The Polypill Approach

Drs Cushing and Goff also remarked that the concept of a “polypill”—a single pill that combines several medications (in this case, antihypertensive and lipid-lowering drugs)—is an attractive public health approach.4 “However, evidence that each component of a polypill would independently reduce the risk of CV events and that the combination of agents would be safe is lacking.”4

The discussion over a potential polypill in CVD risk reduction has been ongoing for the better part of 15 years, as Dr Bakris explained. “So, Salim Yusuf [and the other HOPE-3 investigators] asked the question: ‘Does it matter to treat BP and lipids in this low risk group?’”


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But the use of statins in a lower risk population is different than the use of BP medications, Dr Bakris clarified. A lower risk population will typically experience more of an impact from statin therapy vs BP medications. “With statins, you’re really altering the history of atherosclerosis and that’s huge…the totality of the data across all the spectrum of CVD is that treating lipids does reduce risk, period.”

By the Numbers?

“This is not a numbers game,” Dr Bakris said. “This is a game of understanding CV risk as reflected by numbers. We have done a disservice to our fellow physicians by putting up a number and then couching everything around that number.”

He urged clinicians to be more mindful of confidence intervals and ranges. “That range—that magic bullet—if you have hypertension, is somewhere between a SBP of 126 and 131,” he said. “If you’re outside that systolic range, then you’re not getting the maximal risk reduction. If you’re there naturally [ie, normotensive] and you don’t have a lot of the risks mentioned in SPRINT or a Framingham risk score of >10%—especially if you’re relatively young—then what are we treating?”

Dr Bakris added that this range does not apply to patients with isolated systolic hypertension, particularly since those patients were not studied in SPRINT or HOPE-3.

In their published findings, the HOPE-3 investigators appear to echo Dr Bakris’s sentiment. The data reflected their hypothesis that treating patients without CVD but with an SBP above approximately 140 mm Hg is potentially beneficial. However, attempting to treat persons with consistently lower SBP levels would at best not result in any benefit and at worst may even be harmful.3

Finally, Dr Bakris emphasized the importance of the patient-clinician relationship in hypertension and lipid management. “All of these [cholesterol, BP, glucose control] require patient participation and responsibility,” he said. “If the patient is not willing to work with physician or the physician is not willing to educate the patient, everybody loses.”

References

  1. The SPRINT Research Group. A randomized trial of intensive vs standard blood-pressure control. N Engl J Med. 2015;373(22):2103-2116. doi: 10.1056/NEJMoa1511939.
  2. Lonn EM, HOPE 3 Investigators. Abstract 401-17. Blood pressure lowering in people at moderate risk. The HOPE-3 trial. Presented at the American College of Cardiology Scientific Sessions. April 2-4, 2016; Chicago, IL.
  3. Lonn EM, Bosch J, Lopez-Jaramillo P, et al; for the HOPE-3 Investigators. Blood-pressure lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016. doi: 10.1056/NEJMoa1600175.
  4. Cushman WC, Goff DC. More HOPE for prevention with statins. N Engl J Med. 2016. doi: 10.1056/NEJMe1603504.