Evaluation of LDL goal achievement in statin consumption, south east of Iran.

Lipid goal achievement and statin consumption were estimated at extreme/very-high/high/moderate and low cardiovascular risk categories. In the cross-sectional study, 585 patients treated with statin therapy referring to the heart clinic of Birjand were recruited. Patients were classified and examined LDL-C values and the proportion reaching targets according to the American Association of Clinical Endocrinologists guideline. Three patterns of statin use (high/moderate/low-intensity statin therapy) in all patients were examined and attainments of LDL-C goal in cardiovascular risk groups have been demonstrated. Over half the populations (57.6%) were in the very-high CVD risk group. The results showed that the proportion of patients meeting total LDL-C goal values according to the guidelines was 43.4%. The frequency of patient had achievement LDL goal lower in high-intensity pattern (N = 13, 2.3%), compared with moderate (N = 496, 86.1%) and low-intensity patterns (N = 67, 11.6%). In general, LDL-C goal achievement was greatest with moderate-intensity statin use. LDL-C reduction after statin consumption was estimated about one-third of the studied population. It seems likely that the achievement of a therapeutic target for serum lipids such as LDL-C improved is far more cost-effective and would be able to reach the target LDL as well changing the type and intensity of statins.

Cumulative non-HDL-cholesterol burden in patients with hypertriglyceridemia receiving long-term fibrate therapy: Real life data from a lipid clinic cohort.

OBJECTIVE: Though epidemiological data suggest that an elevated triglyceride (TG) level may be a risk factor for coronary artery disease (CAD), there is still insufficient clinical evidence. This study was designed to evaluate the real-life efficacy and side effects of fibrate treatment for hypertriglyceridemia seen in a lipid clinic, as well as cardiovascular and diabetic outcomes. METHODS: This retrospective study evaluated patients who were followed-up for a diagnosis of hypertriglyceridemia at the lipid outpatient clinic of the Ege University Cardiology Department between 1997 and 2018. Data of demographic and clinical characteristics were obtained from hospital records. All patients (n=240) with at least 1 year of follow-up were included in the analysis. During follow-up, patients were treated with fenofibrate, and less frequently, gemfibrozile (14 patients), at different doses according to the TG level and disease severity. RESULTS: Of the study population, 23% had CAD, 21% were diabetic, and 52% were obese. On admission, 20% were using fibrates and 17% were on statins. The mean admission lipid levels were TG: 281±194 mg/dL, low-density lipoprotein cholesterol: 115±37 mg/dL, high-density lipoprotein (HDL) cholesterol: 43±13 mg/dL, and non-HDL cholesterol: 166±42 mg/dL. The mean length of follow-up was 5.3±4.7 years (range: 1-16 years). A total of 8 (4.3%) patients had adverse effects during follow-up (1 on statin combination and 7 on fibrates alone). The side effects observed were an elevation of liver enzymes in 3, myalgia in 2, insomnia in 1, malaise in 1, and a skin rash in 1 patient. No rhabdomyolysis or myopathy was seen. During follow-up, diabetes developed in 14 and cardiovascular disease (CVD) in 14 patients. The cumulative non-HDL cholesterol level was significantly high in patients who developed diabetes or CVD. Receiver operating curve analysis indicated that a cumulative non-HDL cholesterol value of 1016 mg/dL was predictive of the development of diabetes mellitus or CVD with 85% sensitivity and 70% specificity. CONCLUSION: In real life, long-term fibrate use is effective and safe. The cumulative non-HDL cholesterol burden can be used to assess the efficacy of treatment as a simple and easily calculated method. Large studies are needed to further clarify the value of this parameter in predicting the development of both diabetes and CVD.

[PCSK9 inhibitors; who benefits from these new cholesterol-lowering drugs?] / PCSK9-remmers.

PCSK9 inhibitors are monoclonal antibodies that target the protein PCSK9. These drugs (alirocumab and evolcumab) are a new generation of cholesterol-lowering agents for patients with a very high risk of cardiovascular disease. They lower the LDL cholesterol concentration by approximately 50% in comparison with placebo, thereby lowering the risk of myocardial infarction, stroke and cardiovascular death in high-risk patients. Due to their high cost and the cost-effectiveness, there are strict conditions for reimbursement for these agents in the Netherlands. PCSK9 inhibitors can be given to high-risk patients in whom, despite maximal medicinal therapy with statins and ezetimibe, the target level of LDL cholesterol cannot be reached. This article gives an overview of the efficacy and the safety of PCSK9 inhibitors, and of their use in the Netherlands.

