Informacja

Drogi użytkowniku, aplikacja do prawidłowego działania wymaga obsługi JavaScript. Proszę włącz obsługę JavaScript w Twojej przeglądarce.

Przeglądasz jako GOŚĆ
Tytuł pozycji:

Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial.

Tytuł :
Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial.
Autorzy :
Robinson, Jennifer G
Nedergaard, Bettina S
Rogers, William J
Fialkow, Jonathan
Neutel, Joel M
Ramstad, David
Somaratne, Ransi
Legg, Jason C
Nelson, Patric
Scott, Rob
Wasserman, Scott M
Weiss, Robert
Pokaż więcej
Temat :
Monoclonal/*therapeutic use
Antibodies, Monoclonal
Anticholesteremic Agents/administration & dosage
Evolocumab
Hypercholesterolemia
Anticholesteremic Agents
Heptanoic Acids/administration & dosage
Dyslipidemias/drug therapy
PCSK9
Antibodies
Female
Combination
Double-Blind Method
Drug Therapy
Simvastatin/administration & dosage
lipids (amino acids, peptides, and proteins)
Aged
Sulfonamides/administration & dosage
Pyrroles/administration & dosage
Azetidines/*therapeutic use
Middle Aged
Treatment Outcome
Fluorobenzenes/administration & dosage
Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage
Pyrimidines/administration & dosage
Ezetimibe
Hypercholesterolemia/*drug therapy
[SDV]Life Sciences [q-bio]
Humans
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Male
Źródło :
Journal of the American Medical Association, American Medical Association (AMA), 2014, 311 (18), pp.1870-82. ⟨10.1001/jama.2014.4030⟩
Jama : Journal of the American Medical Association, 311, 1870 - 1882
Journal of the American Medical Association
Wydawca :
American Medical Association (AMA), 2014.
Rok publikacji :
2014
Kolekcja :
INRIA_a_CCSD_electronic_archive_server_enriched
INRIA_a_CCSD_electronic_archive_server
Hyper_Article_en_Ligne_enriched
NARCIS
NARCIS_enriched
Hyper_Article_en_Ligne
Oryginalny identyfikator :
pmid: 24825642
Opis pliku :
STAMPA
Język :
English
ISSN :
0098-7484
1538-3598
DOI :
10.1001/jama.2014.4030
IMPORTANCE: In phase 2 studies, evolocumab, a fully human monoclonal antibody to PCSK9, reduced LDL-C levels in patients receiving statin therapy. OBJECTIVE: To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin. DESIGN, SETTING, AND PATIENTS: Phase 3, 12-week, randomized, double-blind, placebo- and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries. INTERVENTIONS: Patients (n = 2067) were randomized to 1 of 24 treatment groups in 2 steps. Patients were initially randomized to a daily, moderate-intensity (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]) or high-intensity (atorvastatin [80 mg], rosuvastatin [40 mg]) statin. After a 4-week lipid-stabilization period, patients (n = 1899) were randomized to compare evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo (every 2 weeks or monthly) or ezetimibe (10 mg or placebo daily; atorvastatin patients only) when added to statin therapies. MAIN OUTCOMES AND MEASURES: Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) level at the mean of weeks 10 and 12 and at week 12. RESULTS: Evolocumab reduced LDL-C levels by 66% (95% CI, 58% to 73%) to 75% (95% CI, 65% to 84%) (every 2 weeks) and by 63% (95% CI, 54% to 71%) to 75% (95% CI, 67% to 83%) (monthly) vs placebo at the mean of weeks 10 and 12 in the moderate- and high-intensity statin-treated groups; the LDL-C reductions at week 12 were comparable. For moderate-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 115 to 124 mg/dL to an on-treatment mean of 39 to 49 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 123 to 126 mg/dL to an on-treatment mean of 43 to 48 mg/dL. For high-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 35 to 38 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 33 to 35 mg/dL. Adverse events were reported in 36%, 40%, and 39% of evolocumab-, ezetimibe-, and placebo-treated patients, respectively. The most common adverse events in evolocumab-treated patients were back pain, arthralgia, headache, muscle spasms, and pain in extremity (all <2%). CONCLUSIONS AND RELEVANCE: In this 12-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia, evolocumab added to moderate- or high-intensity statin therapy resulted in additional LDL-C lowering. Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01763866.

Ta witryna wykorzystuje pliki cookies do przechowywania informacji na Twoim komputerze. Pliki cookies stosujemy w celu świadczenia usług na najwyższym poziomie, w tym w sposób dostosowany do indywidualnych potrzeb. Korzystanie z witryny bez zmiany ustawień dotyczących cookies oznacza, że będą one zamieszczane w Twoim komputerze. W każdym momencie możesz dokonać zmiany ustawień dotyczących cookies