scholarly journals Cardiovascular outcomes trials with statins in diabetes

2018 ◽  
Vol 18 (1) ◽  
pp. 7-13 ◽  
Author(s):  
Fariha Naeem ◽  
Gerard McKay ◽  
Miles Fisher

Treatment with statins is one of the most effective ways of reducing cardiovascular events in those with diabetes. Many studies containing thousands of subjects with diabetes have demonstrated that statins reduce cardiovascular events when there is no known cardiovascular disease (primary prevention) and in those with confirmed atherosclerotic disease (secondary prevention). High-dose statins appear to be even more effective in established cardiovascular disease, but at the expense of increased drug side effects. In this paper we review the evidence for the benefits of statins in diabetes. In a second review we will examine the evidence for possible benefits of other lipid-lowering therapies when these are added to background statin therapy in diabetes.

Author(s):  
Andrew P. Ambrosy ◽  
Jingrong Yang ◽  
Sue Hee Sung ◽  
Amanda R. Allen ◽  
Jesse K. Fitzpatrick ◽  
...  

Background Patients with risk factors or established atherosclerotic cardiovascular disease remain at high‐risk for ischemic events. Triglyceride levels may play a causal role. Methods and Results We performed a retrospective study of adults aged ≥45 years receiving statin therapy, with a low‐density lipoprotein cholesterol of 41 to 100 mg/dL, and ≥1 risk factor or established atherosclerotic cardiovascular disease between 2010 and 2017. Outcomes included death, all‐cause hospitalization, and major adverse cardiovascular events (myocardial infarction, stroke, or peripheral artery disease). The study sample included 373 389 primary prevention patients and 97 832 secondary prevention patients. The primary prevention cohort had a mean age of 65±10 years, with 51% women and 44% people of color, whereas the secondary prevention cohort had a mean age of 71±11 years, with 37% women and 32% people of color. Median triglyceride levels for the primary and secondary prevention cohorts were 122 mg/dL (interquartile range, 88–172 mg/dL) and 116 mg/dL (interquartile range, 84–164 mg/dL), respectively. In multivariable analyses, primary prevention patients with triglyceride levels ≥150 mg/dL were at lower adjusted risk of death (hazard ratio [HR], 0.91; 95% CI, 0.89–0.94) and higher risk of major adverse cardiovascular events (HR, 1.14; 95% CI, 1.05–1.24). In the secondary prevention cohort, patients with triglyceride levels ≥150 mg/dL were at lower adjusted risk of death (HR, 0.95; 95% CI, 0.92–0.97) and higher risk of all‐cause hospitalization (HR, 1.03; 95% CI, 1.01–1.05) and major adverse cardiovascular events (HR, 1.04; 95% CI, 1.05–1.24). Conclusions In a contemporary cohort receiving statin therapy, elevated triglyceride levels were associated with a greater risk of atherosclerotic cardiovascular disease events and lower risk of death.


BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020309 ◽  
Author(s):  
Sofia Axia Karlsson ◽  
Christel Hero ◽  
Ann-Marie Svensson ◽  
Stefan Franzén ◽  
Mervete Miftaraj ◽  
...  

ObjectivesTo analyse the association between refill adherence to lipid-lowering medications, and the risk of cardiovascular disease (CVD) and mortality in patients with type 2 diabetes mellitus.DesignCohort study.SettingNational population-based cohort of Swedish patients with type 2 diabetes mellitus.Participants86 568 patients aged ≥18 years, registered with type 2 diabetes mellitus in the Swedish National Diabetes Register, who filled at least one prescription for lipid-lowering medication use during 2007–2010, 87% for primary prevention.Exposure and outcome measuresRefill adherence of implementation was assessed using the medication possession ratio (MPR), representing the proportion of days with medications on hand during an 18-month exposure period. MPR was categorised by five levels (≤20%, 21%–40%, 41%–60%, 61%–80% and >80%). Patients without medications on hand for ≥180 days were defined as non-persistent. Risk of CVD (myocardial infarction, ischaemic heart disease, stroke and unstable angina) and mortality by level of MPR and persistence was analysed after the exposure period using Cox proportional hazards regression and Kaplan-Meier, adjusted for demographics, socioeconomic status, concurrent medications and clinical characteristics.ResultsThe hazard ratios for CVD ranged 1.33–2.36 in primary prevention patients and 1.19–1.58 in secondary prevention patients, for those with MPR ≤80% (p<0.0001). The mortality risk was similar regardless of MPR level. The CVD risk was 74% higher in primary prevention patients and 33% higher in secondary prevention patients, for those who were non-persistent (p<0.0001). The mortality risk was 6% higher in primary prevention patients and 18% higher in secondary prevention patients, for non-persistent patients (p<0.0001).ConclusionsHigher refill adherence to lipid-lowering medications was associated with lower risk of CVD in primary and secondary prevention patients with type 2 diabetes mellitus.


