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Neue Arzneimittel 2010

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Arzneiverordnungs-Report 2011

Zusammenfassung

Die Zahl der jährlich neu eingeführten Arzneimittel hatte in Deutschland 1997 mit 41 neuen Wirkstoffen einen einstweiligen Höhepunkt erreicht, zeigt aber seitdem einen generell rückläufigen Trend (Abbildung 2.1). Im Jahre 2010 wurden nur 23 neue Wirkstoffe auf den Markt gebracht und damit kaum mehr als 1994. Eine ähnliche Entwicklung ist auch in anderen Ländern zu beobachten. Trotz ständig steigender Forschungsinvestitionen liegt die Zahl der jährlichen Neueinführungen in den USA nicht höher als vor 50 Jahren (Munos 2009).

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Literatur

  • Afilalo M, Etropolski MS, Kuperwasser B, Kelly K, Okamoto A, Van Hove I, Steup A, Lange B, Rauschkolb C, Haeussler J (2010): Efficacy and safety of Tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: a randomized, doubleblind, placebo- and active-controlled phase III study. Clin Drug Investig 30: 489–505.

    Article  PubMed  CAS  Google Scholar 

  • Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group (2009): Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy 64: 158–165.

    Article  PubMed  CAS  Google Scholar 

  • Battram C, Charlton SJ, Cuenoud B, Dowling MR, Fairhurst RA, Farr D, Fozard JR, Leighton-Davies JR, Lewis CA, McEvoy L, Turner RJ, Trifilieff A (2006): In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5,6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one (indacaterol), a novel inhaled beta(2) adrenoceptor agonist with a 24-h duration of action. J Pharmacol Exp Ther 317: 762–770.

    Article  PubMed  CAS  Google Scholar 

  • Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N (2005): Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 353: 2450–2461.

    Article  PubMed  CAS  Google Scholar 

  • Bork K (2010): Rezidivierende Angioödeme mit potenzieller Erstickungsgefahr. Dtsch Ärztebl Int 107: 408–414.

    PubMed  Google Scholar 

  • Brown JP, Prince RL, Deal C, Recker RR, Kiel DP, de Gregorio LH, Hadji P, Hofbauer LC, Alvaro-Gracia JM, Wang H, Austin M, Wagman RB, Newmark R, Libanati C, San Martin J, Bone HG (2009): Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res 24: 153–161.

    Article  PubMed  CAS  Google Scholar 

  • Brune M, Castaigne S, Catalano J, Gehlsen K, Ho AD, Hofmann WK, Hogge DE, Nilsson B, Or R, Romero AI, Rowe JM, Simonsson B, Spearing R, Stadtmauer EA, Szer J, Wallhult E, Hellstrand K (2006): Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial. Blood 108: 88–96.

    Article  PubMed  CAS  Google Scholar 

  • Bukowski RM, Yasothan U, Kirkpatrick P (2010): Pazopanib. Nat Rev Drug Discov 9: 17–18.

    Article  PubMed  CAS  Google Scholar 

  • Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M (2009): Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet 373: 641–648.

    Article  PubMed  CAS  Google Scholar 

  • Buynak R, Shapiro DY, Okamoto A, Van Hove I, Rauschkolb C, Steup A, Lange B, Lange C, Etropolski M (2010): Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study. Expert Opin Pharmacother 11: 1787–1804.

    Article  PubMed  CAS  Google Scholar 

  • Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2–124 and M2–125 study groups (2009): Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet 374: 685–694.

    Article  PubMed  CAS  Google Scholar 

  • Camilleri M, Beyens G, Kerstens R, Robinson P, Vandeplassche (2009): Safety assessment of prucalopride in elderly patients with constipation: a double-blind, placebocontrolled study. Neurogastroenterol Motil 21: 1256-e117.

    Article  PubMed  CAS  Google Scholar 

  • Camilleri M, Kerstens R, Rykx A, Vandeplassche L (2008): A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med 358: 2344–2354.

