Farmakoterapija sladkorne bolezni 3pa 2
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1 Farmakoterapija sladkorne bolezni 3pa 2 Andrej Janež Katedra družinske medicine, Ljubljana
2 Izločanje insulina ß-celična funkcija Glukagon Inkretinov Produkcija glukoze v jetrih Jetra GIT Pankreas Maščevje Insulinska rezistenca DM2 Insulinska rezistenca Mišičje
3 Primary sites of action of anti-diabetic agents Glitazones Muscle Metformin DPP-4 Inhibitors Adipose Tissue Liver DPP-4 Pancreas Insulin GLP-1 Glucose Kidney GLP-1 Receptor Agonists Sulfonylurea / Glinides Intestine α-glucosidase Inhibitors 1 Adapted from Krentz A and Bailey C. Drugs 2005;65: ; 2 Ahren B. Expert Opin Emerg Drugs 2008;3: ; 3 Todd JF, et al. Diabet Med 2007;24:223 32; 4 Nattrass M, et al. Baillieres Best Pract Res Clin Endocrinol Metab 1999;13:309 29; 5 Jabbour S and Goldstein B. Int J Clin Pract 2008;62:
4 An3hiperglikemiki Zdravilo Način Od leta Učinkovitost kot monoterapija: % in HBA1c Insulin s.c Sulfonilsečnine peros Glinidi peros Me<ormin peros α-glukozidazni inhibitorji peros TZD peros GLP analogi s.c DPP-IV inhibitorji peros Amylin analogue Colesevelam Bromocriptine mesylate
5 Glibenklamid (Glibenklamid, Daonil) Gliklazid (Diaprel MR) Glikvidon (Glurenorm) Glimepirid (Amaryl) Glipizid (Glucotrol XL) Sulfonilsečnine Glinidi Repaglinid (NovoNorm) Metformin (Glucophage, Aglurab,Siofor) Bigvanidi Inhibitorji α-glukozidaze Akarboza (Glucobay) SGLT-2 inhibitorji Dapagliflozin (Forxiga) DPP-4 inhibitorji Sitagliptin (Januvia) Vildagliptin (Galvus) Saksagliptin (Onglyza) Linagliptin (Trajenta)
6 SGLT-2 inhibitorji Dapagliflozin Canagliflozin Empagliflozin Ipragliflozin
7 Antidiabetična terapija POAD monoterapija Metformin Sulfonilsečnine Glinidi α-glukozidazni-inhibitorji POAD-dvotirna terapija HbA1c>7.0% DPP-4 inhibitorji * Metformin + SU Metformin + DPP-4-inhibitor* SU + DPP-4-inhibitor HbA1c>7.0% POAD -trotirna terapija Metformin + SU+DPP-4-inhib. * Oral Triple HbA1c>7.0% POAD+insulin/+GLP-1 BMI 35! NPH insulin, Glargin, Levemir Eksena3d,, Liraglu3d*
