EVITA: A tool for the early EValuation of pharmaceutical Innovations with regard to Therapeutic Advantage

BMC Clinical Pharmacology

Volumn 10, Issue , 2010, Pages

  Püntmann, Isabel ^a   Schmacke, Norbert ^b   Melander, Arne ^c   Lindberg, Gunnar ^c   Mühlbauer, Bernd ^a  

^a KLINIKUM BREMEN MITTE   (Germany)

^b UNIVERSITY OF BREMEN   (Germany)

^c Network for Pharmacoepidemiology Foundation   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; ANTHRACYCLINE DERIVATIVE; BENDAMUSTINE; BORTEZOMIB; CYCLOPHOSPHAMIDE; DEXAMETHASONE; GEMFIBROZIL; HEMOGLOBIN A1C; LENALIDOMIDE; METFORMIN; PAROXETINE; PIOGLITAZONE; PLACEBO; RIFAMPICIN; VENLAFAXINE; VINCRISTINE; ZOLEDRONIC ACID; NEW DRUG;

ACCESS TO INFORMATION; ADD ON THERAPY; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; CLINICAL TRIAL; COMPUTER PROGRAM; CONTROLLED CLINICAL TRIAL; DISEASE SEVERITY; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG RESEARCH; DRUG SCREENING; GOOD CLINICAL PRACTICE; HAMILTON SCALE; HUMAN; INFORMATION PROCESSING; INTERNET; MAJOR DEPRESSION; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTIPLE MYELOMA; NON INSULIN DEPENDENT DIABETES MELLITUS; ONLINE SYSTEM; OUTCOME ASSESSMENT; POSTMENOPAUSE OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SCORING SYSTEM; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; COMPARATIVE STUDY; METHODOLOGY; PHARMACEUTICS; RANDOMIZED CONTROLLED TRIAL (TOPIC); TIME;

DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SOFTWARE; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS;

EID: 77952245698     PISSN: None     EISSN: 14726904     Source Type: Journal    
DOI: 10.1186/1472-6904-10-5     Document Type: Article

References (39)

