Introduction
The increasing levels of acuity in current healthcare delivery requires continuous research to unearth the best evidence in improving patients care. Nurses have a central role in evidence-based practice as they tend to be key drivers of the various findings that result from various research. As researches continue to find better ways of improving cardiovascular health using statins and other medications, it has become important to know how to use statins effectively to reduce the risk for cardiovascular disease in patients with history of cardiovascular diseases.
This paper aims at examining how treating patients with no history of cardiovascular disease or heart disease with statins can help reduce complications or death. Statins happen to be the first line of medication used to treat patients with high cholesterol. This paper will critically look at the efficacy of statins when prescribed at the 7.5% threshold rather than the usual 20% threshold over ten years among patients with no cardiovascular disease risk.
Problem
In the United States and around the world, significant number of people die from cardiovascular diseases annually. This has led to measures to help curtail this problem and look for lasting solutions especially among those with no risk. According to the CDC, Heart disease happens to be the leading cause of death in the United States. More than 600,000 Americans die of heart disease each year which is one in every four deaths (Center for Disease Prevention and Control, 2018). The world health organization estimates that Cardiovascular diseases or heart diseases accounts for thirty-one percent of deaths globally. This is 17.9 million deaths every single year.
The United States Preventive Services Task Force is an independent body which came out in 2016 to recommend that adults without a history of cardiovascular disease take a low- to moderate-dose statin to help prevent cardiovascular events as well as mortality if they meet these three criteria. The criteria includes aged 40 to 75 years; have one or more cardiovascular disease risk factors like smoking, hypertension, diabetes, and dyslipidemia; and a calculated 10-year risk of a cardiovascular event of 10% or greater (USPSTF, 2018).
PICOT Question
Among adults with no history of Cardiovascular disease how does prescribing Statins at the 7.5% threshold compared to the 20% threshold decrease the risk of Cardiovascular disease within ten years? (P-Adults with no history of cardiovascular disease, I- Prescribing statins at the 7.5% threshold, C- Prescribing statins at the 20% threshold, O- Decrease the risk of cardiovascular disease, T- Ten years).
Conceptual Definitions
The National Heart, Lung, and Blood Institute defines cardiovascular disease or heart disease or Coronary heart disease as diseases of the blood vessel of the heart which can lead to a heart attack. A heart attack happens when an artery becomes blocked, preventing oxygen and nutrients from getting to the heart (NIH, 2018). There are risk factors to developing heart disease; some of the risk factors include family history, high cholesterol, high blood pressure, smoking, family history, and inactivity.
Also, heart disease is often diagnosed based on a patients family and medical history, physical assessment, laboratory tests and procedures, and the patients risk factors. There is no single test used to diagnose heart disease. Blood tests are usually used to test for high cholesterol levels, blood sugar levels, and proteins produced by the heart muscle. Laboratory tests and procedures like an EKG or Electrocardiogram is used to record the electrical activity of the heart. An echo or Echocardiography helps determine the shape and size of the heart and how the heart is pumping or working utilizing sound waves. A chest x-ray can also be used to examine the heart. A cardiac MRI or magnetic resonance imaging is used to measure blood flow in the heart. Other tests include stress test, cardiac catheterization, and coronary angiography. Treatment for heart disease typically includes medications like statins, cardiac rehabilitation, surgical procedures, and lifestyle changes.
Search Methods
The PubMed database with MeSH as well the One search feature on the Cedarville Universitys website was used to search for articles. Search criteria and keywords used during the search process is shown in flow diagram named as Figure 1.
