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Volumn 129, Issue 19, 2007, Pages 736-745

Therapeutic equivalence: Concept and evidence levels;Equivalencia terapéutica: Concepto y niveles de evidencia

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOEQUIVALENCE; CLINICAL PRACTICE; HUMAN;

EID: 37149054758     PISSN: 00257753     EISSN: 15788989     Source Type: Journal    
DOI: 10.1157/13113299     Document Type: Article
Times cited : (8)

References (69)
  • 2
    • 85031451054 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CMPH). Guideline on the choice of the non-inferiority margin. EMEA/CPMP/EWP/2158/99. The European Agency for the Evaluation of Medicines Products EMEA; 27 July 2005 [consultado 27/04/2007]. Disponible en: http://www.emea.eu.int
    • Committee for Medicinal Products for Human Use (CMPH). Guideline on the choice of the non-inferiority margin. EMEA/CPMP/EWP/2158/99. The European Agency for the Evaluation of Medicines Products EMEA; 27 July 2005 [consultado 27/04/2007]. Disponible en: http://www.emea.eu.int
  • 3
    • 33644815619 scopus 로고    scopus 로고
    • Lessons from and cautions about noninferiority and equivalence randomized trials
    • Gotzsche P. Lessons from and cautions about noninferiority and equivalence randomized trials. JAMA. 2006;295:1172-4.
    • (2006) JAMA , vol.295 , pp. 1172-1174
    • Gotzsche, P.1
  • 4
    • 85031452195 scopus 로고    scopus 로고
    • Ley 29/2006 de Garantías y Uso Racional de los Medicamentos y Productos Sanitarios. BOE no. 178, de 27 de julio de 2006; p. 28122-65.
    • Ley 29/2006 de Garantías y Uso Racional de los Medicamentos y Productos Sanitarios. BOE no. 178, de 27 de julio de 2006; p. 28122-65.
  • 6
    • 0035739849 scopus 로고    scopus 로고
    • Choice of delta in equivalence testing
    • Tie-Hua N. Choice of delta in equivalence testing. Drug Inf J. 2001;35:1517-27.
    • (2001) Drug Inf J , vol.35 , pp. 1517-1527
    • Tie-Hua, N.1
  • 7
    • 85031442454 scopus 로고    scopus 로고
    • Sociedad Española de Farmacéuticos Atención Primaria (SEPAP). Bioequivalencia: hablemos del ± 20%. Boletín de Uso Racional del Medicamento. 2005;13:1-4.
    • Sociedad Española de Farmacéuticos Atención Primaria (SEPAP). Bioequivalencia: hablemos del ± 20%. Boletín de Uso Racional del Medicamento. 2005;13:1-4.
  • 9
    • 1642355047 scopus 로고    scopus 로고
    • Elección del grupo control. Distintas hipótesis, distinta metodología
    • Cobo E. Elección del grupo control. Distintas hipótesis, distinta metodología. ICB Digital. 2003;(12):2-5.
    • (2003) ICB Digital , vol.12 , pp. 2-5
    • Cobo, E.1
  • 10
    • 0041639486 scopus 로고    scopus 로고
    • Active-control clinical trials to establish equivalence or noninferiority: Methodological and statistical concept linked to quality
    • Gomberg-Maitland M, Frison L, Halperin J. Active-control clinical trials to establish equivalence or noninferiority: methodological and statistical concept linked to quality. Am Heart J. 2003;146:398-403.
    • (2003) Am Heart J , vol.146 , pp. 398-403
    • Gomberg-Maitland, M.1    Frison, L.2    Halperin, J.3
  • 11
    • 85031438692 scopus 로고    scopus 로고
    • EMEA/CPMP/EWP/482/99. Committee for Medicinal Products for Human Use (CMPH). Points to consider on switching between superiority and non-inferiority. The European Agency for the Evaluation of Medicinal Products EMEA; 27 July 2000 [consultado 27 Abril 2007]. Disponible en: http://www.eudra.org/emea.html
    • EMEA/CPMP/EWP/482/99. Committee for Medicinal Products for Human Use (CMPH). Points to consider on switching between superiority and non-inferiority. The European Agency for the Evaluation of Medicinal Products EMEA; 27 July 2000 [consultado 27 Abril 2007]. Disponible en: http://www.eudra.org/emea.html
  • 13
    • 0029987569 scopus 로고    scopus 로고
    • Trials to assess equivalence: The importance of rigorous methods
    • Jones B, Jarvis P, Lewis J, Ebbutt A. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36-9.
