Real world effectiveness of PCSK-9 inhibitors combined with statins versus statins-based therapy among patients with very high risk of atherosclerotic cardiovascular disease in China(RWE-PCSK study)

BACKGROUND The efficacy and safety of proprotein convertase subtilisin/kexin type 9(PCSK-9) inhibitors were confirmed by several clinical trials, but its effectiveness in routine clinical practice in China has not been evaluated. This study aims to describe the real world effectiveness of PCSK-9 inhibitors combined with statins compared with statins-based therapy among patients with very high risk of atherosclerotic cardiovascular disease(ASCVD).METHODS This is a multi-center observational study, enrolled patients from 32 hospitals who underwent percutaneous coronary intervention(PCI) from January to June in 2019. There are 453 patients treated with PCSK-9 inhibitors combined with statins in PCSK-9 inhibitor group and 2,610 patients treated with statins-based lipid lowering therapies in statins-based group. The lipid control rate and incidence of major adverse cardiovascular events(MACE) over six months were compared between two groups.A propensity score-matched(PSM) analysis was used to balance two groups on confounding factors. Survival analysis using Kaplan-Meier methods was applied for MACE.RESULTS In a total of 3,063 patients, 89.91% of patients had received moderate or high-intensity statins-based therapy before PCI, but only 9.47% of patients had low-density lipoprotein cholesterol(LDL-C) levels below 1.4 mmol/L at baseline. In the PSM selected patients, LDL-C level was reduced by 42.57% in PCSK-9 inhibitor group and 30.81%(P < 0.001) in statins-based group after six months. The proportion of LDL-C ≤ 1.0 mmol/L increased from 5.29% to 29.26% in PCSK-9 inhibitor group and 0.23% to 6.11% in statins-based group, and the proportion of LDL-C ≤ 1.4 mmol/L increased from 10.36% to 47.69% in PCSK-9 inhibitor group and 2.99% to 18.43% in statins-based group(P < 0.001 for both). There was no significant difference between PCSK-9 inhibitor and statins-based treatment in reducing the risk of MACE(hazard ratio = 2.52, 95% CI: 0.49-12.97, P = 0.250).CONCLUSIONS In the real world, PCSK-9 inhibitors combined with statins could significantly reduce LDL-C levels among patients with very high risk of ASCVD in China. The long-term clinical benefits for patients received PCSK-9 inhibitor to reduce the risk of MACE is still unclear and requires further study.

Impact of cardiologist intervention on guideline-directed use of statin therapy

BACKGROUND Statins have an important and well-established role in the prevention of atherosclerotic cardiovascular disease(ASCVD).However,several studies have reported widespread underuse of statins in various practice settings and populations.Review of relevant literature reveals opportunities for improvement in the implementation of guideline-directed statin therapy(GDST).AIM To examine the impact of cardiologist intervention on the use of GDST in the ambulatory setting.METHODS Patients with at least one encounter at the adult Internal Medicine Clinic(IMC)and/or Cardiology Clinic(CC),who had an available serum cholesterol test performed,were evaluated.The 2 comparison groups were defined as:(1)Patients only seen by IMC;and(2)Patients seen by both IMC and CC.Patients were excluded if variables needed for calculation of ASCVD risk scores were lacking,and if demographic information lacked guideline-directed treatment recommendations.Data were analyzed using student t-tests or χ^2,as appropriate.Analysis of Variance was used to compare rates of adherence to GDST.RESULTS A total of 268 patients met the inclusion criteria for this study;211 in the IMC group and 57 in the IMC-CC group.Overall,56%of patients were female,mean age 56 years(±10.65,SD),22%Black or African American,56%Hispanic/Latino,14%had clinical ASCVD,13%current smokers,66%diabetic and 63%hypertensive.Statin use was observed in 55%(n=147/268)of the entire patient cohort.In the IMC-CC group,73.6%(n=42/57)of patients were prescribed statin therapy compared to 50.7%(n=107/211)of patients in the IMC group(P=0.002).In terms of appropriate statin use based on guidelines,there was no statistical difference between groups[IMC-CC group 61.4%(n=35/57)vs IMC group,55.5%(n=117/211),P=0.421].Patients in the IMC-CC group were older,had more cardiac risk factors and had higher proportions of non-white patients compared to the IMC group(P<0.02,all).CONCLUSION Although overall use of GDST was suboptimal,there was no statistical difference in appropriate statin use based on guidelines between groups managed by general internists alone or co-managed with a cardiologist.These findings highlight the need to design and implement strategies to improve adherence rates to GDST across all specialties.

Statins in Alcoholic and Non-Alcoholic Fatty Liver Disease and Chronically Elevated Liver Enzymes

The prevalence of alcoholic liver disease and non-alcoholic liver disease patients has nearly doubled over the past decades worldwide. Alcoholic liver disease among patients with chronic liver disease has increased with arisen due to alcohol consumption and obesity. The diagnosis plays a crucial role in treating such conditions based on the stages of liver functioning. The elevated liver enzymes are the key characterizing of identifying the alcoholic liver disease (ALD) and NAFLD. Later on, there is a progression of the disease conditions by developing fibrosis and cirrhosis, leading to liver carcinoma. The other state, steatohepatitis, is associated with an increase in liver-related and can lead to mortality. Risk factors for both diseases are growing, leading to various complications in health. There is no specific treatment up to date for these conditions, but statins play a crucial role in managing several liver disease conditions. The commonly used drug is hydroxymethylglutaryl coenzyme A (HMG Co-A) reductase inhibitors. It is also known as statins, which help normalize liver enzymes in patients with elevated plasma aminotransferases. As a result, external liver damage is considered safe for the liver as the Statin medication at low to moderate dose usage. OBJECTIVES: The main scope of this review is to study the various factors like pharmacological actions, adverse events, and biochemical and liver cell imaging results in patients with ALD and NAFLD. The different types of statins used in alcoholic and non-alcoholic patients’ clinical data for the safety of the statin therapy were concluded in this review. Fatty liver changes of both liver disease conditions were studied using different drugs. The other liver enzymes like Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl Transferase (GGT), and the effectiveness of Statin therapy are considered vital concepts in this review.