Marketingový výzkum kombinovaných léčivých přípravků pro léčbu kardiovaskulárních onemocnění

Stáhnout PDF English version

Autoři: Nataliia S. Behei; Oksana V. Tryhubchak
Vyšlo v časopise: Čes. slov. Farm., 2023; 72, 79-94
Kategorie: Původní článek
doi: https://doi.org/https://doi.org/10.5817/CSF2023-2-79

Souhrn

Práce je věnována výsledkům komplexního marketingového výzkumu všech kombinovaných kardiovaskulárních léčivých přípravků. Byl analyzován trh s kombinovanými léčivými přípravky ze skupiny C podle ATC klasifikace ve 41 zemích světa v letech 2019–2022. Analyzovány byly segmentové trhy 27 zemí Evropské unie, Albánie, Běloruska, Bosny a Heregoviny, Kanady, Kolumbie, Velké Británie, Indie, Moldavska, Norska, Ruské federace, Švýcarska a Ukrajiny. Byl také sledován farmaceutický trh Austrálie a Spojených států amerických. Byla charakterizována struktura této skupiny léčivých přípravků a byly identifikovány nejběžnější kombinace na analyzovaných trzích. Bylo zjištěno, že skupina C09 je nejvíce naplněna kombinovanými léčivými přípravky a počet kombinací je nejrozmanitější ve skupinách C09 léčivé přípravky působící na renin-angiotenzinový systém, C10 hypolipidemika, C07 betablokátory a C03 diuretika, která jsou léky první volby u arteriální hypertenze a ischemické choroby srdeční. Existují dvě perspektivní oblasti pro rozšíření nabídky léčivých přípravků ovlivňujících kardiovaskulární systém.

Klíčová slova:

arteriální hypertenze – kardiovaskulární onemocnění – léčivé přípravky – kombinované kardiovaskulární – marketingový výzkum – směry rozšiřování sortimentu

Zdroje

1. Islam S. M. S., Purnat T. D., Phuong N. T. A., Mwingira U., Schacht K., Fröschl G. Non‐Communicable Diseases (NCDs). In developing countries: a symposium report. Glob. Health 2014; 10(1), 1–8.

2. van Camp G. Cardiovascular disease prevention. Acta Clinica Belgica: Cardiovascular disease prevention. Acta Clin. Belg: JCLA 2014; 69, 407–411.

3. Kjeldsen S. E. Hypertension and cardiovascular risk: General aspects. Pharmacol. Res. 2018; 129, 95–99.

4. Mancia G., de Backer G., Dominiczak A. ESH-ESC practice guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC). J. Hypertens. 2007; 25, 1751–1762.

5. James P. A., Oparil S., Carter B. L., Cushman W. C., Dennison-Himmelfarb C., Handler J., Lackland D. T., LeFevre M., MacKenzie T. D.,Ogedegbe O., Smith S. C., Svetkey L. P., Taler S. J., Townsend R. R., Wright J. T., Narva A. S., Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults. JAMA 2014; 311(5), 507–520.

6. Williams B., Mancia G., Spiering W., Agabiti Rosei E., Azizi M., Burnier M., Clement D. L., Coca A., Simone G., Dominiczak A., Kahan Th., Mahfoud F., Redon J., Ruilope L., Zanchetti A., Kerins M., Kjeldsen S. E., Kreutz r., Leurent S., Lip G. Y. H., McManus R., Narkiewicz K., Ruschitzka F., Schmieder R. E., Shlyakhto E., Tsioufis C., Aboyans V., Desormais I. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). Eur. Heart J. 2018; 39(33), 3021–3104.

7. Wright J. M., Musini V. M., Gill R. First‐line drugs for hypertension. CDSR 2018; 4(4), CD001841.

8. Hermida R. C., Ayala D. E., Fernández J. R., Portaluppi F., Fabbian F., Smolensky M. H. Circadian rhythms in blood pressure regulation and optimization of hypertension treatment with ACE inhibitor and ARB medications. AJH 2011; 24(4), 383–391.

9. Austrian Federal Office for Safety in Health Care. Austrian Medicines and Medical Devices Agency: Austrian medicinal product index; 2020. Available from: https://aspregister.basg.gv.at/aspregister/faces/aspregister. jspx?_afrLoop=3064459845228608&_afrWindow-Mode=0&_adf.ctrl-state=15s1umdsu_4 (last accessed 25.04.2020).

10. Agjencia Kombëtere e Bornave dhe Pajisjeve Mjekësore (AKBPM): Regjistri i barnave; 2020. Available from: http://www.akbpm.gov.al (last accessed 12.04.2020).

