Cardiovascular Disease Medication Use Research Articles

B-vitamin Treatment Modifies the Mortality Risk Associated with Calcium Channel Blockers in Patients with Suspected Stable Angina Pectoris: A Prospective Cohort Study

BackgroundCalcium channel blockers (CCBs) are used for the treatment of cardiovascular disease (CVD), including angina pectoris, and hypertension; however, the effect on survival remains uncertain. CCBs impair fibrinolysis and have been linked to elevated plasma homocysteine (Hcy), a CVD risk marker. ObjectiveWe explored the association between CCB use and mortality in a large prospective cohort of patients with suspected stable angina pectoris (SAP), and potential effect modifications by Hcy-lowering B-vitamin treatment (folic acid, B12, and/or B6) as 61.8% of the patients participated in a randomized placebo-controlled B-vitamin intervention trial. MethodsPatient baseline continuous characteristics according to CCB treatment were tested by linear regression. Hazard ratios (HRs) for mortality associated with CCB treatment, also according to B-vitamin intervention, were examined using Cox regression analysis. The multivariable model included CVD risk factors, medical histories, and the use of CVD medications. ResultsA total of 3991 patients (71.5 % men) were included, of whom 907 were prescribed CCBs at discharge. During 10.3 years of median follow-up, 20.6% died and 8.9% from cardiovascular- and 11.7% from non-cardiovascular causes. Patients treated with CCBs had higher plasma Hcy, fibrinogen levels, and erythrocyte sedimentation rate (all P<0.001). Furthermore, CCB use was positively associated with mortality, also after multivariable adjustments (HRs [95% CIs]: 1.34 [1.15,1.57], 1.35 [1.08,1.70], and 1.33 [1.09,1.64] for total, CVD, and non-CVD death, respectively). Numerically stronger associations were observed among patients not treated with B-vitamins (HR [95% CI]: 1.54 [1.25, 1.88], 1.69 [1.25, 2.30], and 1.41 [1.06, 1.86] for total, CVD deaths, and non-CVD deaths, respectively), whereas no association was seen in patients treated with B-vitamins (HR [95% CI]: 1.15 [0.91, 1.46], 1.09 [0.76, 1.57], and 1.20 [0.88, 1.65]). ConclusionsIn patients with suspected SAP, CCB treatment was associated with increased mortality risk primarily among patients not treated with B-vitamins.

Effect of the Million Hearts Cardiovascular Disease Risk Reduction Model on Initiating and Intensifying Medications

The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model pays provider organizations for measuring and reducing Medicare patients' cardiovascular risk. To assess whether the model increases the initiation or intensification of antihypertensive medications or statins among patients with blood pressure or low-density lipoprotein (LDL) cholesterol levels above guideline thresholds for treatment intensification. This prespecified secondary analysis of a cluster-randomized, pragmatic trial included primary care and cardiology practices, health care centers, and hospital-based outpatient departments across the US. Participants included Medicare patients who were enrolled into the model in 2017 by participating organizations and who were at high risk and at medium risk of a myocardial infarction or stroke in 10 years. Patient outcomes were analyzed for 1 year postenrollment (through December 2018) using an intent-to-treat design. Analysis began November 2019. US Centers for Medicare & Medicaid Services paid organizations for risk stratifying Medicare patients and reducing CVD risk among high-risk patients through discussing risk scores, developing individualized risk reduction plans, and following up with patients twice yearly. Initiating or intensifying statin or antihypertensive therapy within 1 year of enrollment, measured in Medicare Part D claims, and LDL cholesterol and systolic blood pressure levels approximately 1 year after enrollment, measured in usual care and reported to Centers for Medicare & Medicaid Services via a data registry (data complete for 51% of high-risk enrollees). The study's primary outcome (incidence of first-time myocardial infarction and stroke) is not reported because the trial is ongoing. A total of 330 primary care and cardiology practices, health care centers, and hospital-based outpatient departments and 125 436 Medicare patients were included in this analysis. High-risk patients in the intervention group had a mean (SD) age of 74 (4.1), 15 213 (63%) were male, 21 657 (90%) were receiving antihypertensive medication at baseline, and 16 558 (69%) were receiving statins. Almost all (21 791 [91%]) high-risk intervention group patients had above-threshold systolic blood pressure level (>130 mm Hg), LDL cholesterol level (>70 mg/dL), or both. Patients in the intervention group with these risk factors were more likely than control patients (8127 [37.3%] vs 4753 [32.4%]; adjusted difference in percentage points, 4.8; 95% CI, 2.9-6.7; P < .001) to initiate or intensify statins or antihypertensive medication. Centers for Medicare & Medicaid Services did not pay for CVD risk reduction for medium-risk enrollees, but initiation or intensification rates for these enrollees were also higher in the intervention vs control groups (12 668 [27.9%] vs 7544 [24.8%]; adjusted difference in percentage points, 3.1; 95% CI, 1.9-4.3; P < .001). Among high-risk enrollees with clinical data approximately 1 year after enrollment, LDL cholesterol level was slightly lower in the intervention vs control groups (mean [SD], 89 [31.8] vs 91 [32.1] mg/dL; adjusted difference in percentage points, -1.8; 95% CI, -2.9 to -0.6; P = .002), as was systolic blood pressure (mean [SD], 133 [15.7] vs 135 [16.4] mm Hg; adjusted difference in percentage points, -1.7; 95% CI, -2.8 to -0.6; P = .003). In this study, a pay-for-performance model led to modest increases in the use of CVD medications in a range of organizations, despite high medication use at baseline.

