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The prevalence of statin intolerance was 1.0 % (n = 1320) and 5.2 % (n = 6985) using Definitions 1 and 2, respectively. Overall, 45,266 (33.6 %) beneficiaries had statin intolerance by Definition 2 or discontinued statins and 55,990 (41.5 %) beneficiaries had high adherence to statins. Compared with beneficiaries with high adherence to statins, those with statin intolerance and who had statin intolerance or discontinued statins were more likely to be female versus male, and black, Hispanic or Asian versus white. The multivariable adjusted odds ratio for statin intolerance by Definitions 1 and 2 comparing patients initiating high versus low/moderate intensity statins were 2.82 (95%CI: 2.42-3.29), and 8.58 (8.07-9.12), respectively, and for statin intolerance or statin discontinuation was 2.35 (2.25-2.45).
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Based on 2 studies (n = 83,241), the diagnostic yield of universal screening for FH in childhood is 1.3 to 4.8 cases per 1000 screened. There was no eligible evidence on the benefits or harms of FH screening in childhood. Eight placebo trials of statin drugs (n = 1071, 6-104 weeks) found low-density lipoprotein cholesterol (LDL-C) decreases of 20% to 40%; 1 trial (n = 214) showed a 2.01% decrease in carotid intima-media thickness with statins, compared with 1.02% with placebo (P = .02). Three placebo trials of bile acid-sequestering agents (n = 332, 8-52 weeks) showed LDL-C reductions of 10% to 20%. In 1 trial (n = 248), ezetimibe with simvastatin resulted in greater LDL-C reductions compared with simvastatin alone at 33 weeks (mean, -54.0% [SD, 1.4%] vs -38.1% [SD, 1.4%]). One trial of ezetimibe monotherapy (n = 138) showed mean LDL-C decreases of 28% (95% CI, -31% to -25%) from baseline and negligible change with placebo at 12 weeks. Eighteen studies found statins generally well tolerated. One observational study found lower, but still normal, dehydroepiandrosterone sulfate concentrations in statin-treated males with FH at 10-year follow-up. Bile acid-sequestering agents were commonly associated with adverse gastrointestinal symptoms and poor palatability. There was no eligible evidence on the effect of FH treatment on myocardial infarction or stroke in adulthood.
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The risk of habdomyolysis among hospitalized patients receiving statins was low; no difference among the available statins was evident. Further data are needed to establish the risk profile but current findings already offer guidance to physicians.
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Prospective epidemiologic analysis among participants in the Study of Heart and Renal Protection (SHARP), a randomized controlled trial.
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At present, lipoprotein apheresis, combined with high-dose statin and ezetimibe therapy, is the best available means of treating patients with homozygous and statin-refractory heterozygous familial hypercholesterolaemia (FH). However, the extent of cholesterol-lowering achieved is often insufficient to meet the targets set by current guidelines. The recent advent of three new classes of lipid-lowering agents provides new hope that the latter objective may now be achievable. These compounds act either by reducing low-density lipoprotein (LDL) production by inhibiting apolipoprotein B synthesis with an antisense oligonucleotide (mipomersen) or by inhibiting microsomal triglyceride transfer protein (lomitapide), or by enhancing LDL catabolism via monoclonal antibody-mediated inhibition of the activity of proprotein convertase subtilisin/kexin 9 (PCSK9) (evolocumab). Depending on the outcome of current trials, it seems likely that these compounds, used alone or combined with lipoprotein apheresis, will markedly improve the management of refractory FH.