    • (1996) BMJ , vol.313 , pp. 36-39
    • Jones, B.1    Jarvis, P.2    Lewis, J.3    Ebbutt, A.4
  • 14
    • 0037129755 scopus 로고    scopus 로고
    • La ausencia de significación estadística en un ensayo clínico no significa equivalencia terapéutica
    • Argimon J. La ausencia de significación estadística en un ensayo clínico no significa equivalencia terapéutica. Med Clin (Barc). 2002;118: 701-3.
    • (2002) Med Clin (Barc) , vol.118 , pp. 701-703
    • Argimon, J.1
  • 15
    • 0035739145 scopus 로고    scopus 로고
    • Testing noninferiority of resonse rates for regulatory filings using transformations
    • Wiens B, Iglewicz B. Testing noninferiority of resonse rates for regulatory filings using transformations. Drug Inf J. 2001;35:1165-71.
    • (2001) Drug Inf J , vol.35 , pp. 1165-1171
    • Wiens, B.1    Iglewicz, B.2
  • 16
    • 85031441617 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP). Choice of delta. The European Agency for the Evaluation of Medicinal Products (EMEA) 23 Septembrer 1999 [consultado 27 04 2007]. Disponible en http:// www.eudra.org/emea.html
    • Committee for Proprietary Medicinal Products (CPMP). Choice of delta. The European Agency for the Evaluation of Medicinal Products (EMEA) 23 Septembrer 1999 [consultado 27 04 2007]. Disponible en http:// www.eudra.org/emea.html
  • 17
    • 0030879325 scopus 로고    scopus 로고
    • A comparison of reteplase with alteplase for acute myocardial infarction
    • The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators
    • The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators. A comparison of reteplase with alteplase for acute myocardial infarction. N Engl J Med. 1997;337:1118-23.
    • (1997) N Engl J Med , vol.337 , pp. 1118-1123
  • 18
    • 0030847845 scopus 로고    scopus 로고
    • Investigators. A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction
    • The Continuous Infusion versus Double-Bolus Administration of Alteplase COBALT
    • The Continuous Infusion versus Double-Bolus Administration of Alteplase (COBALT) Investigators. A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction. N Engl J Med. 1997;337:1124-30.
    • (1997) N Engl J Med , vol.337 , pp. 1124-1130
  • 20
    • 0028046352 scopus 로고
    • A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. Candidemia Study Group and the National Institute
    • Rex JH, Sugar AM, Pappas PG, Van der Horst CM, Edwards JE, Washburn RG, et al. A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. Candidemia Study Group and the National Institute. N Engl J Med. 1994;331:1325-30.
    • (1994) N Engl J Med , vol.331 , pp. 1325-1330
    • Rex, J.H.1    Sugar, A.M.2    Pappas, P.G.3    Van der Horst, C.M.4    Edwards, J.E.5    Washburn, R.G.6
  • 22
    • 85031443322 scopus 로고    scopus 로고
    • Guidance for industry: antiretroviral drugs using plasma HIV RNA measurements. Clinical considerations for accelerated and traditional approval. U.S. Department of Health and Human Services. Rockville: Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER); October 2002.
    • Guidance for industry: antiretroviral drugs using plasma HIV RNA measurements. Clinical considerations for accelerated and traditional approval. U.S. Department of Health and Human Services. Rockville: Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER); October 2002.
  • 23
    • 85031440710 scopus 로고    scopus 로고
    • Guidance for industry: developing antimicrobial drugs: general considerations for clinical trial (Draft). Rockville: Food and Drug Administration Divission of Anti-Infective Drug Products; 1998.
    • Guidance for industry: developing antimicrobial drugs: general considerations for clinical trial (Draft). Rockville: Food and Drug Administration Divission of Anti-Infective Drug Products; 1998.