Patient Preferences of Low-Dose Aspirin for Cardiovascular Disease and Colorectal Cancer Prevention in Italy: A Latent Class Analysis.

BackgroundPatients taking low-dose aspirin to prevent cardiovascular disease (CVD) may also benefit from a reduced risk of colorectal cancer (CRC).ObjectiveThe aim was to examine the preferences of people eligible for preventive treatment with low-dose aspirin and the trade-offs they are willing to make between CVD prevention, CRC prevention, and treatment risks.MethodsA cross-sectional study using a discrete choice experiment (DCE) survey was conducted in Italy in 2019 to elicit preferences for three benefit attributes (prevention of ischemic stroke, myocardial infarction, and CRC) and four risk attributes (intracranial and gastrointestinal bleeding, peptic ulcer, and severe allergic reaction) associated with use of low-dose aspirin. Latent class logit models were used to evaluate variation in treatment preferences.ResultsThe DCE survey was completed by 1005 participants eligible for use of low-dose aspirin. A four-class model had the best fit for the primary CVD prevention group (n = 491), and a three-class model had the best fit for the secondary CVD prevention group (n = 514). For the primary CVD prevention group, where classes differed on age, education level, type 2 diabetes, exercise, and low-dose aspirin use, the most important attributes were intracranial bleeding (two classes), myocardial infarction (one class), and CRC (one class). For the secondary CVD prevention group, where classes differed on various comorbidities, self-reported health, exercise, and CVD medication use, the most important attributes were intracranial bleeding (two classes), myocardial infarction (one class), and gastrointestinal bleeding (one class).ConclusionPatient preferences for the benefits and risks of low-dose aspirin differ significantly among people eligible for treatment as primary or secondary CVD prevention.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40271-021-00506-2.

Impacts of the Million Hearts® Cardiovascular Disease Risk Reduction Model on Medications, Heart Attacks and Strokes, and Medicare Spending after Two Years: A Cluster‐Randomized Trial