MeSH and subject headings search for: Cardiovascular diseases AND Statins AND Prevention
Cochrane Systematic Reviews and Register of Controlled Trials: 624
CINAHL: 1087
Medline: 2161
PubMed: 7251
N=11,123
Filters applied
Date of publication (2008-2018), peer reviewed journals, English, humans, adult subjects, and US geography
Articles removed N=10,089
Irrelevant by title and/or abstracts:
N=999
Excluded N=29:
Irrelevant after another review (17) Expert Opinion (4)
Case study (5)
Editorial (3)
Unique Abstracts reviewed:
N=35
Added after reviewing references N=0
Studies Included:
N=6
Figure 1. Flow Diagram
Summary of the Evidence
After rigorous searches, six articles were used. All six articles were level 1 which are the highest level of evidence. The first resource is a Systematic review with meta-analysis by Chou et al. (2016) with an objective to review the benefits and harms of statins for the prevention of Cardiovascular disease (CVD). This article found out that adults who have never had a past cardiovascular disease event but are at increased CVD risk, had reduced risk of all-cause and cardiovascular mortality and CVD events with statin therapy with greater absolute benefits in patients at greater baseline risk. The second evidence by Brugts et al. (2009) is a Meta-analysis of randomized trials that investigated if statins reduce all-cause mortality and major coronary and cerebrovascular events in people without established cardiovascular disease but with cardiovascular risk factors. The study also examined if the effects are similar in men and women, in young and older than 65 years, and in people with Diabetes Mellitus. Brugts et al. (2009) suggests that in patients without established cardiovascular disease but with cardiovascular risk factors, statin use was associated with significantly improved survival and large reductions in the risk of major cardiovascular events (Brugts et al., 2009).
It is without a doubt that Statin therapy help improve the lives of patients with Cardiovascular Disease. However, its benefits in patients with low risk for cardiovascular events is what the meta-analysis by Mihaylova et al. (2012) explored. Mihaylova et al. (2012) concluded that in individuals with 5-year risk of major vascular events lower than 10%, each 1 mmol/L reduction in LDL cholesterol produced an absolute reduction in major vascular events of about 11 per 1000 over 5 years. The fourth article is similar to the first article as they both investigated the benefits and harms of statins in patients with no history of cardiovascular disease. Taylor et al. (2013) after looking at the effects of statins in patients with no history of cardiovascular disease arrived at the conclusion that total cholesterol and LDL cholesterol after statin use.
The only article that evaluated the efficacy of statins primarily on the elderly population was by Teng et al. (2015), which focused on those older than 65 years. The authors recommended further studies to evaluate statins on fatal MI, stroke, and all-cause mortality after concluding that statins play a role in preventing cardiovascular diseases in the elderly population. Most of the articles about statin use and its benefits have mostly white people as study participants. This final article focused on ethnically diversed population with no risk for cardiovascular disease. Yusuf et al. (2016), found out from their randomized control trial that patients from ethnically diverse populations who were treated with 10 mg of Rosuvastatin daily, had a significantly decreased risk of cardiovascular disease. All six literatures reviewed suggests that statins are effective in reducing the risk of cardiovascular disease which is summarized in the table (Table 2)
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Chou, R., Dana, T., Blazina, I., Daeges, M., & Jeanne, T. L. (2016). Statins for prevention of cardiovascular disease in adults: Evidence report and systematic review for the US preventive services task force.
