The 2013 ACC/AHA guidelines are based on an elevated 10-year risk of atherosclerotic cardiovascular disease (ASCVD), while the 2016 USPSTF recommendations for primary prevention statin therapy increased the estimated ASCVD risk threshold for patients (including those with diabetes) and required the presence of at least one cardiovascular risk factor (i.e., hypertension, diabetes, dyslipidemia or smoking), in addition to elevated risk.

The study, by Neha J. Pagidipati, MD, MPH, et al., examined data from the 2009-2014 fasting subsample of the continuous National Health and Nutrition Examination Survey, and looked at 3,416 adults aged 40-75 years who were free of cardiovascular disease with triglyceride levels of 400 mg/dL or less. Of these, 747 reported they were currently taking lipid-lowering medication.

"[A]lternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered." — Neha J. Pagidipati, MD, MPH, et al

The authors found that full implementation of the USPSTF recommendations would be associated with an incremental increase of 15.8 percent of U.S. adults receiving statin treatment. In contrast, full implementation of the ACC/AHA guidelines would be associated with an incremental increase of 24.3 percent in statin users. The USPSTF and ACC/AHA recommendations for treatment were consistent for 36.9 percent of individuals, while the recommendations for no treatment were consistent for 53.8 percent of individuals.

Results also showed that 8.9 percent of individuals in the primary prevention population would be recommended for statin therapy under the ACC/AHA guidelines but not under the USPSTF recommendations. “Further exploration of those who are recommended to receive statins by the ACC/AHA guidelines but not by the USPSTF recommendations revealed that younger adults (4.9 percent of the primary prevention population) and persons with diabetes (2.5 percent of the primary prevention population) would account for much of this difference,” said lead author Michael J. Pencina, PhD. “Given that half of all [cardiovascular disease] events in men and one-third in women occur before age 65 years, reliance on 10-year ASCVD risk alone may miss many younger individuals who could potentially benefit from long-term statin therapy,” adds Pencina. Because of this, the authors conclude that moving forward, “alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered.”

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The study, by Patricia A. Cowper, PhD, et al., used patient-level data from the ARISTOTLE trial to compare life expectancies of patients treated with warfarin versus apixaban and looked at quality-of-life adjustment factors. In the trial, 18,201 patients with AFib and one or more risk factors for stroke were randomized to warfarin or apixaban in 39 countries between 2006 and 2010.

Results showed that after two years of anticoagulation therapy, health care costs (excluding the study drug) of patients treated with apixaban and warfarin were not statistically different. Life expectancy was significantly longer with apixaban versus warfarin – 7.94 versus 7.54 QALY.

The incremental cost, including the costs of anticoagulant and monitoring, was “within accepted U.S. norms” ($58,925 per QALY, with 98 percent likelihood of meeting a $100,000 willingness-to-pay threshold).

“Our analysis suggests that anticoagulation therapy for patients with AFib using apixaban rather than warfarin increases average quality-adjusted life expectancy at an additional cost that falls within current U.S. norms for reasonable value in health care,” the authors explain. “This result stems primarily from gains in life-years accumulated over a lifetime of therapy, as we did not find convincing evidence of a meaningful reduction in health care costs to offset the additional ongoing cost of apixaban therapy.”

In a related commentary, Mark A. Hlatky, MD, FACC, notes that “the fundamental principle of cost-effectiveness analysis is that higher costs of a new therapy may be acceptable if clinical outcomes are improved enough.” Although the increased life expectancy of 0.4 years (five months) with apixaban therapy may seem short, Hlatky explains that it is quite significant. “Another way to interpret this number is that it equals the effect of having one more patient survive out of every 19 patients treated, with an average life expectancy of 7.54 years.” Hlatky concludes that “the clinical outcomes were improved sufficiently to provide reasonable value in the setting of the U.S. system.”

Cowper PA, Sheng S, Lopes RD, et al. JAMA Cardiol 2017;March 29:[Epub ahead of print].

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Results from a study by Elizabeth J. Mayer-Davis, PhD, et al., found a significant increase in the number of youths diagnosed with type 1 and type 2 diabetes from 2002 to 2012, particularly among Hispanics. The study analyzed data from the SEARCH study, which identified 11,245 type 1 diabetes patients (0-19 years old at diagnosis) and 2,846 type 2 diabetes patients (10-19 years old at diagnosis) at five clinical centers across the U.S.

