메뉴 건너뛰기




Volumn 178, Issue 1, 2018, Pages 55-63

Use of health care databases to support supplemental indications of approved medications

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; ANTITHROMBOCYTIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; PRESCRIPTION DRUG; RAMIPRIL; TELMISARTAN; ANGIOTENSIN 1 RECEPTOR ANTAGONIST;

EID: 85040011800     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2017.3919     Document Type: Article
Times cited : (96)

References (48)
  • 1
    • 85014617206 scopus 로고    scopus 로고
    • New “21st century cures” legislation
    • Kesselheim AS, Avorn J. New “21st century cures” legislation. JAMA. 2017;317(6):581-582.
    • (2017) JAMA , vol.317 , Issue.6 , pp. 581-582
    • Kesselheim, A.S.1    Avorn, J.2
  • 2
    • 85002412626 scopus 로고    scopus 로고
    • Real-world evidence—what is it and what can it tell us?
    • Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence—what is it and what can it tell us? N Engl J Med. 2016;375(23):2293-2297.
    • (2016) N Engl J Med , vol.375 , Issue.23 , pp. 2293-2297
    • Sherman, R.E.1    Anderson, S.A.2    Dal Pan, G.J.3
  • 3
    • 34447547659 scopus 로고    scopus 로고
    • Developments in post-marketing comparative effectiveness research
    • Schneeweiss S. Developments in post-marketing comparative effectiveness research. Clin Pharmacol Ther. 2007;82(2):143-156.
    • (2007) Clin Pharmacol Ther , vol.82 , Issue.2 , pp. 143-156
    • Schneeweiss, S.1
  • 4
    • 85013188102 scopus 로고    scopus 로고
    • Periodic benefit-risk evaluation reports have substantial promise to guide patient care and should be made publicly available
    • Fralick M, Kesselheim AS. Periodic benefit-risk evaluation reports have substantial promise to guide patient care and should be made publicly available. Pharmacoepidemiol Drug Saf. 2017;26(5): 597-599.
    • (2017) Pharmacoepidemiol Drug Saf , vol.26 , Issue.5 , pp. 597-599
    • Fralick, M.1    Kesselheim, A.S.2
  • 5
    • 0142157169 scopus 로고    scopus 로고
    • Evaluating medication effects outside of clinical trials: New-user designs
    • Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol. 2003;158(9):915-920.
    • (2003) Am J Epidemiol , vol.158 , Issue.9 , pp. 915-920
    • Ray, W.A.1
  • 6
    • 77956625112 scopus 로고    scopus 로고
    • A basic study design for expedited safety signal evaluation based on electronic healthcare data
    • Schneeweiss S. A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiol Drug Saf. 2010;19(8):858-868.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , Issue.8 , pp. 858-868
    • Schneeweiss, S.1
  • 7
    • 85014639703 scopus 로고    scopus 로고
    • Using design thinking to differentiate useful from misleading evidence in observational research
    • Goodman SN, Schneeweiss S, Baiocchi M. Using design thinking to differentiate useful from misleading evidence in observational research. JAMA. 2017;317(7):705-707.
    • (2017) JAMA , vol.317 , Issue.7 , pp. 705-707
    • Goodman, S.N.1    Schneeweiss, S.2    Baiocchi, M.3
  • 8
    • 39349101029 scopus 로고    scopus 로고
    • Immortal time bias in pharmaco-epidemiology
    • Suissa S. Immortal time bias in pharmaco-epidemiology. Am J Epidemiol. 2008;167 (4):492-499.
    • (2008) Am J Epidemiol , vol.167 , Issue.4 , pp. 492-499
    • Suissa, S.1
  • 9
    • 84947205197 scopus 로고    scopus 로고
    • Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: Systematic review
    • Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review. BMJ. 2015;351:h4679.
    • (2015) BMJ , vol.351 , pp. h4679
    • Wang, B.1    Kesselheim, A.S.2
  • 10
    • 84887698540 scopus 로고    scopus 로고
    • The impact of incremental innovation in biopharmaceuticals: Drug utilisation in original and supplemental indications
    • Berndt ER, Cockburn IM, Grépin KA. The impact of incremental innovation in biopharmaceuticals: drug utilisation in original and supplemental indications. Pharmacoeconomics. 2006;24(suppl 2):69-86.
