Ako dosiahnuť maximálnu dlhodobú redukciu celkového kardiovaskulárneho rizika?
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1 Ako dosiahnuť maximálnu dlhodobú redukciu celkového kardiovaskulárneho rizika? MUDr. Ivana Šoóšová, PhD, FESC
2 ESC odporúčania kardiovaskulárnej prevencie 2012
3 Slovensko patrí medzi krajiny s vysokým populačným KV rizikom
4 Rozdiel v riziku KV smrti je medzi krajinami s nízkym a vysokým rizikom takmer 2-násobný
5 Rizikové faktory pôsobia synergicky 5-ročné riziko KV príhody v závislosti od RF hypertenzia BP (mm Hg) % % LDL Porucha Endotelu NO zápal % 24% RF % 12% 3% (DM, fajčenie) Reference + TC + Smoker + HDL + Muž + Diabetes + 60 years Upravené podľa: Mason, R. A rationale for combination therapy in risk factor management: a mechanistic perspective, The American Journal of Medicine (2005) Vol 118 (12A), 54S 61S
6 ASCOT: populácia pacientov častá v klinickej praxi (hypertenzia plus 3 KV rizikových faktorov*) hypertenzia vek 55 rokov muž mikroalbuminuria / proteinuria fajčiar rodinná anamnéza ICHS diabetes mellitus 2.typu pomer TC/HDL-C 6 EKG abnormality Hypertrofia ĽK Predchádzajúca cievna príhoda ICHDK % pacientov s rizikovým faktorom Dva z najčastejšie sa vyskytujúcich RF boli : mužské pohlavie a vek 55 rokov *These risk factors were used as inclusion criteria for the study. The ASCOT Investigators. Available at: Accessed: April 6, 2006.
7 počet KV príhod na 1000 pac. SK ASCOT KV príhody v závislosti od terapie Atenolol (± diuretikum) 9,1 Amlodipín (± perindopril) 8,2 AH liečba + atorvastatín 6,0 Amlodipín/atorvastatín 4,6 (± perindopril) Dahlöf B. et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial Sever PS et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003; 361: Sever P et al. Potential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial. European Heart Journal (2006) 27,
8 SK Originálna fixná kombinácia amlodipín/atorvastatín a redukcia KV príhod účinnosť adherencia synergia
9 účinnosť SK
10 Kumulatívna incidencia (%) Kumulatívna incidencia (%) ASCOT 2x2: účinnosť závisí od antihypertenzíva, ku ktorému sa atorvastatín pridá Primárny cieľ : nefatálny IM + fatálna ICHS Liečba založená na amlodipíne Liečba založená na atenolole Amlodipín + atorvastatín10 ) Amlodipín + placebo -53% Atenolol + atorvastatín 10 Atenolol + placebo -16% Roky Včasný benefit pozorovaný už po 90 dňoch HR=0.47 ( ) p<0.001 HR=0.84 ( ) p= Roky Sever et al. Eur Heart J. 2006;27:
11 Nízke percento pacientov dosahuje súčasne cieľové hodnoty TK a LDL-C 1. Wong ND et al.: Am J Cardiol 2006,98:204-8 SK
12 Štúdia CRUCIAL- dizajn: Prospektívna, otvorená, kohortová štúdia s klastrovou randomizáciou pacientov Vhodný pacient: hypertonik bez známok ICHS TC 6.5 mmol/l klastrovaná randomizácia INVESTIGÁTOROV (z dôvodu zachovania integrity bežnej praxe) fixná kombinácia amlodipín / atorvastatín (5/10 mg al.10/10 mg) + bežná liečba BEŽNÁ LIEČBA samotná (akékoľvek antihypertenzívum, hypolipidemikum, vrátane amlodipínu, atorvastatínu) Každý pacient sledovaný 12 mesiacov Primárny end-point: Výpočet 10-ročného rizika vzniku koronárnej choroby po 12 mesiacoch liečby pomocou Framinghamského skóre Sekundárny end-point: Dosahovanie cieľových hodnôt TK a cholesterolu CRUCIAL trial. Curr Med Res Opin. 2011;27(4):
13 Cieľové hodnoty TK a LDL-C dosiahlo signifikantne viac pacientov na fixnej kombinácii amlodipín/atorvastatín ako na samostatnej bežnej liečbe Fix.kombi: Amlo/atorva CRUCIAL trial. Curr Med Res Opin. 2011;27(4): SK
14 Originálna fixná kombinácia amlo/atorva znížila riziko vzniku ICHS o 27% v porovnaní s bežnou liečbou Fix.kombi: Amlo/atorva CRUCIAL trial. Curr Med Res Opin. 2011;27(4): SK
15 CRUCIAL - záver súbežná liečba hypertenzie a hypercholesterolémie originálnou fixnou kombináciou amlo/atorva je účinnejšia ako bežne používaná liečba po 1 roku liečby amlo/atorva sa znížilo RR vzniku ICHS o 27% v porovnaní s BL (RRR=0,73 (95% CI, ,-22.48) P<0.001) takmer 2x viac pacientov dosiahlo cieľové hodnoty TK a cholesterolu v porovnaní s BL (HR = 1,87 (95% CI, 2.11, 3.80) P<.001) Účinné dosiahnutie redukcie TK a cholesterolu v každodennej praxi je možné malou modifikáciou liečby = použitím originálnej fixnej kombinácie amlodipín / atorvastatín CRUCIAL trial. Curr Med Res Opin. 2011;27(4): SK
16 SK účinnosť adherencia
17 SK Non-adherencia k liečbe = nezávislý rizikový faktor Adherencia k liekom je u pacientov s KV ochorením nízka... Následkom sú horšie liečebné výsledky a zvýšené náklady na liečbu.
