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Use of Cholesterol-Lowering Therapy by Elderly Adults After Myocardial Infarction
John Z. Ayanian, MD, MPP;
Mary Beth Landrum, PhD;
Barbara J. McNeil, MD, PhD
Arch Intern Med. 2002;162:1013-1019.
ABSTRACT
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Background Use of cholesterol-lowering drugs reduces mortality and adverse cardiac
events among people aged 65 to 75 years with coronary heart disease, but previous
studies have shown that most patients have not received this treatment.
Methods We conducted a telephone survey during 1999 and 2000 of 815 Medicare
beneficiaries aged 65 to 74 years hospitalized for an acute myocardial infarction
in California, Florida, Massachusetts, New York, or Pennsylvania during 1994
and 1995. Outcome measures included use of cholesterol-lowering drugs, beliefs
about the importance of lowering cholesterol levels, and knowledge of personal
cholesterol levels, adjusting for demographic and clinical factors using logistic
regression.
Results Among respondents, 59.4% reported taking a cholesterol-lowering drug,
but most were not aware of potential adverse effects. In adjusted analyses,
drug treatment was significantly more common among women, patients aged 65
to 69 years, and those who reported that a cardiologist was mainly responsible
for their cholesterol management. Lowering cholesterol levels was viewed as
"very important" by 77.2% of respondents, but significantly less often by
men, older patients, and those with diabetes mellitus or congestive heart
failure. Only 33.1% of respondents knew their cholesterol level, and this
knowledge was significantly less common among black patients and those with
diabetes mellitus or congestive heart failure.
Conclusions Use of cholesterol-lowering drugs was much greater than in previous
studies of elderly patients after myocardial infarction, demonstrating increased
attention to secondary prevention. However, most patients were unaware of
their cholesterol level or potential adverse effects of drug treatment, indicating
that they may benefit from greater education about cholesterol testing and
treatment.
INTRODUCTION
THE NUMBER of elderly Americans who have survived an acute myocardial
infarction (AMI) is steadily increasing. Major randomized clinical trials1-3 using 3-hydroxy-3-methylglutaryl
coenyzme A reductase inhibitors (ie, statins) to lower cholesterol levels
have demonstrated improved survival and cardiac outcomes in patients with
coronary heart disease. Focused analyses4-7
of patients aged 65 to 75 years have confirmed that the relative benefits
of lowering cholesterol levels for these patients are similar to the benefits
for younger patients. In fact, because older patients with coronary heart
disease have a substantially higher rate of subsequent cardiac events than
younger patients, cholesterol-lowering drug therapy can prevent approximately
twice as many cardiovascular events and deaths in older patients than in patients
younger than 65 years.5-6 Thus,
the National Cholesterol Education Program (NCEP)8
has strongly recommended that cholesterol-lowering therapy be used for secondary
prevention of cardiovascular events in patients aged 65 to 75 years with coronary
heart disease.
Despite these benefits, previous studies9-11
have reported that many patients with coronary heart disease have not received
cholesterol-lowering drug therapy, and underuse of this treatment has been
greatest for patients 65 years and older. These studies, however, assessed
practice patterns before the results of major randomized trials were widely
disseminated, and they obtained little or no information directly from patients
about their care. Therefore, we surveyed 815 Medicare beneficiaries in 5 states
to evaluate their use of cholesterol-lowering drugs and related beliefs approximately
5 years after they experienced an AMI and 3 to 5 years after publication of
major randomized trials demonstrating the benefits of cholesterol-lowering
therapy for this population.