    • (2006) Pharmacoeconomics , vol.24 , pp. 69-86
    • Berndt, E.R.1    Cockburn, I.M.2    Grépin, K.A.3
  • 11
    • 42049107348 scopus 로고    scopus 로고
    • Telmisartan, ramipril, or both in patients at high risk for vascular events
    • Yusuf S, Teo KK, Pogue J, et al; ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008;358(15):1547-1559.
    • (2008) N Engl J Med , vol.358 , Issue.15 , pp. 1547-1559
    • Yusuf, S.1    Teo, K.K.2    Pogue, J.3
  • 12
    • 84924783722 scopus 로고    scopus 로고
    • Validity of myocardial infarction diagnoses in administrative databases: A systematic review
    • McCormick N, Lacaille D, Bhole V, Avina-Zubieta JA. Validity of myocardial infarction diagnoses in administrative databases: a systematic review. PLoS One. 2014;9(3):e92286.
    • (2014) PLoS One , vol.9 , Issue.3
    • McCormick, N.1    Lacaille, D.2    Bhole, V.3    Avina-Zubieta, J.A.4
  • 13
    • 84942876992 scopus 로고    scopus 로고
    • Validity of diagnostic codes for acute stroke in administrative databases: A systematic review
    • McCormick N, Bhole V, Lacaille D, Avina-Zubieta JA. Validity of diagnostic codes for acute stroke in administrative databases: a systematic review. PLoS One. 2015;10(8):e0135834.
    • (2015) PLoS One , vol.10 , Issue.8 , pp. e0135834
    • McCormick, N.1    Bhole, V.2    Lacaille, D.3    Avina-Zubieta, J.A.4
  • 14
    • 84924783722 scopus 로고    scopus 로고
    • Validity of heart failure diagnoses in administrative databases: A systematic review and meta-analysis
    • McCormick N, Lacaille D, Bhole V, Avina-Zubieta JA. Validity of heart failure diagnoses in administrative databases: a systematic review and meta-analysis. PLoS One. 2014;9(8):e104519.
    • (2014) PLoS One , vol.9 , Issue.8 , pp. e104519
    • McCormick, N.1    Lacaille, D.2    Bhole, V.3    Avina-Zubieta, J.A.4
  • 15
    • 18044398603 scopus 로고    scopus 로고
    • A review of uses of health care utilization databases for epidemiologic research on therapeutics
    • Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol. 2005;58 (4):323-337.
    • (2005) J Clin Epidemiol , vol.58 , Issue.4 , pp. 323-337
    • Schneeweiss, S.1    Avorn, J.2
  • 16
    • 70449365700 scopus 로고    scopus 로고
    • Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples
    • Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009;28(25):3083-3107.
    • (2009) Stat Med , vol.28 , Issue.25 , pp. 3083-3107
    • Austin, P.C.1
  • 17
    • 84958956038 scopus 로고    scopus 로고
    • Transparency and reproducibility of observational cohort studies using large healthcare databases
    • Wang SV, Verpillat P, Rassen JA, Patrick A, Garry EM, Bartels DB. Transparency and reproducibility of observational cohort studies using large healthcare databases. Clin Pharmacol Ther. 2016;99(3):325-332.
    • (2016) Clin Pharmacol Ther , vol.99 , Issue.3 , pp. 325-332
    • Wang, S.V.1    Verpillat, P.2    Rassen, J.A.3    Patrick, A.4    Garry, E.M.5    Bartels, D.B.6
  • 18
    • 85020403719 scopus 로고    scopus 로고
    • Risk of diabetic ketoacidosis after initiation of an sglt2 inhibitor
    • Fralick M, Schneeweiss S, Patorno E. Risk of diabetic ketoacidosis after initiation of an sglt2 inhibitor. N Engl J Med. 2017;376(23):2300-2302.
