Author + information
- Received March 15, 2017
- Accepted March 31, 2017
- Published online May 29, 2017.
- Robert S. Rosenson, MDa,∗ (, )
- Michael E. Farkouh, MDb,
- Matthew Mefford, MSc,
- Vera Bittner, MDd,
- Todd M. Brown, MD, MSPHd,
- Ben Taylor, PhDe,
- Keri L. Monda, PhDe,
- Hong Zhao, MSPHc,
- Yuling Dai, MSPHc and
- Paul Muntner, PhDc
- aMount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York
- bPeter Munk Cardiac Centre and Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada
- cDepartment of Epidemiology University of Alabama at Birmingham, Birmingham, Alabama
- dDepartment of Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama
- eCenter for Observational Research, Amgen, Thousand Oaks, California
- ↵∗Address for correspondence:
Dr. Robert S. Rosenson, Mount Sinai Heart, Cardiometablomics Unit, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, MC1 Level, New York, New York 10029.
Background Data prior to 2011 suggest that a low percentage of patients hospitalized for acute coronary syndromes filled high-intensity statin prescriptions upon discharge. Black-box warnings, generic availability of atorvastatin, and updated guidelines may have resulted in a change in high-intensity statin use.
Objectives The aim of this study was to examine trends and predictors of high-intensity statin use following hospital discharge for myocardial infarction (MI) between 2011 and 2014.
Methods Secular trends in high-intensity statin use following hospital discharge for MI were analyzed among patients 19 to 64 years of age with commercial health insurance in the MarketScan database (n = 42,893) and 66 to 75 years of age with U.S. government health insurance through Medicare (n = 75,096). Patients filling statin prescriptions within 30 days of discharge were included. High-intensity statins included atorvastatin 40 or 80 mg and rosuvastatin 20 or 40 mg.
Results The percentage of beneficiaries whose first statin prescriptions filled following hospital discharge for MI were for high-intensity doses increased from 33.5% in January through March 2011 to 71.7% in October through November 2014 in MarketScan and from 24.8% to 57.5% in Medicare. Increases in high-intensity statin use following hospital discharge occurred over this period among patients initiating treatment (30.6% to 72.0% in MarketScan and 21.1% to 58.8% in Medicare) and those taking low- or moderate-intensity statins prior to hospitalization (from 27.8% to 62.3% in MarketScan and from 12.6% to 45.1% in Medicare). In 2014, factors associated with filling high-intensity statin prescriptions included male sex, filling beta-blocker and antiplatelet agent prescriptions, and attending cardiac rehabilitation within 30 days following discharge.
Conclusions The use of high-intensity statins following hospitalization for MI increased progressively from 2011 through 2014.
Several randomized controlled trials have shown high-intensity statin therapy to be more efficacious than lower intensity therapy for preventing recurrent atherosclerotic cardiovascular disease (CVD) events among patients hospitalized for acute coronary syndrome (ACS) (1–3). Analyses of registries and insurance claims databases have documented that between 20% and 40% of patients with ACS fill prescriptions for high-intensity statins following hospital discharge (4,5). However, these studies were conducted among patients having coronary heart disease (CHD) events through 2011, with few more contemporary data being published.
Several events have occurred over the past several years that may have changed the use of high-intensity statins among patients with ACS. In 2011, the American Heart Association (AHA)/American College of Cardiology Foundation secondary prevention guidelines recommended “adequate” doses of statin therapy necessary to achieve specific low-density lipoprotein cholesterol thresholds (6). Although no specific statin intensity was recommended for patients with ACS, this guideline stated that it was reasonable (Class IIa, Level of Evidence: C) to treat patients who were at very high risk, including those with ACS, to an low-density lipoprotein cholesterol level <70 mg/dl. In 2013, the American College of Cardiology (ACC)/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic CVD risk in adults was published and recommended the use of high-intensity statin therapy for patients with established CVD (1). Other considerations that may have influenced prescribing patterns beginning in 2011 include a black-box warning against new prescriptions for simvastatin 80 mg and the generic availability of atorvastatin.