Quantifying Unmet Need in Statin-Treated Hyperlipidemia Patients and the Potential Benefit of Further LDL-C Reduction Through an EHR-Based Retrospective Cohort Study.

BACKGROUND: Statins are effective in helping prevent cardiovascular disease (CVD). However, studies suggest that only 20%-64% of patients taking statins achieve reasonable low-density lipoprotein cholesterol (LDL-C) thresholds. On-treatment levels of LDL-C remain a key predictor of residual CVD event risk. OBJECTIVES: To (a) determine how many patients on statins achieved the therapeutic threshold of LDL-C < 100 mg per dL (general cohort) and < 70 mg per dL (secondary prevention cohort, or subcohort, with preexisting CVD); (b) estimate the number of potentially avoidable CVD events if the threshold were reached; and (c) forecast potential cost savings. METHODS: A retrospective, longitudinal cohort study using electronic health record data from the Indiana Network for Patient Care (INPC) was conducted. The INPC provides comprehensive information about patients in Indiana across health care organizations and care settings. Patients were aged > 45 years and seen between January 1, 2012, and October 31, 2016 (ensuring study of contemporary practice), were statin-naive for 12 months before the index date of initiating statin therapy, and had an LDL-C value recorded 6-18 months after the index date. Subsequent to descriptive cohort analysis, the theoretical CVD risk reduction achievable by reaching the threshold was calculated using Framingham Risk Score and Cholesterol Treatment Trialists' Collaboration formulas. Estimated potential cost savings used published first-year costs of CVD events, adjusted for inflation and discounted to the present day. RESULTS: Of the 89,267 patients initiating statins, 30,083 (33.7%) did not achieve the LDL-C threshold (subcohort: 58.1%). In both groups, not achieving the threshold was associated with patients who were female, black, and those who had reduced medication adherence. Higher levels of preventive aspirin use and antihypertensive treatment were associated with threshold achievement. In both cohorts, approximately 64% of patients above the threshold were within 30 mg per dL of the respective threshold. Adherence to statin therapy regimen, judged by a medication possession ratio of ≥ 80%, was 57.4% in the general cohort and 56.7% in the subcohort. Of the patients who adhered to therapy, 23.7% of the general cohort and 50.5% of the subcohort had LDL-C levels that did not meet the threshold. 10-year CVD event risk in the at-or-above threshold group was 22.78% (SD = 17.24%) in the general cohort and 29.56% (SD = 18.19%) in the subcohort. By reducing LDL-C to the threshold, a potential relative risk reduction of 14.8% in the general cohort could avoid 1,173 CVD events over 10 years (subcohort: 15.7% and 454 events). Given first-year inpatient and follow-up costs of $37,300 per CVD event, this risk reduction could save about $1,455 per patient treated to reach the threshold (subcohort: $1,902; 2017 U.S. dollars) over a 10-year period. CONCLUSIONS: Across multiple health care systems in Indiana, between 34% (general cohort) and 58% (secondary prevention cohort) of patients treated with statins did not achieve therapeutic LDL-C thresholds. Based on current CVD event risk and cost projections, such patients seem to be at increased risk and may represent an important and potentially preventable burden on health care costs. DISCLOSURES: Funding support for this study was provided by Merck (Kenilworth, NJ). Chase and Boggs are employed by Merck. Simpson is a consultant to Merck and Pfizer. The other authors have nothing to disclose.

Comparison of Medical Care Utilization and Costs Among Patients With Statin-Controlled Low-Density Lipoprotein Cholesterol With Versus Without Hypertriglyceridemia.

