The treatment of hyperlipidemia Treatment of hyperlipidemia in

 

 

The
cost of non-adherence to hyperlipidemia medications

 

 

AlHanouf Mohammed Almalaihi   2130003918

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Ghadah Mohammed
AlGofari         2140001071  
                 
Leena Hussain Alluhaibi                  2140005851                                                  
Hind Nasser AlSuwaidan                 2140006974                              
Wejdan Abdulrahman AlHajri       2140003390

 

Content
:

– Introduction
to hyperlipidemia and its complications.
– Pharmacological treatment.
– Hyperlipidemia guidelines.
-Cost of hyperlipidemia medications.
– Complications of non-adherence.
– WHO statistics.
– Cost of non-adherence to hyperlipidemia medications studies ;
1-Relationship between adherence level to
statins, clinical issues and health-care costs in real life clinical setting.
2- Adherence to Statins, Subsequent Healthcare Costs, and Cardiovascular Hospitalizations.
3- The Clinical and Economic Burden of Non-adherence with Antihypertensive and
Lipid-Lowering Therapy in Hypertensive Patients.
4- The economic consequences of non-adherence to lipid-lowering therapy:
results from the Anglo-Scandinavian-Cardiac Outcomes Trial.
– Conclusion.
– References.

 

 

 

 

 

 

Introduction
and complication of hyperlipidemia

Hyperlipidemia
refers to increased levels of lipids in the blood, including triglycerides and
cholesterol. It is one of the most important risk factors for atherosclerosis
and cardiovascular disease(CVD). Despite hyperlipidemia does not cause
symptoms, it can significantly increase your risk of developing CVD, including
disease of blood vessels supplying the heart (coronary artery disease(CAD)),
brain (cerebrovascular disease), and limbs (peripheral vascular disease). These
conditions lead to stroke, chest pain, heart attacks and other problem.
Treatment is recommended for people with hyperlipidemia. 1

 

Pharmacological
treatment of hyperlipidemia

Treatment
of hyperlipidemia in conjunction with therapeutic lifestyle modifications can
be used for both primary and secondary prevention of CVD. Statins have the most
potent data for primary prevention, especially for higher risk patients (i.e.,
those with a 10-year coronary heart disease risk of greater than 20 percent).
Also, recommended for secondary prevention in all patients with known CVD or
the risk equivalent. High-dose statins should be initiated in patients with
acute coronary syndrome (ACS). There is a strong evidence for using statins in
the secondary prevention of stroke and peripheral arterial disease. Omega-3
fatty acids may be an alternative after myocardial infarction (MI) for patients
who cannot tolerate statins. Niacin and fibrates have not been shown to reduce
mortality in secondary prevention, but may be useful adjuncts when statins
alone cannot adequately control lipid levels. Other Lipid-lowering agents used
for primary or secondary prevention of CVD have not been shown to consistently
improve patient-oriented outcomes. 2

 

Hyperlipidemia
guidelines 3

U.S.,
U.K., and Canadian guidelines are available to help manage hyperlipidemia.
These guidelines agreed on that, the therapeutic lifestyle modifications are
the pole of hyperlipidemia management. The primary target of therapy must be
LDL cholesterol. Treatment of hyperlipidemia improves outcomes for patients:

1) with known coronary
heart disease (CHD) or the risk equivalent.

2) for high-risk patients
without known CHD or the risk equivalent.

 

 

 

 

 

 

 

 

Summary of Major
Hyperlipidemia Guidelines

Drug therapy recommendations

LDL cholesterol goal

Risk category

National
Cholesterol Education Program, Adult Treatment Panel III*

Initiate if LDL cholesterol is ?
100 mg per dL
Consider if level is 20 percent

Initiate if LDL cholesterol is ?
130 mg per dL
Consider if level is 100 to 129 mg per dL
(2.59 to 3.34 mmol per L)

136 mg per dL (3.52
mmol per L)
Total/HDL cholesterol > 193 mg per dL (5
mmol per L)
High-sensitivity CRP > 2 mg per L (19.05
nmol per L)
Men older than 50 years
Women older than 60 years
Family history and high-sensitivity CRP
increases risk
(Reynolds risk score)