  • 24
    • 37149001785 scopus 로고    scopus 로고
    • The interpretation of lack of evidence of a difference in efficacy: Equivalence trials and the treatment of fungal infections
    • Moran J, Solomon P. The interpretation of lack of evidence of a difference in efficacy: equivalence trials and the treatment of fungal infections. Critical Care and Resuscitation. 2003;5:216-23.
    • (2003) Critical Care and Resuscitation , vol.5 , pp. 216-223
    • Moran, J.1    Solomon, P.2
  • 27
    • 33644972213 scopus 로고    scopus 로고
    • Planned equivalence or noninferiority trials versus unplanned noninferiority claims: Are they equal?
    • Chung-Ying Zee B. Planned equivalence or noninferiority trials versus unplanned noninferiority claims: are they equal? J Clin Oncol. 2006;24:1026-8.
    • (2006) J Clin Oncol , vol.24 , pp. 1026-1028
    • Chung-Ying Zee, B.1
  • 28
    • 0035739481 scopus 로고    scopus 로고
    • Superiority, noninferiority, equivalence, and bioequivalence-revisited
    • Aras G. Superiority, noninferiority, equivalence, and bioequivalence-revisited. Drug Information Journal. 2001;35:1157-64.
    • (2001) Drug Information Journal , vol.35 , pp. 1157-1164
    • Aras, G.1
  • 29
    • 0035819920 scopus 로고    scopus 로고
    • Scientific and ethical issues in equivalence trials
    • Djulbegovic B, Clarke M. Scientific and ethical issues in equivalence trials. JAMA. 2001;285:1206-8.
    • (2001) JAMA , vol.285 , pp. 1206-1208
    • Djulbegovic, B.1    Clarke, M.2
  • 30
    • 30944468562 scopus 로고    scopus 로고
    • Study 934 Group. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV
    • Gallant DE, DeJesús E, Arribas JR, Pozniak AL, Gazzard B, Campo RE, et al; Study 934 Group. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006;354:251-60.
    • (2006) N Engl J Med , vol.354 , pp. 251-260
    • Gallant, D.E.1    DeJesús, E.2    Arribas, J.R.3    Pozniak, A.L.4    Gazzard, B.5    Campo, R.E.6
  • 31
    • 24944544422 scopus 로고    scopus 로고
    • Preliminary data release for randomized clinical trials of noninferiority: A new proposal
    • Korn E, Hunsberger S, Freidlin B, Smith M, Abrams J. Preliminary data release for randomized clinical trials of noninferiority: a new proposal. J Clin Oncol. 2005;23:5831-6.
    • (2005) J Clin Oncol , vol.23 , pp. 5831-5836
    • Korn, E.1    Hunsberger, S.2    Freidlin, B.3    Smith, M.4    Abrams, J.5
  • 32
    • 0034595229 scopus 로고    scopus 로고
    • Claims of equivalence in medical research: Are they supported by the evidence?
    • Greene W, Concato J, Feinstein A. Claims of equivalence in medical research: are they supported by the evidence? Ann Intern Med. 2000;132:715-22.
    • (2000) Ann Intern Med , vol.132 , pp. 715-722
    • Greene, W.1    Concato, J.2    Feinstein, A.3
  • 33
    • 33644789375 scopus 로고    scopus 로고
    • Quality of reporting of noninferiority and equivalence randomized trials
    • Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA. 2006;295:1147-51.
    • (2006) JAMA , vol.295 , pp. 1147-1151
    • Le Henanff, A.1    Giraudeau, B.2    Baron, G.3    Ravaud, P.4
  • 34
    • 85136368812 scopus 로고    scopus 로고
    • Piaggio G, Elbourne D, Altman D, Pocock S, Evans S, Group FTC. Reporting of noninferiority and equivalence randomized trials. An extension of the CONSORT statement. JAMA. 2006;295:1152-60.
    • Piaggio G, Elbourne D, Altman D, Pocock S, Evans S, Group FTC. Reporting of noninferiority and equivalence randomized trials. An extension of the CONSORT statement. JAMA. 2006;295:1152-60.
