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Published in Geoffrey P. Webb, Nutrition, 2019
The results of what is known as the Jupiter Trial are in some ways even more dramatic because this large collaborative study, involving 26 countries, used patients who did not have high blood cholesterol. These subjects had high levels of an inflammatory marker, (high-sensitivity C-reactive protein). This trial was scheduled to involve 5 years of subject treatment, but it was terminated early because of a recommendation from the independent monitoring board. After around 2 years of treatment, there was a 44% reduction in cardiovascular events, a 54% reduction in heart attacks, a 48% reduction in strokes and a 20% reduction in all-cause mortality. So cholesterol-lowering was beneficial even to people whose cholesterol level was within the normal range.
Additional Supplements That Support Glycemic Control and Reduce Chronic Inflammation
Published in Robert Fried, Richard M. Carlton, Type 2 Diabetes, 2018
Robert Fried, Richard M. Carlton
Furthermore, the Lancet published a study titled “Cardiovascular benefits and diabetes risks of statin therapy in primary prevention.” The investigators undertook an analysis of participants from the “Justification for the Use of Statin in Prevention: An Intervention Trial Evaluating Rosuvastatin,” that is, the JUPITER trial (Ridker. 2009), to address the balance of vascular benefits versus diabetes hazard of statin use.
Inflammation, Inflammatory Markers, and Cardiovascular Risk
Published in P. K. Shah, Risk Factors in Coronary Artery Disease, 2006
Since nearly half of all myocardial infarctions occur in subjects with average or below average cholesterol levels, these tantalizing observations if confirmed in prospective trials would provide a useful way of selecting a relatively high-risk subset of such individuals who could benefit from statin therapy despite average or below average cholesterol levels. Analysis of two recent trials of low (pravastatin, 40 mg) and high dose statin (atorvastatin, 80 mg) therapy in patients with established coronary heart disease showed that patients achieving a reduction in CRP levels had better overall clinical outcomes across all levels of LDL cholesterol, with the best outcomes achieved among patients with LDL below 70 mg/dl and CRP lowering to levels below 2 mg/L (72,73). These intriguing observations raise an interesting question: Should CRP monitoring supplement LDL monitoring in patients receiving statins or, for that matter, other risk modifying therapies? Answers to this question must await additional prospective trials such as the JUPITER trial, which is currently ongoing.
Statins as an adjunctive therapy for COVID-19: the biological and clinical plausibility
Published in Immunopharmacology and Immunotoxicology, 2021
Tarek Kashour, Rabih Halwani, Yaseen M. Arabi, M. Rizwan Sohail, John C. O’Horo, Andrew D. Badley, Imad M. Tleyjeh
Randomized trials demonstrated that statins improve cardiovascular outcomes beyond their lipid lowering effect through reduction of inflammation [28]. The JUPITER trial was an RCT of over 17,000 participants with normal low-density lipoprotein (LDL) and elevated high-sensitivity CRP (hs-CRP) that examined the role of rosuvastatin in the primary prevention of CVD. In this trial, rosuvastatin at 20 mg/day reduced hs-CRP by 37% [25]. Likewise, the investigators of the PROVE-IT-TIMI22 trial explored the relative efficacy of pravastatin 40 mg/day and atorvastatin 80 mg in lowering LDL cholesterol and CRP in 3745 acute coronary syndrome (ACS) patients. Atorvastatin treatment at daily dose of 80 mg/day reduced hs-CRP below 2 mg/L in 57.5% of treated patients [26]. These anti-inflammatory effects were shown to result in significant reduction in cardiovascular events independent of LDL lowering effect [28]. For example, in JUPITER trial, patients who achieved hs-CRP levels below 2 mg/L had 55% reduction in cardiovascular events [25].
Statins and the potential for higher diabetes mellitus risk
Published in Expert Review of Clinical Pharmacology, 2019
Srikanth Yandrapalli, Aaqib Malik, Kenneth Guber, Yogitha Rochlani, Gayatri Pemmasani, Manasa Jasti, Wilbert S Aronow
Several large studies have established the undisputed benefit of statins for primary and secondary ASCVD prevention. It is important to understand the balance between the risks and benefits of statin prescription in various at-risk groups to facilitate safe and successful prevention of CVD especially at the primary prevention level where risks must be carefully balanced against benefit. In the primary CVD prevention JUPITER trial which assessed the vascular benefits as well as diabetes hazard with statin use, it was found that cardiovascular benefits of statin therapy exceeded the risk of DM incidence in both low DM risk (no major risk factors for developing DM) and high DM risk (one or more risk factors) patient population [9]. Compared to non-users of statins, in high DM risk participants, a 39% significant reduction in primary major adverse cardiac end point and 28% increase in DM (p = 0.01) was observed [9]. In low-risk participants, 52% significant reduction in primary endpoint and no increase in diabetes (p = 0.99) was reported [9]. In a matched observational analysis of statin users compared with non-users, statin use was associated with increased incidence of DM (2.4% vs. 2.1%, p < 0.001) but it was also observed that the benefit of statin treatment overweighed the risk of diabetes incidence in high-risk participants with overall favorable outcomes [44]. The risk-benefit analyses suggested that statin treatment was favorable in high-risk (HR: 0.89; 95% CI: 0.83 to 0.95) and secondary prevention (HR 0.89, 95% CI 0.83–0.96) populations with regards to major adverse cardiovascular events. Among diabetic patients, prior statin use was associated with fewer major adverse cardiovascular events (HR 0.75, 95% CI 0.59–0.97) [44].
Fixed-dose combination of rosuvastatin and ezetimibe: treating hypercholesteremia according to cardiovascular risk
Published in Expert Review of Clinical Pharmacology, 2021
Vivencio Barrios, Carlos Escobar
The JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) demonstrated the marked benefits of rosuvastatin on primary prevention of CVD. The study population comprised 17,802 subjects with LDL-C < 130 mg/dL, high-sensitivity C-reactive protein ≥2.0 mg/L, but no known CVD. Patients received rosuvastatin 20 mg or placebo. The study was stopped prematurely owing to the beneficial effects of rosuvastatin on outcomes after a median follow-up of only 1.9 years. During this period, rosuvastatin provided sustained reductions in LDL-C (50%) and in high-sensitivity C-reactive protein (37%). Of note, compared with placebo, rosuvastatin 20 mg significantly reduced the risk of the primary combined endpoint of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, and cardiovascular death by 44%, the risk of major adverse cardiovascular events (MACE) by 47%, nonfatal myocardial infarction by 65%, any myocardial infarction by 54%, nonfatal stroke by 48%, any stroke by 48%, arterial revascularization by 46%, and all-cause death by 20% (Figure 1) [19]. The 5-year number needed to treat in the JUPITER trial for the primary endpoint was only 20 [20]. The results were consistent according to the subgroups of patients. With regard to adverse effects, while rosuvastatin did not increase the risk of myopathy or cancer, it was associated with a significant but not clinically relevant higher incidence of physician-reported diabetes, as the baseline HbA1c of 5.7% increased to 5.9% with rosuvastatin and to 5.8% with placebo; P = 0.001 [19,21]. In addition, a number of substudies of the JUPITER trial have analyzed the role of rosuvastatin in different subgroups of patients (Table 2) [22–29].