1. Fricke U, Klaus W. Neue Arzneimittel - Fakten und Bewertungen von 2004 bis 2006 zugelassenen Arzneimitteln. Wissenschaftliche Verlagsgesellschaft mbH Stuttgart 2008,
2. Caprino L, Russo P. Developing a paradigm of drug innovation: an evaluation algorithm. Drug Discov Today 2006, 11:999-1006. 10.1016/j.drudis.2006.09.009, 17055409.
3. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996, 17:1-12. 10.1016/0197-2456(95)00134-4, 8721797.
4. Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Cancer Therapy Evaluation Program 2006, 3.0:1-71. Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health.
5. European Commission - Enterprise and Industry Directorate-General - Pharmaceuticals A guideline on Summary of Product Characteristics. The Rules Governing Medicinal Products in the European Union 2005, 2C:0-25. European Commission - Enterprise and Industry Directorate-General - Pharmaceuticals., http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/spcguidrev1-oct2005.pdf
6. Celgene Revlimid® Hartkapseln. Fachinformation (Summary of Product Characteristics) - Rote Liste Service GmbH Berlin 2007, 1-8. Access via password, Celgene., http://www.fachinfo.de
7. European Medicines Agency Revlimid® - Scientific Discussion. European Public Assessment Report 2007, 1-42. European Medicines Agency., http://www.ema.europa.eu/humandocs/PDFs/EPAR/revlimid/H-717-en6.pdf
8. Smith A, Wisloff F, Samson D, . UK Myeloma Forum, Nordic Myeloma Study Group, British Committee for Standards in Haematology Guidelines on the diagnosis and management of multiple myeloma. British Journal of Haematology 2005, 132:410-451. UK Myeloma Forum, Nordic Myeloma Study Group, British Committee for Standards in Haematology., http://www.bcshguidelines.com/pdf/multiplemyeloma0206.pdf
9. German-Speaking Myeloma Multicenter Group (GMMG), Deutsche Studiengruppe Multiples Myelom (DSMM) Kompetenznetz Maligne Lymphome. Kompetenznetz online 2008, German-Speaking Myeloma Multicenter Group (GMMG), Deutsche Studiengruppe Multiples Myelom (DSMM)., http://www.lymphome.de/InfoLymphome/MultipleMyelome/
10. Prietzel T, Pötsch W, von Salis-Soglio G, . Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie (DGOOC), Berufsverband der Ärzte für Orthopädie (BVO) Solitäres und multiples Myelom (S1-Leitlinie). AWMF online 2003, Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie (DGOOC), Berufsverband der Ärzte für Orthopädie (BVO).
11. Liebisch P, Peest D, . Deutsche Gesellschaft für Hämatologie und Onkologie (DGHO) Multiples Myelom. Leitlinien der Deutschen Gesellschaft für Hämatologie und Onkologie 2007, 1-11. Deutsche Gesellschaft für Hämatologie und Onkologie (DGHO).
12. Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med 2007, 357:2123-2132. 10.1056/NEJMoa070594, 18032762.
13. Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med 2007, 357:2133-2142. 10.1056/NEJMoa070596, 18032763.
14. Takeda Pharma Actos (TM) Tabletten. Fachinformation (Summary of Product Characteristics) - Rote Liste Service GmbH Berlin 2007, 1-5. Access via password, Takeda Pharma., http://www.fachinfo.de
15. Dormandy JA, Charbonnel B, Eckland DJ, Erdmann E, Massi-Benedetti M, Moules IK, Skene AM, Tan MH, Lefèbvre PJ, Murray GD, Standl E, Wilcox RG, Wilhelmsen L, Betteridge J, Birkeland K, Golay A, Heine RJ, Korányi L, Laakso M, Mokán M, Norkus A, Pirags V, Podar T, Scheen A, Scherbaum W, Schernthaner G, Schmitz O, Skrha J, Smith U, Taton J. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 2005, 366:1279-1289. 10.1016/S0140-6736(05)67528-9, 16214598.
16. Einhorn D, Rendell M, Rosenzweig J, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controlled study. The Pioglitazone 027 Study Group. Clin Ther 2000, 22:1395-1409. 10.1016/S0149-2918(00)83039-8, 11192132.
17. Kipnes MS, Krosnick A, Rendell MS, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study. Am J Med 2001, 111:10-17. 10.1016/S0002-9343(01)00713-6, 11448655.
18. Charbonnel B, Dormandy J, Erdmann E, Massi-Benedetti M, Skene A. The prospective pioglitazone clinical trial in macrovascular events (PROactive): can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients. Diabetes Care 2004, 27:1647-1653. 10.2337/diacare.27.7.1647, 15220241.
19. GlaxoSmithKline Elontril® 150 mg/300 mg. Fachinformation (Summary of Product Characteristics) - Rote Liste Service GmbH Berlin 2007, 1-6. Access via password, GlaxoSmithKline., http://www.fachinfo.de
20. GlaxoSmithKline Zyban® 150 mg Retardtabletten. Fachinformation (Summary of Product Characteristics) - Rote Liste Service GmbH Berlin 2008, 1-6. Access via password, GlaxoSmithKline., http://www.fachinfo.de
