Effectiveness of fixed-dose combination of rosuvastatin and ezetimibe in heterozygous familial hypercholesterolemia from the RENAISSANCE registry

Aim. To study the adequacy and effectiveness of lipid-lowering therapy (LLT) prescribed to patients with heterozygous familial hypercholesterolemia (HeFH), including fixed-dose combinations (FDC) of rosuvastatin with ezetimibe, as well as the frequency of achieving target low-density lipoprotein cholesterol (LDL-C) levels. Material and methods. The clinical and demographic data of 3151 patients with HeFH at high or very high cardiovascular risk from the RENAISSANCE registry were retrospectively analysed. Among the 1612 individuals receiving LLT, 477 patients were treated with a combination of rosuvastatin at various doses and ezetimibe 10 mg daily, either as a free combination or as a FDC. Results. The median age of the patients was 46.0 [32.0; 57.0] years. The median LDL-C level was 6.4 [5.3; 7.8] mmol/L. Although LLT was recommended to all participants, approximately half (49%, n=1539) were not receiving treatment. Among the 1612 patients on LLT, 44% (n=703) received statin monotherapy, and 43% (n=697) were treated with a combination of statins and ezetimibe. Of the 477 patients taking rosuvastatin with ezetimibe, the majority were active adults of working age (35-64 years): 335 (80%) vs 86 (20%), p <0.05. Most patients preferred taking rosuvastatin with ezetimibe in the FDC: 357 (74.8%) vs 120 (25.2%), p <0.05. Among those on FDC, a significantly higher proportion used Zenon® compared to other FDCs: 44.4% (n=212) vs 30.4% (n=145), p <0.05. A significant reduction in LDL-C was observed compared to baseline: 61% in the free combination group and 65% in the FDC group, including a 67% reduction in the Zenon® subgroup (p <0.001). The rate of achieving LDL-C targets among high/very high cardiovascular risk patients was lower in the free combination group compared to the FDC group, with the highest rates observed among Zenon® users: 5.8% (n=7), 17.9% (n=26), and 21.7% (n=46), respectively (p <0.01). Conclusion. Among patients with НeFH, the use of a FDC of rosuvastatin and ezetimibe is associated with higher treatment adherence and a greater likelihood of achieving target LDL-С levels.

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Journal
Rational Pharmacotherapy in Cardiology
Published
2025-08-22
DOI
https://doi.org/10.20996/1819-6446-2025-3205
Primary Topic
Lipoproteins and Cardiovascular Health
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article
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article

Effectiveness of fixed-dose combination of rosuvastatin and ezetimibe in heterozygous familial hypercholesterolemia from the RENAISSANCE registry

A.M. Tuktarov, Е. С. Кылбанова, А. С. Лимонова, V. V. Genkel et al.
Rational Pharmacotherapy in Cardiology
Lipoproteins and Cardiovascular Health
article

Effectiveness of fixed-dose combination of rosuvastatin and ezetimibe in heterozygous familial hypercholesterolemia from the RENAISSANCE registry

A.M. Tuktarov, Е. С. Кылбанова, А. С. Лимонова, V. V. Genkel, Aleksandr Filippov, В. С. Гуревич, Л. Ф. Галимова, Rozhkova Ta, A. S. Vorobyov, Yu. A. Ermakova, Z. F. Kim, M. A. Kiselevа, А. С. Алиева, Т. Yu. Kuznetsova, Д. Н. Зайцев, N. N. Bizyaeva, N. V. Mukhа, M. V. Muzalevskaya, Е. А. Шутемова, N. Kurochkina, N. A. Tmoyan, А. И. Ершова, А. А. Соколов, А. В. Блохина, И. А. Алексеева, М. И. Воевода, У.В. Чубыкина, В. К. Зафираки, О.С. Тимошенко, Т. Е. Колмакова, O. V. Kopylova, E. V. Mikova, Р. А. Хохлов, Т. И. Петелина, А. М. Намитоков, В. О. Константинов, В. А. Корнева, Alexandra V. Tyurina, М. В. Ежов, Alexey N. Meshkov, Е. С. Сластникова, Irina Avdeeva, Yu. A. Malyshenko, И. В. Сергиенко, S. A. Urazgildeevа, И. И. Шапошник, Yu. I. Ragino, М. В. Зыков, Е. Д. Космачева, D. I. Sadykova, И. Д. Астраханцева, V. E. Oleynikov, I. I. Pshenichnikova, A.S. Asekritova, P. V. Vasilenko, V. I. Mikhailina, N. G. Androsyuk, Yu. G. Grigorieva, S. E. Bednova, Анна Викторовна Павлова, Alina Egorova, Svetlana Vladimirovna Yarkovaya, Yu. A. Vorobyeva, E. V. Kudelkina
article en