11. Federal agency for medicines and health products: Medicinal Product Database. Medicinal Products; 2021. Available from: https://banquededonneesmedicaments. fagg-afmps.be/#/query/human/ (last accessed 17.01.2021).

12. Ministry of health of the republic of Belarus. “Center for examinations and tests in health service”. Republican unitary enterprise: Registers of the Unitary Enterprise “Center for Expertise and Testing in Healthcare”; 2021. Available from: https://www.rceth.by/Refbank/reestr_lekarstvennih_sredstvї (last accessed 03.08.2021).

13. Bulgarian Drug Agency (BDA): Registration of medicinal products; 2019. Available from: https://ma.bda.bg/ial_register/Sites/PublicRegister/Default.aspx (last accessed 20.10.2019).

14. Bosna i Hercegovina. Agencija za lijekove I medicinska sredstva: Spisak Lijekova; 2022. Available from: http://lijekovi.almbih.gov.ba:8090/SpisakLijekova.aspx (last accessed 12.02.2022).

15. Danish Medicines Agency: Search results; 2022. Available from: https://laegemiddelstyrelsen.dk (last accessed 05.10.2022).

16. Electronic medical compendium (emc): Search results; 2022. Available from: https://www.medicines.org.uk/emc/browse-medicines (last accessed 25.05.2022).

17. EMC: Search results; 2022. Available from: https://www.medicines.org.uk (last accessed 05.10.2022).

18. EOF: medicinal product search; 2022. Available from: http://www.eof.gr/web/guest/search (last accessed 25.05.2021).

19. Finnish Medicines Agency Fimea: Search for a Medicine; 2022. Available from: https://www.fimea.fi (last accessed 05.10.2022).

20. Le Figaro fr sante: Search for a Medicine; 2022. Available from: https://sante.lefigaro.fr (last accessed 05.10.2022).

21. RX.ee. Еesti meditsiini portaal: ATC Kood; 2022. Available from: https://rx.ee/a (last accessed 25.05.2021).

22. Health Products Regulatory Authority (HPRA): Search for a Medicine; 2022. Available from: http://www.hpra.ie/homepage/medicines/medicines-information/find--a-medicine/results?showadv=true&list=HM (last accessed 05.04.2021).

23. Medline India: Pharmacological Index. Cardiovascular System; 2021. Available from: http://www.medlineindia.com/index.htm (last accessed 13.12.2021).

24. Medicine Online Information Center of AEMPS – CIMA. Agencia Española de Medicamentos y Productos Sanitarios: Browser medicines; 2020. Available from: https://cima.aemps.es/cima/publico/buscadoravanzado.html (last accessed 10.03.2020).

25. Torrinomedica: Farmaci. Codice ATC; 2021. Available from: https://www.torrinomedica.it (last accessed 12.12.2021).

26. Gaverment of Canada: Drug Product Database; 2022. Available from: https://health-products.canada.ca/dpd--bdpp/index-eng.jsp (last accessed 23.01.2021).

27. GOV.CO. Portal Único del Estado Colombiano: Oficina Virtual Invima; 2021. Available from: https://www.invima.gov.co/component/content/article/213-tramites-y-servicios/consultas-registros-y-documentos-asociados/806-listado-codigo-unico-de-medicamentos.html (last accessed 10.10.2021).

28. Republic of Cyprus – Pharmaceutical Services, Ministry of Health: Medicines search; 2022. Available from: https://www.phs.moh.gov.cy (last accessed 05.10.2022).

29. State Agency of Medicines of the Republic of Latvia: Medicinal Product Register of Latvia; 2021. Available from: https://www.zva.gov.lv/zvais/zalu-registrs/?lang= -en (last accessed 20.10.2021).

30. Ministry of Health of The Republic of Lithuania: Medicines search; 2021. Available from: https://vapris.vvkt.lt/vvkt-web/public/medications?lang=en (last accessed 15.10.2021).

31. CNS. Le Gouvernement du Grand-Duché de Luxembourg: Liste des médicaments commercialisés.Triée par code ATC; 2021. Available from: https://cns.public.lu/fr/legislations/textes-coordonnes/liste-positive.html (last accessed 06.11.2021).

32. Malta Medicine Authority: National Medecines; 2020. Available from: http://www.medicinesauthority.gov.mt/advanced-search (last accessed 10.09.2020).

33. AMED: Clasificator medicamente; 2021. Available from: http://www.amed.md/ro/clasificator-medicamente (last accessed 14.07.2021).

