Couverture de 3: High Cholesterol with Internal Medicine

3: High Cholesterol with Internal Medicine

3: High Cholesterol with Internal Medicine

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 In this episode we discuss two articles about high cholesterol, one dealing with new targets for treatment, and one about the PCSK9 inhibitors.Presenters: Nam Ha, MD and Britney Plotnick, MD, Wellspan York Hospital Internal Medicine Residency ProgramHosts: Giselle Aerni, MD and Sonya Del Tredici, MDProducer: Robert Stuntz, MDArticle 1: A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. Amarenco, Pierre MD; Kim, Jong MD et al., N Engl J Med 2020; 382:9-19.BackgroundAfter an ischemic stroke of atherosclerotic origin or TIA, guidelines recommend intensive statin therapy to lower serum lipid levels. The SPARCL trial (2006 by the same author) showed a reduction in recurrent stroke with atorvastatin compared to placebo in patients with stroke, and forms the basis for this recommendation. However, a subsequent analysis of the data from that trial showed patients with LDL < 70 had a 28% lower relative risk reduction of stroke than those with LDL < 100 mg/dL. The current guideline recommends a high intensity statin, but does not specify the LDL target. There are limited data on whether a target LDL of 70 is better than a target LDL of 100. Thus, the Treat Stroke to Target trial (TST) was done.What is the clinical question?Population: 3/2010–12/2018, Adults from France and South Korea, ischemic stroke in prior 3 months or TIA within prior 15 days (modified Rankin 0-3), confirmed with imaging. Some patients were on anticoagulation, but the reason was not given.Intervention: Any type and any dose of statin to reach the target of LDL < 70 mg.dL or LDL 90-110 mg/dL. Ezetimibe was also added throughout the follow-up to maintain target. Other interventions also include blood pressure control (target 130/80 in diabetes; less than 140/90 otherwise), hemoglobin A1c%<7, and encouraging smoking cessation.Comparison: Lower target group versus higher target group.Outcomes: Primary endpoints: Nonfatal cerebral infarction or stroke of undetermined origin, nonfatal myocardial infarction, hospitalization for unstable angina followed by urgent coronary revascularization, TIA with urgent carotid revascularization, cardiovascular death (including unexplained sudden death).Secondary endpoints: MI, urgent coronary revascularization after onset of new symptoms, cerebral infarct or urgent revascularization of carotid or cerebral artery after TIA, cerebral infarction with TIA, urgent or elective revascularization of coronary, cerebral, peripheral artery, CVS death, death from any cause, intracranial hemorrhage, newly diagnosed diabetes.Is the trial valid?Randomized? yesBlinded? Blinded adjudicators of events that are components of end pointsGroups similar at baseline? yes, (although a higher percentage of patients in the lower target group were receiving ezetimibe than the higher target one)Follow-up sufficiently long and complete? Maybe. First follow-up was 3 weeks after randomization to adjust medication dose. Follow-up every 6 months after that with measurement of LDL and readjustment of medication as needed. Median follow-up is 5.3 years for French patients vs 2 years for Korean patients (SK patients recruited much later in the trial). Study stopped short due to sponsors lacking funds. Longer follow-up would help see a better picture (e.g. increased incidence of intracranial hemorrhage with LDL target < 70?).Intention to treat analysis? YesWere there enough patients? There were 3760 patients per protocol, but 2873 patients eventually randomized; this may reduce validity of results.Funding bias? Maybe. Study was funded by Pfizer, AstraZeneca, and Merk. Authors received fees.What are the results?Sample size: 2873 patients; 2860 included.Treatment effects: primary endpoint 8.5% in the lower-target (2.27 per 100 person-years) vs 10.9% in the higher-target (2.98 per 100 person-years). Adjusted hazard ratio, 0.78; 95% CI; 0.61-0.98; P=0.04.NNT = 42 for the follow-up intervalAdverse events: Intracranial hemorrhage 18 patients (1.3%) in lower-target vs 13 patients (0.9%) in higher-target. Hazard ratio 1.38, 95% CI, 0.68-2.82. New diabetes in 103 patients (7.2%) in lower-target vs 82 (5.7%) in higher-target. Hazard ratio 1.27; 95% CI, 0.95-1.70.Will the results help me in patient care?Perhaps…in the future. It is good to keep in mind that keeping a lower target LDL is shown here to prevent more cardiovascular events, although the confidence intervals have not been adjusted for multiple comparisons in the trial. Patients, recruited in the FOURIER trial where there was addition of PCSK9 inhibitor for patients with persistent LDL > 70 despite of being on high-dose statin, have LDL level around 30 mg/dL in the intervention group, and these patients have a reduction in major cardiovascular events (including stroke and cardiovascular death).Secondary endpoints such as intracranial hemorrhage could not be statistically analyzed due to hierarchical testing. Perhaps we need more studies to see whether stricter control of LDL can ...
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