8
9 HbA1c kako nizko naj gremo?
10 Spremljanje urejenos3 sladkorne bolezni Ciljna vrednost HbA1c 7.0% Ker je pri taki vrednos[ tveganje za nastanek ali Napredovanje kroničnih zapletov minimalno Slovenske smernice za klinično obravnavo sladkorne bolezni [pa 2 pri odraslih 2011
11 Spremljanje urejenos3 sladkorne bolezni Ciljna vrednost HbA1c pod 6.5% Če je bolnik zmožen in je tveganje za hipoglikemijo sprejemljivo: Mlajši bolniki brez SŽB Novoodkri[ bolniki Slovenske smernice za klinično obravnavo sladkorne bolezni [pa 2 pri odraslih 2011
12 Spremljanje urejenos3 sladkorne bolezni Ciljna vrednost HbA1c naj ne bo pod 7.0% Pri bolnikih, ki imajo težave s hipoglikemijo Bolniki, ki ne obvladajo samovodenja Bolniki, ki imajo pridružene resnejše bolezni (srčno popuščanje...) Slovenske smernice za klinično obravnavo sladkorne bolezni tipa 2 pri odraslih 2011
13 Bigvanidi Metformin (Glucophage,Aglurab,Siofor)
14 Me<ormin Prednos3 Slabos3 Kombinacija z drugimi zdravili
15 Mecormin- kontraindikacije SPC: preobčutljivost na mecormin ali katero od sestavin zdravila. Diabe[čna ketoacidoza Ledvična odpoved ali popuščanje (klirens krea3nina<60 ml/min). Akutna stanja, ki bi lahko poslabšala ledvično funkcijo: dehidracija, sepsa, šok. Akutno ali kronično obolenje, ki lahko povzroči tkivno hipoksijo: srčna ali dihalna odpoved, nedavni akutni miokardni infarkt, šok. Jetrna insuficienca, akutna zastrupitev z alkoholom, alkoholizem.
16 Mecormin- kontraindikacije SPC: preobčutljivost na mecormin ali katero od sestavin zdravila. Diabe[čna ketoacidoza Ledvična odpoved ali popuščanje (klirens krea3nina<60 ml/min). - Tes[ranje Akutna ledvične stanja, funkcije ki bi lahko (klirens poslabšala krea[nina ledvično po CG funkcijo: enačbi) vsaj dehidracija, 1x letno sepsa, šok. - tes[ranje Akutno ledvične ali kronično funkcije obolenje, vsaj 2x letno ki lahko pri bolnikih povzroči z tkivno ledvično hipoksijo: funkcijo srčna spodnji ali dihalna meji normale in pri odpoved, starejših bolnikih nedavni akutni miokardni infarkt, šok. - Posebno Jetrna pozorno insuficienca, spremljanje akutna ledvične zastrupitev funkcije z alkoholom, pri starejših, alkoholizem. v primeru uvajanja novih zdravil, npr. an[hipertenzivov in NSAID.
17 METFORMIN - PRIPOROČILA ADA/EASD, 2012 Mecormin ukini[ pri ogf pod 30 ml/min/1.73m2 Zniža[ odmerek mecormina ob ogf pod 45 ml/min/1.73m2 AACE, 2011 KDIGO, 2013 Mecormin je kontraindiciran pri KLB 4. in 5. stopnje Z zdravljenjem nadaljujemo, če je GFR nad 45 ml/min/1.73m2 O zdravljenju premislimo, če GFR med 30 in 45 ml/min/1.73m2 Mecormin ukinemo ob GFR pod 30 ml/min/1.73m2 NICE, 2009 NHMRC, AVSTRALIJA, 2009 Preverimo odmerek mecormina, če je krea[nin >1.5 mg/dl ali ogf pod 45 ml/min/1.73m2 Mecormin ukinemo, če je krea[nin >1.7 mg/dl ali ogf pod 30 ml/min/1.73m2 Mecormin kontraindiciran ob ogf pod 30 ml/min/1.73m2 Potrebna previdnost pri uporabi mecormina ob ogf ml/min/ 1.73m2
18 Glibenklamid (Glibenklamid, Daonil) Gliklazid (Diaprel MR) Glikvidon (Glurenorm) Glimepirid (Amaryl) Glipizid (Glucotrol XL) Sulfonilsečnine Glinidi Repaglinid (NovoNorm)