We evaluated secular trends in high-intensity statin use following hospitalization for myocardial infarction (MI) from 2011 through 2014 in 2 large samples of U.S. adults. Also, we identified patient characteristics for those who initiated statins with a high- versus a low- or moderate-intensity dose following their MIs and those who were titrated from low or moderate statin intensity to a high-intensity statin after their MIs in 2014. The results of this study provide contemporary data on the use of high-intensity statins following publication of the most recent ACC/AHA cholesterol guidelines, characterize patients who do versus do not receive high-intensity statins following hospital discharge for MI, and thereby identify those with an unmet treatment need.
We conducted a retrospective cohort study using administrative claims from MarketScan and Medicare. The MarketScan database contains health care claims for persons with commercial, Medicare supplemental, and Medicaid health insurance and was obtained through the Truven Health MarketScan Research Database. Medicare is a government program that provides health insurance for U.S. adults ≥65 years of age and younger adults with end-stage renal disease or who are disabled. Administrative claims for Medicare beneficiaries were obtained from the Chronic Conditions Warehouse, which was created by the Centers for Medicare and Medicaid Services to provide data for research purposes. The Institutional Review Board at the University of Alabama at Birmingham approved this analysis of deidentified data.
We studied MarketScan and Medicare beneficiaries who were hospitalized with overnight stays for MI between January 1, 2011, and November 30, 2014 (Online Figures 1 and 2). We restricted the analyses to patients whose hospital stays for their index MIs were ≤30 days, who were alive 30 days following hospital discharge, who had continuous MarketScan or Medicare fee-for-service insurance, and who were living in the United States from 365 days prior to hospital admission for their MIs through 30 days following discharge. Medicare fee-for-service coverage includes Parts A (inpatient), B (outpatient), and D (prescription). Beneficiaries enrolled in Medicare Advantage plans (Medicare Part C) were excluded, because complete claims are not available for these persons. We excluded MarketScan and Medicare beneficiaries with stays at skilled nursing facilities or hospice facilities within 30 days following their index MIs or with outpatient statin fills during their MI hospitalizations. To avoid overlap between the 2 samples, we restricted the MarketScan analysis to beneficiaries <65 years of age and Medicare analyses to beneficiaries 66 to 75 years of age at the time of hospital admission for MI. An age ≥66 years was used, rather than ≥65 years, to allow a 1-year look-back period to identify characteristics of Medicare beneficiaries. We analyzed Medicare beneficiaries >75 years of age separately because there are only limited data supporting high-intensity statins for this group. We restricted these analyses to beneficiaries who filled statin prescriptions within 30 days following hospital discharge for MI. The first MI each beneficiary experienced that met these criteria was included and is referred to as the index MI.
Statin use was identified by pharmacy prescription fills in MarketScan claims and Medicare Part D pharmacy claims in combination with national drug codes. Statins included atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. High-intensity statins use prior to the index MI included atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg, and simvastatin 80 mg (1). Because simvastatin 80 mg is no longer recommended for patients with ACS, MarketScan and Medicare beneficiaries filling prescriptions for simvastatin 80 mg were excluded for analyses of high-intensity statin use following MI (see statistical methods). Beneficiaries with any statin fills in the 365 days prior to their index MI were categorized as prevalent statin users. The statin intensity among prevalent users was based on the fill most proximate to, yet preceding, each beneficiary’s index MI.
Age and sex were identified from the MarketScan Commercial Claims and Encounters database and the Medicare beneficiary summary file. Each beneficiary’s age was calculated on the date of his or her index MI. Information on race/ethnicity is available for Medicare beneficiaries through the beneficiary summary file, but information on race is not available for MarketScan beneficiaries. In Medicare, receipt of a low-income subsidy under Medicare Part D and Medicare/Medicaid dual eligibility from the Medicare beneficiary enrollment file were used as markers of low socioeconomic status. Diabetes, CHD, stroke, heart failure, peripheral artery disease, chronic kidney disease, depression, Charlson comorbidity index, all-cause hospitalizations, cardiologist care, use of nonstatin lipid-lowering therapy, and the total number of different medication prescriptions filled were identified using claims in the 365 days prior to hospital admission for MI and previously published algorithms (Online Table 1) (7–13). The presence of dementia was determined for Medicare beneficiaries but was not included in the analysis of MarketScan beneficiaries given its low prevalence (<1%) in this younger population. We identified the use of cardiac rehabilitation and prescription fills for beta-blockers, antiplatelet agents, and nonstatin lipid-lowering therapies within 30 days after hospital discharge for the index MI.