    Article  PubMed  CAS  Google Scholar 

  • Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernandez Fernandez E; on behalf of the European Silodosin Study Group (2010): Silodosin Therapy for Lower Urinary Tract Symptoms in Men with Suspected Benign Prostatic Hyperplasia: Results of an International, Randomized, Double-Blind, Placebo- and Active-Controlled Clinical Trial Performed in Europe. Eur Urol. 2010 Nov 10. [Epub ahead of print].

    Google Scholar 

  • Chen ZM, Pan HC, Chen YP, Peto R, Collins R, Jiang LX, Xie JX, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group (2005): Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 366: 1622–1632.

    Article  PubMed  CAS  Google Scholar 

  • Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB (2011): Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet 377: 393–402.

    Article  PubMed  CAS  Google Scholar 

  • Clark PE (2010): Rationale for targeted therapies and potential role of pazopanib in advanced renal cell carcinoma. Biologics 4: 187–197.

    PubMed  CAS  Google Scholar 

  • Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Flensburg M, Petersen J, Robak T (2008): Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1–2 study. Blood 111: 1094–1100.

    Article  PubMed  CAS  Google Scholar 

  • COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group (2005): Addition of clopidogrel to aspirin in 45852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 366: 1607–1621.

    Article  CAS  Google Scholar 

  • Cox TM (2010): Gaucher disease: clinical profile and therapeutic developments. Biologics 4: 299–313.

    PubMed  CAS  Google Scholar 

  • Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial (2009): Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 361: 756–765.

    Article  PubMed  CAS  Google Scholar 

  • Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators (2010): Efficacy of a new oncedaily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 65: 473–479.

    Article  PubMed  Google Scholar 

  • Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators (2009): A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod 24: 3063–3072.

    Article  PubMed  CAS  Google Scholar 

  • Dighiero G, Hamblin TJ (2008): Chronic lymphocytic leukaemia. Lancet 371: 1017–1029.

    Article  PubMed  CAS  Google Scholar 

  • Dobrev D, Nattel S (2010): New antiarrhythmic drugs for treatment of atrial fibrillation. Lancet 375: 1212–1223.

    Article  PubMed  CAS  Google Scholar 

  • Elion GB, Callahan S, Nathan H, Bieber S, Rundles RW, Hitchings GH (1963): Potentiation by inhibition of drug degradation: 6-substituted purines and xanthine oxidase. Biochem Pharmac 12: 85–93.

    Article  CAS  Google Scholar 

  • Esposito S, Tansey S, Thompson A, Razmpour A, Liang J, Jones JR, Ferrera G, Maida A, Bona G, Sabatini C, Pugni L, Emini EA, Gruber WC, Scott DA, Principil N (2010): Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine compared to 7-valent pneumococcal conjugate vaccine given as a 3-dose series with routine vaccines in healthy infants and toddlers. Clin Vaccine Immunol 17: 1017–1026.

    Article  PubMed  CAS  Google Scholar 

  • Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, Christiansen C, Delmas PD, Zanchetta JR, Stakkestad J, Gluer CC, Krueger K, Cohen FJ, Eckert S, Ensrud KE, Avioli LV, Lips P, Cummings SR (1999): Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282: 637–645.

    Article  PubMed  CAS  Google Scholar 

  • European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery, Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH (2010): Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 31: 2369–2429.

    Article  PubMed  Google Scholar 

  • European Medicines Agency (2006): Questions and answers on recommendation for refusal of marketing application for Zelnorm. Internet: www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/000621/WC500017528.pdf

  • European Medicines Agency (2008): CHMP Assessment Report for Adenuric. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000777/WC500021815.pdf

  • European Medicines Agency (2010a): CHMP Assessment Report Firdapse. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001032/WC500069918.pdf

  • European Medicines Agency (2010b): CHMP Assessment Report Sycrest. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001177/WC500096898.pdf

  • European Medicines Agency (2010c): CHMP Assessment Report Ceplene. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000796/WC500023115.pdf