19 Insulinski sekretagogi Prednos3 Slabos3 Kombinacija z drugimi zdravili
20 Zmanjšanje celotne umrljivosti Gliclazide XR 60 Schramm TK et al, Eur Heart J. 2009
21 Hazard ratios (95% CI) for different endpoints in relation to monotherapies with different glucose-lowering agents according to previous myocardial infarction. Schramm T K et al. Eur Heart J 2011;32:
22 Inhibitorji α-glukozidaze Akarboza (Glucobay)
23 Inkre3nska terapija Sekrecija GLP-1 je motena pri DM2 Endogeni GLP-1 ima kratko delovanje GLP-1 analogi s podaljšanim delovanjem: Eksenatid (Byetta) Liraglutid (Victoza) Injekcije Inhibicija encimov DPP-4, ki razgradijo endogeni GLP-1: Sitaglip[n (Januvia) Vildaglip[n (Galvus) Saksaglip[n (Onglyza) Linaglip[n (Trajenta) Tablete
24 Zdravila ki delujejo na inkretinski sistem GLP-1 targetira številne vidike diabetičnega fenotipa (spodbuja izločanje insulina ob obroku, inhibicija izločanja glukagona) Nativni GLP-1 hitro razgradijo encimi DPP-4 Metaboliti nimajo insulinotropnega učinka Terapevtska strategija: DPP-4 rezistentni analogi GLP-1 (GLP-1 receptor agonisti; inkretinski mimetiki) Namen: povečati plazemsko koncentracijo agonistov v nivo farmakološke učinkovitosti Inhibirati aktivnost encimov DPP-4 (DPP-4 inhibitorji; spodbujevalci inkretinov) Namen: Preprečiti razpad endogenih inkretinov in s tem povečati plazemski nivo intaktnih peptidov DPP-4 (kapilarni endotelij) GLP-1 (L-celica) Hansen L et al, Endocrinology 1999 Deacon CF et al. Diabetes 1995; 44:
25 Inkre3nska terapija Sekrecija GLP-1 je motena pri DM2 Endogeni GLP-1 ima kratko delovanje GLP-1 analogi s podaljšanim delovanjem: Eksenatid (Byetta) Liraglutid (Victoza) Injekcije Inhibicija encimov DPP-4, ki razgradijo endogeni GLP-1: Sitaglip[n (Januvia) Vildaglip[n (Galvus) Saksaglip[n (Onglyza) Linaglip[n (Trajenta) Tablete
26 Inkre3nska terapija Način vnosa GLP1 koncentracija Mehanizem delovanja Vpliv na izločanje insulina Zniža izločanje glukagona Praznjenje želodca Izguba telesne mase Vpliva na beta celično maso Razred DPP-4 Slabost/bruhanje inhibitorji Potencialna imunogenost GLP-1 agonisti GLP1R agonisti Injekcije Farmakološka GLP1 DA DA Inhibira DA DA DA DA DPP4 Inhibitorji Tablete Fiziološke GLP1 +GIP DA DA Ni učinka NE DA Stranski učinki NE Okužbe zgornjih dihal,glavobol, okužbe sečil, gastroenteritis NE Slabost, bruhanje, akutni pankreatitis Drucker D. J Clin Invest 2007; 117:
27 DPP-4 inhibitorji: podobnosti in razlike
28 DPP-4 inhibitorji so bila prospektivno načrtovana antidiabetična zdravila DPP-4 inhibitor Odkritje kristalne strukture in karakteristike vezalnega mesta so omogočale načrtovati zdravila, ki so visoko selektivna in potentna. DPP-4 inhibitorji so majhne molekule, ki se lepo prilegajo v katalitično mesto encima. DPP-4 inhibitorji ne spreminjajo terciarne strukture DPP-4/CD26 molekule ali vplivajo na njeno vezavno sposobnost. DPP-4 inhibitorji v klinični praksi imajo primerljive stranske učinke s placebom. Rasmussen O et al. Nature, 2003.