All analyses were conducted for MarketScan beneficiaries <65 years of age and Medicare beneficiaries 66 to 75 years of age separately. Below, we describe the analyses for MarketScan beneficiaries. Identical analyses were conducted for Medicare beneficiaries. Characteristics of beneficiaries included in this analysis were calculated overall and for each calendar year. The study period from 2011 through 2014 was divided into calendar quarters (January to March, April to June, July to September, and October to December, except 2014, for which the fourth quarter included only October and November to allow a 30-day follow-up period to identify statin prescription fills post–hospital discharge). For each quarter, we assessed the first type of statin prescription and dose filled following hospital discharge for each beneficiary’s index MI. As mentioned earlier, we excluded from the remaining analyses beneficiaries (n = 754 in MarketScan and n = 1,476 in Medicare) whose first statin prescription fill following hospital discharge was for simvastatin 80 mg (1). We calculated the percentage of MarketScan beneficiaries whose first prescription fills following their index MIs were for high-intensity statins. This was done for the overall population, among statin initiators, among low- and moderate-intensity prevalent users, and among high-intensity prevalent statin users.
Characteristics of MarketScan beneficiaries filling and not filling high-intensity statin prescriptions following hospital discharge for MI in 2014 were calculated among statin initiators and among prevalent low- and moderate-intensity and among high-intensity statin users separately. This analysis was restricted to 2014 to provide data for the time period after publication of the ACC/AHA cholesterol management guideline. We used Poisson regression with sandwich estimators to calculate the relative risks for a high-intensity statin as the first statin prescription fill within 30 days after discharge. Relative risks were calculated in an unadjusted model, after demographic adjustment (age and sex in MarketScan and age, sex, and race/ethnicity in Medicare) and in a model that included age, sex, race (Medicare only), low income or dual subsidy (Medicare only), history of diabetes, CHD, stroke, heart failure, peripheral artery disease, chronic kidney disease, dementia (Medicare only), Charlson comorbidity index, depression, hospitalization in the year prior to MI, cardiologist care, nonstatin lipid-lowering therapy use, total number of medications taken, 30-day post-discharge cardiac rehabilitation, or 30-day post-discharge fills for beta-blockers, antiplatelet agents, and nonstatin lipid-lowering therapy, simultaneously.
We calculated the percentage of beneficiaries who switched from low- or moderate-intensity to high-intensity statins within 182 days following discharge. To allow 182 days of follow-up, this analysis was restricted to beneficiaries with index MIs in the first quarter of 2011 through the second quarter of 2014; those who died or lost insurance coverage within 182 days of hospital discharge for their index MI were excluded. This analysis included 17,574 MarketScan beneficiaries and 37,213 Medicare beneficiaries whose first statin prescription fills following hospital discharge were for low- or moderate-intensity statin doses.
In a final analysis, we assessed the type of statin prescription and dose filled following hospital discharge for MI among Medicare beneficiaries >75 years of age for each calendar quarter in 2011 through 2014. We also calculated the percentage of Medicare beneficiaries >75 years of age whose first statin fill following their index MI was for a high-intensity dose. All data management and statistical analyses were conducted using SAS version 9.4 (SAS Institute, Cary, North Carolina).
Trends in statin prescription fills
The current analysis included 42,893 MarketScan beneficiaries <65 years of age and 75,096 Medicare beneficiaries 66 to 75 years of age who filled statin prescriptions within 30 days following hospital discharge for MI. A higher proportion of MarketScan beneficiaries were male, and a higher proportion of Medicare beneficiaries had comorbidities (Online Table 2). Beneficiary characteristics in MarketScan and Medicare are presented by calendar year in Online Tables 3 and 4. Between 2011 and 2014, the percentage of MarketScan and Medicare beneficiaries whose first statin prescription fills following hospital discharge were for simvastatin or rosuvastatin decreased, whereas prescription fills for atorvastatin increased (Figure 1, Online Tables 5 and 6).