High triglyceride (TG) levels are associated with higher medical costs, but the long-term impact of high TG on costs among patients with statin-controlled low-density lipoprotein cholesterol (LDL-C) is unclear. We compared medical utilization and costs over 6.5years between patients with high (200 to 400 mg/dl) versus normal (<150 mg/dl) TG levels, all of whom had established atherosclerotic cardiovascular disease (ASCVD). This was an observational cohort study of 17,183 patients with TG measured in 2010 and followed until death, disenrollment or the end of 2016. All patients had LDL-C levels between 40 and 100 mg/dl and were receiving statin therapy at the time of their TG measurement. We compared annualized medical utilization adjusted for differences between group in age, sex, race, and study site. We also compared annualized medical costs, further adjusting for baseline costs as a proxy for resource-intensive comorbidities. After multivariable adjustment, patients with high TG levels (n=2,702) had a mean of 13% more inpatient admissions per year (p <0.001). Despite adjustment for comorbidities such as diabetes and chronic kidney disease, total outpatient costs were 5% greater (p = 0.035) among those with high TG, including emergency care costs (6% greater) and hospital ambulatory costs (25% greater). The overall difference in annual costs of $964 per patient in the high TG cohort totaled over $2.6million per year in excess annual costs and more than $13.5million over the mean follow-up of 5.2years.

Modelling the cost-effectiveness of PCSK9 inhibitors vs. ezetimibe through LDL-C reductions in a Norwegian setting.

Aims: Despite the success of statins, there remains unmet clinical need in cardiovascular disease (CVD) prevention. New proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors reduce low-density lipoprotein cholesterol (LDL-C) by 55-65%. Two PCSK9 inhibitors, evolocumab, and alirocumab, were approved for use in Norway but not yet for reimbursement through public national insurance. We aim to explore the cost-effectiveness of these compared with available treatments in a Norwegian setting. Methods and results: A state transition Markov model was developed to model the cost-effectiveness of PCSK9 inhibitors for prevention of coronary heart disease, ischaemic strokes, and death among high-risk patient subpopulations in Norway, in both primary and secondary settings. Evolocumab and alirocumab are compared against ezetimibe and standard treatment. Risk of CVD is based on population incidence rates and adjusted according to baseline risk factors. Preventative effect of treatment was modelled according to absolute reduction in LDL-C. PCSK9 inhibitors were never found to be cost-effective in primary prevention. In secondary prevention they were cost-effective only for older, high-risk patients. The lowest cost-effectiveness ratios were for heterozygous familial hypercholesterolaemia patients and high-risk diabetics, with €63 200 and €68 400 per quality-adjusted life-year, respectively. Conclusion: High lifetime costs of PCSK9 inhibitors may not be offset by estimated health gains for most eligible patients. PCSK9 inhibitors are found in the model only to be cost-effective in secondary prevention for older patients with high absolute risk of CVD. This picture is likely to change as price decreases. Future research is needed to determine the long-term preventative effects of PCSK9 inhibitors.

Impact of Gender on Satisfaction and Confidence in Cholesterol Control Among Veterans at Risk for Cardiovascular Disease.

BACKGROUND: Compared with men, women have poorer lipid control. Although potential causes of this disparity have been explored, it is unknown whether patient-centered factors such as satisfaction and confidence contribute. We evaluated (1) whether satisfaction with lipid control and confidence in ability to improve it vary by gender and (2) whether sociodemographic characteristics modify the association. MATERIALS AND METHODS: We evaluated baseline survey responses from the Cardiovascular Intervention Improvement Telemedicine Study, including self-rated satisfaction with cholesterol levels and confidence in controlling cholesterol. Participants had poorly controlled hypertension and/or hypercholesterolemia. RESULTS: A total of 428 veterans (15% women) participated. Compared with men, women had higher low-density lipoprotein values at 141.2 versus 121.7 mg/dL, respectively (p < 0.05), higher health literacy, and were less likely to have someone to help track their medications (all p < 0.05). In an adjusted model, women were less satisfied with their cholesterol levels than men with estimated mean scores of 4.3 versus 5.6 on a 1-10 Likert scale (p < 0.05). There was no significant difference in confidence by gender. Participants with support for tracking medications reported higher confidence levels than those without, estimated mean 7.8 versus 7.2 (p < 0.05). CONCLUSIONS: Women veterans at high risk for cardiovascular disease were less satisfied with their lipid control than men; however, confidence in ability to improve lipid levels was similar. Veterans without someone to help to track medications were less confident, and women were less likely to have this type of social support. Lack of social support for medication tracking may be a factor in lingering gender-based disparities in hyperlipidemia.