Results showed that the unadjusted estimated incidence rates increased annually by 1.4 percent for type 1 diabetes and 7.1 percent for type 2 diabetes. The increase in type 1 diabetes diagnosis affected primarily Hispanic boys, whereas type 2 diabetes increases were seen across all age, sex, race and ethnic groups, except non-Hispanic whites at one clinical center.

“These findings highlight the critical need to identify approaches to reduce disparities among racial and ethnic groups,” the authors conclude. “Longer follow-up will be required to establish long-term trends.”

Meanwhile, a separate study, by Aidin Rawshani, MD, et al., found that a combination of improvements in patient education, management of risk factors and advances in clinical decision-making support may have contributed to marked reductions in cardiovascular disease and mortality among Swedish adults with type 1 or type 2 diabetes.

The study included data from the Swedish National Diabetes Register and followed 36,869 patients with type 1 diabetes and 457,473 patients with type 2 diabetes until 2014. Over the 16-year study period, the mortality rate declined by 29 percent in the type 1 diabetes group and 21 percent in the type 2 diabetes group. Additionally, hospitalization for cardiovascular disease complications decreased by 36 percent among type 1 diabetes patients and 44 percent among type 2 diabetes patients.

“Although it is difficult to compare event-rate reductions across countries owing to differences in access to care, standards of clinical care, and diagnostic criteria for diabetes, our findings are generally consistent with trends in overall mortality and cardiovascular diseases associated with diabetes that have been observed in North America and Europe,” the study authors conclude.

In a related editorial comment, Julie R. Ingelfinger, MD, and John A. Jarcho, MD, FACC, explain that “the basic findings of these two studies, taken together, confirm the larger trends reported in the [Global Burden of Disease report for 2015].” They conclude that “it is clear that we are far from controlling the negative effects of diabetes on health worldwide. As the prevalence increases, we clearly need new approaches to reduce the burden of this disease on public health.”

Mayer-Davis EJ, Lawrence JM, Dabelea D, et al. N Engl J Med 2017;376:1419-29.
Rawshani A, Rawshani A, Franzén S, et al. N Engl J Med 2017;376:1407-18.

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The study compared socioeconomic status with the seven major risk factors identified by the World Health Organization’s (WHO) Global Action Plan for the Prevention and Control of Non-Communicable Diseases (NCDs) – harmful use of alcohol, insufficient physical activity, current tobacco use, high blood pressure, intake of salt or sodium, diabetes and obesity – also called the 25x25 risk factors after the WHO’s 25x25 initiative, a plan to cut mortality due to NCDs by 25 percent by 2025.

In this multicohort study – the first to compare the impact of low socioeconomic status with other major risk factors – researchers conducted a meta-analysis of individual-level data from 48 independent prospective cohort studies with information about socioeconomic status, indexed by occupational position, 25x25 risk factors and mortality, for a total population of 1,751,479 patients (54 percent women) from the United Kingdom, France, Switzerland, Portugal, Italy, the U.S. and Australia.

Results showed that low socioeconomic status was associated with a reduced life expectancy of 2.1 years, similar with being inactive (2.4 years). Comparatively, high blood pressure, obesity and high alcohol consumption were associated with smaller reductions in life expectancy (1.6, 0.7 and 0.5 years, respectively) than low socioeconomic status. The greatest reductions were for smoking and diabetes (4.8 and 3.9 years, respectively).

“The finding that socioeconomic status is associated with death risk independently of conventional risk factors suggests that both socioeconomic adversity and 25x25 risk factors should be targeted by health strategies,” said lead author Silvia Stringhini, PhD.

In an accompanying editorial, Martin Tobias, MD, explains that “Whatever the exact effect and impact of low social rank on the health of individuals and populations might be, the authors’ key message is clear: social rank deserves consideration alongside the established 25x25 risk factors.” He adds that “the United Nations’ Sustainable Development Goals … provide a timely opportunity to go beyond the WHO 25x25 goal and place social determinants squarely at the centre of sustainable development.”

Stringhini S, Carmeli C, Jokela M, et al. Lancet 2017;389:1229-37.

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