill, J.5    Miles, J.6    Hollander, P.7
  • 27
    • 33846260745 scopus 로고    scopus 로고
    • Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events
    • Bradburn MJ, Deeks JJ, Berlin JA, Russell LA. Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Stat Med. 2007;26(1):53-77.
    • (2007) Stat Med , vol.26 , Issue.1 , pp. 53-77
    • Bradburn, M.J.1    Deeks, J.J.2    Berlin, J.A.3    Russell, L.A.4
  • 29
    • 84885359689 scopus 로고    scopus 로고
    • Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension
    • Hodkinson A, Kirkham JJ, Tudur-Smith C, Gamble C. Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension. BMJ Open. 2013;3(9):e003436. doi:10.1136/bmjopen-2013-003436.
    • (2013) BMJ Open , vol.3 , Issue.9
    • Hodkinson, A.1    Kirkham, J.J.2    Tudur-Smith, C.3    Gamble, C.4
  • 30
    • 84879364075 scopus 로고    scopus 로고
    • Restoring invisible and abandoned trials: a call for people to publish the findings
    • Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T, et al. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013;346:f2865. doi:10.1136/bmj.f2865.
    • (2013) BMJ. , vol.346
    • Doshi, P.1    Dickersin, K.2    Healy, D.3    Vedula, S.S.4    Jefferson, T.5
  • 31
    • 84880059680 scopus 로고    scopus 로고
    • Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion
    • Rodgers MA, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Simmonds MC, et al. Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion. BMJ. 2013;346:f3981-1.
    • (2013) BMJ. , vol.346 , pp. f3981-f3981
    • Rodgers, M.A.1    Brown, J.V.2    Heirs, M.K.3    Higgins, J.P.4    Mannion, R.J.5    Simmonds, M.C.6
  • 32
    • 84902176817 scopus 로고    scopus 로고
    • Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications
    • Maund E, Tendal B, Hróbjartsson A, Jørgensen KJ, Lundh A, Schroll J, et al. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. BMJ. 2014;4(348):g3510. doi:10.1136/bmj.g3510.
    • (2014) BMJ , vol.4 , Issue.348
    • Maund, E.1    Tendal, B.2    Hróbjartsson, A.3    Jørgensen, K.J.4    Lundh, A.5    Schroll, J.6
  • 33
    • 84977544479 scopus 로고    scopus 로고
    • On clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union. Accessed 20 Jun 2015.
    • REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014. On clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.158.01.0001.01.ENG. Accessed 20 Jun 2015.
  • 34
    • 84945899614 scopus 로고    scopus 로고
    • Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence
    • Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320. doi:10.1136/bmj.h4320.
    • (2015) BMJ. , vol.351
    • Noury, J.1    Nardo, J.M.2    Healy, D.3    Jureidini, J.4    Raven, M.5    Tufanaru, C.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.