The treatment of hyperlipidemia Treatment of hyperlipidemia in

  Thecost of non-adherence to hyperlipidemia medications   AlHanouf Mohammed Almalaihi   2130003918Ghadah MohammedAlGofari         2140001071                   Leena Hussain Alluhaibi                  2140005851                                                  Hind Nasser AlSuwaidan                 2140006974                               Wejdan Abdulrahman AlHajri       2140003390 Content:- Introductionto 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 tostatins, 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 andLipid-Lowering Therapy in Hypertensive Patients.

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4- The economic consequences of non-adherence to lipid-lowering therapy:results from the Anglo-Scandinavian-Cardiac Outcomes Trial.- Conclusion.- References.       Introductionand complication of hyperlipidemia Hyperlipidemiarefers to increased levels of lipids in the blood, including triglycerides andcholesterol. It is one of the most important risk factors for atherosclerosisand cardiovascular disease(CVD). Despite hyperlipidemia does not causesymptoms, it can significantly increase your risk of developing CVD, includingdisease of blood vessels supplying the heart (coronary artery disease(CAD)),brain (cerebrovascular disease), and limbs (peripheral vascular disease). Theseconditions lead to stroke, chest pain, heart attacks and other problem.Treatment is recommended for people with hyperlipidemia.

1 Pharmacologicaltreatment of hyperlipidemia Treatmentof hyperlipidemia in conjunction with therapeutic lifestyle modifications canbe used for both primary and secondary prevention of CVD. Statins have the mostpotent 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 orthe risk equivalent. High-dose statins should be initiated in patients withacute coronary syndrome (ACS). There is a strong evidence for using statins inthe secondary prevention of stroke and peripheral arterial disease. Omega-3fatty acids may be an alternative after myocardial infarction (MI) for patientswho cannot tolerate statins. Niacin and fibrates have not been shown to reducemortality in secondary prevention, but may be useful adjuncts when statinsalone cannot adequately control lipid levels. Other Lipid-lowering agents usedfor primary or secondary prevention of CVD have not been shown to consistentlyimprove patient-oriented outcomes. 2 Hyperlipidemiaguidelines 3U.

S.,U.K., and Canadian guidelines are available to help manage hyperlipidemia.These guidelines agreed on that, the therapeutic lifestyle modifications arethe pole of hyperlipidemia management. The primary target of therapy must beLDL cholesterol. Treatment of hyperlipidemia improves outcomes for patients:1) with known coronaryheart disease (CHD) or the risk equivalent.

2) for high-risk patientswithout 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 < 100 mg per dL < 100 mg per dL (2.59 mmol per L) Optional goal of < 70 mg per dL (1.81 mmol per L) is favored in patients at very high risk (CHD plus multiple major or poorly controlled risk factors) High risk CHD or risk equivalent 10-year CHD risk > 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) < 130 mg per dL (3.

37 mmol per L) Optional goal < 100 mg per dL Moderately high risk ? two risk factors 10-year CHD risk of 10 to 20 percent Consider if LDL cholesterol is ? 160 mg per dL (4.14 mmol per L) < 130 mg per dL Moderate risk ? two risk factors 10-year CHD risk < 10 percent Consider if LDL cholesterol is ? 190 mg per dL (4.92 mmol per L) < 160 mg per dL Low risk One or no risk factors National Institute for Health and Clinical Excellence Initiate simvastatin (Zocor), 40 mg daily, if CHD risk is ? 20 percent (routine measurement of lipid levels is not necessary) No target level for total or LDL cholesterol Primary prevention Initiate simvastatin, 40 mg daily, as soon as possible Consider increasing dosage to 80 mg daily if LDL cholesterol goal is not achieved Consider a higher-intensity statin in patients with acute coronary syndrome < 78 mg per dL (2.02 mmol per L) Secondary prevention Canadian Cardiovascular Society Offer treatment to all patients < 78 mg per dL or 50 percent LDL cholesterol reduction (alternate apolipoprotein B level < 80 mg per dL 0.

