Rationale for intensive statin treatment in high-risk patients.
ABSTRACT Intensive lipid-lowering therapy with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) is now an established regimen for patients at high risk for cardiovascular events, regardless of baseline low-density lipoprotein cholesterol levels. Treatment with statins to reduce low-density lipoprotein cholesterol levels significantly below 100 mg/dL has been shown to further reduce the risk of cardiovascular morbidity and mortality in high-risk patients and has provided the necessary data for an update to the National Cholesterol Education Program's Third Adult Treatment Panel (ATP III) guidelines. Intensive statin therapy is also well tolerated, with no increased risk of noncardiovascular adverse events and a low incidence of clinically significant liver or muscle enzyme abnormalities. Results of recent clinical and surrogate end point trials confirm that intensive lowering of low-density lipoprotein cholesterol is beneficial and safe in a majority of high-risk patients.
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ABSTRACT: Abstract Objective: To examine outcomes associated with colesevelam treatment among patients with hypercholesterolemia in real-world clinical practice Methods: This analysis was conducted as a retrospective, observational cohort study in an ambulatory-care medical network in Northern California. Patients with orders for colesevelam were identified in the electronic health record between January 2004 and December 2011. The date of the first order during the study period was designated the index date. Patients were evaluated for the following eligibility criteria: a diagnosis of hypercholesterolemia, ≥18 years of age at index date, baseline laboratory values ≤3 months before the index date, ≥12 months of treatment and follow-up, and no prior orders for colesevelam ≤12 months before the index date. Patients who were pregnant during the study period were excluded. Changes in LDL-C and percentage of patients at LDL-C goal were examined. Among patients with diabetes mellitus (DM), changes in glycated hemoglobin (HBA1C) and percentage of patients at HBA1C goal were also examined. Results: Overall, 468 and 181 patients with hypercholesterolemia met the predefined inclusion criteria with treatment and follow-up through 12 and 24 months, respectively. LDL-C decreased significantly from baseline by a mean of 11.4 mg/dL and 15.7 mg/dL (p<0.0001, for each) at 12 and 24 months, respectively, and the percentages of patients at LDL-C goal increased by 13.9% and 21.0%. Among patients with DM and a baseline HBA1C ≥8%, 113 and 39 had treatment and follow-up through 12 and 24 months, respectively. HBA1C decreased significantly by a mean of 0.72% (P=0.0001) and 0.75% (P=0.010) and 11.5% and 12.8% were at HBA1C goal at 12 and 24 months, respectively. This study is limited by its retrospective and observational study design. Conclusions: Colesevelam treatment in a real-world setting was associated with improvements in LDL-C and HBA1C through 24 months of follow-up.Current Medical Research and Opinion 09/2013; · 2.26 Impact Factor
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ABSTRACT: Colesevelam HCl is a bile acid sequestrant (BAS) which has been specifically designed with a unique structure for the purpose of improving tolerability and reducing potential drug interactions compared to older BAS, such as cholestyramine and colestipol. As a class, BAS are known to reduce cholesterol and glucose levels, and to reduce atherosclerotic coronary heart disease (CHD) risk as monotherapy, and in combination with other lipid-altering drug therapies. Colesevelam HCl has specifically been shown to reduce total and low-density lipoprotein (LDL) cholesterol levels, and has been approved as a cholesterol-lowering drug since year 2000. It has also been shown to reduce glucose levels. This discussion reviews mechanisms by which BAS lower cholesterol, and potential mechanisms by which BAS lower glucose levels in patients with type 2 diabetes mellitus. Finally this paper specifically reviews colesevelam HCl's pharmacology, lipid and glucose efficacy, safety/tolerability, and clinical use.Vascular Health and Risk Management 02/2007; 3(5):733-42.