PATIENTS AND METHODS
STUDY POPULATION
The study population was identified from the Cooperative Cardiovascular
Project (CCP), a national program conducted by the Health Care Financing Administration
in collaboration with peer review organizations in each state to assess the
quality of AMI care for approximately 225 000 elderly Medicare beneficiaries
hospitalized during 1994 and 1995.12 Medicare
patients hospitalized with a principal diagnosis of AMI within an 8-month
period at each hospital were eligible for the CCP. Because Medicare beneficiaries
enrolled in health maintenance organizations (HMOs) were underrepresented
in the CCP, the US General Accounting Office (GAO) conducted a related project
under the auspices of the CCP to evaluate the AMI care of an additional random
sample of 8476 Medicare HMO enrollees.13-14
We studied 3 geographically diverse regionsCalifornia, Florida,
and the 3 northeastern states of Massachusetts, New York, and Pennsylvaniathat
had substantial numbers of Medicare patients receiving care from fee-for-service
(FFS) and HMO providers. We focused on patients aged 65 to 74 years at the
time of their AMI because randomized clinical trials4-7
have demonstrated the benefits of cholesterol-lowering therapy in this age
range. Based on Health Care Financing Administration administrative records,
we identified patients hospitalized for an AMI for at least 4 consecutive
days between July 1, 1994, and June 30, 1995, who were alive as of July 1,
1998, and who were residing in the United States. From the CCP and GAO cohorts,
we identified 9835 FFS patients and 1746 HMO patients aged 65 to 74 years
who met these criteria. To obtain an initial sample of approximately 2600
patients with equal numbers of FFS and HMO enrollees, we matched 1297 patients
from each group (FFS and HMO) by region (California, Florida, or Massachusetts/New
York/Pennsylvania), sex, age (within 1 year), and month of AMI hospital admission
(within 1 month) to control for demographic and temporal trends in AMI care.
All 2594 patients were contacted about the survey with an initial letter
of introduction in English and Spanish from the administrator of the Health
Care Financing Administration describing the purpose and the voluntary, confidential
nature of the survey. Patients subsequently received a letter from one of
us (J.Z.A.) inviting their participation in the telephone interview, and nonrespondents
received an additional letter reiterating this invitation. During administration
of the survey, we excluded individuals who did not have valid address or telephone
information, had mental or physical impairments that precluded participation
in a telephone interview, did not speak English or Spanish, or were residing
in a nursing home or outside the United States. The study protocol was approved
by the Human Studies Committee of Harvard Medical School and as a federal
Cooperative Research and Development Agreement between Harvard Medical School
(Boston, Mass), Merck & Co Inc (Whitehouse Station, NJ), and the Agency
for Healthcare Research and Quality (Rockville, Md).
PATIENT SURVEY
We designed a telephone survey to assess patients' use of cholesterol-lowering
drugs, dietary changes, and their beliefs about cholesterol management, including
risks of drug therapy. The survey asked patients about their most recent total
cholesterol measurement ("When was your blood last tested for the following
types of cholesterol, if you can recall?" and "What was the result of this
blood test, if you can recall?") and how much information (a lot, some, a
little, or none) they had received from multiple sources about dietary changes
and drug therapy to lower their cholesterol level. Other survey questions
elicited patients' racial and ethnic background, income, education, marital
status, employment status, current enrollment in an HMO or Medicaid, prescription
drug benefits, current smoking status, and overall health.
The telephone survey was administered in English or Spanish by trained
interviewers from a professional survey firm between May 15, 1999, and May
9, 2000. Eligible patients provided oral consent at the start of the interview.
Interviewers made at least 10 attempts during a 4-week period to contact patients,
and patients could also call a toll-free number to participate. Survey supervisors
periodically monitored telephone interviews to maintain the quality of data
collection.