Research ObjectiveIn 2017, the Centers for Medicare &amp; Medicaid Services launched the Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model with the aim to reduce first‐time heart attacks and strokes among high‐risk Medicare fee‐for‐services (FFS) beneficiaries within 5 years. This large‐scale randomized trial pays providers to assess each of their Medicare patient’s risk of a heart attack or stroke and then makes additional payment if they reduce CVD risk among their high‐risk cohort. We assess whether, during its first two years, the model increased use of CVD medications, reduced incidence of heart attacks and strokes, and reduced Medicare spending.Study DesignA pragmatic, cluster‐randomized trial. CMS enrolled 516 organizations (primary and specialty practices, health centers, and hospitals) throughout the country and assigned half to the intervention group. For the 313 organizations that enrolled beneficiaries in 2017, we linked enrollment and clinical data with Medicare claims and estimated impacts as intervention‐control differences (regression adjusted) in outcomes.Population Studied300,550 Medicare FFS beneficiaries, 18% of whom were high risk (≥30% or higher risk of a heart attack or stroke in the next 10 years) and 40% were medium risk (15‐30% risk) in both groups. Intervention and control group beneficiaries were similar at enrollment in demographics, CVD risk factors, and recent utilization and spending.Principal FindingsAmong the high‐risk group, almost 40% of CVD risk at baseline was modifiable, mainly from elevated blood pressure and cholesterol. High‐risk intervention group enrollees were 4 percentage points more likely than the control group (28 vs 24%, P &lt; .001) to initiate or intensify statins or antihypertensive medications factors within 6 months of enrollment. When including the larger medium‐risk group—for whom CMS does not separately pay for CVD risk reduction—rates of initiation or intensification were 3 percentage points higher in the intervention versus control groups (23 vs 20%, P &lt; .001). Over a mean follow‐up of 17 months, the incidence of first‐time heart attack and stroke was similar in the intervention versus the control groups for the high‐risk group (90% confidence interval for hazard ratio: 0.93‐1.14) and for the medium‐ and high‐risk groups combined (90% CI: 0.93, 1.06). Medicare Part A and B spending was also similar in the intervention and control groups.ConclusionsThus far, the Million Hearts model has improved initiation and intensification of medications to treat modifiable risk factors among the high‐risk group, with positive spillover to the much larger medium‐risk group. However, the model has not reduced heart attacks and strokes or generated any savings to offset model costs.Implications for Policy or PracticeWhile CVD risk factors have declined substantially over the past 50 years, progress has slowed recently and even reversed in some groups. Value‐based purchasing efforts to date have focused on achieving control for individual CVD risk factors. This trial shows that a new “pay for prevention” approach that rewards assessing and reducing total CVD risk (combining individual risk factors into a single score readily interpretable by patients and providers) can improve use of CVD medications. More time is needed to assess whether the model will eventually reduce incidence of heart attacks and strokes.Primary Funding SourceThe study was funded by the Centers for Medicare and Medicaid Services.

Abstract 19: Impacts of the Million Hearts® Cardiovascular Disease Risk Reduction Model on the Initiation or Intensification of Statins and Anti-hypertensive Medications: A Pragmatic, Cluster-randomized Trial

Introduction: The Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model pays providers for measuring cardiovascular risk among their Medicare beneficiaries and for reducing risk among their high-risk patients. The Centers for Medicare and Medicaid Services (CMS) is testing whether this model can improve cardiovascular care and reduce the incidence of first-time heart attacks and strokes over 5 years. This study assesses whether, in its first 2 years, the model (1) increased use of CVD medications among those with elevated blood pressure or cholesterol, and (2) increased provider awareness of CVD risks among their patients. Methods: In this pragmatic, cluster-randomized trial, CMS enrolled 516 organizations (primary and specialty practices, health centers, and hospitals) throughout the country and assigned half to the intervention group. Organizations enrolled beneficiaries (age 40-79 without a prior CVD event) during routine office visits. We linked enrollment and clinical data with Medicare Part D claims and estimated impacts as intervention-control differences in outcomes. We surveyed one randomly selected provider in each organization about their use of risk CVD stratification (70% response rate). Results: The intervention and control organizations enrolled 300,550 Medicare beneficiaries. In both groups, 18% of enrollees were high risk per CMS definitions (≥30% or higher risk of a heart attack or stroke in the next 10 years), 40% were medium risk (15-30% risk), and the remainder were low risk (&lt;15% risk). While almost all high-risk enrollees were taking anti-hypertensive medications or statins at baseline, most (90%) had elevated blood pressure, cholesterol, or both. High-risk enrollees in the intervention group were 4 percentage points more likely than control enrollees (28 vs 24%, p&lt;0.001) to initiate or intensify statins or anti-hypertensive medications within 6 months of enrollment. When including the larger medium-risk group—for whom CMS does not separately pay for CVD risk reduction—rates of initiation or intensification were 3 percentage points higher in the intervention versus control groups (23 vs 20%, p&lt;0.001). According to the survey, intervention group providers were much more likely than control group providers to risk assess at least half of their Medicare patients (71 vs 39%, p&lt;0.001). Most intervention group providers (73%) said that their greater use of risk stratification helped them better identify beneficiaries at risk of CVD events. Conclusions: The Million Hearts model significantly improved use of CVD medications among high-risk enrollees, mainly through intensification, and had positive spillover to the much larger medium risk group. These improvements were likely driven, at least partly, by providers become more aware of their patients’ CVD risk through greater use of risk stratification.