21. Weihs KL, Houser TL, Batey SR, Ascher JA, Bolden-Watson C, Donahue RM, Metz A. Continuation phase treatment with bupropion SR effectively decreases the risk for relapse of depression. Biol Psychiatry 2002, 51:753-761. 10.1016/S0006-3223(01)01317-8, 11983189.
22. Jefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2006, 67:865-873. 10.4088/JCP.v67n0602, 16848645.
23. GlaxoSmithKline AK130940 - A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible Dose Study to Evaluate the Efficacy, Safety and Tolerability of Extended-release Bupropion Hydrochloride (150 mg-300 mg once daily) in Elderly Subjects with Major Depressive Disorder. online GSK clinical trial register 2006, 1-7. GlaxoSmithKline., http://www.gsk-clinicalstudyregister.com/
24. Weihs KL, Settle EC, Batey SR, Houser TL, Donahue RM, Ascher JA. Bupropion sustained release versus paroxetine for the treatment of depression in the elderly. J Clin Psychiatry 2000, 61:196-202.
25. GlaxoSmithKline WXL101497 - A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150 mg - 300 mg once daily), Extended-Release Venlafaxine Hydrochloride (75 mg - 150 mg once daily) and Placebo in Subjects with Major Depressive Disorder. online GSK clinical trial register 2006, 1-8. GlaxoSmithKline., http://www.gsk-clinicalstudyregister.com/
26. GlaxoSmithKline AK130939 - A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150 mg - 300 mg once daily), Extended-Release Venlafaxine Hydrochloride (75 mg - 150 mg once daily) and Placebo in Subjects with Major Depressive Disorder. online GSK clinical trial register 2006, 1-7. GlaxoSmithKline., http://www.gsk-clinicalstudyregister.com/
27. Novartis Pharma Aclasta® 5 mg Infusionslösung. Fachinformation (Summary of Product Characteristics) - Rote Liste Service GmbH Berlin 2008, 1-6. Access via password, Novartis Pharma., http://www.fachinfo.de
28. Novartis Pharma GmbH Anhang 1 - Zusammenfassung der Merkmale des Arzneimittels (Aclasta 5 mg Infustionslösung). EMEA EPAR Produktinformation 2008, H-595-PI:1-30. Novartis Pharma GmbH., http://www.ema.europa.eu/humandocs/PDFs/EPAR/aclasta/emea-combined-h595de.pdf
29. Novartis Pharma Zometa® 4 mg/5 ml. Fachinformation (Summary of Product Characteristics) - Rote Liste Service GmbH Berlin 2008, 1-7. Access via password, Novartis Pharma., http://www.fachinfo.de
30. European Medicines Agency Aclasta® - Scientific Discussion. European Public Assessment Report 2005, 1-24. European Medicines Agency., http://www.ema.europa.eu/humandocs/Humans/EPAR/aclasta/aclasta.htm
31. European Medicines Agency Aclasta® - Scientific Discussion - Procedure number: EMEA-H-595-II-10-AR. European Public Assessment Report 2007, 1-37. European Medicines Agency., http://www.ema.europa.eu/humandocs/Humans/EPAR/aclasta/aclasta.htm
32. European Medicines Agency Assessment Report Aclasta® - (INN: zoledronic acid) - Aclasta H-535-II-10-AR Scientific Discussion. European Public Assessment Report 2008, 1-60. European Medicines Agency., http://www.ema.europa.eu/humandocs/Humans/EPAR/aclasta/aclasta.htm
33. Reid IR, Brown JP, Burckhardt P, Horowitz Z, Richardson P, Trechsel U, Widmer A, Devogelaer JP, Kaufman JM, Jaeger P, Body JJ, Brandi ML, Broell J, Di Micco R, Genazzani AR, Felsenberg D, Happ J, Hooper MJ, Ittner J, Leb G, Mallmin H, Murray T, Ortolani S, Rubinacci A, Saaf M, Samsioe G, Verbruggen L, Meunier PJ. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med 2002, 346:653-661. 10.1056/NEJMoa011807, 11870242.
34. Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007, 356:1809-1822. 10.1056/NEJMoa067312, 17476007.
35. Akiyama T, Pawitan Y, Greenberg H, Kuo CS, Reynolds-Haertle RA. Increased risk of death and cardiac arrest from encainide and flecainide in patients after non-Q-wave acute myocardial infarction in the Cardiac Arrhythmia Suppression Trial. CAST Investigators. Am J Cardiol 1991, 68:1551-1555. 10.1016/0002-9149(91)90308-8, 1720917.
36. Scheen AJ. Thiazolidinediones and liver toxicity. Diabetes Metab 2001, 27:305-313.
37. Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004, 291:1701-1712. 10.1001/jama.291.14.1701, 15082697.
38. Stefanick ML, Anderson GL, Margolis KL, Hendrix SL, Rodabough RJ, Paskett ED, Lane DS, Hubbell FA, Assaf AR, Sarto GE, Schenken RS, Yasmeen S, Lessin L, Chlebowski RT. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA 2006, 295:1647-1657. 10.1001/jama.295.14.1647, 16609086.
39. Testa L, Bhindi R, Agostoni P, Abbate A, Zoccai GG, van Gaal WJ. The direct thrombin inhibitor ximelagatran/melagatran: a systematic review on clinical applications and an evidence based assessment of risk benefit profile. Expert Opin Drug Saf 2007, 6:397-406. 10.1517/14740338.6.4.397, 17688383.