18 SK ESC odporúča intervenciu lekára Most important new information: Evidence suggests that reducing dosage demands is the most effective single approach to enhancing medication adherence. ESC odporúča Zjednodušiť liečbu Znížiť počet tabliet
19 Spracované podľa Chapman RH, et al. Arch Intern Med. 2005;165: SK Len 7% pacientov je adherentných k statínovej Adherencia k antihypertenzívnej a statínovej liečbe liečbe po roku 3 x vyššia pravdepodobnosť, že pacient z liečby vynechá statín ako liek na vysoký TK
20 Prečo je ADHERENCIA dôležitá? Väčšina pacientov potrebuje na dosiahnutie cieľových hodnôt viacero liekov S rastúcim počtom liekov klesá adherencia k liečbe Nízka adherencia je kľúčovým faktorom prispievajúcim k nedosahovaniu cieľových hodnôt K nízkej adherencii výrazne prispieva striedanie liekov Non adherencia k liekom zvyšuje KV riziko Hypertension, 2009, 53: SK
21 Patients with MPR 80 (%) Schwartz JS, et al. J Am Coll Cardiol. 2003: 41: 526A. SK Adherencia klesá s narastajúcim počtom tabliet 80 P=0.05 vs obe AHT (antihypertenzívum) HLP (hypolipidemikum) Obe Month 1-2 Month 3-4 Month 5-6 Month 7-8 Month 9-10 Retrospektívna analýza databázy (PharMetrics Integrated Outcomes Database). Adherencia stanovená v 2- mesačných intervaloch u 5341 patientov na AHT a HLP vyjadrená MPR (medication possession ratio).
22 Zlepšenie adherencie nižší počet tabliet fixné kombinácie efektívna th počas prvých 6 mesiacov minimálne striedanie liekov Spracované podľa Chapman RH, et al. Arch Intern Med. 2005;165:1149. SK
23 CARPE štúdia: adherencia k liečbe 1 tbl - fixná kombinácia amlo/atorva vs 2 tbl kombinovanej liečby 4703 pacientov novonastavených na kalc.blokátor alebo statín v 5 skupinách: fixná kombinácia amlodipín/atorvastatín atorvastatín + amlodipín amlodipín + iný statín atorvastatín + iný kalciový blokátor iný kalc. blokátor + iný statín Primárny cieľ : pravepodobnosť dosiahnutia adherencie fixnou kombináciou amlodipín/atorvastatín vs iné liečebné režimy - adherencia = podiel dní, kedy boli užité oba lieky počas 180 dní, pacienti boli považovaní za adherentných, ak aspoň 80% dní z tohto obdobia užili odporúčanú th - retrospektívny dizajn - výsledky odrážajú skutočnú realitu v praxi Patel et al. Hypertension, 2009, 53: SK
24 Percento adherentných pacientov CARPE: Adherencia po 6 mesiacoch liečby Fixná kombinácia Amlo/Atorva Všetky porovnávané kohorty - signifikantne nižšia adherencia ako fixná kombinácia amlodipín/atorvastatín, P <.0001 Patel et al. Hypertension, 2009, 53: SK
25 CARPE: multivariantná analýza adherencie k liečbe Fixná kombinácia amlodipín/atorvastatín 2x vyššia pravdepodobnosť adherencie k 1 tbl ako k 2 tbl amlodipínu a atorvastatínu (OR 1,95 (CI 1,8-2,13) p<0,001) 3x vyššia pravdepodobnosť adherencie k 1 tbl ako k 2 tbl iného Ca blokátora alebo statínu (OR 3,1 (CI 2,85-3,38) p<0,001) zjednoduší liečebný režim zvýši účinnosť Spracované podľa Patel et al. Hypertension, 2009, 53: SK
26 SK účinnosť adherencia synergia
27 Mason RP, The American Journal of Medicine (2005) Vol 118 (12A), 54S 61S SK Vedecké zdôvodnenie pre synergiu