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Prior to the start of rosuvastatin treatment, on diet alone, mean LDL-C levels were 291 ± 59 mg/dL and decreased to 141 ± 30 mg/dL on rosuvastatin 40 mg daily at the substudy baseline prior to ezetimibe. After 12 weeks, the addition of ezetimibe produced an additional 15% ±9% reduction in LDL-C (P < 0.001) compared to pre-rosuvastatin levels and a mean LDL-C of 103 ± 27 mg/dL, resulting in 59% of patients reaching their LDL-C goals. The combination reduced LDL-C by 65% ± 9% from diet alone. Combination with ezetimibe also produced significant additional percent reductions in non-high-density lipoprotein (14%), apolipoprotein B (10%), and triglycerides (6%). Median C-reactive protein was reduced 54% (P < 0.001) by the combination compared with diet alone, a further incremental reduction of 13% (P < 0.001) with the addition of ezetimibe. The combination was well tolerated, with no patients developing myopathy or clinically significant elevations of creatine kinase or transaminases.
Combining low-dose statin and ezetimibe reduces the low-density lipoprotein cholesterol (LDL-C) similar to high-dose statin. However, whether there is a difference in the effect of these 2 lipid-lowering regimes on endothelial function is still controversial.
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We conclude that the cholesterol absorption inhibitor ezetimibe can suppress hepatic injury in non-obese patients with NAFLD and that ezetimibe may offer a novel treatment for NAFLD.
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A total of 44% of Hong Kong patients not at LDL-C goals at baseline did not achieve them over 1.9 years. More effective and well-tolerated therapies, including adjunctive regimens (e.g., ezetimibe-statin, niacin-statin), may be necessary to enhance LDL-C goal achievement and increase event-free time.
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The purpose of this study was to examine the efficacy and safety of ezetimibe (EZE) coadministered with simvastatin (SIMVA) in a large cohort of African Americans with primary hypercholesterolemia. In a multicenter, randomized, double-blind study, patients were considered eligible for enrollment if after a washout/placebo run-in period, low-density-lipoprotein (LDL) cholesterol level was > or = 145 and < or = 250 mg/dl and triglyceride level was < or = 350 mg/dl. Eligible patients were randomized to SIMVA 20 mg coadministered with either EZE 10 mg (n = 124) or placebo (n = 123) for 12 weeks. At study endpoint, EZE/SIMVA 10/20 mg resulted in a significant mean percent reduction in LDL cholesterol from baseline of 45.6% compared with 28.3% for SIMVA 20 mg alone (p < or = 0.01). There were significantly greater mean reductions in total cholesterol (33% vs. 21%), triglycerides (median 22% vs. 15%), nonhigh-density-lipoprotein (non-HDL) cholesterol (42% vs. 26%), and apolipoprotein B (38% vs. 25%) with EZE/SIMVA 10/20 mg compared with SIMVA 20 mg alone, respectively (p < or = 0.01). There was no difference in HDL cholesterol between the EZE/SIMVA 10/20-mg and SIMVA 20-mg alone groups (+1% vs. +2%, respectively). Coadministration of EZE/SIMVA 10/20 mg demonstrated a safety profile similar to that of SIMVA 20 mg. In conclusion, EZE/SIMVA 10/20 mg provided significantly greater improvement in atherogenic lipid profiles and was well tolerated compared with SIMVA 20-mg monotherapy in a large cohort of African Americans with primary hypercholesterolemia.
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Although many studies have documented that reduction of plasma cholesterol levels decreases the risk of coronary artery disease, it remains the most common cause of death in the Western world. Current therapeutic options are effective in lowering cholesterol, especially in clinical trials, but clinical application is not optimized for many reasons. Dietary restriction for long-term management of hypercholesterolemia is helpful but usually insufficient to reduce low-density lipoprotein cholesterol (LDL-C) to goal levels. Powerful drugs are available, but these are often insufficient to meet the clinical demands for cholesterol-lowering therapy. Phytosterols and phytostanols have been partially effective by providing some inhibition of absorption of cholesterol. Compounds that specifically and more effectively block intestinal absorption of dietary and biliary cholesterol should provide a significant new agent for altering lipoprotein concentrations favorably. Ezetimibe is the first of this class of compounds that act at the gut epithelium to reduce cholesterol absorption in the milligram dose range markedly. Clinical studies indicate that ezetimibe effectively decreases LDL-C by 15 to 20% as monotherapy, with a favorable safety profile. Moreover, results from preliminary clinical trials indicate that ezetimibe given concomitantly with a statin provides additive efficacy. The combination represents a new approach to lipid management, achieving greater LDL-C and triglyceride reductions and greater improvements in HDL-C than statin monotherapy. This could offer another important option in clinical practice for management of hypercholesterolemic patients.