Variations in common diseases, hospital admissions, and deaths in middle-aged adults in 21 countries from five continents (PURE): a prospective cohort study

To our knowledge, no previous study has prospectively documented the incidence of common diseases and related mortality in high-income countries (HICs), middle-income countries (MICs), and low-income countries (LICs) with standardised approaches. Such information is key to developing global and context-specific health strategies. In our analysis of the Prospective Urban Rural Epidemiology (PURE) study, we aimed to evaluate differences in the incidence of common diseases, related hospital admissions, and related mortality in a large contemporary cohort of adults from 21 HICs, MICs, and LICs across five continents by use of standardised approaches. The PURE study is a prospective, population-based cohort study of individuals aged 35-70 years who have been enrolled from 21 countries across five continents. The key outcomes were the incidence of fatal and non-fatal cardiovascular diseases, cancers, injuries, respiratory diseases, and hospital admissions, and we calculated the age-standardised and sex-standardised incidence of these events per 1000 person-years. This analysis assesses the incidence of events in 162 534 participants who were enrolled in the first two phases of the PURE core study, between Jan 6, 2005, and Dec 4, 2016, and who were assessed for a median of 9·5 years (IQR 8·5-10·9). During follow-up, 11 307 (7·0%) participants died, 9329 (5·7%) participants had cardiovascular disease, 5151 (3·2%) participants had a cancer, 4386 (2·7%) participants had injuries requiring hospital admission, 2911 (1·8%) participants had pneumonia, and 1830 (1·1%) participants had chronic obstructive pulmonary disease (COPD). Cardiovascular disease occurred more often in LICs (7·1 cases per 1000 person-years) and in MICs (6·8 cases per 1000 person-years) than in HICs (4·3 cases per 1000 person-years). However, incident cancers, injuries, COPD, and pneumonia were most common in HICs and least common in LICs. Overall mortality rates in LICs (13·3 deaths per 1000 person-years) were double those in MICs (6·9 deaths per 1000 person-years) and four times higher than in HICs (3·4 deaths per 1000 person-years). This pattern of the highest mortality in LICs and the lowest in HICs was observed for all causes of death except cancer, where mortality was similar across country income levels. Cardiovascular disease was the most common cause of deaths overall (40%) but accounted for only 23% of deaths in HICs (vs 41% in MICs and 43% in LICs), despite more cardiovascular disease risk factors (as judged by INTERHEART risk scores) in HICs and the fewest such risk factors in LICs. The ratio of deaths from cardiovascular disease to those from cancer was 0·4 in HICs, 1·3 in MICs, and 3·0 in LICs, and four upper-MICs (Argentina, Chile, Turkey, and Poland) showed ratios similar to the HICs. Rates of first hospital admission and cardiovascular disease medication use were lowest in LICs and highest in HICs. Among adults aged 35-70 years, cardiovascular disease is the major cause of mortality globally. However, in HICs and some upper-MICs, deaths from cancer are now more common than those from cardiovascular disease, indicating a transition in the predominant causes of deaths in middle-age. As cardiovascular disease decreases in many countries, mortality from cancer will probably become the leading cause of death. The high mortality in poorer countries is not related to risk factors, but it might be related to poorer access to health care. Full funding sources are listed at the end of the paper (see Acknowledgments).

Ankle brachial index (ABI) in a cohort of older women in the Philippines: Prevalence of peripheral artery disease and predictors of ABI.