2018 ◽  
Vol 18 (3) ◽  
pp. 101-105
Author(s):  
Fariha Naeem ◽  
Gerard McKay ◽  
Miles Fisher

Statin therapy is proven to reduce cardiovascular morbidity and mortality in people with diabetes, and high-dose statins are recommended for people with established atherosclerotic vascular disease. In two dedicated studies in people with diabetes, fibrates did not significantly reduce cardiovascular events and were associated with serious side effects. A similar lack of benefit was seen in two large studies of niacin. Ezetimibe, when added to statins, may further reduce LDL cholesterol and non-fatal vascular events. The PCSK9 inhibitors are a new class of subcutaneous lipid- lowering drugs which cause profound reductions in LDL cholesterol when added to statins. Evolocumab reduced non-fatal cardiovascular events when added to background statin therapy in a larger group of subjects and the benefits were confirmed in a diabetes subgroup. In another large trial alirocumab reduced major adverse cardiovascular events and total mortality. The clinical use of ezetimibe and PCSK9 inhibitors is currently limited by cost.


2018 ◽  
Vol 36 (1) ◽  
pp. 35
Author(s):  
Rattanaporn Chootong ◽  
Silom Jamulitrat

Objective: The American Diabetes Association (ADA) and the American Heart Association (AHA) recommend aspirin use for primary and secondary prevention of cardiovascular disease in patients with diabetes. There are, however, some doubts regarding the prescription of aspirin therapy to prevent cardiovascular events in diabetic patients, aspects of its safety, and contraindications of the drug administration. This study was conducted in order to evaluate the amount of prescribed aspirin for diabetic patients who received the treatment at Songklanagarind Hospital.Material and Method: A cross-sectional study was conducted to review the medical records of diabetic patients who received the treatment at outpatient departments from 1st-31st December 2013.Results: A total of 1,342 diabetic patients are included in this study: 80.3% from the primary prevention group and 19.7% from the secondary prevention group. Mean age was 64.3 years old. Of the patients, 44.7% were male. The study revealed that prescribed aspirin accounted for one-third of total prescriptions (31.7%). The primary prevention group was 19.0% (95% confidence interval (CI)=12.0-21.3) and the secondary prevention group was 83.7% (95% CI=78.6-87.9). The departments that frequently prescribed aspirin for the primary prevention group was endocrinology (21.2%) and for the secondary prevention group it was the Primary Care Unit (87.5%). Aspirin side effects were gastrointestinal 1.0% and tinnitus 0.1%. Aspirin contraindications were active peptic ulcer (0.1%), history of gastrointestinal bleeding (0.4%), bleeding disorders (0.2%), history of recent intracranial bleeding (0.2%) and severe liver disease (0.9%). There was a positive correlation between age, hemoglobin A1c (HbA1c) and the dose of prescribed aspirin (p-value<0.001, 0.003 respectively). These patients were more likely to have the dose of aspirin increased as age and HbA1c increased.Conclusion: Despite aspirin being a safe, inexpensive and readily available therapy that is effective in preventing cardiovascular disease in diabetic patients and likely to provide benefits rather than side effects and contraindications. The author found significant underuse of aspirin therapy, especially in the primary prevention of cardiovascular disease in diabetic patients. 


2002 ◽  
Vol 36 (11) ◽  
pp. 1749-1758 ◽  
Author(s):  
Simon de Denus ◽  
Sarah A Spinler

OBJECTIVE: To review the clinical benefit of statins in the early management of acute coronary syndromes (ACSs) and their possible mechanisms of benefit. DATA SOURCES: A MEDLINE search (1966–September 2001) was conducted using the following terms: pravastatin, lovastatin, simvastatin, atorvastatin, cerivastatin, fluvastatin, statins, hydroxymethylglutaryl coenzyme A reductase inhibitor, acute coronary syndromes, unstable angina, and myocardial infarction. Pertinent articles referenced in these publications were also reviewed. STUDY SELECTION AND DATA EXTRACTION: French- and English-language human and animal studies were selected and analyzed. DATA SYNTHESIS: In addition to their lipid-lowering properties, statins produce several nonlipid-related properties. These pleiotropic properties include improved endothelial function, reduction of inflammation at the site of the atherosclerotic plaque, inhibition of platelet aggregation, and anticoagulant effects, all of which may result in clinical benefit during ACSs. Preliminary studies and retrospective analyses of large clinical trials support the hypothesis that statins may be of benefit in ACSs. A recently published randomized, double-blind, multicenter trial evaluated the clinical impact of high-dose atorvastatin in patients with ACSs. Use of atorvastatin resulted in a decrease in a combined endpoint of cardiovascular events. Furthermore, initiation of statin therapy during hospitalization improves long-term compliance and may significantly improve clinical outcome. CONCLUSIONS: Early use of statins in ACSs appears to decrease cardiovascular events. We believe statin therapy should be initiated early (at the latest before hospital discharge) in all patients who have been hospitalized for ACSs. Ongoing studies will clarify the benefit of these agents in ACSs, the importance of their nonlipid-lowering properties, and the optimal cholesterol-target concentrations.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ann M Navar-Boggan ◽  
Tomasz Zdrojewski, ◽  
Adam Wyszomirski ◽  
Mateusz Lachacz ◽  
Grzegorz Opolski ◽  
...  