CLINICAL DATA
For the CCP and GAO, trained abstracters collected detailed clinical
data from patients' medical records of their AMI hospitalizations, as previously
described.12, 14 These data included
comorbid illnesses, severity and complications of the AMI, and use of coronary
revascularization procedures (angioplasty or bypass surgery). Use of cholesterol-lowering
drugs at hospital discharge was recorded for CCP patients in our cohort (n
= 604) but not for GAO patients. Cholesterol measurements were not abstracted
from hospital records for the CCP or GAO. The quality of data from hospital
records was monitored through random reabstractions. The interrater reliability
of hospital data was very good, with agreement on clinical measures exceeding
90% ( = 0.72-0.88).15 Overall variable
agreement averaged 95%.12
DATA ANALYSIS
We compared the demographic and clinical characteristics of respondents
and nonrespondents to our telephone survey with CCP data using the t test for continuous variables and the Pearson 2 test
for categorical variables. Based on standard clinical classifications, we
categorized cholesterol-lowering drugs reported by survey respondents as statins
or other agents (bile acid sequestrants, clofibrate, niacin, or probucol).
Awareness of personal cholesterol levels was demonstrated by respondents who
reported that their total cholesterol level had been tested within the previous
2 years and that they could recall the result.
Our analysis focused on 3 primary outcomes: (1) patients' use of a cholesterol-lowering
drug when surveyed, (2) their belief that lowering their cholesterol level
was "very important" after AMI, and (3) their knowledge of their own cholesterol
level. Using Pearson 2 tests, we assessed demographic and
clinical factors and health beliefs that were associated with each of these
outcomes. We also analyzed other beliefs and experiences reported by respondents,
including dietary changes, sources of information about lowering cholesterol
levels, perceived risks of cholesterol-lowering drugs, and assessments of
how well their physicians explained tests and drug treatments. We report 2-tailed P values for these descriptive analyses.
To assess adjusted predictors of the 3 primary outcomes, we created
a logistic regression model for each outcome. The models included patient
age, region of residence (California, Florida, or Massachusetts/New York/Pennsylvania),
FFS or HMO status at the time of the survey, sex, race or ethnicity (black,
Hispanic, or other vs white), self-reported total household income in 1998
(<$12 000, $12 000-$24 999, and $50 000 vs $25 000-$49 999),
highest grade of school completed (nonhigh school graduate or high
school graduate vs college graduate), Medicaid enrollment, insurance coverage
for prescription drugs, marital status, employment status, smoking status,
major related conditions (diabetes mellitus, hypertension, cerebrovascular
disease, and congestive heart failure), self-reported overall health (fair
or poor vs good, very good, or excellent), any coronary revascularization
procedure within 3 months after MI, and the type of physician primarily responsible
for their cholesterol management (cardiologist or other specialist vs internist
or family practitioner). Income data were missing for 133 (16%) of the patients
in our sample. Because deleting these cases or using an indicator variable
for missing income in adjusted analyses could introduce potential biases,
we used NORM statistical software (The Pennsylvania State University, University
Park, Pa) to obtain multiple imputed income values for respondents with missing
income data.16 We report adjusted odds ratios
and 95% confidence intervals for all variables in these logistic models.
RESULTS
PATIENT CHARACTERISTICS
In the matched random sample of 2594 potentially eligible patients,
114 were deceased at the time of survey contact, 682 did not have valid address
or telephone information in the Health Care Financing Administration records,
199 had mental or physical impairments that precluded interviewing, 31 did
not speak English or Spanish, 18 were residing in a nursing home, and 3 were
not residing in the United States. Of the remaining 1547 patients eligible
for our survey, 815 (52.7%) completed the telephone interview, 606 (39.2%)
refused or terminated the interview, and 126 (8.1%) could not be interviewed
despite multiple attempts.
Interviews were completed with 404 FFS patients and 411 HMO patients
based on type of Medicare coverage during the month of their AMI, and the
response rates were similar for each group (51.3% vs 53.9%; P = .36). The median interval from AMI hospitalization to completion
of the interview was 56.0 months for FFS patients and 56.6 months for HMO
patients, with a range of 51 to 69 months for each group. Patients who responded
to the telephone interview were slightly younger than nonrespondents at the
time of their AMI (mean age, 69.4 vs 69.7 years; P
= .05) and were less likely to have diabetes mellitus (20.6% vs 27.2%; P = .002) or cerebrovascular disease (5.2% vs 8.7%; P = .005). Respondents and nonrespondents did not differ
significantly by sex, race, receipt of revascularization procedures, or proportions
with hypertension or congestive heart failure (P>.10
for all).
