In high-risk patients with mild hypertriglyceridemia, omega-3 fatty acids improved triglyceride levels and reduced major adverse cardiovascular events, according to a new meta-analysis.
The data showed MAEs onset was significantly faster with atorvastatin and rosuvastatin compared with simvastatin; a comparison with other statins could not be established due to the small number of cases identified.
The likelihoods of nonadherence and discontinuation were increased in association with diabetes, while hypertension, angina, and congestive heart failure correlated with a reduced likelihood of nonadherence and discontinuation.
The study utilized patient-reported side effects to determine the tolerability of the PCSK9 inhibitors evolocumab and alirocumab.
Specifically, the panel recommends that testing include the genes encoding the low-density lipoprotein receptor, apolipoprotein B, and proprotein convertase subtilisin/kexin 9. Depending on patient phenotype, other genes may also need to be considered for analysis.
The sBLA is supported by data from the Phase 3 ODYSSEY OUTCOMES trial which included 18,924 patients who had experienced an acute coronary syndrome (ACS) in the previous 12 months.
"We are extremely disappointed with the FDA's decision. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS," said Akcea CEO, Paula Soteropoulos.
The dosing recommendation was based on data from a double-blind, placebo-controlled study conducted in 62 patients with HeFH undergoing LDL apheresis.
There was a significant increase in statin prescribing in the active choice with peer comparison arm compared with usual care.
Given the lack of differences seen via the NIS, the authors suggested that subjective questionnaires may not be a trustworthy method to assess possible statin-associated cognitive deficits.
The new rule allows pharmacists to prescribe medications for cold sores, seasonal influenza, strep throat, and urinary tract infections, as well as statins for patients with diabetes.
Multiple studies have indicated that the 2013 PCEs - published by the American College of Cardiology/American Heart Association Task Force on Practice Guidelines - substantially misestimated CVD risk.
For this study, researchers investigated the pharmacodynamics of evolocumab in two Phase 2 placebo-controlled studies (MENDEL and LAPLACE-TIMI 57) in order to determine which dosing regimens provided the most consistent LDL-C reduction.
AKI was independently associated with higher rates of the composite outcome of hospitalization for heart failure and atherosclerotic events 1-year post-discharge.
Antisense technology refers to the use of synthetic nucleic acid sequences to interrupt specific protein production by targeting the corresponding messenger RNA that encodes that protein.
Doses of Zypitamag >4mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies, therefore dosing should not exceed 4mg once daily.
Women were less likely to fill a high-intensity statin than men overall, among those with no prior statin use, among those taking low/moderate-intensity statins prior to MI, and among those taking high-intensity statins prior to their MI.
Statin-associated muscle pain can hinder medication adherence which could potentially lead to an increased risk of cardiovascular events.
Among adults with definite/probable FH or severe dyslipidemia, the frequency of cholesterol screening and awareness was high (>80%); statin use was uniformly low among adults with definite/probable FH and with severe dyslipidemia (52.3 and 37.6%, respectively).
After classifying patients into 5 groups based on their blood linoleic level, the researchers found a 43% reduced risk of premature death among those with the highest level when compared with the group with the lowest level (adjusted hazard ratio [HR] 0.57, 95% CI: 0.46, 0.71; P<0.00).
Use of ticagrelor resulted in similar rates of major bleeding compared to clopidogrel in patients with ST elevation myocardial infarction treated with thrombolysis.
The ODYSSEY Outcomes trial (N=18,924) evaluated the effect of alirocumab on the occurrence of MACE in patients who had an ACS between 1-12 months prior to trial enrollment, and who were already taking maximally-tolerated statins (atorvastatin or rosuvastatin).