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To systematically review benefits and harms of statins for development of recommendations on statin therapy for prevention of CVD in adults 40 years or older without prior cardiovascular events. |
Design: Systematic review with meta-analysis. using 19 RCTs. Method: A research librarian searched the Cochrane Central Register of Controlled Trials (from 1991), the Cochrane Database of Systematic Reviews (from 2005), and Ovid MEDLINE (from 1946) to June 2016 for English language publications and reference lists. After the draft report was posted for public comment and peer reviewed. The search was updated in June 2016 and 1 additional trial was added. |
N=71,344 19 RCTs Adults greater than 40 years without CVD events Mean ages 51-66 years |
Independent variable: Using statins Dependent variables: DV1: CVD-related morbidity or mortality DV2: All-cause mortality DV3: Adverse reactions defined as cancer, fatal cancer myalgias, elevated aminotransferase levels, rhabdomyolysis, myopathy, renal dysfunction, cognitive harms, diabetes. |
USPSTF quality level assessment and validity tools Dersimonian-Laird random effects model Internal validity assessed using USPSTF methods |
NNT ARD risk ratio, I2 statistic, sensitivity stratified analyses |
DV1: CV mortality (10 trial) RR 0.69, 95% CI (0.54-0.88), ARD -0.43%, NNT 233 DV2: all-cause mortality (15 RCT) RR 0.86 (0.80-0.93), ARD -0.40%, NNT 250 DV3: serious adverse events (7 RCT) RR 0.99, 95% CI (0.94-1.04) |
Level I |
Strengths: Two independent reviewers Large sample size NNT included
No access to patient data Only 6 trials rated good quality Limited age group Researchers excluded non-English studies |
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Brugts, J. J., Yetgin, T., Hoeks, S. E., Gotto, A. M., Shepherd, J., Westendorp, R. G., de Craen, A. J., Knopp, R. H., Nakamura, H., Ridker, P., van Domburg, R.,Deckers, J. W. (2009). The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomized controlled trials. |
To investigate whether statins reduce all-cause mortality and major coronary and cerebrovascular events in people without established cardiovascular disease but with cardiovascular risk factors, and whether these effects are similar in men and women, in young and older (>65 years) people, and in people with diabetes mellitus. |
Design/ Setting: Meta-analysis of randomized trials. |
Sample:/Setting: 10 RCT n= 70,388 statin vs. placebo mean age 63 years 34% women 23% w/DM >80% without CVD 12 studies excluded |
Independent variables: IV1: statin use. Placebo is the control group Dependent variables: DV1: all-cause mortality (primary endpoint) DV2: Major coronary events DV3: Major cerebrovascular events DV4: Cancer |
Egger regression test |
OR CI I2, Q statistics and odd ratio |
In patients without established cardiovascular disease but with cardiovascular risk factors, statin use was associated with significantly improved survival and large reductions in the risk of major cardiovascular events. DV1: OR: 0.88, 95% CI (0.81-0.96) DV2: OR 0.70 95% CI (0.61-0.81) DV3: OR 0.81 95% CI (0.71-0.93) DV4: OR 0.97 95%CI (0.89-1.05)
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I
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Strengths: Large sample size Level I study Results from study can be used in practice Jadad scale is used to determine quality of the studies, Limitations No NNT 3 of the trials included participants with CVD Dose and type of statin differed between trials
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Mihaylova, B., Emberson, J., Blackwell, L., Keech, A., Simes, J., Barnes, E. H., . . . Baigent, C. (2012). The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: Meta-analysis of individual data from 27 randomized trials.
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To determine the effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease |
Design: Meta-analysis Method: Earlier studies referenced. Analyzed 27 RCT that met 3 criteria: at least one intervention to lower LDL, unconfounded with respect to intervention, at least 1000 participants for at least 2 years |
Sample/Setting: 27 RCT Sample size: 174,149 Participants were assigned to baseline categories of 5-year risk from 12/2009-6/2011 |
Independent variables IV1: minimum of 2 years statin use IV2: Intensity of statin use Dependent variables DV1: Major vascular events DV2: Major coronary events DV3: Stroke DV4: Revascularization DV5: Cancers DV6: Cause-specific mortality |
Cox proportional hazard models analysis tool |
RR CI |
DV1: 0.79 RR DV2: RR: 0.76 DV3: RR 0.85 DV4: RR 0.76 DV5: RR 1 DV6: RR 0.88 In individuals with 5-year risk of major vascular events lower than 10%, each 1 mmol/L reduction in LDL cholesterol produced an absolute reduction in major vascular events of about 11 per 1000 over 5 years. This benefit greatly exceeds any known hazards of statin therapy. Under present guidelines, such individuals would not typically be regarded as suitable for LDL-lowering statin therapy. |
Level I |
Studied benefit in primary prevention which is of clinical significance. Inclusion of primary prevention trial data Large sample size
More male than female Participants
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