    • (2017) N Engl J Med , vol.376 , Issue.23 , pp. 2300-2302
    • Fralick, M.1    Schneeweiss, S.2    Patorno, E.3
  • 19
    • 85018971196 scopus 로고    scopus 로고
    • Cardiovascular safety of tocilizumab versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis: A multi-database cohort study
    • Kim SC, Solomon DH, Rogers JR, et al. Cardiovascular safety of tocilizumab versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis: a multi-database cohort study. Arthritis Rheumatol. 2017;69(6):1154-1164.
    • (2017) Arthritis Rheumatol , vol.69 , Issue.6 , pp. 1154-1164
    • Kim, S.C.1    Solomon, D.H.2    Rogers, J.R.3
  • 20
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control trials in the evaluation of new treatments, part 1: Ethical and scientific issues
    • Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments, part 1: ethical and scientific issues. Ann Intern Med. 2000;133(6):455-463.
    • (2000) Ann Intern Med , vol.133 , Issue.6 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 22
    • 85029886626 scopus 로고    scopus 로고
    • When and how can real world data analyses substitute for randomized controlled trials?
    • Franklin JM, Schneeweiss S. When and how can real world data analyses substitute for randomized controlled trials? Clin Pharmacol Ther. 2017;102 (6):924-933. doi:10.1002/cpt.857
    • (2017) Clin Pharmacol Ther , vol.102 , Issue.6 , pp. 924-933
    • Franklin, J.M.1    Schneeweiss, S.2
  • 23
    • 39549100109 scopus 로고    scopus 로고
    • Aprotinin during coronary-artery bypass grafting and risk of death
    • Schneeweiss S, Seeger JD, Landon J, Walker AM. Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med. 2008;358 (8):771-783.
    • (2008) N Engl J Med , vol.358 , Issue.8 , pp. 771-783
    • Schneeweiss, S.1    Seeger, J.D.2    Landon, J.3    Walker, A.M.4
  • 24
    • 85013131090 scopus 로고    scopus 로고
    • Comparative safety and effectiveness of denosumab versus zoledronic acid in patients with osteoporosis: A cohort study
    • Choi N-K, Solomon DH, Tsacogianis TN, Landon JE, Song HJ, Kim SC. Comparative safety and effectiveness of denosumab versus zoledronic acid in patients with osteoporosis: a cohort study. J Bone Miner Res. 2017;32(3):611-617.
    • (2017) J Bone Miner Res , vol.32 , Issue.3 , pp. 611-617
    • Choi, N.-K.1    Solomon, D.H.2    Tsacogianis, T.N.3    Landon, J.E.4    Song, H.J.5    Kim, S.C.6
  • 26
    • 84996590366 scopus 로고    scopus 로고
    • Stroke, bleeding, and mortality risks in elderly medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation
    • Graham DJ, Reichman ME, Wernecke M, et al. Stroke, bleeding, and mortality risks in elderly medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation. JAMA Intern Med. 2016;176(11):1662-1671.
    • (2016) JAMA Intern Med , vol.176 , Issue.11 , pp. 1662-1671
    • Graham, D.J.1    Reichman, M.E.2    Wernecke, M.3
  • 27
    • 84907218121 scopus 로고    scopus 로고
    • Comparative effectiveness of generic and brand-name statins on patient outcomes: A cohort study
    • Gagne JJ, Choudhry NK, Kesselheim AS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400-407.
    • (2014) Ann Intern Med , vol.161 , Issue.6 , pp. 400-407
    • Gagne, J.J.1    Choudhry, N.K.2    Kesselheim, A.S.3
  • 28
    • 28244431743 scopus 로고    scopus 로고
    • Risk of death in elderly users of conventional vs. Atypical antipsychotic medications
    • Wang PS, Schneeweiss S, Avorn J, et al. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med. 2005;353 (22):2335-2341.
    • (2005) N Engl J Med , vol.353 , Issue.22 , pp. 2335-2341
    • Wang, P.S.1    Schneeweiss, S.2    Avorn, J.3
  • 29
    • 58349114259 scopus 로고    scopus 로고
    • Atypical antipsychotic drugs and the risk of sudden cardiac death
    • Ray WA, Chung CP, Murray KT, Hall K, Stein CM. Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med. 2009;360(3):225-235.