  • European Medicines Agency (2010d): CHMP Assessment Report Votrient. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001141/WC500094275.pdf

  • European Medicines Agency (2010e): CHMP Assessment Report Prevenar 13. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/001104/WC500057248.pdf

  • European Medicines Agency (2010f): CHMP Assessment Report Daxas. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001179/WC500095213.pdf

  • European Medicines Agency (2010g): Assessment Report for Vpriv. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001249/WC500096489.pdf

  • European Medicines Agency (2010h): Assessment Report for Brinavess. Internet: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001215/WC500097150.pdf

  • European Medicines Agency (2011): European Medicines Agency reviews cardiovascular risk of Multaq. Ongoing benefit-risk assessment broadened. Press release 11 July 2011. Internet: www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/07/WC500108650.pdf

  • Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2–127 and M2–128 study groups (2009): Roflumilast in moderate-tosevere chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet 374: 695–703.

    Article  PubMed  CAS  Google Scholar 

  • Fauser BC, Mannaerts BM, Devroey P, Leader A, Boime I, Baird DT (2009); Advances in recombinant DNA technology: corifollitropin alfa, a hybrid molecule with sustained follicle-stimulating activity and reduced injection frequency. Hum Reprod Update 15: 309–321.

    Article  PubMed  CAS  Google Scholar 

  • Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INLIGHT 1 study group (2010): Efficacy and safety of indacaterol 150 microg oncedaily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med 10: 11.

    Article  PubMed  CAS  Google Scholar 

  • Ferrari-Lacraz S, Ferrari S (2010): Do RANKL inhibitors (denosumab) affect inflammation and immunity? Osteoporos Int 2010 Jun 23. [Epub ahead of print].

    Google Scholar 

  • Food and Drug Administration (2000): FDA Talk Paper: Janssen Pharmaceutica stops marketing cisapride in the US. Internet: www.fda.gov/ohrms/dockets/ac/00/backgrd/3634b1a_tab4a.htm

  • Food and Drug Administration (2007): FDA announces discontinued marketing of GI drug, Zelnorm, for safety reasons. Internet: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108879.htm

  • Frampton JE (2009): Prucalopride. Drugs 69: 2463–2476.

    Article  PubMed  CAS  Google Scholar 

  • Fricke U (2000): Arzneimittelinnovationen – Neue Wirkstoffe: 1978–1999. Eine Bestandsaufnahme. In: Klauber J, Schroder H, Selke GW (Hrsg): Innovation im Arzneimittelmarkt, Springer-Verlag, Berlin-Heidelberg-New York, pp. 85–97.

    Chapter  Google Scholar 

  • Fricke U (2011): Neue Arzneimittel 2010. Pluspunkt Nr. 1 Februar 2011. Kassenärztliche Vereinigung Westfalen-Lippe, pp. 15–18.

    Google Scholar 

  • Frye MA (2011): Clinical practice. Bipolar disorder – a focus on depression. N Engl J Med 364:51–59.

    Article  PubMed  CAS  Google Scholar 

  • Global Initiative for Chronic Obstructive Lung Disease (GOLD) (2009): Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease (update 2009). http://www.goldcopd.org.

  • Grunenthal Pharma (2010): Expertos proponen tapentadol como representante de la nueva clase farmacologica MOR-NRI. Internet: www.grunenthal.es/cms/cda/_common/inc/display_file.jsp?fileID=144100129

  • Hair PI, McCormack PL, Keating GM (2008): Febuxostat. Drugs 68: 1865–1874.

    Article  PubMed  CAS  Google Scholar 

  • Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grunhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jager U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Buhler A, Winkler D, Zenz T, Bottcher S, Ritgen M, Mendila M, Kneba M, Dohner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group (2010): Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet 376: 1164–1174.

    Article  PubMed  CAS  Google Scholar 

  • Hansel TT, Barnes PJ (2009): New drugs for exacerbations of chronic obstructive pulmonary disease. Lancet 374: 744–755.