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context.

AIM: To estimate real-world cardiovascular disease (CVD) burden and value-based price range of evolocumab for a US-context, high-risk, secondary-prevention population. MATERIALS AND METHODS: Burden of CVD was assessed using the UK-based Clinical Practice Research Datalink (CPRD) in order to capture complete CV burden including CV mortality. Patients on standard of care (SOC; high-intensity statins) in CPRD were selected based on eligibility criteria of FOURIER, a phase 3 CV outcomes trial of evolocumab, and categorized into four cohorts: high-risk prevalent atherosclerotic CVD (ASCVD) cohort (n = 1448), acute coronary syndrome (ACS) (n = 602), ischemic stroke (IS) (n = 151), and heart failure (HF) (n = 291) incident cohorts. The value-based price range for evolocumab was assessed using a previously published economic model. The model incorporated CPRD CV event rates and considered CV event reduction rate ratios per 1 mmol/L reduction in low-density lipoprotein-cholesterol (LDL-C) from a meta-analysis of statin trials by the Cholesterol Treatment Trialists Collaboration (CTTC), i.e. CTTC relationship. RESULTS: Multiple-event rates of composite CV events (ACS, IS, or coronary revascularization) per 100 patient-years were 12.3 for the high-risk prevalent ASCVD cohort, and 25.7, 13.3, and 23.3, respectively, for incident ACS, IS, and HF cohorts. Approximately one-half (42%) of the high-risk ASCVD patients with a new CV event during follow-up had a subsequent CV event. Combining these real-world event rates and the CTTC relationship in the economic model, the value-based price range (credible interval) under a willingness-to-pay threshold of $150,000/quality-adjusted life-year gained for evolocumab was $11,990 ($9,341-$14,833) to $16,856 ($12,903-$20,678) in ASCVD patients with baseline LDL-C levels ≥70 mg/dL and ≥100 mg/dL, respectively. CONCLUSION: Real-world CVD burden is substantial. Using the observed CVD burden in CPRD and the CTTC relationship, the cost-effectiveness analysis showed that, accounting for uncertainties, the expected value-based price for evolocumab is higher than its current annual cost, as long as the payer discount off list price is greater than 20%.

A study in high-risk, maximally pretreated patients to determine the potential use of PCSK9 inhibitors at various thresholds of total and LDL cholesterol levels.

PURPOSE OF THE STUDY: Statins and ezetimibe reduce low-density lipoprotein cholesterol (LDL-c) and cardiovascular disease (CVD) risk. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors lower LDL-c by 50%-70% and might be useful in refractory patients. The National Institute for Health and Care Excellence (NICE) technology appraisal guidance (TAG) recommends use of these drugs in secondary prevention and familial hypercholesterolaemia (FH) at differing LDL-c thresholds. We have estimated the proportion of patients in whom this third-line drug might be useful. STUDY DESIGN: We used data from a lipid-lowering audit programme to study 72 with FH and/or CVD of 271 patients referred over 12 months who failed to achieve target total cholesterol (TC) and LDL-c levels. All 72 patients were treated with ezetimibe, and 69 cases also received statins. We used LDL-c thresholds 1.5-5.5 mmol/L to estimate how many of these refractory patients could benefit from PCSK9 inhibitors. RESULTS: In 72 patients, TC and LDL-c targets were not met by 64 and 53 patients, respectively. We judged using the NICE TAG that only one patient (1.4% ezetimibe requiring and 0.4% total referrals) required a PCSK9 inhibitor. CONCLUSIONS: We determined that the proportion of patients eligible for a PCSK9 inhibitor at various TC and LDL-c levels is modest. This may reflect the use of all available statins in UK lipid clinics often at non-daily frequency. We suggest that cost-effective use of PCSK9 inhibitors requires prescribing being restricted to clinicians working in specialised lipid clinics.

Patterns and predictors of lipid-lowering therapy in patients with atherosclerotic cardiovascular disease and/or diabetes mellitus in 2014: Insights from a large US managed-care population.

