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ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia.

Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M - Eur. Heart J. (2015)

Bottom Line: Primary endpoint (both studies) was percentage change in calculated LDL-C from baseline to Week 24.These reductions were maintained through Week 78.In patients with HeFH and inadequate LDL-C control at baseline despite maximally tolerated statin ± other LLT, alirocumab treatment resulted in significant LDL-C lowering and greater achievement of LDL-C target levels and was well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Room F4-159.2, 1105 AZ Amsterdam, The Netherlands j.j.kastelein@amc.uva.nl.

No MeSH data available.


Related in: MedlinePlus

Randomization and treatment. ITT, intention-to-treat. Completion of the study was defined as follows: last study-drug injection received (Week 76) and end-of-treatment visit (Week 78) occurred within 21 days of last injection and at least 525 days post-randomization.
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EHV370F1: Randomization and treatment. ITT, intention-to-treat. Completion of the study was defined as follows: last study-drug injection received (Week 76) and end-of-treatment visit (Week 78) occurred within 21 days of last injection and at least 525 days post-randomization.

Mentions: A total of 735 patients were randomized in the two studies: 486 in FH I (323 to alirocumab and 163 to placebo) and 249 in FH II (167 to alirocumab and 82 to placebo; Figure 1). Baseline characteristics were well balanced between groups in the individual studies, with some differences noted between the studies (e.g. in percentage diagnosed by genotyping; Table 1). Prior CHD was reported in 46% of patients in FH I and 36% in FH II, and CHD risk equivalents were present in 16 and 8%, respectively (see Supplementary material online, Table S1 for further details). Over 80% of patients were receiving high-dose statin, and over half were also receiving ezetimibe 10 mg (Table 1). In FH I and FH II, respectively, 85.8 and 91.6% of alirocumab-treated patients (87.7 and 90.1% of placebo) received study treatment for ≥76 weeks.Table 1


ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia.

Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M - Eur. Heart J. (2015)

Randomization and treatment. ITT, intention-to-treat. Completion of the study was defined as follows: last study-drug injection received (Week 76) and end-of-treatment visit (Week 78) occurred within 21 days of last injection and at least 525 days post-randomization.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4644253&req=5

EHV370F1: Randomization and treatment. ITT, intention-to-treat. Completion of the study was defined as follows: last study-drug injection received (Week 76) and end-of-treatment visit (Week 78) occurred within 21 days of last injection and at least 525 days post-randomization.
Mentions: A total of 735 patients were randomized in the two studies: 486 in FH I (323 to alirocumab and 163 to placebo) and 249 in FH II (167 to alirocumab and 82 to placebo; Figure 1). Baseline characteristics were well balanced between groups in the individual studies, with some differences noted between the studies (e.g. in percentage diagnosed by genotyping; Table 1). Prior CHD was reported in 46% of patients in FH I and 36% in FH II, and CHD risk equivalents were present in 16 and 8%, respectively (see Supplementary material online, Table S1 for further details). Over 80% of patients were receiving high-dose statin, and over half were also receiving ezetimibe 10 mg (Table 1). In FH I and FH II, respectively, 85.8 and 91.6% of alirocumab-treated patients (87.7 and 90.1% of placebo) received study treatment for ≥76 weeks.Table 1

Bottom Line: Primary endpoint (both studies) was percentage change in calculated LDL-C from baseline to Week 24.These reductions were maintained through Week 78.In patients with HeFH and inadequate LDL-C control at baseline despite maximally tolerated statin ± other LLT, alirocumab treatment resulted in significant LDL-C lowering and greater achievement of LDL-C target levels and was well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Room F4-159.2, 1105 AZ Amsterdam, The Netherlands j.j.kastelein@amc.uva.nl.

No MeSH data available.


Related in: MedlinePlus