Demographic and clinical characteristics of the 815 patients who responded
are given in Table 1. Among these
patients, 73.2% reported that they had been "diagnosed as having a high cholesterol
level" by a physician, and 66.7% had changed their diet "some" or "a lot"
to reduce their cholesterol level. Nearly three quarters of patients (71.6%)
reported that the physician mainly responsible for their cardiac care explained
test indications and results "very well," and 53.9% reported that their physician
was similarly effective in explaining the benefits and adverse effects of
drugs. Although most patients (66.1%) reported that an internist or family
practitioner was primarily responsible for their cholesterol management, about
two thirds of patients (65.4%) reported at least one office visit with a cardiologist
in the past year.
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Table 1. Characteristics of 815 Surveyed Elderly Patients After Myocardial
Infarction
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USE OF CHOLESTEROL-LOWERING DRUGS
Among survey respondents from the CCP, 11.8% were prescribed a cholesterol-lowering
drug when discharged from the hospital after their AMI, and 58.9% reported
taking a cholesterol-lowering drug when surveyed approximately 5 years later.
Among all respondents, 59.4% reported taking a cholesterol-lowering drug when
surveyed, including 48.5% taking a statin drug alone, 8.6% taking another
agent, and 2.3% taking both a statin and another class of drug. Rates of cholesterol-lowering
drug use were 73.1% among patients who reported that they had been diagnosed
as having an elevated cholesterol level and 22.8% among those who did not
report this diagnosis. In unadjusted analyses (Table 2), drug therapy was more common among women, patients aged
65 to 69 years, white patients, those with higher incomes or more education,
those reporting better health, and those reporting that a cardiologist was
responsible for their cholesterol management. Rates of cholesterol-lowering
drug therapy were almost identical between patients receiving FFS care and
those enrolled in an HMO at the time of our survey, as well as in the 3 regions
we studied. In adjusted analyses (Table
3), drug therapy was significantly more common among women, patients
aged 65 to 69 years, and patients who reported that a cardiologist was primarily
responsible for their cholesterol management.
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Table 2. Patients' Use of Cholesterol-Lowering Drugs and Related Beliefs
After Myocardial Infarction
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Table 3. Adjusted Predictors of Patients' Use of Cholesterol-Lowering
Drugs and Related Beliefs After Myocardial Infarction*
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Sources of information about cholesterol-lowering drugs and diet are
depicted in Figure 1. Primary care
physicians, cardiologists, and brochures or other reading materials were the
most common sources of information, followed by nurses, nutritionists, and
advertisements. Computers and the Internet were rarely sources of information
in this cohort. Only 23.7% of patients were aware that cholesterol-lowering
drugs can cause hepatitis, and only 4.0% were aware that these drugs can cause
muscle damage.
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Sources of information about cholesterol-lowering drugs and dietary
changes.
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BELIEFS ABOUT LOWERING CHOLESTEROL LEVELS
Of all respondents, 77.2% believed that lowering cholesterol levels
was very important after AMI to reduce the chance of experiencing another
MI. In unadjusted analyses (Table 2),
this belief was more common among women, patients aged 65 to 69 years, and
those who did not have congestive heart failure or diabetes mellitus. Other
demographic and clinical factors were not significantly associated with the
belief that lowering cholesterol levels was very important. In adjusted analyses
(Table 3), men, patients aged
70 to 74 years, and those with diabetes mellitus or congestive heart failure
were significantly less likely than other patients to report this belief.
