Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial
| Autor: | Paul D. Thompson, Christopher P. Cannon, Eric Bruckert, Franklin J. Zieve, Marie T. Baccara-Dinet, Jian Zhao, Jean Bergeron, Garen Manvelian, Shazia Ali, Terry A. Jacobson, John R. Guyton, Patrick M. Moriarty, Stephen Donahue, Robert Pordy |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Statin medicine.drug_class Endocrinology Diabetes and Metabolism Atorvastatin Population Hypercholesterolemia 030204 cardiovascular system & hematology Antibodies Monoclonal Humanized 03 medical and health sciences 0302 clinical medicine Ezetimibe Double-Blind Method Internal medicine Internal Medicine medicine Humans 030212 general & internal medicine education Muscle Skeletal Alirocumab Aged education.field_of_study Nutrition and Dietetics business.industry PCSK9 Hazard ratio PCSK9 Inhibitors Cholesterol LDL Middle Aged Confidence interval Female Hydroxymethylglutaryl-CoA Reductase Inhibitors Proprotein Convertase 9 Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Journal of clinical lipidology. 14(1) |
| ISSN: | 1933-2874 |
| Popis: | Background The 24-week randomized, double-blind ODYSSEY ALTERNATIVE trial (NCT01709513) demonstrated significant low-density lipoprotein cholesterol (LDL-C) reductions with the PCSK9 inhibitor alirocumab vs ezetimibe in statin-intolerant patients, with significantly fewer skeletal muscle events (SMEs; 32.5%) vs atorvastatin (46.0%; hazard ratio: 0.61, 95% confidence interval: 0.38 to 0.99, P = .042). Objective ALTERNATIVE participants could enter an open-label treatment period (OLTP) for assessment of long-term safety. Methods Two hundred and eighty one patients entered the OLTP; 93.7%, 84.0%, and 92.9% of patients who received atorvastatin, ezetimibe, and alirocumab, respectively, during double-blind treatment, including 216 patients (76.9%) who completed double-blind treatment, as well as patients who either prematurely discontinued treatment due to SME (n = 51 [18.1%]) or other reasons (n = 14 [5.0%]) but completed week 24 assessments. All patients in the OLTP received alirocumab (75 or 150 mg every 2 weeks based on investigator decision) for ∼3 years or until commercial availability, whichever came first. Results SMEs were reported by 38.4% of patients in the OLTP. Safety results from the OLTP were similar to those of the alirocumab group in the double-blind period, except for a lower rate of discontinuations due to SMEs observed with alirocumab in the OLTP (3.2% vs 15.9% in the double-blind period). At OLTP week 8, mean LDL-C reduction from baseline (=week 0 of double-blind period) was 52.0%, with reductions sustained through to the end-of-treatment visits (55.4% and 53.7% reduction at weeks 100 and 148, respectively). Conclusions In this population of statin-intolerant patients, alirocumab was well tolerated and produced durable LDL-C reductions over 3 years. |
| Databáze: | OpenAIRE |
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