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The chromatographic separation of the drugs were performed on an X-Terra C8 (4.6 x 150 mm, 3.5 mm), with phosphate buffer [pH 3.5 with Ortho Phosphoric Acid] - acetonitrile 40:60 (v/v) as mobile phase. The detection was performed at 235 nm. The flow rate was maintained at 1.2 mL/min. The run time was 8.0 min.
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Both HeFH and HoFH require dietary and lifestyle modification. Pharmacotherapy of adult HeFH patients is largely driven by the American Heart Association (AHA) algorithm. A high-potency statin is started initially with a goal low-density lipoprotein cholesterol (LDL-C) reduction of >50 %. The LDL-C target is adjusted to <100 or <70 mg/dL in subjects with coronary artery disease (CAD) with ezetimibe being second line. If necessary, a third adjunctive therapy, such as a PSCK9 inhibitor (not yet approved in children) or bile acid-binding resin, can be added. Finally, LDL-C apheresis can be considered in patients with LDL-C >300 mg/dL (or >200 mg/dL with significant CAD, although now approved for LDL-C as low as 160 mg/dL with CAD). Due to the early, severe LDL-C elevation in HoFH patients, concerning natural history, rarity of the condition, and nuances of treatment, all HoFH patients should be treated at a pediatric or adult center with HoFH experience. LDL-C apheresis should be considered as early as 5 years of age. However, apheresis availability and tolerability is limited and pharmacotherapy is required. Generally, the AHA algorithm with reference to the European Atherosclerosis Society Consensus Panel recommendations is reasonable with all patients initiated on high-dose, high-potency statin, ezetimibe, and bile acid-binding resins. In most, additional LDL-C lowering is required with PCSK9 inhibitors and/or lomitapide or mipomersen. Liver transplantation can also be considered at experienced centers as a last resort.
Direct-to-consumer advertising (DTCA) of prescription drugs is the most common form of health communication Americans are exposed to. The effects of DTCA on prescription requests and utilization are well established, but little is known about the effects of advertisements on health behaviors. Many advertisements, especially those promoting drugs to prevent or treat cardiovascular disease, refer to lifestyle change as a way to improve health. However, no studies have examined how consumers interpret these frequently ambiguous messages. We used in-depth interviews with 45 participants, recruited in Los Angeles, USA between April 2007 and July 2008, to explore perceptions of 5 advertisements for drugs that prevent or treat cardiovascular disease (Lipitor(®), Vytorin(®), Zetia(®), Caduet(®), Plavix(®)). We found that participants interpreted advertising messages within their own life context and identified four trajectories for enacting behavior change versus taking prescription drugs: Negotiators, Avoiders, Embracers and Jumpstarters. Underlying these four typologies were beliefs about whether lifestyle change was something an individual could do or was willing to do. Our results also show how an advertisement narrative could potentially shift perceptions of causality by suggesting that high cholesterol is primarily hereditary, thereby obviating the need for lifestyle change. Some participants stated that they would prefer lifestyle change to a particular prescription drug, but felt that others would be more likely to embrace taking a prescription drug. This "Third Person Effect" may be masking participants' intentions by identifying a more socially desirable route to therapeutic change. These findings raise questions about how the typologies are distributed in the population and how advertising may shift consumers' beliefs over time, thereby contributing to new forms of medicalization. Effective regulation of DTCA may require expanding scrutiny beyond the accuracy of claims about benefits and risks, to also considering the broader narratives in which these claims are made.