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Antihyperglycemic Medications and Cardiovascular Risk Reduction.

ABSTRACT: Cardiovascular disease (CVD) remains a leading cause of death in patients with type 2 diabetes (T2D). In addition to glycemic control, a major focus of diabetes treatment involves cardiovascular (CV) risk reduction. In 2008, the US Food and Drug Administration (FDA) instituted a new requirement that new drugs developed and studied for the treatment of T2D must undergo CV safety testing. Since the advent of this new policy, canagliflozin, empagliflozin, liraglutide and semaglutide have demonstrated superior CV event reduction - via a composite of reduction in CV death, nonfatal myocardial infarction (MI), and nonfatal stroke - compared with placebo in patients with T2D and existing CVD, or at high risk of CVD. Multiple studies are underway to evaluate the CV outcomes of other antihyperglycemic agents. In a time when there are numerous drugs in the T2D armamentarium, positive CV outcomes data influence drug selection and aids practitioners in making more individualised therapeutic recommendations for their patients.

SUBMITTER: Anderson SL

PROVIDER: S-EPMC5813471 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Antihyperglycemic Medications and Cardiovascular Risk Reduction.

Anderson Sarah L SL Marrs Joel C JC

European endocrinology 20170822 2

Cardiovascular disease (CVD) remains a leading cause of death in patients with type 2 diabetes (T2D). In addition to glycemic control, a major focus of diabetes treatment involves cardiovascular (CV) risk reduction. In 2008, the US Food and Drug Administration (FDA) instituted a new requirement that new drugs developed and studied for the treatment of T2D must undergo CV safety testing. Since the advent of this new policy, canagliflozin, empagliflozin, liraglutide and semaglutide have demonstrat ...[more]

PMID: 29632614

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Project description:ImportanceThe Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model pays provider organizations for measuring and reducing Medicare patients' cardiovascular risk.ObjectiveTo 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.Design, setting, and participantsThis 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.InterventionsUS 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.Main outcomes and measuresInitiating 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.ResultsA 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).Conclusions and relevanceIn 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.

Project description:More than 1.5 million US adults use stimulants and other medications labeled for treatment of attention-deficit/hyperactivity disorder (ADHD). These agents can increase heart rate and blood pressure, raising concerns about their cardiovascular safety.To examine whether current use of medications prescribed primarily to treat ADHD is associated with increased risk of serious cardiovascular events in young and middle-aged adults.Retrospective, population-based cohort study using electronic health care records from 4 study sites (OptumInsight Epidemiology, Tennessee Medicaid, Kaiser Permanente California, and the HMO Research Network), starting in 1986 at 1 site and ending in 2005 at all sites, with additional covariate assessment using 2007 survey data. Participants were adults aged 25 through 64 years with dispensed prescriptions for methylphenidate, amphetamine, or atomoxetine at baseline. Each medication user (n = 150,359) was matched to 2 nonusers on study site, birth year, sex, and calendar year (443,198 total users and nonusers).Serious cardiovascular events, including myocardial infarction (MI), sudden cardiac death (SCD), or stroke, with comparison between current or new users and remote users to account for potential healthy-user bias.During 806,182 person-years of follow-up (median, 1.3 years per person), 1357 cases of MI, 296 cases of SCD, and 575 cases of stroke occurred. There were 107,322 person-years of current use (median, 0.33 years), with a crude incidence per 1000 person-years of 1.34 (95% CI, 1.14-1.57) for MI, 0.30 (95% CI, 0.20-0.42) for SCD, and 0.56 (95% CI, 0.43-0.72) for stroke. The multivariable-adjusted rate ratio (RR) of serious cardiovascular events for current use vs nonuse of ADHD medications was 0.83 (95% CI, 0.72-0.96). Among new users of ADHD medications, the adjusted RR was 0.77 (95% CI, 0.63-0.94). The adjusted RR for current use vs remote use was 1.03 (95% CI, 0.86-1.24); for new use vs remote use, the adjusted RR was 1.02 (95% CI, 0.82-1.28); the upper limit of 1.28 corresponds to an additional 0.19 events per 1000 person-years at ages 25-44 years and 0.77 events per 1000 person-years at ages 45-64 years.Among young and middle-aged adults, current or new use of ADHD medications, compared with nonuse or remote use, was not associated with an increased risk of serious cardiovascular events. Apparent protective associations likely represent healthy-user bias.

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Antihyperglycemic Medications and Cardiovascular Risk Reduction.

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Antihyperglycemic Medications and Cardiovascular Risk Reduction.

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