The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial
Open accessAbstract
AIM: To evaluate the effect of alirocumab on frequency of standard apheresis treatments [weekly or every 2 weeks (Q2W)] in heterozygous familial hypercholesterolaemia (HeFH). METHODS AND RESULTS: ODYSSEY ESCAPE (NCT02326220) was a double-blind study in 62 HeFH patients undergoing regular weekly or Q2W lipoprotein apheresis. Patients were randomly assigned (2:1, respectively) to receive alirocumab 150 mg (n = 41) or placebo (n = 21) Q2W subcutaneously for 18 weeks. From day 1 to week 6, apheresis rate was fixed according to the patient's established schedule; from weeks 7 to 18, apheresis rate was adjusted based on the patient's low-density lipoprotein cholesterol (LDL-C) response in a blinded fashion. Apheresis was not performed when the LDL-C value was ≥30% lower than the baseline (pre-apheresis) value. The primary efficacy endpoint was the rate of apheresis treatments over 12 weeks (weeks 7-18), standardized to number of planned treatments. In the alirocumab group the least square (LS) mean ± SE (95% confidence interval [CI]) per cent change in pre-apheresis LDL-C from baseline at week 6 was -53.7 ± 2.3 (-58.2 to - 49.2) compared with 1.6 ± 3.1 (-4.7 to 7.9) in the placebo group. The primary efficacy endpoint showed statistically significant benefit in favour of alirocumab (Hodges-Lehmann median estimate of treatment difference: 0.75; 95% CI 0.67-0.83; P < 0.0001). Therefore, alirocumab-treated patients had a 0.75 (75%) additional reduction in the standardized rate of apheresis treatments vs. placebo-treated patients. During this period, 63.4% of patients on alirocumab avoided all and 92.7% avoided at least half of the apheresis treatments. Adverse event rates were similar (75.6% of patients on alirocumab vs. 76.2% on placebo). CONCLUSIONS: Lipoprotein apheresis was discontinued in 63.4% of patients on alirocumab who were previously undergoing regular apheresis, and the rate was at least halved in 92.7% of patients. Alirocumab was generally safe and well tolerated.
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Stone, N. J., Robinson, J. G., Lichtenstein, A. H., Bairey Merz, C. N., Blum, C. B., Eckel, R. H., Goldberg, A. C., Gordon, D., Levy, D., Lloyd-Jones, D. M., et al. (2014) · Circulation · doi:10.1161/01.cir.0000437738.63853.7a · Cited by 7,081
ESC/EAS Guidelines for the management of dyslipidaemias
Reiner, Ž., Catapano, A. L., De Backer, G., Graham, I., Taskinen, M.-R., Wiklund, O., Agewall, S., Alegria, E., Chapman, M. J., Durrington, P., et al. (2011) · European Heart Journal · doi:10.1093/eurheartj/ehr158 · Cited by 3,549
Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events
Robinson, J. G., Farnier, M., Krempf, M., Bergeron, J., Luc, G., Averna, M., Stroes, E. S., Langslet, G., Raal, F. J., El Shahawy, M., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501031 · Cited by 2,296
Neil, A., Cooper, J., Betteridge, J., Capps, N., McDowell, I., Durrington, P., Seed, M., Humphries, S. E., & on behalf of the Simon Broome Familial Hyperlipidaemia Register Group (2008) · European Heart Journal · doi:10.1093/eurheartj/ehn422 · Cited by 425
Kereiakes, D. J., Robinson, J. G., Cannon, C. P., Lorenzato, C., Pordy, R., Chaudhari, U., & Colhoun, H. M. (2015) · American Heart Journal · doi:10.1016/j.ahj.2015.03.004 · Cited by 349
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Connelly‐Smith, L., Alquist, C. R., Aqui, N. A., Hofmann, J. C., Klingel, R., Onwuemene, O. A., Patriquin, C. J., Pham, H. P., Sanchez, A. P., Schneiderman, J., et al. (2023) · Journal of Clinical Apheresis · doi:10.1002/jca.22043 · Cited by 684
The Evolving Future of PCSK9 Inhibitors
Rosenson, R. S., Hegele, R. A., Fazio, S., & Cannon, C. P. (2018) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2018.04.054 · Cited by 264
Karatasakis, A., Danek, B. A., Karacsonyi, J., Rangan, B. V., Roesle, M. K., Knickelbine, T., Miedema, M. D., Khalili, H., Ahmad, Z., Abdullah, S., et al. (2017) · Journal of the American Heart Association · doi:10.1161/jaha.117.006910 · Cited by 215
Landmesser, U., Chapman, M. J., Stock, J. K., Amarenco, P., Belch, J. J. F., Borén, J., Farnier, M., Ference, B. A., Gielen, S., Graham, I., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehx549 · Cited by 200
PCSK9 inhibition in the management of familial hypercholesterolemia
Ogura, M. (2018) · Journal of Cardiology · doi:10.1016/j.jjcc.2017.07.002 · Cited by 84
Metadata
- Authors
- Moriarty, P. M., Parhofer, K. G., Babirak, S. P., Cornier, M.-A., Duell, P. B., Hohenstein, B., Leebmann, J., Ramlow, W., Schettler, V., Simha, V., Steinhagen-Thiessen, E., Thompson, P. D., Vogt, A., von Stritzky, B., Du, Y., & Manvelian, G.
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2016-08-29
- Volume
- 37
- Issue
- 48
- Pages
- 3588-3595
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- OpenAlex
- W2512572393
- Cited by
- 197
- References
- 5
- FWCI
- 36.51
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Moriarty, P. M., Parhofer, K. G., Babirak, S. P., Cornier, M.-A., Duell, P. B., Hohenstein, B., Leebmann, J., Ramlow, W., Schettler, V., Simha, V., Steinhagen-Thiessen, E., Thompson, P. D., Vogt, A., von Stritzky, B., Du, Y., & Manvelian, G. (2016). Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial. European Heart Journal. https://doi.org/10.1093/eurheartj/ehw388
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