BACKGROUND: Lowering low-density lipoprotein cholesterol with statins reduces risk of cardiovascular events. We examined patterns and predictors of filled prescriptions for lipid-lowering therapy (LLT) in subgroups of patients with atherosclerotic cardiovascular disease (ASCVD) and/or diabetes mellitus (DM). HYPOTHESIS: Statin treatment remains underutilized across subgroups of high CV risk patients. METHODS: Patients in the Optum Research Database with these criteria were included: age ≥20 years, 2 years continuous enrollment, and ASCVD and/or DM. Patients were hierarchically classified by the presence of recent acute coronary syndrome, other coronary heart disease, ischemic stroke, peripheral arterial disease (PAD), or only DM. Predictors of filled LLT regimens were examined using multinomial logistic regression. RESULTS: A total of 1 055 932 individuals met all inclusion criteria. Evidence by point-in-time analysis of filled (not only written) statin prescriptions was 45% for the overall cohort. By subgroups, this was 62%, 52%, 43%, 36%, and 40% for recent acute coronary syndrome, other coronary heart disease, ischemic stroke, PAD, and only DM, respectively. Predictors of higher rates of any statin regimen included age 50 to 69 years, male sex, absence of comorbidities, and filled prescriptions of other standard-of-care therapies. CONCLUSIONS: In 2014, only 49% of patients with ASCVD and 40% with only DM had evidence for a filled statin prescription. Those with indications of ischemic stroke, PAD, and DM were less likely to receive statins than those with coronary conditions. Other characteristics such as advanced age, female sex, and noncardiac conditions predicted less statin utilization, thereby representing good targets for quality improvement.

[Lipids and cerebrovascular disease - New therapeutic options in lowering LDL-cholesterol]. / Lipidek és az agyérbetegség ­ Új lehetoségek az LDL-koleszterin-szint csökkentésére.

Stroke is the third most common cause of death worldwide following myocardial infaction and malignancies, furthermore, its functional outcome is the worst of all conditions. Cholesterol, especially LDL-cholesterol plays a key role in the formation of atherosclerotic plaques. It has been verified recently that escalating incidence and mortality of cerebrovascular diseases are proportional to increased levels of LDL-cholesterol. Statin therapy undeniably reduces the risk of stroke, however other methods for decreasing lipid levels have not been proved significantly effective. Preventive effect of high-dose statin treatment is without doubt, although administration of such high dosage might require special precautions for patients with prior intracerebral hemorrhage and it also risks development of incident diabetes. The recently published IMPROVE-IT study is the first to prove that the addition of ezetimibe as a non-statin type drug, to statin treatment contributes to further reduction of LDL-cholesterol. The combination treatment results in additional decrease in the incidence and mortality of cerebrovascular events, without any expansion in the number or adverse effects. These results confirm the importance of any further reduction of LDL-cholesterol levels. Achieving target values with statin-ezetimibe combination allows administration of low to moderate dose of statin, which decreases risks of adverse effects related to high-dose statin therapy. Orv. Hetil., 2016, 157(52), 2059-2065.

Prevalence and management of familial hypercholesterolaemia in patients with acute coronary syndromes.

AIMS: We aimed to assess the prevalence and management of clinical familial hypercholesterolaemia (FH) among patients with acute coronary syndrome (ACS). METHODS AND RESULTS: We studied 4778 patients with ACS from a multi-centre cohort study in Switzerland. Based on personal and familial history of premature cardiovascular disease and LDL-cholesterol levels, two validated algorithms for diagnosis of clinical FH were used: the Dutch Lipid Clinic Network algorithm to assess possible (score 3-5 points) or probable/definite FH (>5 points), and the Simon Broome Register algorithm to assess possible FH. At the time of hospitalization for ACS, 1.6% had probable/definite FH [95% confidence interval (CI) 1.3-2.0%, n = 78] and 17.8% possible FH (95% CI 16.8-18.9%, n = 852), respectively, according to the Dutch Lipid Clinic algorithm. The Simon Broome algorithm identified 5.4% (95% CI 4.8-6.1%, n = 259) patients with possible FH. Among 1451 young patients with premature ACS, the Dutch Lipid Clinic algorithm identified 70 (4.8%, 95% CI 3.8-6.1%) patients with probable/definite FH, and 684 (47.1%, 95% CI 44.6-49.7%) patients had possible FH. Excluding patients with secondary causes of dyslipidaemia such as alcohol consumption, acute renal failure, or hyperglycaemia did not change prevalence. One year after ACS, among 69 survivors with probable/definite FH and available follow-up information, 64.7% were using high-dose statins, 69.0% had decreased LDL-cholesterol from at least 50, and 4.6% had LDL-cholesterol ≤1.8 mmol/L. CONCLUSION: A phenotypic diagnosis of possible FH is common in patients hospitalized with ACS, particularly among those with premature ACS. Optimizing long-term lipid treatment of patients with FH after ACS is required.