28 Kombinácia unikátnych molekúl Atorvastatín metabolit má výraznú antioxidačnú aktivitu vďaka fenoxy-skupine, ktorá môže byť donorom protónu Amlodipín jediný CaB s pozitívnym nábojom má výraznú antioxidačnú aktivitu vďaka vysokej lipofilite Mason RP, The American Journal of Medicine (2005) Vol 118 (12A), 54S 61S SK
29 Synergia amlodipínu s atorvastatínom LEPŠÍ PRIENIK DO BUNIEK Atorvastatín kalcium Amlodipín besylát Komplementárny náboj zvyšuje permeabilitu kombinácie Atorvastatín Negatívny náboj Amlodipín Pozitívny náboj Koncentrácia kombinácie v lipidovej dvojvrstve je vyššia ako pri ich podaní samostatne Mason RP, The American Journal of Medicine (2005) Vol 118 (12A), 54S 61S
30 Synergický efekt originálnej fixnej kombinácie amlodipín / atorvastatín na LDLc Fix.kombi: Amlo/atorva Upravené podľa: Preston RA, The Respond Trial. J Clin Pharmacol 2007;47: SK
31 Originálna fixná kombinácia amlodipín /atrovastatín - synergia - produkcie NO Lepšia kontrola TK LDL-C + oxidácie LDL Cholesterolu je menej a nelepí sa na cievu zníženie KV príhod zníženie mortality (ASCOT) Zlepšenie pružnosti ciev (štúdia AVALON) Spomalenie aterosklerózy (štúdia CAMELOT)
32 Bioekvivalncia terapeutická ekvivalencia Napriek regulačným opatreniam o bioekvivalencii pretrvávajú pochybnosti ohľadne zameniteľnosti generík a pôvodných liekov. Limity bioekvivalnecie teoreticky pripúšťajú rozdiel 20% v miere absorpcie. Závery o bioekvivalencii sa opierajú o štúdie často jednej dávky lieku na malej skupine (20!!!) zdravých dobrovolníkov. Bioekvivalencia definovaná podľa európskych a amerických štandardov síce implikuje, ale negarantuje terapeutickú ekvivalenciu. Meredith PA: Potential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt forms. CURRENT MEDICAL RESEARCH AND OPINION VOL. 25, NO. 9, 2009, Meredith PA. Bioequivalence and Other Unresolved Issues in Generic Drug Substitution. CLINICAL THERAPEUTICS / VOL. 25, NO. 11, SK
33 Použitie inej pomocnej látky môže mať vplyv na: Biologickú dostupnosť a degradáciu Toxicitu Stabilitu lieku Liekové interakcie Meredith PA: Potential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt forms. CURRENT MEDICAL RESEARCH AND OPINION VOL. 25, NO. 9, 2009, Verbeeck RK, Kanfer I., Walker RB. Generic substitution: The use of medicinal products containing different salts and implications for safety and efficacy. SK
34 ESC odporúčania kardiovaskulárnej prevencie 2012
35 Manažment hypertenzie Statín patrí do liečby hypertenzie KVO DM2 SCORE>5%
36 Manažment hyperlipidémie Cieľom liečby je redukcia LDL Liekom voľby je statín
37 Spĺňa originálna fixná kombinácia amlodipínu s atorvastatínom kritériá ESC pre KV prevenciu? Zaistiť farmakoterapiu, ktorá zníži mortalitu Dôkaz v štúdii ASCOT 2x2 Zahrnúť statín do liečby hypertenzie Fixná kombinácia antihypertenzíva a statínu Zvýšiť adherenciu k liečbe zjednodušením liečebného režimu Dokázaná lepšia adherencia a dosahovanie cieľových hodnôt (štúdia Crucial)
38 Fixná kombinácia amlodipín / atorvastatín možnosti klinického použitia SK Pridaná k existujúcej terapii Vymenená za amlodipín a atorvastatín Iniciálna terapia u nových pacientov s AH a hyperlipidémiou Iniciálna terapia u nových pacientov s AH a KVR 5% (SCORE)
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