    Article  PubMed  CAS  Google Scholar 

  • Hirt MN, Eschenhagen T (2010): Vernakalant: Ein neues Antiarrhythmikum zur Akutbehandlung von Vorhofflimmern. Dtsch Med Wochenschr 135: 971–976.

    Article  PubMed  CAS  Google Scholar 

  • Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C, Connolly SJ; ATHENA Investigators (2010): Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 360: 668–678.

    Article  Google Scholar 

  • Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM (2009): A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis J 28: 86–91.

    Article  PubMed  Google Scholar 

  • Jeys LM, Grimer RJ, Carter SR, Tillman RM, Abudu A (2007): Post operative infection and increased survival in osteosarcoma patients: are they associated? Ann Surg Oncol 14: 2887–2895.

    Article  PubMed  CAS  Google Scholar 

  • Kager L, Pötschger U, Bielack S 2010): Review of mifamurtide in the treatment of patients with osteosarcoma. Ther Clin Risk Manag 6: 279–286.

    Article  PubMed  CAS  Google Scholar 

  • Kassenärztliche Bundesvereinigung (2009): Bekanntmachungen: Rahmenvorgaben nach § 84 Absatz 7 SGB V – Arzneimittel – für das Jahr 2010 vom 30. September 2009. Dtsch Ärztebl 106: A 2271-A 2275.

    Google Scholar 

  • Kassenärztliche Bundesvereinigung (2011): Verordnungsfahigkeit von Resolor®. Informationen an die Pharmakotherapieberater der KVen vom 11. Februar 2011.

    Google Scholar 

  • Kawabe K, Yoshida M, Homma Y; Silodosin Clinical Study Group (2006): Silodosin, a new alpha1A-adrenoceptor-selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo-controlled, double-blind study in Japanese men. BJU Int 98: 1019–1024.

    Article  PubMed  CAS  Google Scholar 

  • Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG (2010): Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res 25: 72–81.

    Article  PubMed  CAS  Google Scholar 

  • Keogh M, Sedehizadeh S, Maddison P (2011): Treatment for Lambert-Eaton myasthenic syndrome. Cochrane Database Syst Rev. 2011 Feb 16; 2: CD003279.

    PubMed  Google Scholar 

  • Khosla S (2009): Increasing options for the treatment of osteoporosis. N Engl J Med 361: 818–820.

    Article  PubMed  CAS  Google Scholar 

  • Kieninger DM, Kueper K, Steul K, Juergens C, Ahlers N, Baker S, Jansen KU, Devlin C, Gruber WC, Emini EA, Scott DA; 006 study group (2010: Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine 28: 4192–4203.

    Article  PubMed  CAS  Google Scholar 

  • Køber L, Torp-Pedersen C, McMurray JJ, Gøtzsche O, Lévy S, Crijns H, Amlie J, Carlsen J; Dronedarone Study Group (2008): Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med 358: 2678–2687.

    Article  PubMed  Google Scholar 

  • Kornmann O, Dahl R, Centanni S, Dogra A, Owen R, Lassen C, Kramer B; INLIGHT-2 (Indacaterol Efficacy Evaluation Using 150-μg Doses with COPD Patients) study investigators (2011): Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J 37: 273–279.

    Article  PubMed  CAS  Google Scholar 

  • Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators (2009): Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol 2: 652–659.

    Article  PubMed  Google Scholar 

  • Kress HG (2010): Tapentadol and its two mechanisms of action: is there a new pharmacological class of centrally-acting analgesics on the horizon? Eur J Pain 14: 781–783.

    Article  PubMed  CAS  Google Scholar 

  • Kuna P, Bachert C, Nowacki Z, van Cauwenberge P, Agache I, Fouquert L, Roger A, Sologuren A, Valiente R; Bilastine International Working Group (2009): Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy 39: 1338–1347.