Benefit-risk assessment of pitavastatin for the treatment of hypercholesterolemia in older patients.

With the practice-shifting changes made with the most recent guidelines for treating blood cholesterol, more older patients may be prescribed statin therapy. Therefore, it is imperative that practitioners have not only a working knowledge of information related to statins, but more specifically to their efficacy and safety in elderly populations. Pitavastatin is the most recent statin to receive regulatory approval. It is indicated for the treatment of primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet. The overall body of evidence for the efficacy and safety of pitavastatin in elderly patients is small. The available data suggest that the ability of pitavastatin to lower low-density lipoprotein cholesterol in elderly patients is at least similar, and may be greater than that seen in comparatively younger cohorts. Taken together, the limited available data suggest that pitavastatin is effective at improving lipid parameters in elderly patients with a similar safety profile to other agents in the class. Until data become available distinguishing pitavastatin from the other available options, its ultimate role in the hyperlipidemia treatment armamentarium remains unclear.

Evidence of sample use among new users of statins: implications for pharmacoepidemiology.

BACKGROUND: Epidemiologic studies of prescription medications increasingly rely on large administrative health care databases. These data do not capture patients' use of medication samples. This could potentially bias studies of short-term effects where date of initiation may be inaccurate. OBJECTIVES: To assess the extent of sample use among patients initiating statin therapy. RESEARCH DESIGN: Retrospective cohort of patients who filled a first prescription for a statin after at least 6 months of statin-free period in 2007-2010. Low-density lipoprotein (LDL) values obtained within the 15 days preceding the first prescription were analyzed using a 2-component Gaussian mixture model to look for evidence of prior treatment. SUBJECTS: A total of 26,033 statin initiators with at least 1 LDL laboratory result within the 15 days preceding the prescription fill. MEASURES: Estimators for the proportion of patients filling a new prescription already on treatment. RESULTS: Among 9256 patients filling a branded statin, LDL distribution was bimodal, consisting of 2 Gaussian distributions: one, which made up 13.4% of the total population, had much lower LDL values (mean=71.8 mg/dL) compared with the second (mean=148.0 mg/dL), suggesting drug use before first dispensed prescription. Among 16,777 patients filling a generic statin, LDL levels were substantially higher with no evidence of bimodality that would suggest prior sample use. CONCLUSIONS: These results provide indirect evidence that the initial period of branded medication use may often be missed when using pharmacy claims data to define drug initiation. Further research is needed to examine approaches to better identify incident medication use when assessing short-term effects.

Self-reported adherence by MARS-CZ reflects LDL cholesterol goal achievement among statin users: validation study in the Czech Republic.

RATIONALE, AIMS AND OBJECTIVES: Measuring self-reported adherence may contribute to minimizing the risk of therapy failure. Hence, the main aim of the study was to assess the psychometric properties of the Czech version of Medication Adherence Report Scale (MARS-CZ) and its appropriateness for use in long-term statin therapy where goal levels of low-density lipoprotein cholesterol (LDL-c) should be achieved. METHODS: Anonymous structured interview was performed to determine self-reported adherence by MARS-CZ in outpatients chronically treated with statins. At the same time, medication records were reviewed for inclusion of patients into groups of those who achieved and do not achieved LDL-c goal according to cardiovascular risk level. Reliability and validity of MARS-CZ were tested as well as the relationship between adherence and LDL-c goal achievement was examined. RESULTS: A total of 136 (86.6%) patients completed the interview; mean age was 66.1 years; 49.3% were male. The mean score of MARS-CZ was 24.4 and showed positive skewing. Satisfactory internal consistency (Cronbach's α=0.54), strong test-retest reliability (r=0.83, P<0.001; intra-class correlation=0.63, 95% confidence interval: 0.35-0.81) and positive correlation with eight-item Morisky Medication Adherence Scale (r=0.62, P<0.001) were indicated. Low validity values were found between MARS-CZ and 12-item Short Form Health Survey mental and physical subscales. MARS-CZ score significantly correlated with LDL-c goal achievement (P<0.05) when all patients who achieved LDL-c goal (35%) reported high adherence to statin. MARS-CZ score also correlated with cardiovascular risk level and doctor's judgments on adjusting treatment targets for each patient. CONCLUSION: This study proved MARS-CZ as an acceptable self-reported adherence measure. In routine clinical practice, MARS-CZ could be helpful to reveal medication non-adherence before the alteration of drug regimen and thereby contributing to enhancement of statin therapy management.

