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Volanesorsen and Triglyceride Levels in Familial Chylomicronemia Syndrome
This phase 3 trial showed that treatment with volanesorsen, an antisense oligonucleotide drug complementary to mRNA encoding apolipoprotein C-III, resulted in a mean reduction in triglyceride levels of 77% over the course of 3 months.
Journal Article
The Genealogy of a Gene
InThe Genealogy of a Gene, Myles Jackson uses the story of the CCR5 gene to investigate the interrelationships among science, technology, and society. Mapping the varied \"genealogy\" of CCR5 -- intellectual property, natural selection, Big and Small Pharma, human diversity studies, personalized medicine, ancestry studies, and race and genomics -- Jackson links a myriad of diverse topics. The history of CCR5 from the 1990s to the present offers a vivid illustration of how intellectual property law has changed the conduct and content of scientific knowledge, and the social, political, and ethical implications of such a transformation. The CCR5 gene began as a small sequence of DNA, became a patented product of a corporation, and then, when it was found to be an AIDS virus co-receptor with a key role in the immune system, it became part of the biomedical research world -- and a potential moneymaker for the pharmaceutical industry. When it was further discovered that a mutation of the gene found in certain populations conferred near-immunity to the AIDS virus, questions about race and genetics arose. Jackson describes these developments in the context of larger issues, including the rise of \"biocapitalism,\" the patentability of products of nature, the difference between U.S. and European patenting approaches, and the relevance of race and ethnicity to medical research.
eBook
Team Yankee : a novel of World War III
\"This revised and updated edition of the classic Cold War novel ... reminds us once again might have occurred had the United States and its Allies taken on the Russians in Europe, had cooler geopolitical heads not prevailed\"--Publisher marketing.
Book
Antisense Inhibition of Apolipoprotein C-III in Patients with Hypertriglyceridemia
Weekly doses of an antisense inhibitor of apolipoprotein C-III (APOC3) in persons with severe or uncontrolled hypertriglyceridemia resulted in a reduction in APOC3 and triglyceride levels at the end of 13 weeks.
Elevated triglyceride levels are associated with several pathologic conditions, including insulin resistance, the metabolic syndrome, diabetes, cardiovascular disease, and hereditary disorders, such as the familial chylomicronemia syndrome, familial combined hyperlipidemia, and familial hypertriglyceridemia.
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Patients with triglyceride levels above 2000 mg per deciliter (22.6 mmol per liter), measured at the peak of abdominal pain, are at high risk for pancreatitis.
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Current guidelines from the Endocrine Society and the European Atherosclerosis Society recommend that fasting triglyceride levels should be maintained at values below 1000 mg per deciliter (11.3 mmol per liter) or 10 mmol per liter, respectively, to prevent intermittent . . .
Journal Article
Plozasiran, an RNA Interference Agent Targeting APOC3, for Mixed Hyperlipidemia
Persons with mixed hyperlipidemia are at risk for atherosclerotic cardiovascular disease due to an elevated non-high-density lipoprotein (HDL) cholesterol level, which is driven by remnant cholesterol in triglyceride-rich lipoproteins. The metabolism and clearance of triglyceride-rich lipoproteins are down-regulated through apolipoprotein C3 (APOC3)-mediated inhibition of lipoprotein lipase.
We carried out a 48-week, phase 2b, double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of plozasiran, a hepatocyte-targeted APOC3 small interfering RNA, in patients with mixed hyperlipidemia (i.e., a triglyceride level of 150 to 499 mg per deciliter and either a low-density lipoprotein [LDL] cholesterol level of ≥70 mg per deciliter or a non-HDL cholesterol level of ≥100 mg per deciliter). The participants were assigned in a 3:1 ratio to receive plozasiran or placebo within each of four cohorts. In the first three cohorts, the participants received a subcutaneous injection of plozasiran (10 mg, 25 mg, or 50 mg) or placebo on day 1 and at week 12 (quarterly doses). In the fourth cohort, participants received 50 mg of plozasiran or placebo on day 1 and at week 24 (half-yearly dose). The data from the participants who received placebo were pooled. The primary end point was the percent change in fasting triglyceride level at week 24.
A total of 353 participants underwent randomization. At week 24, significant reductions in the fasting triglyceride level were observed with plozasiran, with differences, as compared with placebo, in the least-squares mean percent change from baseline of -49.8 percentage points (95% confidence interval [CI], -59.0 to -40.6) with the 10-mg-quarterly dose, -56.0 percentage points (95% CI, -65.1 to -46.8) with the 25-mg-quarterly dose, -62.4 percentage points (95% CI, -71.5 to -53.2) with the 50-mg-quarterly dose, and -44.2 percentage points (95% CI, -53.4 to -35.0) with the 50-mg-half-yearly dose (P<0.001 for all comparisons). Worsening glycemic control was observed in 10% of the participants receiving placebo, 12% of those receiving the 10-mg-quarterly dose, 7% of those receiving the 25-mg-quarterly dose, 20% of those receiving the 50-mg-quarterly dose, and 21% of those receiving the 50-mg-half-yearly dose.
In this randomized, controlled trial involving participants with mixed hyperlipidemia, plozasiran, as compared with placebo, significantly reduced triglyceride levels at 24 weeks. A clinical outcomes trial is warranted. (Funded by Arrowhead Pharmaceuticals; MUIR ClinicalTrials.gov number NCT04998201.).
Journal Article
Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia
Among patients with moderate hypertriglyceridemia and high cardiovascular risk, monthly olezarsen injections resulted in significantly greater reduction in triglyceride levels at 6 months than placebo.
Journal Article