$125

Colestipol

= > $125

Zetia

= > $125

ezetimibe/simvastatin

Available at discounted prices ($10 or less
per prescription) at national retail chains

Gemfibrozil

 $75
to $125

Micronized fenofibrate

$75 to $125

Multiple prescription preparations
(fenofibrate)

Available at discounted prices ($10 or less
per prescription) at national retail chains

Lovastatin

Available at discounted prices ($10 or less
per prescription) at national retail chains

Pravastatin

= $25 to $75

Simvastatin

$75 to $125

Atorvastatin (Lipitor)

$75 to $125

Fluvastatin (Lescol)

= > $125

Rosuvastatin (Crestor)

 

 

Complication
of Non- adherence to hyperlipidemia medications 

The
effectiveness of lipid-lowering therapy may remain far from desired outcomes. Patient
non-adherence to medication consider as one of the important factors
responsible for this problem. Non-adherence to antihyperlipidemic occurs with
various prevalence and with varying degrees depending on many factors, such as
type of prescribed medication. The World Health Organization(WHO) estimates
that it affects about 50% of patients treated for chronic diseases. Among
patients receiving lipid-lowering drugs, after 6 months only 36% satisfactorily
adhered to treatment and during the first year of treatment, a third of
patients stopped the treatment completely. The main reason of non-adherence to
antihyperlipidemic is multiple drug regimens. The main consequence of
medication non-adherence is ineffectiveness of the treatment. Thus, failure to
achieve full benefits of evidence-based therapies. 4

Taking
a lower percentage of prescribed doses leads to significant reduction in the
effectiveness of treatment, increased risk of cardiovascular incidents and
mortality. As observed, patients not adherent to the statin therapy had 40%
greater risk of cardiovascular incident during the 3-year follow-up period,
compared with the adherent ones. Negative outcomes such as increased
hospitalizations and MI have been associated with non-adherence to
hyperlipidemia medications. 4

 

World
Health Organization(WHO) statistics

Raised
cholesterol increases the risks of heart disease and stroke. Globally, a third
of ischemic heart disease is attributable to high cholesterol. Overall, raised
cholesterol is estimated to cause 2.6 million deaths (4.5% of total) and 29.7
million disability adjusted life years (DALYS), or 2.0% of total DALYS. Raised
total cholesterol is a major cause of disease burden in both the developed and
developing world as a risk factor for Ischemic heart disease and stroke. A 10%
reduction in serum cholesterol in men aged 40 has been reported to result in a
50% reduction in heart disease within 5 years; the same serum cholesterol
reduction for men aged 70 years can result in an average 20% reduction in heart
disease occurrence in the next 5 years. 5

The
prevalence of elevated total cholesterol was highest in the WHO Region of
Europe (54% for both sexes), followed by the WHO Region of the Americas (48%
for both sexes). The WHO African Region and the WHO South East Asian Region
showed the lowest percentages (22.6% for AFR and 29.0% for SEAR). 5

The
prevalence of raised total cholesterol increased noticeably according to the
income level of the country. In low income countries around a quarter of adults
had raised total cholesterol, in lower middle-income countries this rose to
around a third of the population for both sexes. In high-income countries, over
50% of adults had raised total cholesterol; more than double the level of the low-income
countries. 5

 

 

Cost of non-adherence to
hyperlipidemia medications studies:

1.    Relationship
between adherence level to statins, clinical issues and health-care costs in
real life clinical setting.             

 

The
study was mainly a comparison between statin adherent and non-adherent patient
groups in Canada. Results showed that low adherence level to statin was
associated with an increased risk of hospitalization and having cardiovascular
complications. Cost of hospitalization was increasing with low adherence level
by around $1060 per person in a 3-year duration of follow-up. Total costs of
hospitalization among adherent patients were $65.9 M compared to $71.0 M for non-adherent
patients which interpreted as an excess cost of hospitalization to low
adherence of $9.5 M. Researchers anticipate that the indirect cost of low
adherence would also be higher. 6

2.    Adherence to
Statins, Subsequent Healthcare Costs, and Cardiovascular Hospitalizations

 

Statins are the primary
treatment used to reduce LDL cholesterol. Adherence to statins leads to
positive clinical outcomes, however statin non-adherence has negative impact on
healthcare costs. In 2011 a retrospective cohort study of 381,422 patients, aged
18 to 61 years was conducted to examine the relation among statin adherence,
subsequent hospital admissions and healthcare costs by using an integrated
pharmacy and medical claims database. The adherence was measured by the
medication possession ratio (MPR) for 12 months and the healthcare costs and
cardiovascular disease-related hospital admission during the subsequent 18
months. The primary evaluation, MPR was used to categorize the patients into 3
adherence group: adherent (MPR_80%), moderate adherence (MPR 60% to 79%), and
low adherence (MPR _0% to 59%).