  • 35
    • 27544490169 scopus 로고    scopus 로고
    • Equivalence and noninferiority trials-are they viable alternatives for registration of new drugs? (III)
    • Pater C. Equivalence and noninferiority trials-are they viable alternatives for registration of new drugs? (III). Curr Control Trials Cardiovasc Med. 2004;5:8-15.
    • (2004) Curr Control Trials Cardiovasc Med , vol.5 , pp. 8-15
    • Pater, C.1
  • 36
    • 1642396545 scopus 로고    scopus 로고
    • No more equivalence trials for antibiotics in exacerbations of COPD, please
    • Miravitlles M, Torres A. No more equivalence trials for antibiotics in exacerbations of COPD, please. Chest. 2004;125:811-3.
    • (2004) Chest , vol.125 , pp. 811-813
    • Miravitlles, M.1    Torres, A.2
  • 37
    • 0037374008 scopus 로고    scopus 로고
    • Validity of indirect comparison for estimating efficacy of competing interventions: Empirical evidence from published meta-analyses
    • Song F, Altman D, Glenny A, Deeks J. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ. 2003;326:472-6.
    • (2003) BMJ , vol.326 , pp. 472-476
    • Song, F.1    Altman, D.2    Glenny, A.3    Deeks, J.4
  • 38
    • 27644527080 scopus 로고    scopus 로고
    • FUINSA sobre guías terapéuticas. Guías terapéuticas, ¿qué puede esperarse de ellas?
    • Moreno-González A y Grupo de trabajo FUINSA sobre guías terapéuticas. Guías terapéuticas, ¿qué puede esperarse de ellas? Med Clin (Barc). 2005;125:421-2.
    • (2005) Med Clin (Barc) , vol.125 , pp. 421-422
    • Moreno-González, A.1    de trabajo, G.2
  • 39
    • 0029633646 scopus 로고
    • Evaluación de la evidencia científica
    • Jovel AJ, Navarro-Rubio MD. Evaluación de la evidencia científica. Med Clin (Barc). 1995;105:740-3.
    • (1995) Med Clin (Barc) , vol.105 , pp. 740-743
    • Jovel, A.J.1    Navarro-Rubio, M.D.2
  • 41
    • 0033612881 scopus 로고    scopus 로고
    • Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: The ASSENT-2 double-blind randomized trial
    • Van de Werf F, Adgey J, Ardissino D, Armstrong PW, Aylward P, Barbash G, et al. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-22.
    • (1999) Lancet , vol.354 , pp. 716-722
    • Van de Werf, F.1    Adgey, J.2    Ardissino, D.3    Armstrong, P.W.4    Aylward, P.5    Barbash, G.6
  • 42
    • 0037250159 scopus 로고    scopus 로고
    • A randomized double-blind multicenter phase III study of fixed-dose single-administration PEGF versus daily filgrastim in patients receiving myelosupressive chemotherapy
    • Green W. A randomized double-blind multicenter phase III study of fixed-dose single-administration PEGF versus daily filgrastim in patients receiving myelosupressive chemotherapy. Ann Oncol. 2003;14:29-35.
    • (2003) Ann Oncol , vol.14 , pp. 29-35
    • Green, W.1
  • 43
    • 0036467835 scopus 로고    scopus 로고
    • Blinded, randomized, multicenter study to evaluate single administration PEGF once per cycle versus dayly filgrastim as an adjunt to chemotherapy in patients with high-risc stage II or stage III/IV breast cancer
    • Holmes F. Blinded, randomized, multicenter study to evaluate single administration PEGF once per cycle versus dayly filgrastim as an adjunt to chemotherapy in patients with high-risc stage II or stage III/IV breast cancer. J Clin Oncol. 2002;20:727-31.
    • (2002) J Clin Oncol , vol.20 , pp. 727-731
    • Holmes, F.1
  • 44
    • 1342331401 scopus 로고    scopus 로고
    • Randomized, double-blind placebo and tolterodine-controlled trial of the once-daily antimuscarinicagent solifencin in patients with symptomatic overactive bladder
    • Chapple CR, Rechberger T, Al-Shukri S, Meffan P, Everaert K, Huang M, et al. Randomized, double-blind placebo and tolterodine-controlled trial of the once-daily antimuscarinicagent solifencin in patients with symptomatic overactive bladder. BJU Int. 2004;93:303-10.