    Article  PubMed  CAS  Google Scholar 

  • Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM (2010): A shortterm, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol 21: 597–605.

    Article  PubMed  Google Scholar 

  • Lewiecki EM (2010): Treatment of osteoporosis with denosumab. Maturitas 66: 182–186.

    Article  PubMed  CAS  Google Scholar 

  • Lussier D, Huskey AG, Portenoy RK (2004): Adjuvant analgesics in cancer pain management. Oncologist 9: 571–591.

    Article  PubMed  CAS  Google Scholar 

  • Macklon NS, Stouffer RL, Giudice LC, Fauser BC (2006): The science behind 25 years of ovarian stimulation for in vitro fertilization. Endocr Rev 27: 170–207.

    Article  PubMed  Google Scholar 

  • Maddison P, Newsom-Davis J (2005): Treatment for Lambert-Eaton myasthenic syndrome. Cochrane Database Syst Rev 2005 Apr 18; (2): CD003279.

    PubMed  Google Scholar 

  • McCormack PL (2010): Dienogest: a review of its use in the treatment of endometriosis. Drugs 70: 2073–2088.

    Article  PubMed  CAS  Google Scholar 

  • McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, Peacock M, Miller PD, Lederman SN, Chesnut CH, Lain D, Kivitz AJ, Holloway DL, Zhang C, Peterson MC, Bekker PJ; AMG 162 Bone Loss Study Group (2006): Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 354: 821–831.

    Article  PubMed  CAS  Google Scholar 

  • McEvoy KM, Windebank AJ, Daube JR, Low PA (1989): 3,4-Diaminopyridine in the treatment of the Lambert-Eaton myasthenic syndrome. N Engl J Med 321: 1567–1571.

    Article  PubMed  CAS  Google Scholar 

  • McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J (2009): A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord 11: 673–686.

    Article  PubMed  CAS  Google Scholar 

  • McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J (2010): Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord 12: 27–38.

    Article  CAS  Google Scholar 

  • Meyers PA, Schwartz CL, Krailo M, Kleinerman ES, Betcher D, Bernstein ML, Conrad E, Ferguson W, Gebhardt M, Goorin AM, Harris MB, Healey J, Huvos A, Link M, Montebello J, Nadel H, Nieder M, Sato J, Siegal G, Weiner M, Wells R, Wold L, Womer R, Grier H (2005): Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. J Clin Oncol 23: 2004–2011.

    Article  PubMed  CAS  Google Scholar 

  • Meyers PA, Schwartz CL, Krailo MD, Healey JH, Bernstein ML, Betcher D, Ferguson WS, Gebhardt MC, Goorin AM, Harris M, Kleinerman E, Link MP, Nadel H, Nieder M, Siegal GP, Weiner MA, Wells RJ, Womer RB, Grier HE; Children’s Oncology Group (2008): Osteosarcoma: the addition of muramyl tripeptide to chemotherapy improves overall survival–a report from the Children’s Oncology Group. J Clin Oncol 26: 633–638.

    Article  PubMed  CAS  Google Scholar 

  • Moen MD (2010): Telmisartan/amlodipine: single-pill combination in hypertension. Am J Cardiovasc Drugs 10: 401–412.

    Article  PubMed  CAS  Google Scholar 

  • Morgan BP (2010): Hereditary angioedema–therapies old and new. N Engl J Med 363: 581–583.

    Article  PubMed  CAS  Google Scholar 

  • Morgia G (2010): Does the Use of Silodosin to Treat Benign Prostatic Hyperplasia Really Offer Something New? Eur Urol. 2010 Nov 24. [Epub ahead of print].

    Google Scholar 

  • Munos B (2009): Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov 8: 959–968.

    Article  PubMed  CAS  Google Scholar 

  • Nelson R (2006): Postconsolidation immunotherapy in leukaemia remission. Lancet Oncol 7: 367.