80 g per L) High risk CHD, peripheral vascular disease, atherosclerosis (i.e., any vascular bed, including carotid arteries) Usually diabetes mellitus Framingham or Reynolds risk score ? 20 percent Consider for patients with any of the following factors: LDL cholesterol > 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) < 78 mg per dL or 50 percent LDL cholesterol reduction (alternate apolipoprotein B level < 80 mg per dL) Moderate risk Framingham risk score 10 to 19 percent Consider if LDL cholesterol is ? 193 mg per Dl (5 mmol per L) ? 50 percent reduction in LDL cholesterol Low risk Framingham risk score < 10 percent CHD = coronary heart disease; CRP = C-reactive protein; HDL = high-density lipoprotein; LDL = low-density lipoprotein.   Costof hyperlipidemia medications 3Adherenceto medications is directly associated with improved clinical outcomes, higherquality of life and lower healthcare costs across many chronic conditions. Thefollowing table shows the Monthly retail cost based on information fromhttp://www.drugstore.

com (accessed May 16, 2011):  Monthly retail cost Hyperlipidemia medication $75 to $125 Cholestyramine = > $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)   Complicationof Non- adherence to hyperlipidemia medications Theeffectiveness of lipid-lowering therapy may remain far from desired outcomes. Patientnon-adherence to medication consider as one of the important factorsresponsible for this problem. Non-adherence to antihyperlipidemic occurs withvarious prevalence and with varying degrees depending on many factors, such astype of prescribed medication. The World Health Organization(WHO) estimatesthat it affects about 50% of patients treated for chronic diseases. Amongpatients receiving lipid-lowering drugs, after 6 months only 36% satisfactorilyadhered to treatment and during the first year of treatment, a third ofpatients stopped the treatment completely.

The main reason of non-adherence toantihyperlipidemic is multiple drug regimens. The main consequence ofmedication non-adherence is ineffectiveness of the treatment. Thus, failure toachieve full benefits of evidence-based therapies. 4Takinga lower percentage of prescribed doses leads to significant reduction in theeffectiveness of treatment, increased risk of cardiovascular incidents andmortality. 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 increasedhospitalizations and MI have been associated with non-adherence tohyperlipidemia medications. 4 WorldHealth Organization(WHO) statistics Raisedcholesterol increases the risks of heart disease and stroke. Globally, a thirdof ischemic heart disease is attributable to high cholesterol.

Overall, raisedcholesterol is estimated to cause 2.6 million deaths (4.5% of total) and 29.7million disability adjusted life years (DALYS), or 2.0% of total DALYS. Raisedtotal cholesterol is a major cause of disease burden in both the developed anddeveloping 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 a50% reduction in heart disease within 5 years; the same serum cholesterolreduction for men aged 70 years can result in an average 20% reduction in heartdisease occurrence in the next 5 years. 5Theprevalence of elevated total cholesterol was highest in the WHO Region ofEurope (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 Regionshowed the lowest percentages (22.6% for AFR and 29.0% for SEAR). 5Theprevalence of raised total cholesterol increased noticeably according to theincome level of the country. In low income countries around a quarter of adultshad raised total cholesterol, in lower middle-income countries this rose toaround a third of the population for both sexes.

In high-income countries, over50% of adults had raised total cholesterol; more than double the level of the low-incomecountries. 5  Cost of non-adherence tohyperlipidemia medications studies:1.    Relationshipbetween adherence level to statins, clinical issues and health-care costs inreal life clinical setting.               Thestudy was mainly a comparison between statin adherent and non-adherent patientgroups in Canada. Results showed that low adherence level to statin wasassociated with an increased risk of hospitalization and having cardiovascularcomplications. Cost of hospitalization was increasing with low adherence levelby around $1060 per person in a 3-year duration of follow-up.

Total costs ofhospitalization among adherent patients were $65.9 M compared to $71.0 M for non-adherentpatients which interpreted as an excess cost of hospitalization to lowadherence of $9.5 M. Researchers anticipate that the indirect cost of lowadherence would also be higher. 62.    Adherence toStatins, Subsequent Healthcare Costs, and Cardiovascular Hospitalizations Statins are the primarytreatment used to reduce LDL cholesterol. Adherence to statins leads topositive clinical outcomes, however statin non-adherence has negative impact onhealthcare costs.