Cardiovascular disease (CVD) is rising in low and middle-income countries, but studies of CVD epidemiology in such settings often focus on risk factors rather than measures of disease progression. Here we use the ankle brachial index (ABI) to assess the prevalence of peripheral artery disease (PAD) among older women living in Metropolitan Cebu, Philippines, and relationships between ABI and CVD risk factors and body composition. ABI was measured using the Doppler technique in 538 female participants in the 2015 Cebu Longitudinal Health and Nutrition Survey (mean age 58 years, range 47-78 years). ABI was related to a panel of CVD risk factors measured in 2005 and 2012, and to 2012 body composition measures. The prevalence of PAD (1.8%) was among the lowest reported in any comparably-aged sample, and only 9.9% of participants had an ABI indicating borderline PAD risk. Smoking (P < 0.011) and use of CVD medications (P < 0.0001) predicted lower ABI (indicating higher PAD risk), which was also lower in relation to 2012 systolic blood pressure (P < 0.054). ABI was unrelated to other CVD risk factors. An apparent protective relationship between body mass index (BMI) and ABI, noted in previous studies, was found to be confounded by protective relationships between ABI and fat free mass, height, and grip strength (all P < 0.05). The prevalence of PAD is low in Cebu Longitudinal Health and Nutrition Survey participants, and ABI was related to few CVD risk factors. Past reports of lower PAD risk in relation to BMI may reflect confounding by lean mass, which has protective relationships with ABI.

Cardiovascular disease risk and androgen deprivation therapy in patients with localised prostate cancer: a prospective cohort study

Background:As androgen deprivation therapy (ADT) is increasingly being used in men with localised prostate cancer, our goal was to examine the association between ADT and the risk of cardiovascular disease (CVD).Methods:We conducted a prospective cohort study using records of a large health-care system in California. The study included men with newly diagnosed localised prostate cancer (1998–2008) who initially underwent active surveillance (N=7637) and were followed through 2010. We examined 10 individual CVD outcomes. Cox proportional hazard models incorporated time-varying treatment variables and controlled for race/ethnicity, age, and tumour characteristics, recurrence risk, CVD medication use, and CVD risk factors.Results:Of the 7637 subjects, nearly 30% were exposed to ADT. In the multivariable analyses, ADT was associated with an increased risk of heart failure (adjusted HR=1.81, 95% CI 1.40–2.32) in men without preexisting CVD. Elevated risks of arrhythmia (adjusted HR=1.44, 95% CI 1.02–2.01), and conduction disorder (adjusted HR=3.11, 95% CI 1.22, 7.91) were only observed among patients with preexisting CVD.Conclusions:In men with clinically localised prostate cancer who were initially under active surveillance, ADT was associated with a greater risk of heart failure in men without any preexisting CVD. We also found an increased risk of arrhythmia and conduction disorder in men with preexisting CVD. This study provides the basis for identifying high-risk men treated with ADT who might benefit from regular cardiac monitoring and lifestyle modification recommendations.

Household Air Pollution and Cardiovascular Disease Risk: Results from the Prospective Urban and Rural Epidemiological Study

Introduction: An estimated 2.9 million deaths in 2013 were attributable to exposure to household air pollution (HAP). The majority (52%) of this burden is from cardiovascular disease (CVD), yet to date no prospective study has examined HAP and CVD incidence. Here we investigate the association between HAP and CVD within the Prospective Urban and Rural Epidemiology (PURE) cohort. Methods: We examined 26 centers in the PURE study that reported greater than 10% solid fuel use for cooking, resulting in 97,350 participants with CVD follow-up across 10 countries (Bangladesh, Brazil, Chile, China, Colombia, India, Pakistan, South Africa, and Zimbabwe). Average follow-up in the cohort was 4.1 years, yielding 1,073 myocardial infarctions (MI), 878 strokes, 2,195 severe CVD events, 1,080 fatal CVD events, and 2,782 total deaths. We ran Cox-proportional hazards models, controlling for the INTERHEART risk score (a validated score for existing CVD risk-factors), urban/rural status, education, outdoor PM2.5, CVD medication use, country, and center. Results: We observed increases in risk of all-cause mortality (HR 1.16; 95% CI: 1.02-1.32) for individuals living in households with solid fuel use for cooking compared to electricity or liquefied petroleum gas (LPG). Increases (not statistically significant) in the risk of MI (7-20%), Stroke (9-46%) and Severe CVD (8-23%) were observed in models including all countries and in China/India models. The largest risks were observed in India. There was heterogeneity in risk estimates across study centers, although meta-analysis of these results were similar to overall models. Conclusions: In this large, multi-country prospective cohort we observed increases in all-cause mortality and CVD incidence for individuals living in households using solid fuel for cooking compared to electricity or LPG. Although effect sizes were modest, these results contribute the first direct evidence of an association between HAP and CVD incidence.

