Publications by authors named "Jennifer McGinniss"
Article Synopsis
- Fibrodysplasia ossificans progressiva (FOP) is a rare condition where bones form in soft tissue, referred to as heterotopic ossification (HO), and this study examined imaging methods to identify and measure new HO lesions.
- The research analyzed data from a phase 2 clinical trial comparing the effectiveness of garetosmab (a therapy) with a placebo in adults with FOP, utilizing both PET/CT and CT scans to detect lesions over 28 weeks.
- Results showed that both PET/CT and CT-only methods detected a similar number and volume of new lesions, indicating that CT-only imaging is an effective alternative for monitoring HO changes in FOP patients.
Article Synopsis
- Fibrodysplasia ossificans progressiva (FOP) is a rare disorder causing painful flare-ups and abnormal bone growth, known as heterotopic ossification (HO).
- In a clinical trial, patients receiving the anti-activin A antibody garetosmab experienced fewer severe and lengthy flare-ups compared to those given a placebo, leading to a notable difference in quality of life.
- The study found that 71% of placebo patients had flare-ups linked to new HO lesions, while garetosmab reduced the severity, duration, and frequency of these flare-ups throughout the trial.
Article Synopsis
- - The ODYSSEY OUTCOMES trial evaluated the impact of alirocumab, a drug that targets cholesterol, compared to a placebo on major cardiovascular events in patients with recent acute coronary syndrome, involving over 18,000 participants.
- - Results showed that while both men and women experienced significant reductions in cholesterol levels and cardiovascular events with alirocumab, women had higher initial cholesterol and lipoprotein(a) levels and more co-morbidities.
- - The study concluded that alirocumab improves cardiovascular outcomes post-acute coronary syndrome for both sexes, especially in individuals with higher baseline levels of lipoprotein(a).
Background: Homozygous familial hypercholesterolemia (HoFH) is characterized by early-onset atherosclerotic cardiovascular disease due to the high low-density lipoprotein cholesterol (LDL-C) burden. Patients with null-null low-density lipoprotein receptor () variants respond poorly, if at all, to statins and proprotein convertase subtilisin/kexin type 9 inhibitors, which act by upregulating expression. The 24-week double-blind treatment period (DBTP) of the phase 3 ELIPSE HoFH (Evinacumab Lipid Studies in Patients with Homozygous Familial hypercholesterolemia; NCT03399786) study demonstrated significant LDL-C reductions in patients with HoFH; LDL-C reductions were also observed in those with null-null mutations.
View Article and Find Full Text PDFBackground And Aims: Homozygous familial hypercholesterolaemia (HoFH) is a rare genetic disorder characterized by severely elevated LDL cholesterol (LDL-C) and premature atherosclerotic cardiovascular disease. In the pivotal Phase 3 HoFH trial (NCT03399786), evinacumab significantly decreased LDL-C in patients with HoFH. This study assesses the long-term safety and efficacy of evinacumab in adult and adolescent patients with HoFH.
View Article and Find Full Text PDFPurpose: Natural selection (Mendelian randomization) studies support a causal relationship between elevated triglyceride-rich lipoproteins (TRLs) and atherosclerotic cardiovascular disease (ASCVD). This post-hoc analysis assessed the efficacy of evinacumab in reducing TRLs in patient cohorts from three separate clinical trials with evinacumab.
Methods: Patients with homozygous familial hypercholesterolemia (HoFH) and low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL were enrolled in a phase III trial (R1500-CL-1629; NCT03399786).
Importance: Patients with refractory hypercholesterolemia who do not achieve their guideline-defined low-density lipoprotein cholesterol (LDL-C) thresholds despite treatment with maximally tolerated combinations of lipid-lowering therapies (LLTs) have an increased risk of atherosclerotic cardiovascular disease (ASCVD).
Objective: To evaluate longer-term efficacy and safety of evinacumab in patients with refractory hypercholesterolemia.
Design, Setting, And Participants: This randomized clinical trial included a 2-week screening period followed by a 16-week double-blind treatment period (DBTP) for subcutaneous regimens (evinacumab, 450 mg, once weekly [QW]; evinacumab, 300 mg, QW; evinacumab, 300 mg, every 2 weeks; or placebo QW) or a 24-week DBTP for intravenous regimens (evinacumab, 15 mg/kg, every 4 weeks [Q4W]; evinacumab, 5 mg/kg, Q4W; or placebo Q4W); a 48-week open-label treatment period (OLTP) for intravenous treatment only; and a 24-week follow-up period.
Severe hypertriglyceridemia (sHTG) is an established risk factor for acute pancreatitis. Current therapeutic approaches for sHTG are often insufficient to reduce triglycerides and prevent acute pancreatitis. This phase 2 trial ( NCT03452228 ) evaluated evinacumab (angiopoietin-like 3 inhibitor) in three cohorts of patients with sHTG: cohort 1, familial chylomicronemia syndrome with bi-allelic loss-of-function lipoprotein lipase (LPL) pathway mutations (n = 17); cohort 2, multifactorial chylomicronemia syndrome with heterozygous loss-of-function LPL pathway mutations (n = 15); and cohort 3, multifactorial chylomicronemia syndrome without LPL pathway mutations (n = 19).
View Article and Find Full Text PDFArticle Synopsis
- - Elevated red blood cell distribution width (RDW) is linked to a higher risk of major adverse cardiovascular events (MACE) and death in individuals with cardiovascular disease, as shown in the ODYSSEY OUTCOMES trial involving nearly 19,000 patients with recent acute coronary syndrome (ACS). - This analysis specifically looked at whether RDW could independently predict the risk of MACE and death after ACS and found that higher RDW levels were associated with various risk factors, including age, hypertension, and diabetes. - Despite treatment with alirocumab, which lowered MACE risks, RDW levels remained unchanged and still significantly correlated with increased risks of MACE and death, indicating that RDW is a strong independent predictor regardless of other risk
Background: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain.
Methods: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy.
Article Synopsis
- European guidelines recommend LDL cholesterol (LDL-C) treatment goals of <1.4 mmol/L after an acute coronary syndrome (ACS) event and <1.0 mmol/L for those with recurrent cardiovascular events within the last 2 years.
- In the ODYSSEY OUTCOMES trial, 94.6% of patients who added alirocumab to their statin therapy achieved the LDL-C goal of <1.4 mmol/L, compared to only 17.3% in the placebo group.
- The addition of ezetimibe was projected to achieve LDL-C <1.4 mmol/L in just 10.6% of patients, highlighting the effectiveness of alirocumab over ezetim
Background: Patients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options.
Methods: A retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV®) under emergency compassionate use. Objective were to describe safety and response to REGEN-COV, focusing on the subset of patients who had COVID-19 duration ≥21 days before treatment.
Background: Patients with cognitive impairment associated with schizophrenia may benefit from treatments targeting dysfunctional glutamatergic neurotransmission. BI 409306, a potent and selective phosphodiesterase 9 inhibitor, was assessed in patients with schizophrenia using a learn-and-confirm adaptive trial design.
Methods: This double-blind, parallel-group trial randomized patients 2:1:1:1:1 to once-daily placebo or BI 409306 (10, 25, 50, or 100 mg) for 12 weeks.