The percentage of beneficiaries whose first statin prescription fills following hospital discharge for MI were for high-intensity doses increased from 33.5% to 71.7% among MarketScan beneficiaries and from 24.8% to 57.5% among Medicare beneficiaries 66 to 75 years of age (Central Illustration, Online Table 7). An increase in the percentage of beneficiaries filling high-intensity statin prescriptions following hospital discharge for MI occurred for MarketScan and Medicare beneficiaries initiating statins (from 30.6% to 72.0% and from 21.1% to 58.8%, respectively) and those who were taking low- or moderate-intensity statins (from 27.8% to 62.3% and from 12.6% to 45.1%, respectively) prior to their index MIs. Among prevalent high-intensity statin users prior to their MI hospitalizations, the percentage filling high-intensity statin prescriptions following hospital discharge was 86.1% in the first quarter of 2011 and 90.6% in the fourth quarter of 2014 for MarketScan beneficiaries and 85.0% and 90.3%, respectively, among Medicare beneficiaries 66 to 75 years of age.
Factors associated with high-intensity statin fills in 2014
Demographic characteristics, the prevalence of comorbidities, and health care use are presented by intensity of statin prescriptions filled following hospital discharge for MI in 2014 among MarketScan and Medicare beneficiaries, 66 to 75 years of age, initiating treatment and for those taking low- or moderate-intensity and high-intensity statins prior to their MIs in Tables 1 and 2, respectively. After multivariate adjustment and among both MarketScan and Medicare beneficiaries, men, those filling beta-blocker and antiplatelet agent prescriptions within 30 days following discharge, and those attending cardiac rehabilitation after their MIs were more likely to initiate statins with a high- versus low- or moderate-intensity dose or titrate from a low- or moderate-intensity to a high-intensity dose (Figure 2, Online Tables 8 to 11). Beneficiaries taking more medications prior to their index MIs were less likely to initiate statin therapy with high-intensity doses. Among Medicare beneficiaries, African Americans were more likely than whites to initiate treatment with high-intensity statins following their MIs. MarketScan and Medicare beneficiaries with histories of CHD, cardiologist care in the year prior to their index MIs, and filling prescriptions for nonstatin lipid-lowering therapy within 30 days of discharge were less likely to titrate from a low- or moderate-intensity to a high-intensity dose. Among MarketScan beneficiaries taking high-intensity statins prior to their MIs, no factors studied were associated with filling high-intensity statin prescriptions following hospital discharge (Online Table 12). Among Medicare beneficiaries taking high-intensity statins prior to their MIs, men were more likely than women to fill high-intensity statin prescriptions post-discharge (Online Table 13).
Titration to a high-intensity statin within 182 days of hospital discharge
Among those whose first statin prescription fills post-discharge were for low- or moderate-intensity doses, the percentage who up-titrated to high-intensity statins within 182 days of hospital discharge increased between the first quarter of 2011 and the second quarter of 2014 from 6.1% to 12.9% among MarketScan beneficiaries (Online Table 14, left column) and from 3.7% to 9.2% among Medicare beneficiaries (Online Table 14, right column).
High-intensity statin use among medicare beneficiaries >75 years of age
Among Medicare beneficiaries >75 years of age, the percentage whose first statin prescription fills following hospital discharge were for simvastatin decreased from 55.1% in the first quarter of 2011 to 14.6% in the fourth quarter of 2014, while atorvastatin prescriptions increased from 22.8% to 66.3% (Online Figure 3, left). The percentage of beneficiaries >75 years of age whose first statin prescription fills following hospital discharge for MI were for high-intensity doses increased from 19.2% to 47.4% (Online Figure 3, right). An increase in the percentage of beneficiaries filling high-intensity statin prescriptions following hospital discharge for MI occurred for beneficiaries initiating statin therapy (from 17.3% to 50.4%) and those taking low- or moderate-intensity statins (from 10.4% to 34.6%) and high-intensity statins (from 82.7% to 87.8%) prior to their index MIs.