29 Značilnosti DPP-4 inhibitorjev Učinkovina t½ Odmerjanje DPP-4 inhibicija Sitagliptin 8 24 h 100 mg / 1x dan Maks ~97%; >80% 24 h po odmerku Vildagliptin 1½ 4½ h 50 mg / 2x dan Maks ~95%; >80% 12 h po odmerku Saxagliptin 2 4 h (prvotna oblika) 3 7 h (metaboliti) 5 mg / 1x dan Maks ~80%; ~70% 24 h po odmerku Alogliptin h 25 mg qd / 1x dan Max Maks ~90%; ~75% h h post-dose odmerku Linagliptin h 5 mg / 1x dan Maks ~80%; ~70% 24 h po odmerku Deacon CF.Diabetes Obes Metab,
30 DPP-4 inhibitorji: klinične indikacije (EMA, 2014) Indikacije Sitagliptin Vildagliptin Saxagliptin Linagliptin Monoterapija!!!! + Metformin!!!! + SU!!! +TZD!!!! Trotirna terapija!!! + Insulin!!!!
31 DPP-4 zaviralci Prednos3 Slabos3 Kombinacija z drugimi zdravili
32 Prilagoditev odmerkov glede na ledvično okvaro Stopnja ledvične bolezni ogf 90 90** <15 50ml/min Sitagliptin 100mg 50 mg Saxagliptin 5 mg 50 mg 2,5 mg 50 mg 25 mg Vildagliptin 100mg 50 mg Linagliptin 5mg- ni potrebno prilagoditi odmerka
33 Inkre3nska terapija Sekrecija GLP-1 je motena pri DM2 Endogeni GLP-1 ima kratko delovanje GLP-1 analogi s podaljšanim delovanjem: Eksenatid (Byetta) Liraglutid (Victoza) Eksenatid KAR (Byduren) Injekcije Inhibicija encimov DPP-4, ki razgradijo endogeni GLP-1: Sitaglip[n (Januvia) Vildaglip[n (Galvus) Saksaglip[n (Onglyza) Linaglip[n (Trajenta) Tablete
34 Učinki GLP-1 so odvisni od odmerka
35 Vpliv GLP-1 agonistov na HbA1c (meta analiza) -1,0% Amori RE. JAMA 2007;(2):
36
37 Recept, ZZZS 2013: GLP-1 agonisti Le za bolnike s sladkorno boleznijo tipa 2 ob maksimalnih odmerkih dvotirne peroralne terapije, ki imajo indeks telesne mase enak ali višji od 35 kg/m2; le, če je prišlo do znižanja glikiranega hemoglobina za več kot eno odstotno točko v 6 mesecih po uvedbi zdravljenja.
38 Zdravljenje z insulinom
39 Bolnik J.L., December 15, NPH insulin 1975 Februar 15, 1923 Pozno Insulin glargin HbA1c Insulinske črpalke Insulinska terapija Glukometri Lente insulin 2000 Insulinski analogi
40
41 Insulinska terapija DM1:DM2 DM1: nadomeščamo popolno pomanjkanje insulina. DM2: delno pomanjkanje endogenega insulina. DM1: uvedba ob postavitvi diagnoze. DM2: začetek zdravljenja običajno 5-10 let kasneje. DM1: stabilna potreba po insulinu (Honey moon). DM2: progresivno povečana potreba (debelost,ir, MetS).
42 Insulin v plazmi in profil glukoze pri zdravem Insulin v pazmi (µu/ml) PRANDIALNA SEKRECIJA BAZALNA SEKRECIJA Glukoza v plazmi (mg/dl) Čas.
43 Bazalno-bolusno insulinsko zdravljenje zajtrk kosilo večerja Plazma insulin Aspart Glulisin Lispro Bazalni insulin 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Čas 8:00
44 Delovanje insulinov Nivo plazemskega insulina Ultra kratko delujoči Kratko delujoči Srednje dolgo delujoči PRANDIALNI INSULINI Dolgo delujoči BAZALNI INSULINI Čas (h)
45 Insulinska terapija pri DM2 Bazalni insulin 1x, po potrebi 2x dnevno (ob POAD) Dvofazni insulini 1x ali 2x dnevno Bazalni insulin 1x ali 2x dnevno in prandialni insulin pred obroki Samo prandialni insulin ob nadaljevanju POAD
46
47 Hvala za Vašo pozornost!"
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