Objective: To evaluate the addition of ezetimibe or placebo to on-going simvastatin treatment on attaining the LDL-C treatment target of = 2.60 mmol/L (100 mg/dL) in coronary heart disease (CHD) patients with hypercholesterolemia.
Methods: Patients with documented CHD were recruited if they were on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks, had LDL-C > 2.60 mmol/L and = 4.20 mmol/L (> 100 mg/dL and = 160 mg/dL), triglycerides = 4.00 mmol/L (355 mg/dL) and hepatic transaminases and creatine kinase = 50% above the upper limit of normal. After a 4-week placebo and diet run-in period, eligible patients were randomized to a double-blind, placebo-controlled comparative study with ezetimibe 10mg co-administered with on-going simvastatin 10mg or 20 mg (n = 208) versus placebo to match ezetimibe co-administered with simvastatin 10mg or 20mg for 6 weeks (n = 210).
Results: When ezetimibe was added to on-going simvastatin therapy, a significantly greater percentage of patients attained the LDL-C target of = 2.60 mmol/L after 6 weeks of treatment compared to placebo added to on-going simvastatin (80.4% vs. 17.4%, respectively;p = 0.001). When co-administered with on-going simvastatin therapy, mean percentage reduction in LDL-C from baseline was significantly larger in the ezetimibe group compared to placebo (27.1% vs. 4.1%, respectively; p = 0.001). The co-administration of ezetimibe or placebo to on-going simvastatin treatment was generally well tolerated.
Conclusions: Ezetimibe co-administered with on-going simvastatin 10 mg or 20 mg treatment enabled more CHD patients with hypercholesterolemia to attain the LDL-C treatment target of = 2.60 mmol/L.
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http://dx.doi.org/10.1185/030079905X382004 | DOI Listing |
Expert Opin Drug Saf
January 2025
Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Background: Statin-associated autoimmune hepatitis (AIH) is a rare but potentially life-threatening adverse event. Currently, no studies have investigated the association between AIH and different statins.
Research Design And Methods: This retrospective analysis of statin-associated AIH utilized the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q1 2024) and a systematic literature review.
Arch Dermatol Res
January 2025
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Observational studies have shown that the risk of developing herpes zoster (HZ) increases with the use of statins. However, there are many confounding factors in observational studies. Therefore, our Mendelian randomization (MR) study aimed to explore the causal role of lipids in HZ and to assess the causal impact of lipid-lowering drug targets on HZ risk.
View Article and Find Full Text PDFExpert Opin Pharmacother
December 2024
Department of Metabolic Medicine/Chemical Pathology Guy's, St Thomas' Hospitals, London, UK.
Introduction: Lipid-lowering therapies are well established for the treatment of cardiovascular disease (CVD). Historically monotherapy studies have been performed, but the introduction of statins has led to these drugs being recognized as baseline therapies and to the investigation of combination therapy of both older and newer medications with them.
Areas Covered: Surrogate marker studies have shown additive effects on LDL-C, triglycerides and HDL-C of combination therapies with statins and these have extended to lipoprotein (a).
Expert Opin Drug Saf
December 2024
Department of Cardiology, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Background: Ezetimibe is known for its lipid-lowering safety and tolerability, but its real-world adverse effects have not been fully evaluated. In this study, adverse events associated with ezetimibe were investigated using the FAERS database for the period 2004 to 2023.
Research Design And Methods: Adverse events data for ezetimibe, spanning from the first quarter of 2004 to the fourth quarter of 2023, were standardized and analyzed using signal quantification methods like Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (EBGM).
Pharmacotherapy
December 2024
Department of Pharmacotherapy & Outcomes Science, Virginia Commonwealth University School of Pharmacy, Richmond, Virginia, USA.
Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of death worldwide. Lowering low-density lipoprotein cholesterol (LDL-C) levels is a primary strategy to reduce ASCVD risk. Although statin therapy remains the initial therapy of choice to reduce LDL-C and ASCVD risk, statin intolerance and suboptimal LDL-C lowering response prompts the need for additional non-statin therapies.
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