 

It has
been found that about 1/3 of the 381,422 tested patients were non-adherent to their
statin therapy in the baseline year and that non-adherence was associated with
a $400 to $900 per patient greater total healthcare cost and increased
likelihood of a cardiovascular disease related hospitalization in the
subsequent 18 months. In the adherent group, greater statin drug costs were
compensated by the lower medical costs, leading to lower total healthcare
costs.

 

 

Year 1 MPR

Statin Prescription
Costs

All Other Prescription
Costs

All-Cause
Medical Costs

Cardiovascular
Medical Costs

All-Cause Total
Healthcare Costs

Low adherence (MPR 0–59%; n _ 57,614)

$488 _ 2.2

$2,906 _ 14.9

$7,708 _ 81.9

$2,689 _ 43.9

$11,102 _ 84.3

Moderate adherence (MPR 60–79%; n _ 65,795)

$664 _ 2.0†

$2,684 _ 13.7

$7,261 _ 75.5

$2,583 _ 40.4

$10,609 _ 77.7

Adherent (80–100%; n _ 258,013)

$838 _ 1.0

$2,651 _ 7.0

$6,709 _ 38.3

$2,395 _ 20.5

$10,198 _ 39.4

Costs of care
during 18 months of follow-up by level of adherence to statins in year 1*

 

In
conclusion, statin adherence is associated with reductions in subsequent total
healthcare costs and cardiovascular disease-related hospitalizations. In this
study there were no statistically significant associations between a greater
MPR and lower medical and total healthcare costs. 7

 

 

 

 

3.    The Clinical
and Economic Burden of Non-adherence with Antihypertensive and Lipid-Lowering
Therapy in Hypertensive Patients:

A
study take place in USA and published in 2009. By using tree Markov models,
this study compares three different adherence groups in aspect of the cost and
outcomes associated with varying adherence pattern to antihypertensive and lipid
lowering agents (statin) therapy in hypertensive patients. These groups divided
as follow; no treatment, ideal adherence, and real-world adherence. The
real-world adherence group employed adherence data from an observational study
of a US population; risk reductions at each level of adherence were based on data
from clinical trials. Outputs included life expectancy, frequencies of primary
and secondary cardiovascular diseases and stroke. Direct medical costs in 2006
US $, the incremental cost per life-year gained and incremental cost per event
avoided were calculated comparing the three adherence groups. The result of
this study shown below:

 
    

The
average number of cardiovascular events per patients

 
The main life expectancy

 

0.738

14.73
years

No-treatment
group

0.610

15.07
years

Real-world
adherence

0.441

15.49
years

Ideal
adherence

 

The real-world adherence group cost a
$30,585 per life year gained as incremental cost compared to no treatment group
while $22,121 per life-year gained for ideal adherence group comparing to
real-world adherence. The study also reports that applying an effective
adherence intervention program has an incremental bene?ts which make it an
attractive value.

 

Finally,
Hypertensive
patients on antihypertensive and lipid-lowering medication at real-world
adherence receive approximately 50% of the benefit showed in the clinical
trials and have an increased life expectancy in addition to lower
cardiovascular event but the adherence to the antihypertensive and statin will
be more cost effective if it will be taken at level as in the clinical trials. 8

 

 

4.    The economic
consequences of non-adherence to lipid-lowering therapy: results from the
Anglo-Scandinavian-Cardiac Outcomes Trial

 