Abstract

Aim. To study the adequacy and effectiveness of lipid-lowering therapy (LLT) prescribed to patients with heterozygous familial hypercholesterolemia (HeFH), including fixed-dose combinations (FDC) of rosuvastatin with ezetimibe, as well as the frequency of achieving target low-density lipoprotein cholesterol (LDL-C) levels. Material and methods. The clinical and demographic data of 3151 patients with HeFH at high or very high cardiovascular risk from the RENAISSANCE registry were retrospectively analysed. Among the 1612 individuals receiving LLT, 477 patients were treated with a combination of rosuvastatin at various doses and ezetimibe 10 mg daily, either as a free combination or as a FDC. Results. The median age of the patients was 46.0 [32.0; 57.0] years. The median LDL-C level was 6.4 [5.3; 7.8] mmol/L. Although LLT was recommended to all participants, approximately half (49%, n=1539) were not receiving treatment. Among the 1612 patients on LLT, 44% (n=703) received statin monotherapy, and 43% (n=697) were treated with a combination of statins and ezetimibe. Of the 477 patients taking rosuvastatin with ezetimibe, the majority were active adults of working age (35-64 years): 335 (80%) vs 86 (20%), p <0.05. Most patients preferred taking rosuvastatin with ezetimibe in the FDC: 357 (74.8%) vs 120 (25.2%), p <0.05. Among those on FDC, a significantly higher proportion used Zenon® compared to other FDCs: 44.4% (n=212) vs 30.4% (n=145), p <0.05. A significant reduction in LDL-C was observed compared to baseline: 61% in the free combination group and 65% in the FDC group, including a 67% reduction in the Zenon® subgroup (p <0.001). The rate of achieving LDL-C targets among high/very high cardiovascular risk patients was lower in the free combination group compared to the FDC group, with the highest rates observed among Zenon® users: 5.8% (n=7), 17.9% (n=26), and 21.7% (n=46), respectively (p <0.01). Conclusion. Among patients with НeFH, the use of a FDC of rosuvastatin and ezetimibe is associated with higher treatment adherence and a greater likelihood of achieving target LDL-С levels.

Rational Pharmacotherapy in CardiologyVol. 21(3)
Penza State University (RU), Russian Academy of Sciences (RU), North-Eastern Federal University (RU), Altair Engineering (United States) (US), Immanuel Kant Baltic Federal University (RU), Kuban State Medical University (RU), St Petersburg University (RU), Kazan State Medical University (RU), Petrozavodsk State University (RU), Voronezh State Medical Academy named after N.N. Burdenko (RU), S. M. Kirov Military Medical Academy (RU), Chelyabinsk State Medical Academy (RU), Federal Almazov North-West Medical Research Centre (RU), Institute for Soil Science and Agrochemistry Research (UA), Voronezh Regional Clinical Oncology Center (RU), Ulyanovsk Regional Clinical Hospital (RU), Russian Medical Academy of Continuous Professional Education (RU), Astrakhan State Medical University (RU), Institute of Cytology and Genetics (RU), Tomsk National Research Medical Center (RU), Scientific Research Institute of Healthcare Organization and Medical Management (RU), Kursk Regional Clinical Oncology Center (RU), Sochi State University (RU), National Medical Research Center of Cardiology (RU), State Healthcare Institution "Regional Clinical Oncological Dispensary" (RU), North-Western State Medical University named after I.I. Mechnikov (RU), Ministry of Health (GR), Samara Regional Clinical Oncology Center (RU), Irkutsk State Medical University (RU), Chita State Academy of Medicine (RU), Saint Petersburg State Pediatric Medical University (RU)
Openalex Percentile: Top 64%
Lipoproteins and Cardiovascular Health
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