    • (2004) BJU Int , vol.93 , pp. 303-310
    • Chapple, C.R.1    Rechberger, T.2    Al-Shukri, S.3    Meffan, P.4    Everaert, K.5    Huang, M.6
  • 45
    • 0037161058 scopus 로고    scopus 로고
    • El intervalo de confianza, algo más que un valor de significación estadística
    • Argimon J. El intervalo de confianza, algo más que un valor de significación estadística. Med Clin (Barc). 2002;118:382-4.
    • (2002) Med Clin (Barc) , vol.118 , pp. 382-384
    • Argimon, J.1
  • 46
    • 0037648462 scopus 로고    scopus 로고
    • A meta-analysis of fondaparinux versus enoxaparin in the prevention of venous thromboembolism after major orthopaedic surgery
    • Turpie AG, Eriksson BI, Lassen MR, Bauer KA. A meta-analysis of fondaparinux versus enoxaparin in the prevention of venous thromboembolism after major orthopaedic surgery. J South Orthop Assoc. 2002;11:182-8.
    • (2002) J South Orthop Assoc , vol.11 , pp. 182-188
    • Turpie, A.G.1    Eriksson, B.I.2    Lassen, M.R.3    Bauer, K.A.4
  • 47
    • 84971580244 scopus 로고
    • Absence of evidence is not evidence of absence
    • Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995;311:485.
    • (1995) BMJ , vol.311 , pp. 485
    • Altman, D.G.1    Bland, J.M.2
  • 48
    • 0035024390 scopus 로고    scopus 로고
    • The oxytocin antagonist atosiban versus the beta-agonist terbutaline in the treatment of preterm labor. A randomized, double-blind, controlled study
    • European Atosiban Study Group
    • European Atosiban Study Group. The oxytocin antagonist atosiban versus the beta-agonist terbutaline in the treatment of preterm labor. A randomized, double-blind, controlled study. Acta Obstetr Gynecol Scand. 2001;80:413-22.
    • (2001) Acta Obstetr Gynecol Scand , vol.80 , pp. 413-422
  • 49
    • 0035487869 scopus 로고    scopus 로고
    • Treatment of preterm labor with the oxytocin antagonist atosiban: A double-blind, randomized, controlled comparison with salbutamol
    • French/Australian Atosiban Investigators Group
    • French/Australian Atosiban Investigators Group. Treatment of preterm labor with the oxytocin antagonist atosiban: a double-blind, randomized, controlled comparison with salbutamol. Eur J Obstet Gynecol Reprod Biol. 2001;98:177-85.
    • (2001) Eur J Obstet Gynecol Reprod Biol , vol.98 , pp. 177-185
  • 50
    • 0034048090 scopus 로고    scopus 로고
    • Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: A multicenter effectiveness and safety study
    • Moutquin JM, Sherman D, Cohen H, Mohide PT, Hochner-Celnikier D, Fejgin M, et al. Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: a multicenter effectiveness and safety study. Am J Obstet Gynecol. 2000;182:1191-9.
    • (2000) Am J Obstet Gynecol , vol.182 , pp. 1191-1199
    • Moutquin, J.M.1    Sherman, D.2    Cohen, H.3    Mohide, P.T.4    Hochner-Celnikier, D.5    Fejgin, M.6
  • 51
    • 0029155045 scopus 로고    scopus 로고
    • Kragh-Sorensen P, Muller B, Andersen JV, Buch D, Stage KB. Moclobemide versus clomipramine in depressed patients in general practice. A randomized, double-blind, parallel, multicenter study. J Clin Psychopharmacol. 1995;15 4 Suppl 2:24-30.
    • Kragh-Sorensen P, Muller B, Andersen JV, Buch D, Stage KB. Moclobemide versus clomipramine in depressed patients in general practice. A randomized, double-blind, parallel, multicenter study. J Clin Psychopharmacol. 1995;15 4 Suppl 2:24-30.