In our study, prescription fills for high-intensity statin therapy following hospital discharge for MI increased progressively between 2011 and 2014 among U.S. adults. Among patients who filled statin prescriptions, the percentage filling high-intensity doses more than doubled over this time period, and by the end of 2014, the majority of patients discharged following hospitalization for MI filled high-intensity doses. This trend was present among younger adults with commercial health insurance and older adults with Medicare government health insurance. The most commonly prescribed statin changed from simvastatin in the first quarter of 2011 to atorvastatin by 2014.
Several events occurred during the study period that may have contributed to the changes in high-intensity statin use. In November 2011, the patent for atorvastatin expired, making this agent available in a generic version to some pharmacy benefit plans. By mid-2012, exclusive manufacturing rights expired, resulting in more widespread and less costly generic formulations of atorvastatin becoming available. Although rosuvastatin 20 and 40 mg are considered high-intensity statin therapy, fills for rosuvastatin declined following the generic availability of atorvastatin. Previous studies have documented a transition from branded to generic medication after a drug comes off patent (14). In this study, the increase in atorvastatin use began in 2011, which is consistent with the timing of its generic availability.
In June 2011, the U.S. Food and Drug Administration issued a black-box warning cautioning against new prescriptions for simvastatin 80 mg because of potential muscle toxicity, as reported in 2 clinical trials (15,16). The percentage of MarketScan and Medicare beneficiaries who filled prescriptions for simvastatin 80 mg following hospital discharge for MI declined more than 10-fold, and fewer than 1% of patients filled this medication in 2013 and 2014. Some, but not all, studies have reported black-box warnings to be associated with reductions in medication use (16–18). Our study further highlights the potential impact black-box warnings may have on drug prescriptions.
In November 2011, the AHA/ACC secondary prevention guidelines recommended that patients take the lowest statin dose needed to achieve a low-density lipoprotein cholesterol level <70 mg/dl (6). Also, the ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic CVD risk in adults was published in November 2013 (1). This latter guideline recommended high-intensity statin use for patients ≤75 years of age with ACS and moderate-intensity statins in those >75 years of age with consideration of high-intensity statins on the basis of potential benefits for atherosclerotic CVD reduction versus the risk for adverse reactions. The impact of the 2013 ACC/AHA guideline on high-intensity statin use post-MI is not apparent from these results. Similar observations were reported from the ACC PINNACL (Practice Innovation and Clinical Excellence) registry, which evaluated trends in moderate- and high-intensity statins in participants primarily with atherosclerotic CVD (19). It is possible that most physicians were aware of the benefit of high-intensity statins on the basis of the 2004 update of the Adult Treatment Panel III guidelines (20) and 2011 secondary prevention guidelines (6). Also, we had only 1 year of follow-up after the publication of the 2013 ACC/AHA guideline, which may not have provided sufficient time to observe its full impact on high-intensity statin use following hospital discharge for MI.
Among patients filling low- or moderate-intensity statin prescriptions upon hospital discharge for MI, the percentage who were titrated to high-intensity statins within 6 months increased between 2011 and 2014. However, 80% to 90% of patients in the MarketScan and Medicare databases filling low- or moderate-intensity statin prescriptions following hospital discharge for MI in 2014 did not fill high-intensity statin prescriptions within the next 6 months. The reasons why few patients switch from low- or moderate-intensity to high-intensity statins within 6 months of hospital discharge are unknown but may reflect previous intolerance, the presence of comorbid conditions, or clinical inertia (21). Being hospitalized for MI represents a teachable moment, and many patients may be amenable to treatment changes (22). Patient acceptability to change following an MI, in conjunction with the low percentage of titration that occurs within 6 months of hospital discharge, highlights the importance of prescribing high-intensity statins upon hospital discharge following MI.