34. Medicines Evaluation Board: Medicines Information Bank; 2020. Available from: https://www.geneesmiddeleninformatiebank.nl/ords/f?p=111:1:0:::RP,1:P0_DOMAIN, P0_LANG:H,EN (last accessed 25.09.2020).

35. BCFi: Repertoriun; 2020. Available from: http://www.bcfi.be/nl/start (Last accessed 02.11.2021).

36. Rote Liste: Arzneimittelinformationen für Deutschland; 2021. Available from: https://www.rote-liste.de (last accessed 18.11.2021).

37. States legemiddelverk: Legemiddelsøk; 2022. Available from: https://www.legemiddelsok.no/sider/default.aspx?searchquery=&f=Han;MtI;Vir;ATC;Var;for;Mar;-Mid;Avr;gen;par;&pane=0 (last accessed 10.03.2022).

38. Informed: Medicines database; 2021. Available from: http://app7.infarmed.pt/infomed/pesquisa.php (last accessed 23.07.2021).

39. Centrum e-Zdrowia: Rejestry mediczne; 2021. Available from: https://pub.rejestrymedyczne.csioz.gov.pl (last accessed 24.12.2021).

40. State Register of Medicines: Pharmacotherapeutic group; 2022. Available from: https://grls.rosminzdrav.ru/grls.aspx (last accessed 09.03.2022).

41. Agenția Națională a Medicamentului și a Dispozitivelor Medicale România (ANMDMR) – Nomenclatorul medicamentelor pentru uz uman: Lista medicamen-telor din NOMENCLATOR; 2021. Available from: https://www.anm.ro/nomenclator/medicamente (last accessed 10.11.2021).

42. ADC: Humánne lieky; 2021. Available from: https://www.adc.sk/databazy/humanne-lieky?n=&nai=&cla=&frm=&hol=&sup=&code=&mf=&cat=&dr=&ord=a1 (last accessed 27.06.2021).

43. Republika Slovenija Ministrstvo za zdravje: Centralna baza zdravil; 2021. Available from: http://www.cbz.si/cbz/bazazdr2.nsf/Search/$searchForm?SearchView (last accessed 25.05.2021).

44. U.S. Food & Drug Administration: Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations; 2021. Available from: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm (last accessed 12.12.2021).

45. Ministry of Health of Ukraine: State Register of Medicinal Products of Ukraine; 2022. Available from: http://www.drlz.com.ua (last accessed 25.03.2022).

46. L’Agence nationale de sécurité du médicament (ANSM): Domaine medical. produit de santé; 2021. Available from: https://www.ansm.sante.fr/var/ansm_site/storage/original/application/07789b90857c5c64930a-53ec208907c9 (last accessed 20.09.2021).

47. ALMP: Basa lijekova; 2021. Available from: http://www.almp.hr/en/Lijekovi/Baza-lijekova/#rezultati (last accessed 01.12.2021).

48. Státní ústav pro kontrolu léčiv (SUKL): Databáze léků 2021. Available from: http://www.sukl.cz (last accessed 03.10.2021).

49. Swiss Medic. Swiss Agency for Therapeutic Products: Lists and directories; 2021. Available from: https://www.swissmedic.ch/swissmedic/de/home/services/listen_neu.html#-257211596 (last accessed 10.04.2021).

50. Läkemedelsverket. Swedish Medical Products Agency: Drug; 2021. Available from: https://lakemedelsverket.se/LMF/?q=acetylsalicylsyra (last accessed 12.11.2021).

51. National Institute of Pharmacy and Nutrition - institute of Hungary: Lists and directories 2022. Available from: https://ogyei.gov.hu (last accessed 05.10.2022).

52. Wang J., Xiong X., Feng B. Effect of crataegus usage in cardiovascular disease prevention: an evidence-based approach. Evid. Based Complement. Alternat. Med. 2013; 2013, ID 149363, 16.

53. Domuschiev I. How the Natural Sedatives Hawthorn, Mint and Valerian Affect The Orthostatic Test by Measuring Pulse Rate Variability (PRV) in A 60-Year-Old Man. BJSTR 2021; 35(4), 27941–27942.

54. Cheung M, Parmar M. Reserpine. In: StatPearls. Treasure Island (FL): StatPearls Publishing. http://www.ncbi.nlm.nih.gov/books/NBK557767/ (20.07.2022).

55. Titko T., Perekhoda L., Drapak I., Tsapko Y. Modern trends in diuretics development. Eur. J. Med. Chem. 2020; 208, 112855.