In 2011 a retrospective cohort study of 381,422 patients, aged18 to 61 years was conducted to examine the relation among statin adherence,subsequent hospital admissions and healthcare costs by using an integratedpharmacy and medical claims database. The adherence was measured by themedication possession ratio (MPR) for 12 months and the healthcare costs andcardiovascular disease-related hospital admission during the subsequent 18months. The primary evaluation, MPR was used to categorize the patients into 3adherence group: adherent (MPR_80%), moderate adherence (MPR 60% to 79%), andlow adherence (MPR _0% to 59%). It hasbeen found that about 1/3 of the 381,422 tested patients were non-adherent to theirstatin therapy in the baseline year and that non-adherence was associated witha $400 to $900 per patient greater total healthcare cost and increasedlikelihood of a cardiovascular disease related hospitalization in thesubsequent 18 months.

In the adherent group, greater statin drug costs werecompensated by the lower medical costs, leading to lower total healthcarecosts.   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 careduring 18 months of follow-up by level of adherence to statins in year 1* Inconclusion, statin adherence is associated with reductions in subsequent totalhealthcare costs and cardiovascular disease-related hospitalizations. In thisstudy there were no statistically significant associations between a greaterMPR and lower medical and total healthcare costs. 7    3.

    The Clinicaland Economic Burden of Non-adherence with Antihypertensive and Lipid-LoweringTherapy in Hypertensive Patients:Astudy 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 andoutcomes associated with varying adherence pattern to antihypertensive and lipidlowering agents (statin) therapy in hypertensive patients. These groups dividedas follow; no treatment, ideal adherence, and real-world adherence. Thereal-world adherence group employed adherence data from an observational studyof a US population; risk reductions at each level of adherence were based on datafrom clinical trials.

Outputs included life expectancy, frequencies of primaryand secondary cardiovascular diseases and stroke. Direct medical costs in 2006US $, the incremental cost per life-year gained and incremental cost per eventavoided were calculated comparing the three adherence groups. The result ofthis 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 groupwhile $22,121 per life-year gained for ideal adherence group comparing toreal-world adherence. The study also reports that applying an effectiveadherence intervention program has an incremental bene?ts which make it anattractive value. Finally,Hypertensivepatients on antihypertensive and lipid-lowering medication at real-worldadherence receive approximately 50% of the benefit showed in the clinicaltrials and have an increased life expectancy in addition to lowercardiovascular event but the adherence to the antihypertensive and statin willbe more cost effective if it will be taken at level as in the clinical trials.

8  4.    The economicconsequences of non-adherence to lipid-lowering therapy: results from theAnglo-Scandinavian-Cardiac Outcomes Trial  In2010, this study was conducted to assess the impact of non-adherence tolipid-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 weredivided into three groups (low adherence, medium adherence, and high adherence group).The study showed that; patients who are highly adherents to their therapy havea lower risk of cardiac events compared with low adherence group. The long-termcost 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   TheTotal cost for high adherence group would be higher compare to non-adherents group(£1689, £1323 respectively), for high adherence group the saved cost throughreduction of other health care cost is 10% of drug cost. the survival and QALYwould be longer for high adherence patients compared to others with predictionof 0.

02 QALYs for prevented events. 9  Conclusion Lipid-lowering agents are that agents whichthe treat the increased low-density lipoprotein cholesterol. Several studiesshow that high adherence to lipid-lowering therapy will decrease risk ofcardiovascular events, improve clinical outcomes, prolong life survival andreduce health cost which associated with cardiovascular diseases andhospitalization therefore High adherence to lipid lowering agents isworthwhile. in the other hand statins non-adherence can lead to negativeclinical sequences which include high risk of cardiovascular events, increaseuse of health care services, thus increase cost. Hence, it is important todevelop an appropriate cost effective interventions to minimize the burden oflow adherence to lipid lowering agents. Such an intervention we may consider toovercome the problem of poor adherence is to emphasize the value of a patient’sregimen, making the regimen simple and customizing the regimen to the patient’slifestyle to enhance the adherence.

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M. (2011). Adherence tostatins, subsequent healthcare costs, and cardiovascular hospitalizations. TheAmerican journal of cardiology, 107(11), 1662-1666.? 8.

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