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OBJECTIVE: In primary hypercholesterolemia many people treated with statins do not reach their plasma LDL-C goals and are at increased risk of cardiovascular disease (CVD). This study aimed to evaluate efficacy and safety of a new fixed-dose combination (FDC) formulation of rosuvastatin/ezetimibe (R/E) in this population. METHODS: This was a multicenter, multinational, randomized, double-blind, double-dummy, active-controlled, parallel-arm study of FDC R/E in people with primary hypercholesterolemia at very high risk (VHR) or high risk (HR) of CVD, inadequately controlled with 20 mg or 10 mg stable daily dose of rosuvastatin or equipotent dose of another statin. The primary objective was to demonstrate superiority of FDC R/E versus rosuvastatin monotherapy uptitrated to 40 mg (R40) or 20 mg (R20) in reduction of LDL-C after 6 weeks. RESULTS: Randomized VHR participants (n = 244) were treated with R40, R40/E10, or R20/E10; randomized HR participants (n = 208) received R10/E10 or R20. In VHR participants, superiority of R40/E10 and R20/E10 versus R40 was demonstrated on LDL-C percent change from baseline to Week 6 with least squares mean differences (LSMD) of -19.66% (95% CI: -29.48% to -9.84%; P < .001) and -12.28% (95% CI: -22.12% to -2.44%; P = .015), respectively. In HR participants, superiority of R10/E10 over R20 was not demonstrated (LSMD -5.20%; 95% CI: -15.18% to 4.78%; P = .306), despite clinically relevant LDL-C reduction with R10/E10. No unexpected safety findings were reported. CONCLUSIONS: The results from this study suggest that R/E FDCs improve LDL-C reduction and goal achievement in people with primary hypercholesterolemia inadequately controlled with statins and at VHR/HR of CVD.

MeSH
ezetimib terapeutické užití MeSH
hypercholesterolemie * diagnóza farmakoterapie MeSH
kardiovaskulární nemoci * farmakoterapie MeSH
LDL-cholesterol MeSH
lidé MeSH
rosuvastatin kalcium škodlivé účinky MeSH
statiny * terapeutické užití MeSH
Check Tag
lidé MeSH
Publikační typ
časopisecké články MeSH
klinické zkoušky, fáze III MeSH
multicentrická studie MeSH
práce podpořená grantem MeSH
randomizované kontrolované studie MeSH

Článek online

Jak prodloužit životy našich pacientů ve zdraví? A lze to?
[How to prolong the lives of our patients in health? And is it possible?]

Linhart, Aleš, 1964-
Autor Autorita ORCID II. interní klinika kardiologie a angiologie, Komplexní kardiovaskulární centrum VFN a 1. LF UK Praha

Vnitřní lékařství. 2021 ; 67 (2) : 125-129.

ISSN 0042-773X
Medvik
Zdroj

Zdá se, že zatím dokážeme kardiovaskulární (KV) onemocnění spíše zaléčit než vyléčit. Prodlužujeme tak pacientům život, nikoliv ale život ve zdraví. Jak ukázala analýza dat z britské BioBank, dlouhodobá expozice geneticky determinované nízké hladině LDL cholesterolu a nízkému tlaku krve je spojena s nižším KV rizikem. To je velmi příznivá zpráva v situaci, kdy má medicína prostředky pro časný záchyt a intervenci těchto KV rizikových faktorů. Dokážeme tak předcházet časnému stárnutí cév. Stačí tyto prostředky uplatňovat v praxi a u osob s včas zachycenou hypertenzí a dyslipidemií vést léčbu rychle k doporučeným cílovým hodnotám při využití násobícího se přínosu současné kompenzace více rizikových faktorů. To vše u informovaného pacienta.

Recent data suggest that cardiovascular diseases are treatable but not curable. We are prolonging our patients lives, unfortunately not their life years spent in health. As shown by the British BioBank trial a longstandingexposition to genetically determined low LDL substantially lower cardiovascular risk. This is particularly relevant considering that modern medicinemakes possible to detect and safely intervene these risk factors in a timely fashion. This approach should be able to prevent early vascular aging. These methods should be applies in patients early after detection of high blood pressure and hypercholesterolemia and treat them to target levels. This approach my be particularlyrewarding in a well informed patient considering the mutual potentiation of multiple risk factors.