56. Mullens W., Damman K., Harjola V. P., Mebazaa A., Brunner‐La Rocca H. P., Martens P., Testani J. M., Tang W. H. W., Orso F., Rossignol P., Metra M., Filippatos G., Seferovic P. M., Ruschchitzka F., Coats A. J. The use of diuretics in heart failure with congestion–a position statement from the Heart Failure Association of the European Society of Cardiology. EJHF 2019; 21(2), 137–155.

57. Sarkar G., Gaikwad V. B., Sharma A., Halder S. K., Kumar D. A., Anand J., Mehta S. Fixed-dose Combination of Metoprolol, Telmisartan, and Chlorthalidone for Essential Hypertension in Adults with Stable Coronary Artery Disease: Phase III Study. Adv. Ther. 2022; 39(2), 923–942.

58. Hocking K. M., Putumbaka G., Wise E. S., Cheung-Flynn J., Brophy C. M., Komalavilas P. Papaverine prevents vasospasm by regulation of myosin light chain phosphorylation and actin polymerization in human saphenous vein. PloS One 2016; 11(5), e0154460. doi:10.1371/journal.pone.0154460.

59. Hnátek L. Therapeutic potential of micronized purified flavonoid fraction (MPFF) of diosmin and hesperidin in treatment chronic venous disorder. Vnitř. Lek. 2015; 61(9), 807–814.

60. Gerges S. H., Wahdan S. A., Elsherbiny D. A., El-Demerdash E. Pharmacology of diosmin, a citrus flavone glycoside: an updated review. European Journal of Drug Metabolism and Pharmacokinetics 2021; 47(1), 1–18.

61. Pareek A., Karnik N., Salagre S. B., Zawar S. D., Joglekar V. K., Chandurkar N., Naik G. S. Clinical effectiveness of low-dose chlorthalidone (6.25 mg) + atenolol combination in stage I hypertensive patients: a multicenter, randomized, controlled study. CMRO 2008; 24(6), 1771–1779.

62. Gilarevskii S. R., Lantsova E. V., Akimov A. A. Efficacy and Safety of Combined Treament with Ivabradine and Metoprolol in Patients with Stable Angina Pectoris-a Systematic Review. Kardiologiia 2020; 60(11), 1357–1357.

63. Leal U., Rincón D. Comparison of two products containing bisoprolol-hydrochlorothiazide therapeutic equivalence in patients with arterial hypertension. Revista Colombiana de Cardiología 2020; 27(4), 262–269.

64. Regulski M., Regulska K., J Stanisz B., Murias M., Gieremek P., Wzgarda A., Niznik B. Chemistry and pharmacology of Angiotensin-converting enzyme inhibitors. Current Pharmaceutical Design 2015; 21(13), 1764–1775.

65. Taddei S. Combination therapy in hypertension: what are the best options according to clinical pharmacology principles and controlled clinical trial evidence? Am. J. Cardiovasc. 2015; 15(3), 185–194.

66. Reboldi G, Gentile G, Angeli F, Verdecchia P. Choice of ACE inhibitor combinations in hypertensive patients with type 2 diabetes: update after recent clinical trials. Vasc. Health Risk Manag. 2009; 5(1): 411–427. doi: 10.2147/vhrm.s4235. PMID: 19475778; PMCID: PMC2686259.

67. Borghi C., Soldati M., Bragagni A., Cicero A. F. Safety implications of combining ACE inhibitors with thiazides for the treatment of hypertensive patients. Expert Opin. Drug Saf. 2020; 19(12), 1577–1583.

68. Molvanov N. H., Tursunova D. E. Combined Antihypertensive and Hypolipidemic Therapy for Arterial Hypertension Hemodynamic Changes and Lipid Spectrum. IJHMS 2022; 1(1), 57–59.

69. Pappa E., Rizos C. V., Filippatos T. D., Elisaf M. S. Emerging fixed-dose combination treatments for hyperlipidemia. JCPT 2019; 24(4), 315–322.

70. Smith M. C. Principles of pharmaceutical marketing. New York: Routledge 2014.

71. Kim D. W., Weon K. Y. Pharmaceutical application and development of fixed-dose combination: Dosage form review. J. Pharm. Investig. 2021; 51(5), 555–570.

72. Ferrario A., Dedet G., Humbert T., Vogler S., Suleman F., Pedersen H. B. Strategies to achieve fairer prices for generic and biosimilar medicines. BMJ 2020; 368, 5444.

73. Xanthopoulou S. S., Katsaliaki K. Policies and perceptions on generic drugs: The case of Greece. HSMR 2019; 32(1), 49–56.