    Article  PubMed  Google Scholar 

  • Niederau C, Rolfs A, vom Dahl S, Haussinger D, Poll LW, Mengel E, Beck M (2001): Diagnose und Therapie des Morbus Gaucher. Aktuelle Empfehlungen der deutschen Therapiezentren im Jahr 2000. Med Klin 96: 32–39.

    Article  CAS  Google Scholar 

  • N. N: (2011): Netzwerk aktuell. Allergie gegen Indacaterol (Onbrez Breezhaler). Arznei-Telegramm 6/11, Seite 56.

    Google Scholar 

  • Nurden AT, Viallard JF, Nurden P (2009): New-generation drugs that stimulate platelet production in chronic immune thrombocytopenic purpura. Lancet 373: 1562–1569.

    Article  PubMed  CAS  Google Scholar 

  • Pletz MW, Maus U, Hohlfeld JM, Lode H, Welte T(2008): Pneumokokkenimpfung: Konjugatimpfstoff induziert Herdenimmunitat und reduziert Antibiotikaresistenz. Dtsch Med Wochenschr 133: 358–362.

    Article  PubMed  CAS  Google Scholar 

  • Pratt CM, Roy D, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Retyk E, Drenning DH; Atrial Arrhythmia Conversion Trial (ACT-III) Investigators (2010): Usefulness of vernakalant hydrochloride injection for rapid conversion of atrial fibrillation. Am J Cardiol 106: 1277–1283.

    Article  PubMed  CAS  Google Scholar 

  • Ossipov MH, Malseed RT, Goldstein FJ (1982): Augmentation of central and peripheral morphine analgesia by desipramine. Arch Int Pharmacodyn Ther 259: 222–229.

    PubMed  CAS  Google Scholar 

  • Quigley EM, Vandeplassche L, Kerstens R, Ausma J (2009): Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation–a 12-week, randomized, double-blind, placebo-controlled study. Aliment Pharmacol Ther 29: 315–328.

    Article  PubMed  CAS  Google Scholar 

  • Rauschkolb C, Lange B, Etropolski M, Lange R, Steup A, Ashworth J (2010): Efficacy of tapentadol prolonged release (PR) for the management of chronic nociceptive and neuropathic pain in phase 3 studies. Ann Rheum Dis 69 (Suppl 3): 288 (abstract).

    Google Scholar 

  • Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM (2009): Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol 16: 1810–1815.

    Article  PubMed  CAS  Google Scholar 

  • Richette P, Bardin T (2010): Gout. Lancet 375: 318–328.

    Article  PubMed  CAS  Google Scholar 

  • Rini BI, Campbell SC, Escudier B (2009): Renal cell carcinoma. Lancet 373: 1119–1132.

    Article  PubMed  CAS  Google Scholar 

  • Robak T, Dmoszynska A, Solal-Céligny P, Warzocha K, Loscertales J, Catalano J, Afanasiev BV, Larratt L, Geisler CH, Montillo M, Zyuzgin I, Ganly PS, Dartigeas C, Rosta A, Maurer J, Mendila M, Saville MW, Valente N, Wenger MK, Moiseev SI (2010): Rituximab plus fludarabine and cyclophosphamide prolongs progressionfree survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol 28: 1756–1765.

    Article  PubMed  CAS  Google Scholar 

  • Robert-Koch-Institut (2009): Zur Situation bei ausgewählten Infektionskrankheiten in Deutschland: Invasive Meningokokken-Erkrankungen im Jahr 2008. Epidemiologisches Bulletin 45: 463–470.

    Google Scholar 

  • Robert Koch-Institut und Gesellschaft der epidemiologischen Krebsregister in Deutschland (Hrsg) (2010): Krebs in Deutschland 2005/2006. Häufigkeiten und Trends. 7. Ausgabe. (Internet: www.rki.de/cln_160/nn_204124/DE/Content/GBE/Gesundheitsberichterstattung/GBEDownloadsB/KID2010,templateId=raw,property=publicationFile.pdf/KID2010.pdf

  • Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group (2010): The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol 57: 123–131.