Inflammatory/Hemostatic Biomarkers and Coronary Artery Calcium Progression in Women at Midlife (from the Study of Women's Health Across the Nation, Heart Study)

It is unknown whether inflammatory/hemostatic biomarkers are associated with coronary artery calcium (CAC) progression. Our purpose was to evaluate the associations of baseline levels of C-reactive protein, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), tissue plasminogen activator antigen, and circulating factor VII with CAC progression in healthy midlife women. Inflammatory/hemostatic biomarkers were measured at baseline. CAC was quantified by computed tomography scans at baseline and after 2.3 ±0.5years of follow-up. Significant CAC progression was defined as present if (1) follow-up CAC Agatston score was >0 if baseline CAC score= 0; (2) annualized change in CAC score was ≥10 if baseline CAC score >0 to <100; and (3) annualized percent change in CAC score was ≥10% if baseline CAC score ≥100. Extent of CAC progression was defined as [log(CAC(follow-up)+25)- log(CAC(baseline)+25)]/year. Logistic and linear regression models were used as appropriate, and the final models were adjusted for baseline CAC score, age, study site, race/ethnicity, menopausal status, sociodemographics, traditional cardiovascular disease (CVD) risk factors, family history of CVD, and CVD medication use. The study included 252 women (baseline age 51.2 ± 2.6years; 67.5% white; 56.4% premenopausal or early perimenopausal). In final models, only log(PAI-1) was associated with presence of CAC progression (odds ratio 1.91, 95% CI 1.24 to 2.93; per 1 log unit increase in PAI-1; p= 0.003). In addition, higher log(PAI-1) was marginally associated with greater extent of CAC progression (p= 0.06). In conclusion, PAI-1 is associated with the presence of CAC progression in middle-aged women. Targeting PAI-1 may decrease atherogenesis beyond conventional CVD risk factors.

Increase HDL-C level over the menopausal transition is associated with greater atherosclerotic progression

Experimental and observational evidence demonstrates that high-density lipoprotein (HDL) can lose its well-documented atheroprotective functions and even adopt a paradoxically proinflammatory nature in certain conditions. Hormonal alterations, especially estradiol reduction, influence the accumulation of risk factors that could potentially impair the quality of HDL during the menopausal transition (MT). Limited data exist to evaluate the relationship between changes in HDL-cholesterol (HDL-C) and its main carried protein, apolipoprotein A (apoA), over the MT, and atherosclerosis development. To evaluate the associations of changes in HDL-C and apoA with progression of carotidintima-media thickness (cIMT), carotid adventitial diameter (cAD), and presence of carotid plaquerelative to the onset of the postmenopause. A total of 213 participants (age [mean (SD)]: 45.7 [2.5] years at baseline; 70% white) from the Study of Women's Health Across the Nation Pittsburgh site were included. Participants had up to 5 measures of cIMT, cAD, and carotid plaque over a maximum of 9years of follow-up. Adjusting for sociodemographic, cardiovascular disease risk factors, cardiovascular disease medication use, and C-reactive protein, a larger increase in HDL-C since baseline was significantly associated with a greater cIMT progression (P=.008). Additionally, a higher apoA level at baseline was significantly associated with a lower cIMT progression (P=.03). No significant associations were found with cAD or plaque presence. As women transition through menopause, increases in HDL-C levels are independently associated with greater cIMT progression. Thus, the quality of HDL may be altered over the MT rendering HDL dysfunctional and not providing the expected cardioprotective effect.

Pre‐existing diabetes significantly increases the risk of graft failure and mortality following renal transplantation

The aim of this study was to examine the impact of pre-existing diabetes mellitus (DM) on acute rejection, graft loss, and mortality following kidney transplant and whether glycemic control or cardiovascular disease (CVD) risk control with medications influenced outcomes. This was a cohort study of 1002 renal transplants conducted between 2000 and 2008. Patients were included if they received a kidney transplant within the allotted time and were at least 18 yr of age. Cox regression was used to assess acute rejection, graft failure, or death controlling for relevant sociodemographic, clinical, and post-transplant variables. Five-yr patient survival (83% vs. 93%, p < 0.001) and graft survival (74% vs. 79%, p = 0.005) were significantly lower in patients with pre-existing DM. Sequential Cox regression models demonstrated that pre-existing DM was consistently associated with a higher risk of death (HR 2.3-3.0, p < 0.01) and graft failure (HR 1.5-1.8, p < 0.04) in all models except after adjusting for CVD medication use (HR 1.9, p = 0.174 and HR 1.5, p = 0.210, respectively). These data suggest pre-existing DM is a significant risk factor for graft failure and death following renal transplantation and aggressive CVD risk reduction with medications may be an important strategy to reduce mortality and graft failure.