  • 52
    • 31344467118 scopus 로고    scopus 로고
    • Are statins created equal? Evidence from randomized trials of pravastatin, simvastatin, and atorvastatin for cardiovascular disease prevention
    • Zhou Z, Rahme E, Pilote L. Are statins created equal? Evidence from randomized trials of pravastatin, simvastatin, and atorvastatin for cardiovascular disease prevention. Am Heart J. 2006;151:273-81.
    • (2006) Am Heart J , vol.151 , pp. 273-281
    • Zhou, Z.1    Rahme, E.2    Pilote, L.3
  • 53
    • 0142156483 scopus 로고    scopus 로고
    • Comparison of the efficacy of the tumour necrosis factor a blocking agents adalimumab, etanercept, and infliximab when added to methotrexate in patients with active rheumatoid arthritis
    • Hochberg MC, Tracy JK, Hawkins-Holt M, Flores RH. Comparison of the efficacy of the tumour necrosis factor a blocking agents adalimumab, etanercept, and infliximab when added to methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2003;62 Suppl 2:13-6.
    • (2003) Ann Rheum Dis , vol.62 , Issue.SUPPL. 2 , pp. 13-16
    • Hochberg, M.C.1    Tracy, J.K.2    Hawkins-Holt, M.3    Flores, R.H.4
  • 54
    • 0037231533 scopus 로고    scopus 로고
    • Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial
    • Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48:35-45.
    • (2003) Arthritis Rheum , vol.48 , pp. 35-45
    • Weinblatt, M.E.1    Keystone, E.C.2    Furst, D.E.3    Moreland, L.W.4    Weisman, M.H.5    Birbara, C.A.6
  • 55
    • 0033611472 scopus 로고    scopus 로고
    • A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate
    • Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340:253-9.
    • (1999) N Engl J Med , vol.340 , pp. 253-259
    • Weinblatt, M.E.1    Kremer, J.M.2    Bankhurst, A.D.3    Bulpitt, K.J.4    Fleischmann, R.M.5    Fox, R.I.6
  • 56
    • 0033524159 scopus 로고    scopus 로고
    • Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: A randomised phase III trial. ATTRACT Study Group
    • Maini R, St. Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet. 1999;354:1932-9.
    • (1999) Lancet , vol.354 , pp. 1932-1939
    • Maini, R.1    St. Clair, E.W.2    Breedveld, F.3    Furst, D.4    Kalden, J.5    Weisman, M.6
  • 57
    • 0037417252 scopus 로고    scopus 로고
    • Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction (EPHESUS)
    • Pitt B, Remme W, Zannad F, Neaton J, Martínez F, Roniker B, et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction (EPHESUS). N Engl J Med. 2003;348:1309-21.
    • (2003) N Engl J Med , vol.348 , pp. 1309-1321
    • Pitt, B.1    Remme, W.2    Zannad, F.3    Neaton, J.4    Martínez, F.5    Roniker, B.6
  • 58
    • 0033517302 scopus 로고    scopus 로고
    • The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators
    • Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Pérez A, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999;341:709-17.
    • (1999) N Engl J Med , vol.341 , pp. 709-717
    • Pitt, B.1    Zannad, F.2    Remme, W.J.3    Cody, R.4    Castaigne, A.5    Pérez, A.6
  • 59
    • 1642378789 scopus 로고    scopus 로고
    • Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute exacerbations of chronic bronchitis
    • Wilson R, Allegra L, Huchon G, Izquierdo JL, Jones P, Schaberg T, et al. Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute exacerbations of chronic bronchitis. Chest. 2004;125:953-64.
    • (2004) Chest , vol.125 , pp. 953-964
    • Wilson, R.1    Allegra, L.2    Huchon, G.3    Izquierdo, J.L.4    Jones, P.5    Schaberg, T.6
  • 60
    • 0036255914 scopus 로고    scopus 로고
    • A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and longterm clinical outcomes
    • Wilson R, Schentag JJ, Ball P, Mandell L. A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and longterm clinical outcomes. Clin Ther. 2002;24:639-52.