An increase in high-intensity statin use was observed among MarketScan and Medicare beneficiaries. However, high-intensity statin use following MI was lower among Medicare beneficiaries compared with their counterparts in the MarketScan database. This may be partially attributable to the age difference between these 2 cohorts and a greater burden of polypharmacy in older adults. High-intensity statin prescriptions were more likely to be filled among men and those who received beta-blockers and antiplatelet agents and attended cardiac rehabilitation following hospital discharge for MI among both MarketScan and Medicare beneficiaries. It is well documented that women are less likely than men to receive secondary prevention therapies following MI (23,24). Filling high-intensity statin prescriptions in conjunction with beta-blockers and antiplatelet agents and attending cardiac rehabilitation may reflect variation in use of evidence-based therapies across hospitals and providers or the use of intensive medical management for select high-risk patients (25,26). Patients filling prescriptions for nonstatin lipid-lowering medications in Medicare were less likely to fill prescriptions for high-intensity statins. One possible reason may be that these patients are intolerant to high-intensity statins. Statin intolerance has been associated with an increased risk for recurrent MI, suggesting the need for additional risk reduction therapies (27).
Strengths of the present study include the analysis of 2 large cohorts, 1 of younger patients with commercial health insurance and 1 of older patients with government insurance. Using these 2 datasets, we were able to investigate the use of high-intensity statins across a broad age spectrum. Most U.S. adults ≥65 years of age have health insurance through Medicare, providing a high degree of generalizability. The large sample size provided stable estimates of high-intensity statin prescription fills.
Despite these strengths, the present study has known and potential limitations. We relied on pharmacy claims to identify statin use in the present analysis. However, substantial agreement between pharmacy claims and self-reported use and pill bottle review has been reported previously (28,29). Patient behavioral and social support characteristics and characteristics of the prescribing physician are not available in MarketScan and Medicare claims. Data were available only through 2014, and there may have been an impact of the ACC/AHA cholesterol guideline on high-intensity statin use in 2015 and 2016. The present study relied on claims data, and we were unable to ascertain whether prescription fills for low- or moderate-intensity statins were appropriate on the basis of drug interactions, intolerance to high-intensity statins, or sufficient control of low-density lipoprotein cholesterol. Data were available only for statin prescription fills and not prescriptions written. Race/ethnicity data are not available in MarketScan.
The percentage of U.S. adults filling high-intensity statin prescriptions following hospital discharge for MI increased substantially between 2011 and 2014. This trend was present among younger commercially insured U.S. adults and older U.S. adults with government health insurance. Despite this favorable trend, a substantial percentage of patients filled low- or moderate-intensity statin prescriptions following hospital discharge for MI in 2014. The present study highlights the need to continue efforts to increase high-intensity statin use following hospital discharge for MI.
COMPETENCY IN PRACTICE-BASED LEARNING AND IMPROVEMENT: High-intensity statin therapy prescriptions after hospitalization for MI increased from 2011 to 2014, concurrent with the availability of generic atorvastatin. Prescription fills for high-intensity statins were associated with other good practices such as fills for antiplatelet and beta-blocker medications and attendance at cardiac rehabilitation.
TRANSLATIONAL OUTLOOK: Further efforts are needed to increase high-intensity statin use following hospital discharge for MI.
For supplemental tables and figures, please see the online version of this article.
The present study was funded by an industry-academic collaboration between Amgen, the University of Alabama at Birmingham, and the Icahn School of Medicine at Mount Sinai. Dr. Rosenson has received grant support from Akcea, Amgen, AstraZeneca, Eli Lilly, Esperion, The Medicines Company, and Sanofi; serves on advisory boards for Amgen, Eli Lilly, Regeneron, and Sanofi; has received honoraria from Akcea and Kowa; and has received royalties from UpToDate. Dr. Farkouh has received grant support from Amgen. Dr. Bittner has received grant support from Amgen, AstraZeneca, DalCor, Sanofi-Regeneron, Pfizer, and Bayer Healthcare; and has served on advisory boards for Amgen and Eli Lilly. Dr. Brown has received grant support from Amgen and AstraZeneca. Dr. Taylor is employed by Amgen. Dr. Monda is employed by and holds stock in Amgen. Dr. Muntner has received grant support from Amgen; and honoraria from Amgen. Freny Vaghaiwalla Mody, MD, served as Guest Editor for this paper.
- Abbreviations and Acronyms
- American College of Cardiology
- acute coronary syndrome
- American Heart Association
- coronary heart disease
- cardiovascular disease
- myocardial infarction
- Received March 15, 2017.
- Accepted March 31, 2017.
- 2017 American College of Cardiology Foundation
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