Utilization and Costs of Cardiovascular Disease Medications in Dialysis Patients in Medicare Part D

Cardiovascular disease (CVD) is a major source of mortality and morbidity in dialysis patients. Population-level descriptions of CVD medication use are lacking in this population. Retrospective cohort study. Adult dialysis patients in the United States, alive on December 31, 2006, with Medicare Parts A and B and enrollment in Medicare Part D continuously in 2007. CVDs and demographic characteristics. ≥1 prescription fill during follow-up (2007). Average out-of-pocket costs per user per month and average total drug costs per member per month were calculated. Of 225,635 dialysis patients who met inclusion criteria during the entry period, 70% (n = 158,702) had continuous Part D coverage during follow-up. Of these, 76% received the low-income subsidy. β-Blockers were the most commonly used CVD medication (64%), followed by renin-angiotensin system inhibitors (52%), calcium channel blockers (51%), lipid-lowering agents (44%), and α-agonists (23%). Use varied by demographics, geographic region, and low-income subsidy status. For CVD medications, mean out-of-pocket costs per user per month were $3.44 and $49.59 and mean total costs per member per month were $124.02 and $110.32 for patients with and without the low-income subsidy, respectively. Information was available for only filled prescriptions under the Part D benefit; information for clinical contraindications was lacking, information for over-the-counter medications was unavailable, and medication adherence and persistence were not examined. Most Medicare dialysis patients in 2007 were enrolled in Part D, and most enrollees received the low-income subsidy. β-Blockers were the most used CVD medication. Total costs of CVD medications were modestly higher for low-income subsidy patients, but out-of-pocket costs were much higher for patients not receiving the subsidy. Further study is warranted to delineate sources of variation in the use and costs of CVD medications across subgroups.

Cardiovascular Disease Medications After Renal Transplantation: Results From the Patient Outcomes in Renal Transplantation Study

Cardiovascular disease (CVD) is the most common cause of death after kidney transplantation. Nevertheless, the use of potentially protective CVD medications has not been examined in a large international cohort of kidney transplant patients. Using the Patient Outcomes in Renal Transplantation database, we retrospectively examined CVD medication use in 14,236 kidney transplant patients from 10 centers worldwide at 4 and 12 months posttransplant. Use of CVD medications posttransplant increased between 1990 to 1994 and 2000 to 2006, with a 12-fold increase in the use of statins (odds ratio [OR] 12.28, 95% confidence interval [CI] 10.18-14.80). Use of β-blockers also increased (OR 3.74, 95% CI 3.20-4.38), as did use of angiotensin converting enzyme inhibitors or angiotensin II receptor blockers (OR 3.68, 95% CI 3.07-4.40) and antiplatelet agents (OR 1.93, 95% CI 1.66-2.24). Use of most CVD medications was not higher in patients with diabetes than in patients without diabetes, despite a higher risk of CVD among patients with diabetes. Although use of several CVD medications was higher in patients with previous CVD events than in patients with no previous CVD, less than 75% of patients with previous CVD were using a statin or antiplatelet agent. Although use of CVD medications after kidney transplant has increased in recent years, use of potentially cardioprotective medications may be suboptimal given the high CVD risk in kidney transplant patients.

Use of cardiovascular disease medications and mortality in people with older onset diabetes.

Mortality follow-up for a cohort defined in 1980 with diabetes diagnosed at 30 years of age or older has been completed through 1988. History of medication use was obtained during the initial evaluation. There were 605 (44.2%) confirmed deaths; heart disease was the underlying cause in 49.9% of the deaths. Use of loop diuretics was associated with an odds ratio of death of 1.8 (95% CI = 1.4, 2.2). Although a causal relationship cannot be inferred, it is reasonable to suggest that blood chemistries be monitored regularly in persons on these drugs since electrolyte imbalance may be related to death.