    Article  PubMed  Google Scholar 

  • Roy D, Pratt CM, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Nielsen T, Rasmussen SL, Stiell IG, Coutu B, Ip JH, Pritchett EL, Camm AJ; Atrial Arrhythmia Conversion Trial Investigators (2008): Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial. Circulation 117: 1518–1525.

    Article  PubMed  CAS  Google Scholar 

  • Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendón JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITYTIMI 28 Investigators (2005): Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med 352: 1179–1189.

    Article  PubMed  CAS  Google Scholar 

  • Sanders DB, Massey JM, Sanders LL, Edwards LJ (2000): A randomized trial of 3,4-diaminopyridine in Lambert-Eaton myasthenic syndrome. Neurology 54: 603–607.

    PubMed  CAS  Google Scholar 

  • Sanford M (2010): Roflumilast: in chronic obstructive pulmonary disease. Drugs 70: 1615–1627.

    Article  PubMed  CAS  Google Scholar 

  • Sanford M, McCormack PL (2010): Ofatumumab. Drugs 70: 1013–1019.

    Article  PubMed  CAS  Google Scholar 

  • Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N (2008): Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum 59: 1540–1548.

    Article  PubMed  CAS  Google Scholar 

  • Scott LJ, Perry CM (2000): Tramadol: a review of its use in perioperative pain. Drugs 60: 139–176.

    Article  PubMed  CAS  Google Scholar 

  • Silverman SL, Christiansen C, Genant HK, Vukicevic S, Zanchetta JR, de Villiers TJ, Constantine GD, Chines AA (2008): Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res 23: 1923–1934.

    Article  PubMed  CAS  Google Scholar 

  • Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH; EURIDIS and ADONIS Investigators (2007): Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 357: 987–999.

    Article  PubMed  CAS  Google Scholar 

  • Smith MR, Egerdie B, Hernandez Toriz N, Feldman R, Tammela TL, Saad F, Heracek J, Szwedowski M, Ke C, Kupic A, Leder BZ, Goessl C; Denosumab HALT Prostate Cancer Study Group (2009): Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med 361: 745–755.

    Article  PubMed  CAS  Google Scholar 

  • Ständige Impfkommission am Robert-Koch-Institut (2009): Mitteilung der STIKO zur Impfung gegen invasive Pneumokokken-Infektionen bei Kindern unter 24 Monaten, bei denen die Impfserie mit dem konjugierten 7-valenten Impfstoff begonnen wurde. Epidemiologisches Bulletin Nr. 49, Seite 507.

    Google Scholar 

  • Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE (2010): Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 28: 1061–1068.

    Article  PubMed  CAS  Google Scholar 

  • Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A (2010): Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol 28: 5132–5139.

    Article  PubMed  CAS  Google Scholar 

  • Tack J, van Outryve M, Beyens G, Kerstens R, Vandeplassche L (2009): Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives. Gut 58: 357–365.

    Article  PubMed  CAS  Google Scholar 

  • The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators (2001): Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without st-segment elevation. N Engl J Med 345: 494–502.

    Article  Google Scholar 

  • The corifollitropin alfa Ensure study group (2010): Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women. Reprod Biomed Online 21: 66–76.

    Article  CAS  Google Scholar 

  • The Institute for Safe Medication Practices (2010): QuarterWatch: 2010 Quarter 1. Monitoring MedWatch Reports, November 4, 2010. Signals for acetaminophen, dronedarone and botulinum toxin products. Internet: http://freepdfhosting.com/078147c86d.pdf

  • Thorpe A, Neal D (2003): Benign prostatic hyperplasia. Lancet 361: 1359–1367.

    Article  PubMed  CAS  Google Scholar 

  • Van Der Poll T, Opal SM (2009): Pathogenesis, treatment, and prevention of pneumococcal pneumonia. Lancet 374: 1543–1556.