    • (2009) N Engl J Med , vol.360 , Issue.3 , pp. 225-235
    • Ray, W.A.1    Chung, C.P.2    Murray, K.T.3    Hall, K.4    Stein, C.M.5
  • 30
    • 0027463811 scopus 로고
    • Decreased risk of stroke among postmenopausal hormone users: Results from a national cohort
    • Finucane FF, Madans JH, Bush TL, Wolf PH, Kleinman JC. Decreased risk of stroke among postmenopausal hormone users: results from a national cohort. Arch Intern Med. 1993;153(1):73-79.
    • (1993) Arch Intern Med , vol.153 , Issue.1 , pp. 73-79
    • Finucane, F.F.1    Madans, J.H.2    Bush, T.L.3    Wolf, P.H.4    Kleinman, J.C.5
  • 31
    • 0034726387 scopus 로고    scopus 로고
    • 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors and the risk of cancer: A nested case-control study
    • Blais L, Desgagné A, LeLorier J. 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors and the risk of cancer: a nested case-control study. Arch Intern Med. 2000;160(15): 2363-2368.
    • (2000) Arch Intern Med , vol.160 , Issue.15 , pp. 2363-2368
    • Blais, L.1    Desgagné, A.2    LeLorier, J.3
  • 32
    • 0037534909 scopus 로고    scopus 로고
    • Effect of estrogen plus progestin on stroke in postmenopausal women: The Women’s Health Initiative: A randomized trial
    • Wassertheil-Smoller S, Hendrix SL, Limacher M, et al; WHI Investigators. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women’s Health Initiative: a randomized trial. JAMA. 2003;289(20):2673-2684.
    • (2003) JAMA , vol.289 , Issue.20 , pp. 2673-2684
    • Wassertheil-Smoller, S.1    Hendrix, S.L.2    Limacher, M.3
  • 34
    • 0035880296 scopus 로고    scopus 로고
    • Comparison of evidence of treatment effects in randomized and nonrandomized studies
    • Ioannidis JP, Haidich AB, Pappa M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA. 2001;286(7):821-830.
    • (2001) JAMA , vol.286 , Issue.7 , pp. 821-830
    • Ioannidis, J.P.1    Haidich, A.B.2    Pappa, M.3
  • 35
    • 85027943139 scopus 로고    scopus 로고
    • Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association
    • Gruber S, Chakravarty A, Heckbert SR, et al. Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association. Pharmacoepidemiol Drug Saf. 2016;25(9):973-981.
    • (2016) Pharmacoepidemiol Drug Saf , vol.25 , Issue.9 , pp. 973-981
    • Gruber, S.1    Chakravarty, A.2    Heckbert, S.R.3
  • 36
    • 0027968619 scopus 로고
    • Evidence of the depletion of susceptibles effect in non-experimental pharmacoepidemiologic research
    • Moride Y, Abenhaim L. Evidence of the depletion of susceptibles effect in non-experimental pharmacoepidemiologic research. J Clin Epidemiol. 1994;47(7):731-737.
    • (1994) J Clin Epidemiol , vol.47 , Issue.7 , pp. 731-737
    • Moride, Y.1    Abenhaim, L.2
  • 37
    • 34848820064 scopus 로고    scopus 로고
    • Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results
    • Schneeweiss S, Patrick AR, Stürmer T, et al. Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results. Med Care. 2007;45(10)(suppl 2):S131-S142.
    • (2007) Med Care , vol.45 , Issue.10 , pp. S131-S142
    • Schneeweiss, S.1    Patrick, A.R.2    Stürmer, T.3
  • 38
    • 84900423293 scopus 로고    scopus 로고
    • Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: Cohort study of older patients with heart failure
    • Setoguchi S, Warner Stevenson L, Stewart GC, et al. Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure. BMJ. 2014;348:g2866.