    • (2002) Clin Ther , vol.24 , pp. 639-652
    • Wilson, R.1    Schentag, J.J.2    Ball, P.3    Mandell, L.4
  • 61
    • 33846363313 scopus 로고    scopus 로고
    • Seguridad de la utilización de inhibidores de la bomba de protones
    • Esplugues JV, Martí-Cabrera M, Ponce J. Seguridad de la utilización de inhibidores de la bomba de protones. Med Clin (Barc). 2006;127:790-5.
    • (2006) Med Clin (Barc) , vol.127 , pp. 790-795
    • Esplugues, J.V.1    Martí-Cabrera, M.2    Ponce, J.3
  • 62
    • 26844549131 scopus 로고    scopus 로고
    • Grupo Conferencia Española de Consenso sobre Helicobacter pylori. Tratamiento erradicador de Helicobacter pylori. Recomendaciones de la II Conferencia Española de consenso
    • Gisbert JP, Calvet X, Gomollon F, Mones J, Grupo Conferencia Española de Consenso sobre Helicobacter pylori. Tratamiento erradicador de Helicobacter pylori. Recomendaciones de la II Conferencia Española de consenso. Med Clin (Barc). 2005;125:301-16.
    • (2005) Med Clin (Barc) , vol.125 , pp. 301-316
    • Gisbert, J.P.1    Calvet, X.2    Gomollon, F.3    Mones, J.4
  • 63
    • 33847409654 scopus 로고    scopus 로고
    • Proton pump inhibitor therapy for peptic ulcer bleeding: Cochrane Collaboration meta-anlysis of randomised controlled trials
    • Leontiadis GI, McIntyre L, Sharma VK, Howden CW. Proton pump inhibitor therapy for peptic ulcer bleeding: Cochrane Collaboration meta-anlysis of randomised controlled trials. Mayo Clin Proc. 2007;82:286-96.
    • (2007) Mayo Clin Proc , vol.82 , pp. 286-296
    • Leontiadis, G.I.1    McIntyre, L.2    Sharma, V.K.3    Howden, C.W.4
  • 64
    • 85031441434 scopus 로고    scopus 로고
    • Anónimo. L'année du médicament: quand la publicité masque l'absence de progrès thèrapeutique. Revue Prescrire. 2007;280:140-9.
    • Anónimo. L'année du médicament: quand la publicité masque l'absence de progrès thèrapeutique. Revue Prescrire. 2007;280:140-9.
  • 65
    • 37149001160 scopus 로고    scopus 로고
    • La experiencia del Comité Mixto de Evaluación de Nuevos Medicamentos (CMENM). Farm Aten Primaria
    • Catalán A, Recalde J, Aizpurua I, Aza M, Erviti J. La experiencia del Comité Mixto de Evaluación de Nuevos Medicamentos (CMENM). Farm Aten Primaria. 2006;4 Extra:7-16.
    • (2006) Extra:7-16 , vol.4
    • Catalán, A.1    Recalde, J.2    Aizpurua, I.3    Aza, M.4    Erviti, J.5
  • 68
    • 14844303784 scopus 로고    scopus 로고
    • Valor terapéutico añadido de los medicamentos, ¿qué es, cómo se evalúa y cuál debería ser su papel en política farmacéutica?
    • Soto J. Valor terapéutico añadido de los medicamentos, ¿qué es, cómo se evalúa y cuál debería ser su papel en política farmacéutica? An Med Interna (Madrid). 2005;22:39-42.
    • (2005) An Med Interna (Madrid) , vol.22 , pp. 39-42
    • Soto, J.1
  • 69
    • 85031452198 scopus 로고    scopus 로고
    • GENESIS Grupo de trabajo de la SEFH. Programa madre de ayuda a la redacción de informes de evaluación de un nuevo medicamento. Manual de procedimientos. Versión 3.0. Septiembre 2005 [publicación electrónica] [consultado 27 Abril 2007]. Disponible en: http://genesis.sefh.es
    • GENESIS Grupo de trabajo de la SEFH. Programa madre de ayuda a la redacción de informes de evaluación de un nuevo medicamento. Manual de procedimientos. Versión 3.0. Septiembre 2005 [publicación electrónica] [consultado 27 Abril 2007]. Disponible en: http://genesis.sefh.es


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