Introduction: The American Heart Association and American College of Cardiology (AHA/ACC) recently released updated guidelines for management of blood cholesterol, which differ from current European Society of Cardiology and European Atherosclerosis Society (ESC/EAS) guidelines. How these differences affect the overall number of individuals recommended for statin therapy in a country with high cardiovascular disease (CVD) risk remains unclear. Hypothesis: Due to the lower threshold for statin recommendations for primary prevention based on 10-year CVD risk under the AHA/ACC guidelines, more adults overall would be recommended for statin therapy under American compared to European guidelines. Methods: Using 2011 data from a nationwide cross-sectional survey in Poland (NATPOL), we estimated the number and characteristics of adults aged 40-65 recommended for lipid lowering therapy under the ESC/EAS and AHA/ACC guidelines. The survey sample of 1060 adults represented 13.5 million adults in Poland aged 40-65. Results: Under ESC/EAS guidelines, 47.6% of adults (44.6-50.7%) aged 40-65 were recommended for immediate statin therapy, compared to 49.9% (46.9-52.9%) under AHA/ACC guidelines. Among adults free of cardiovascular disease (CVD), 10.5% had discordant recommendations between guidelines. Individuals recommended for statin therapy under ACC/AHA but not ESC/EAS guidelines had less chronic kidney disease, higher HDL cholesterol, higher 10-year (AHA/ACC calculator) risk, and higher 30-year (Framingham) risk than adults recommended under ESC/EAS but not under ACC/AHA guidelines. Ten-year CVD mortality risk estimated by the SCORE algorithm was similar between the two groups. Conclusions: In spite of differences between current European and American cholesterol guidelines, when applied to a nationwide representative sample from a country with high CVD risk, the number of adults aged 40-65 recommended for cholesterol lowering therapy under each guideline was nearly identical. Although more adults met criteria for primary prevention based on 10-year CVD risk under new American guidelines, the impact of this is offset by additional criteria for statin therapy in current European guidelines.


2019 ◽  
Vol 20 (1) ◽  
pp. 72-82 ◽  
Author(s):  
Mohammad Alkhalil

Background: Statins have been a major keystone in the management of patients with atherosclerotic cardiovascular disease. The benefits of inhibiting HMG CoA reductase, via statins, were translated into reduction in LDL-c with proportionate decrease in cardiovascular events in response to the magnitude of LDL-c reduction. Despite major advances in pharmacological treatments, including the use of high-dose statins, there are urgent need to further reduce future cardiovascular risk. This is in particularly important since 1 out of 5 high-risk atherosclerotic patients who achieve low LDL-c return with a second cardiovascular event within five years. Although this residual risk post-statin is largely heterogeneous, lowering LDL-c beyond ‘normal’ or guidelines-recommended level using novel therapies has resulted in further reduction in cardiovascular events. </P><P> Objective: The current review will discuss the use of PCSK9 inhibitors in patients with atherosclerotic disease. PCSK9 inhibitors are a new class of lipid-lowering drugs that are either fully human monoclonal antibodies (evolocumab and alirocumab) or humanised monoclonal antibodies (bococizumab) that effectively reduce LDL-c to unprecedented level. By blocking circulating PCSK9, these drugs would preserve LDL receptors and prevent them from cellular degradation. This process promotes recycling of LDL receptors back to hepatocytes surface, leading into further reduction of LDL-c. Combining PCSK9 inhibitors with statin have led into lower LDL-c, reduction in plaque volume and more importantly reduction in future cardiovascular events. Conclusion: These drugs are very promising, nonetheless, the unselective approach of applying these monoclonal antibodies may not prove to be cost-effective and potentially exposing some patients to unnecessary side effects.


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