    • (2014) BMJ , vol.348 , pp. g2866
    • Setoguchi, S.1    Warner Stevenson, L.2    Stewart, G.C.3
  • 39
    • 0037472837 scopus 로고    scopus 로고
    • Non-inferiority trials: Design concepts and issues—the encounters of academic consultants in statistics
    • D’Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med. 2003;22(2):169-186.
    • (2003) Stat Med , vol.22 , Issue.2 , pp. 169-186
    • D’Agostino, R.B.1    Massaro, J.M.2    Sullivan, L.M.3
  • 41
    • 85014638634 scopus 로고    scopus 로고
    • Adjusted analyses in studies addressing therapy and harm users’ guides to the medical literature clinical scenario
    • Agoritsas T, Merglen A, Shah ND, O’Donnell M, Guyatt GH, et al. Adjusted analyses in studies addressing therapy and harm users’ guides to the medical literature clinical scenario. JAMA. 2017;317 (7):748-759.
    • (2017) JAMA , vol.317 , Issue.7 , pp. 748-759
    • Agoritsas, T.1    Merglen, A.2    Shah, N.D.3    O’Donnell, M.4    Guyatt, G.H.5
  • 42
    • 85030784708 scopus 로고    scopus 로고
    • Randomization—there is no substitute
    • Fonarow GC. Randomization—there is no substitute. JAMA Cardiol. 2016;1(6):633-635.
    • (2016) JAMA Cardiol , vol.1 , Issue.6 , pp. 633-635
    • Fonarow, G.C.1
  • 43
    • 84888266883 scopus 로고    scopus 로고
    • Making inferences on treatment effects from real world data: Propensity scores, confounding by indication, and other perils for the unwary in observational research
    • Freemantle N, Marston L, Walters K, Wood J, Reynolds MR, Petersen I. Making inferences on treatment effects from real world data: propensity scores, confounding by indication, and other perils for the unwary in observational research. BMJ. 2013;347:f6409.
    • (2013) BMJ , vol.347 , pp. f6409
    • Freemantle, N.1    Marston, L.2    Walters, K.3    Wood, J.4    Reynolds, M.R.5    Petersen, I.6
  • 44
    • 33846563409 scopus 로고    scopus 로고
    • Why most published research findings are false
    • Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2(8):e124.
    • (2005) PLoS Med , vol.2 , Issue.8 , pp. e124
    • Ioannidis, J.P.1
  • 45
    • 84901502488 scopus 로고    scopus 로고
    • Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials
    • Bero L, ed. Chichester, England: John Wiley & Sons
    • Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. In: Bero L, ed. Cochrane Database of Systematic Reviews. Chichester, England: John Wiley & Sons; 2014:MR000034.
    • (2014) Cochrane Database of Systematic Reviews , pp. MR000034
    • Anglemyer, A.1    Horvath, H.T.2    Bero, L.3
  • 46
    • 0034702175 scopus 로고    scopus 로고
    • Randomized, controlled trials, observational studies, and the hierarchy of research designs
    • Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000; 342(25):1887-1892.
    • (2000) N Engl J Med , vol.342 , Issue.25 , pp. 1887-1892
    • Concato, J.1    Shah, N.2    Horwitz, R.I.3
  • 47
    • 84960156608 scopus 로고    scopus 로고
    • Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: Meta-epidemiological survey
    • Hemkens LG, Contopoulos-Ioannidis DG, Ioannidis JPA. Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey. BMJ. 2016;352:i493.
    • (2016) BMJ , vol.352 , pp. i493
    • Hemkens, L.G.1    Contopoulos-Ioannidis, D.G.2    Ioannidis, J.P.A.3
  • 48
    • 84864626015 scopus 로고    scopus 로고
    • Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes
    • Dahabreh IJ, Sheldrick RC, Paulus JK, et al. Do observational studies using propensity score methods agree with randomized trials? a systematic comparison of studies on acute coronary syndromes. Eur Heart J. 2012;33(15):1893-1901.
    • (2012) Eur Heart J , vol.33 , Issue.15 , pp. 1893-1901
    • Dahabreh, I.J.1    Sheldrick, R.C.2    Paulus, J.K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.