    Article  PubMed  CAS  Google Scholar 

  • Vestergaard P, Thomsen SV (2009): Treating postmenopausal osteoporosis in women at increased risk of fracture – critical appraisal of bazedoxifene: a review. Int J Womens Health 1: 97–103.

    Article  CAS  Google Scholar 

  • Vogelmeier C, Buhl R, Criée CP, Gillissen A, Kardos P, Köhler D, Magnussen H, Morr H, Nowak D, Pfeiffer-Kascha D, Petro W, Rabe K, Schultz K, Sitter H, Teschler H, Welte T, Wettengel R, Worth H (2007): Leitlinie der Deutschen Atemwegsliga und der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin zur Diagnostik und Therapie von Patienten mit chronisch obstruktiver Bronchitis und Lungenemphysem (COPD). Pneumologie 61: 323–340 (Teil 1); 394–409 (Teil 2).

    Google Scholar 

  • Walker EP (2010): Panel votes against new PDE4 inhibitor for COPD. MedPage Today. Internet: www.medpagetoday.com/tbprint.cfm?tbid=19448

  • Weber J, McCormack PL (2009): Asenapine. CNS Drugs 23: 781–792.

    Article  PubMed  CAS  Google Scholar 

  • Wierda WG, Kipps TJ, Mayer J, Stilgenbauer S, Williams CD, Hellmann A, Robak T, Fürman RR, Hillmen P, Trneny M, Dyer MJ, Padmanabhan S, Piotrowska M, Kozak T, Chan G, Davis R, Losic N, Wilms J, Russell CA, Osterborg A; Hx-CD20–406 Study Investigators (2010): Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 28: 1749–1755.

    Article  PubMed  CAS  Google Scholar 

  • Yildiz A, Vieta E, Leucht S, Baldessarini RJ (2011): Efficacy of antimanic treatments: meta-analysis of randomized, controlled trials. Neuropsychopharmacology 36: 375–389.

    Article  PubMed  CAS  Google Scholar 

  • Zhang W, Doherty M, Bardin T, Pascual E, Barskova V, Conaghan P, Gerster J, Jacobs J, Leeb B, Liote F, McCarthy G, Netter P, Nuki G, Perez-Ruiz F, Pignone A, Pimentao J, Punzi L, Roddy E, Uhlig T, Zimmermann-Gorska I; EULAR Standing Committee for International Clinical Studies Including Therapeutics (2006b): EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 65: 1312–1324.

    Article  CAS  Google Scholar 

  • Zimran A, Loveday K, Fratazzi C, Elstein D (2007): A pharmacokinetic analysis of a novel enzyme replacement therapy with Gene-Activated human glucocerebrosidase (GAGCB) in patients with type 1 Gaucher disease. Blood Cells Mol Dis 39: 115–118.

    Article  PubMed  CAS  Google Scholar 

  • Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antepara I, Jauregui I, Valiente R; Bilastine International Working Group (2010): Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 65: 516–528.

    Article  PubMed  CAS  Google Scholar 

  • Zuraw B, Cicardi M, Levy RJ, Nuijens JH, Relan A, Visscher S, Haase G, Kaufman L, Hack CE (2010): Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol 126: 821–827.

    Article  PubMed  CAS  Google Scholar 

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  1. Institut für Pharmakologie, Universität zu Köln, Gleueler Straße 24, 50924, Köln

    Prof. Dr. rer. nat. Uwe Fricke

  2. Pharmakologisches Institut, Universität Heidelberg, Im Neuenheimer Feld 366, 69120, Heidelberg

    Prof. Dr. med. Ulrich Schwabe

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    Ulrich Schwabe

  2. AOK NORDWEST, Die Gesundheitskasse, Edisonstraße 70, 24145, Kiel

    Dieter Paffrath

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Fricke, U., Schwabe, U. (2011). Neue Arzneimittel 2010. In: Schwabe, U., Paffrath, D. (eds) Arzneiverordnungs-Report 2011. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-21992-4_2

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