KNOWLEDGE OF PERSONAL CHOLESTEROL LEVELS
Only one third of respondents (33.1%) knew the results of their own
cholesterol test conducted within the previous 2 years. In unadjusted analyses
(Table 2), awareness of personal
cholesterol levels was higher among patients who were white, married, nonsmokers,
or in better health; those without Medicaid coverage, diabetes mellitus, or
congestive heart failure; and those with higher incomes, higher educational
levels, or a cardiologist or other specialist responsible for their cholesterol
management. There were no subgroups, however, in which at least half of the
patients knew their cholesterol level. In adjusted analyses (Table 3), knowledge of personal cholesterol levels was less common
among black patients, and those with diabetes mellitus or congestive heart
failure relative to other patients.
COMMENT
In this survey of elderly patients who had survived an MI in 3 different
areas of the United States, nearly 60% were taking a cholesterol-lowering
drug approximately 5 years later. This proportion using drug therapy in 1999
and 2000 was substantially higher than the 12% in our cohort prescribed a
cholesterol-lowering drug at discharge in 1994 and 1995, or the 29% using
cholesterol-lowering drug therapy (37% for those aged 65-74 years and 17%
for those aged 75-84 years) in another cohort of elderly patients after AMI
from the same geographic areas surveyed in 1996.17
This rate was also much higher than in the 4 communities of the Cardiovascular
Health Study,10 in which only 18% of adults
aged 67 to 75 years with coronary heart disease were using a cholesterol-lowering
drug during 1995 and 1996. Similar increases in the use of cholesterol-lowering
drugs have been reported after AMI for patients 70 years and younger in 9
European countries, increasing from 31% in 1995-1996 to 64% in 1999-2000.18 Together, these findings suggest that promotional
efforts since 1996, such as AMI guidelines for physicians,8, 19
public and professional educational campaigns, and advertisements, have been
effective in substantially increasing the use of cholesterol-lowering drugs
among elderly patients after AMI.
Although we did not have access to patients' actual cholesterol measurements
in our study, the proportion of patients undergoing drug therapy was similar
to the approximately 60% who had elevated low-density lipoprotein cholesterol
levels ( 130 mg/dL [ 3.36 mmol/L]) among people aged 65 to 74 years
with coronary heart disease in the Third National Health and Nutrition Examination
Survey.20 Other investigators21
have also suggested a target rate of 60% for use of cholesterol-lowering statin
drugs among elderly patients after AMI. Thus, a reasonably appropriate proportion
of respondents to our survey reported using cholesterol-lowering drugs during
1999. Future studies should assess whether elderly patients using these drugs
and those who are not undergoing drug therapy have achieved target low-density
lipoprotein cholesterol levels of less than 100 mg/dL (<2.59 mmol/L) as
recommended by the NCEP.22
A somewhat surprising finding in our survey was that women were more
likely than men to report use of cholesterol-lowering drugs, in contrast to
previous studies23-25
that have demonstrated greater use of invasive procedures among men with coronary
heart disease or AMI. Our finding may reflect higher serum cholesterol levels
among elderly women than men20 or greater awareness
about the importance of lowering cholesterol levels among women, as we found
in our survey.
More than three quarters of the elderly patients in our survey viewed
lowering their cholesterol level as very important. Patients tended to receive
information about dietary changes and drugs to lower cholesterol levels from
a range of sources, particularly primary care physicians, cardiologists, and
brochures or other written materials. Advertisements provided some or a lot
of information about drug treatment for one quarter of the patients, reflecting
the increasing role of direct consumer advertising by pharmaceutical companies26 and educational campaigns by other organizations
such as the NCEP.27 In our elderly cohort surveyed
during 1999 and 2000, computers and the Internet were not yet major sources
of information about lowering cholesterol levels, but their role may increase
in coming years.
One concerning finding was that only one third of the patients had knowledge
of their cholesterol level from a test conducted within the previous 2 years.