The large social value resulting from use of statins warrants steps to improve adherence and broaden treatment.

Statins are considered a clinically important breakthrough for the treatment of cardiovascular disease. However, their social value at the US population level has not previously been studied. From an economic perspective, social value measures the quantity of resources--in monetary terms--that society would be willing to give up in order to retain the survival gains resulting from statin therapy. Using combined population and clinical data, this article calculates statins' social value to consumers, or the value of survival benefits above actual payments for the drug, and to producers, or drug revenues, for the period 1987-2008. National survey data suggest that statin therapy reduced low-density lipoprotein levels by 18.8 percent, which translated into roughly 40,000 fewer deaths, 60,000 fewer hospitalizations for heart attacks, and 22,000 fewer hospitalizations for strokes in 2008. For people starting statin therapy in 1987-2008, consumers captured $947.4 billion (76 percent) of the total social value of the survival gains. Even greater consumer benefits could be achieved in the future if statins were prescribed in full compliance with cholesterol guidelines and patients adhered to prescribed regimens. In addition, statin costs are declining because of patent expirations. Policy makers should consider interventions at the patient and provider levels to encourage both therapy for untreated patients with high cholesterol and greater adherence after therapy is initiated.

Do different methods of modeling statin treatment effectiveness influence the optimal decision?

PURPOSE: Modeling studies that evaluate statin treatment for the prevention of cardiovascular disease (CVD) use different methods to model the effect of statins. The aim of this study was to evaluate the impact of using different modeling methods on the optimal decision found in such studies. METHODS: We used a previously developed and validated Monte Carlo-Markov model based on the Rotterdam study (RISC model). The RISC model simulates coronary heart disease (CHD), stroke, cardiovascular death, and death due to other causes. Transition probabilities were based on 5-year risks predicted by Cox regression equations, including (among others) total and high-density lipoprotein (HDL) cholesterol as covariates. In a cost-effectiveness analysis of implementing the ATP-III guidelines, we evaluated the impact of using 3 different modeling methods of statin effectiveness: 1) through lipid level modification: statins lower total cholesterol and increase HDL cholesterol, which through the covariates in the Cox regression equations leads to a lower incidence of CHD and stroke events; 2) fixed risk reduction of CVD events: statins decrease the odds of CHD and stroke with an associated odds ratio that is assumed to be the same for each individual; 3) risk reduction of CVD events proportional to individual change in low-density lipoprotein (LDL) cholesterol: the relative risk reduction with statin therapy on the incidence of CHD and stroke was assumed to be proportional to the absolute reduction in LDL cholesterol levels for each individual. The probability that the ATP-III strategy was cost-effective, compared to usual care as observed in the Rotterdam study, was calculated for each of the 3 modeling methods for varying willingness-to-pay thresholds. RESULTS: Incremental cost-effectiveness ratios for the ATP-III strategy compared with the reference strategy were €56,642/quality-adjusted life year (QALY), €21,369/QALY, and €22,131/QALY for modeling methods 1, 2, and 3, respectively. At a willingness-to-pay threshold of €50,000/QALY, the probability that the ATP-III strategy was cost-effective was about 40% for modeling method 1 and more than 90% for both methods 2 and 3. Differences in results between the modeling methods were sensitive to both the time horizon modeled and age distribution of the target CONCLUSIONS: Modeling the effect of statins on CVD through the modification of lipid levels produced different results and associated uncertainty than modeling it directly through a risk reduction of events. This was partly attributable to the modeled effect of cholesterol on the incidence of stroke.