In
2010, this study was conducted to assess the impact of non-adherence to
lipid-lowering therapy on cardiovascular events and health economic end points.
A total of 4671 patients who already had been on treatment for 3.3years(median)
were included in this study with a median follow up of 2.4 years. They were
divided into three groups (low adherence, medium adherence, and high adherence group).
The study showed that; patients who are highly adherents to their therapy have
a lower risk of cardiac events compared with low adherence group. The long-term
cost of health outcomes are shown below:

 

Group

Cost of drug /patient

Cost of other health care/patient

Total cost/patient

Predicted life years/patient

Predicted QALY/patient

High adherence

 427 £

1252 £

1689 £

10.83

8.13

Low adherence

33 £

1290 £

1323 £

10.81

8.11

 

 

The
Total cost for high adherence group would be higher compare to non-adherents group
(£1689, £1323 respectively), for high adherence group the saved cost through
reduction of other health care cost is 10% of drug cost. the survival and QALY
would be longer for high adherence patients compared to others with prediction
of 0.02 QALYs for prevented events. 9

 

 

Conclusion

 

Lipid-lowering agents are that agents which
the treat the increased low-density lipoprotein cholesterol. Several studies
show that high adherence to lipid-lowering therapy will decrease risk of
cardiovascular events, improve clinical outcomes, prolong life survival and
reduce health cost which associated with cardiovascular diseases and
hospitalization therefore High adherence to lipid lowering agents is
worthwhile. in the other hand statins non-adherence can lead to negative
clinical sequences which include high risk of cardiovascular events, increase
use of health care services, thus increase cost. Hence, it is important to
develop an appropriate cost effective interventions to minimize the burden of
low adherence to lipid lowering agents. Such an intervention we may consider to
overcome the problem of poor adherence is to emphasize the value of a patient’s
regimen, making the regimen simple and customizing the regimen to the patient’s
lifestyle to enhance the adherence.

 

 

 

 

 

 

 

 

References

 

1.    
Patient education: High cholesterol
and lipids (hyperlipidemia) (Beyond the Basics). (n.d.). Retrieved December 15,
2017, from https://www.uptodate.com/contents/high-cholesterol-and-lipids-hyperlipidemia-beyond-the-basics

 

2.    
ALLEN R. LAST, MD, MPH,
University of Wisconsin Fox Valley Family Medicine Residency Program, Appleton,
Wisconsin JONATHAN D. FERENCE, PharmD, Wilkes University Nesbitt College of
Pharmacy and Nursing, Wilkes-Barre, Pennsylvania JULIANNE FALLERONI, DO, MPH,
University of Wisconsin Fox Valley Family Medicine Residency Program, Appleton,
Wisconsin

 

3.    
Kardas, P. cent.eur.j.med
(2013) 8: 539. https://doi.org.library.iau.edu.sa/10.2478/s11536-013-0198 

 

4.    
Benner, J. S., Chapman, R.
H., Petrilla, A. A., Tang, S. K., Rosenberg, N., & Schwartz, J. S. (2009).
Association between prescription burden and medication adherence in patients
initiating antihypertensive and lipid-lowering therapy. American Journal Of
Health-System Pharmacy, 66(16), 1471-1477. doi:10.2146/ajhp080238

 

5.    
Raised cholesterol. (n.d.).
Retrieved December 15, 2017, from http://www.who.int/gho/ncd/risk_factors/cholesterol_text/en

 

6.     Dragomir
A, Coˆte ? R, White M, et al. Relationship between adher- ence level to
statins, clinical issues and health-care costs in real- life clinical setting.
Value Health. 2010;13(1):87-94.

 

7.     Pittman,
D. G., Chen, W., Bowlin, S. J., & Foody, J. M. (2011). Adherence to
statins, subsequent healthcare costs, and cardiovascular hospitalizations. The
American journal of cardiology, 107(11), 1662-1666.?

 

8.     Cherry
SB, Benner JS, Hussein MA, Tang SS, Nichol MB. The clinical and economic burden
of nonadherence with antihypertensive and lipid-lowering therapy in
hypertensive patients. Value Health 2009;12:489- 497

9.     Lindgren
P, Eriksson J, Buxton M, et al. The economic consequences of non-adherence to
lipid-lowering therapy: results from the Anglo-Scandinavian-Cardiac Outcomes
Trial. Int J Clin Pract. 2010;64(9):1228–34