The NCEP has recommended that Americans know their cholesterol levels,27 and this awareness may promote greater adherence
to cholesterol-lowering diets and drug therapy. Very few black patients, in
particular, were aware of their cholesterol level, and patients with diabetes
mellitus or congestive heart failure were less likely than other patients
to be aware of their cholesterol level or to recognize the importance of lowering
their cholesterol level. Most patients were also unaware of the potential
adverse hepatic or muscle effects of cholesterol-lowering drugs, and only
about half of the patients reported that their physician explained the benefits
and adverse effects of drugs very well. These findings indicate ample opportunities
for more effective counseling of patients by physicians, nurses, and pharmacists
regarding cholesterol management.
A strength of our study was that we assessed a representative sample
of Medicare patients who were receiving FFS or HMO care in 3 distinct geographic
regions of the United States, thereby enabling us to evaluate variations in
cholesterol management by type of insurance and region. A previous study14 demonstrated differences between FFS and HMO care
in the use of coronary angiography during the initial hospitalization of Medicare
patients for AMI. However, we found no difference in the proportions of FFS
or HMO patients who were taking a cholesterol-lowering drug, viewed cholesterol
lowering as very important, or were aware of their personal cholesterol level.
We also found no significant difference in the use of cholesterol-lowering
drugs in the 3 regions we studied, in contrast to a previous study17 in which elderly post-AMI patients in California
were more likely than those in Massachusetts, New York, and Pennsylvania to
be receiving cholesterol-lowering drugs during 1996.
Our study has several limitations. Patients who responded to our survey
were slightly younger and less likely to have diabetes mellitus or cerebrovascular
disease than were nonrespondents, and respondents may have been more interested
in cholesterol-lowering therapy. We did not have access to patients' actual
cholesterol test results, so we could not evaluate whether they had achieved
low-density lipoprotein cholesterol levels less than 100 mg/dL (<2.59 mmol/L),
consistent with NCEP guidelines. Many patients receiving cholesterol-lowering
drugs may not be achieving these targets.28-31
Most patients could not recall their personal cholesterol level, but some
may have known whether it was elevated or not and incorporated this perception
into their decisions about cholesterol-lowering diets and drug therapy.
In conclusion, the results of our study demonstrate that use of cholesterol-lowering
drugs among elderly adults who have survived an AMI has substantially increased
in recent years. Although most patients recognized the importance of cholesterol-lowering
therapy, many patients were not aware of their personal cholesterol levels
or of the risks of taking cholesterol-lowering drugs. We found no difference
in the use of cholesterol-lowering drugs for Medicare beneficiaries under
FFS or managed care or in 3 regions of the United States, but these drugs
were used more often by patients who reported that a cardiologist was responsible
for their cholesterol management. Future studies should assess these and other
health system characteristics that promote the appropriate use of cholesterol-lowering
drugs for elderly patients who are likely to benefit from them.
AUTHOR INFORMATION
Accepted for publication September 18, 2001.
This study was supported by a research grant provided by Merck &
Co Inc to Harvard Medical School under the auspices of a federal Cooperative
Research and Development Agreement among Harvard University, Merck, and the
Agency for Healthcare Research and Quality.
We thank Christine Kreider, MPA, for overseeing the survey administration;
Margaret Volya, MS, and Jeff Souza, MA, for assisting with data analysis;
and Nancy C. Santanello, MD, MS, for providing helpful comments on an earlier
draft of the manuscript.
Corresponding author and reprints: John Z. Ayanian, MD, MPP, Department
of Health Care Policy, Harvard Medical School, 180 Longwood Ave, Boston, MA
02115 (e-mail: ayanian{at}hcp.med.harvard.edu).
From the Division of General Medicine and Primary Care, Department
of Medicine (Dr Ayanian), and the Department of Radiology (Dr McNeil), Brigham
and Women's Hospital and Harvard Medical School, and the Department of Health
Care Policy, Harvard Medical School (Drs Ayanian, Landrum, and McNeil), Boston,
Mass.
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