Statin Monotherapy Group Research Articles

GW24-e0076 Safety of fenofibrate-statin therapy versus statin alone: a meta-analysis

ObjectivesAlthough fenofibrate-statin combination therapy could improve the lipid parameters in patients with mixed dyslipidemia, the coadministration is still underutilised because of safety of the combination therapy.MethodsRandomised, controlled trials were searched...

Adverse events following statin–fenofibrate therapy versus statin alone: A meta‐analysis of randomized controlled trials

The combination of fenofibrate with statins is a beneficial therapeutic option for patients with mixed dyslipidaemia, but concerns about adverse events (AEs) make physicians reluctant to use this combination therapy. Medline, Embase and the Cochrane Library were searched to identify 13 randomized controlled trials, involving 7712 patients, of statin-fenofibrate therapy versus statin alone for review. There were significant decreases in low-density lipoprotein-cholesterol, triglycerides and total cholesterol and increases in high-density lipoprotein-cholesterol in patients receiving combination therapy compared with statin therapy alone. The incidence of aminotransferase elevations in the fenofibrate-statin therapy group was significantly higher than in the statin monotherapy group (odds ratio (OR), 1.66; 95% confidence interval (CI) 1.17-2.37; P < 0.05). The incidence of elevated creatine kinase levels (OR 0.88; 95% CI 0.63-1.23; P > 0.05), muscle-associated AEs (OR 0.98; 95% CI 0.88-1.09; P > 0.05) and withdrawals attributed to liver and muscle dysfunction did not differ significantly between the two groups. The efficacy of fenofibrate + standard-dose statin and incidence of AEs in the fenofibrate + standard-dose statin group were almost identical to those in the fenofibrate-statin group. In conclusion, combination therapy improves the blood lipid profile of patients. Fenofibrate-statin combination therapy appears to be as well tolerated as statin monotherapy. Physicians should consider fenofibrate-statin combination therapy in patients but monitor aminotransferase levels to avoid hepatic complications.

Cardiovascular Events in Patients Received Combined Fibrate/Statin Treatment versus Statin Monotherapy: Acute Coronary Syndrome Israeli Surveys Data

BackgroundThe effect of combination of fibrate with statin on major adverse cardiovascular events (MACE) following acute coronary syndrome (ACS) hospitalization is unclear. The main aim of this study was to investigate the 30-day rate of MACE in patients who participated in the nationwide ACS Israeli Surveys (ACSIS) and were treated on discharge with a fibrate (mainly bezafibrate) and statin combination vs. statin alone.MethodsThe study population comprised 8,982 patients from the ACSIS 2000, 2002, 2004, 2006, 2008 and 2010 enrollment waves who were alive on discharge and received statin. Of these, 8,545 (95%) received statin alone and 437 (5%) received fibrate/statin combination. MACE was defined as a composite measure of death, recurrent MI, recurrent ischemia, stent thrombosis, ischemic stroke and urgent revascularization.ResultsPatients from the combination group were younger (58.1±11.9 vs. 62.9±12.6 years). However, they had significantly more co-morbidities (hypertension, diabetes), current smokers and unfavorable cardio-metabolic profiles (with respect to glucose, total cholesterol, triglyceride and HDL-cholesterol). Development of MACE was recorded in 513 (6.0%) patients from the statin monotherapy group vs. 13 (3.2%) from the combination group, p = 0.01. 30-day re-hospitalization rate was significantly lower in the combination group: 68 (15.6%) vs. 1691 (19.8%) of patients, respectively; p = 0.03. Multivariable analysis identified the fibrate/statin combination as an independent predictor of reduced risk of MACE with odds ratio of 0.54, 95% confidence interval 0.32–0.94.ConclusionA significantly lower risk of 30-day MACE rate was observed in patients receiving combined fibrate/statin treatment following ACS compared with statin monotherapy. However, caution should be exercised in interpreting these findings taking into consideration baseline differences between our observational study groups.

Comparative effectiveness of statin plus fibrate combination therapy and statin monotherapy in patients with type 2 diabetes: use of propensity‐score and instrumental variable methods to adjust for treatment‐selection bias

Type 2 diabetes is associated with increased cardiovascular risk. The comparative effectiveness of statin plus fibrate combination therapy and statin monotherapy in reducing risk of cardiovascular disease in real-world settings is unknown. A retrospective database analysis was performed using a large managed care claims database of patients identified with type 2 diabetes based on diagnosis codes from January 2002 through December 2003 and continuously enrolled for the entire study period, 5.5 years. A statin plus fibrate combination therapy group (patients who used statins less than 6 months and augmented with fibrates for more than 6 months) and a statin monotherapy group (patients who used statins persistently) among patients with type 2 diabetes were followed for 3 years to examine the relationship between the intervention and cardiovascular events using a multivariable logistic regression model, propensity score method, and instrumental variable approach. The statin plus fibrate combination therapy group of 318 and the statin monotherapy group of 9928 were identified from 75,515 diabetics. After adjusting for factors that can impact cardiovascular outcomes, the combination therapy group did not significantly experience a reduction in cardiovascular disease, as compared with the statin monotherapy group (OR = 0.77; p = 0.083). The statin plus fibrate combination therapy group was significantly associated with a reduction in cardiovascular events after propensity matching (OR = 0.53; p = 0.002). Using the physician prescribing preference instrument to adjust for unmeasured confounding, we did not find evidence that subjects in the statin plus fibrate combination therapy group versus stain monotherapy group experienced a significant reduction in cardiovascular events (p = 0.124). We did not find a difference in effectiveness regarding cardiovascular outcomes between the statin plus fibrate combination therapy and the statin monotherapy after controlling for hidden bias.

Squalene Synthase Inhibitor Lapaquistat Acetate

Elevated serum cholesterol level is an important risk factor for cardiovascular disease,1 and cholesterol lowering by 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors or statins has been shown to reduce cardiovascular events.2 The reduction in cardiovascular risks with statin therapy, whether for primary or secondary prevention, correlates almost linearly with the reduction in serum cholesterol levels.3 Indeed, for every 30 mg/dL decrease in low-density lipoprotein-cholesterol (LDL-C), there is a concomitant 30% decrease in cardiovascular events.2 For patients presenting with acute coronary syndrome,4 or in patients with stable coronary artery disease,5 intensive lipid-lowering therapy provides even greater clinical benefits, implying that the lower the LDL-C, the better the outcome is, especially for high-risk patients. Because most of the US adult population with coronary heart disease has serum LDL-C levels between 135 and 145 mg/dL,6 to achieve an Adult Treatment Panel III/National Cholesterol Education Panel guideline for LDL-C target goal of <100 mg/dL with an optional goal of <70 mg/dL, most high-risk patients with coronary heart disease will likely require at least a 40% to 50% reduction in LDL-C.2 Article see p 1974 Depending on the dose used, most statins can reduce serum cholesterol by 30% to 58%.7 This is compared with bile acid sequestrants or intestinal cholesterol absorption inhibitors, which tend to lower serum cholesterol by only 15% to 18%. Thus, it is not surprising that statins have emerged as the principal cholesterol-lowering therapy for patients at risk for cardiovascular disease. However, most statins, with the exception of the more potent statins, such as atorvastatin and rosuvastatin, will require near-maximum dosages to achieve a 40% to 50% LDL-C reduction. This is because the majority of statins' LDL-C–lowering efficacy occurs at the starting dose with only a modest 4% to 6% further LDL-C reduction with …