2015's Unmissable Moments for Primary Care

Linda Brookes, MSc

Disclosures

December 29, 2015

In This Article

From SPRINT to Biosimilars: Major Moments in Primary Care

For primary care providers, clinical practice in 2015 brought both known and anticipated as well as unknown challenges. Some turned out better than expected, and others are likely to resolve soon, but some controversial issues remained, with no resolution in sight by year end. For how all of this played out in 2015, please read on.

Blood Pressure Guideline Overload

A plethora of hypertension advisories and guidelines greeted primary care providers in 2014. Guidelines were released by the American Heart Association (AHA), in collaboration with the American College of Cardiology (ACC) and the Centers for Disease Control and Prevention (CDC),[1] the American Society of Hypertension and the International Society of Hypertension,[2] the original Joint National Committee (JNC) 8 panel,[3] and the JNC8 "Minority."[4] Consequently, in February, the ACC and AHA began work on another new guideline for the management of hypertension to update the JNC guidelines[5] published in 2003.

Most guidelines to date have favored a target blood pressure of <140/90 mm Hg for the general population, based largely on evidence from epidemiologic studies and meta-analyses. This appeared to be challenged in September, when the National Heart, Lung, and Blood Institute announced that its Systolic Blood Pressure Intervention Trial (SPRINT) had been terminated early after meeting its primary endpoint.[6] The topline results showed that treating to a systolic blood pressure of 120 mm Hg (rather than 140 mm Hg) in high-risk, but not diabetic, hypertensive adults reduced rates of cardiovascular (CV) events by almost one third and the risk for death by almost one fourth. In November, the analysis confirmed a 25% lower relative risk for the primary composite endpoint of myocardial infarction, acute coronary syndrome, stroke, acute decompensated heart failure, and CV death.[7,8]

Many commentators viewed the SPRINT findings as practice-changing, and several saw them as "another cautionary reminder about using data from nonrandomized trials or biologic plausibility to assess efficacy and safety."[9] But others were wary about extrapolating the concept of a systolic blood pressure target of <120 mm Hg beyond patients without diabetes or a history of stroke.[10,11] Questions were also raised about the serious adverse events associated with intensive treatment, which were twice as frequent as with standard therapy.[12] Further data from SPRINT are eagerly awaited, including the effects of reducing systolic blood pressure on cognitive function (SPRINT-MIND). From a practical point of view, many pointed out that that office blood pressure is rarely measured the same way as in clinical trials and that intensifying treatment could mean patients having to take more drugs and make more visits to practitioners' offices, with a consequent increase in cost to the healthcare system.[12,13]

The AHA/ACC guidelines group will have to decide whether the SPRINT findings can be applied to patients who were omitted from the trial—patients with diabetes, patients aged <50 years, and those with untreated systolic blood pressure of 120-140 mm Hg in real life. The new guideline is scheduled for publication in 2016.

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