for a black male cohort of participants, according to 12-month data from the project.
© Bonnie Schupp
Of the 319 black, non-Hispanic male participants, 180 were randomized to participate in an intensive 6-month hypertension intervention. The study protocol allowed pharmacists, who visited participants at their barbershops, to prescribe hypertension medication under collaborative practice agreements with participants’ primary care providers (PCPs).
Compared with an active control group who received instruction about blood pressure and lifestyle modification, participants receiving the intervention saw significant reductions in systolic BP at 6 months (N Engl J Med. 2018 Apr 5;378:1291-391). From 6 months onward, participants in the intervention arm received fewer visits from pharmacists, though they still regularly visited the barbershop, where blood pressure was recorded. At the end of 12 months, systolic BP – at least 140 mm Hg at enrollment – dropped by 28.6 mm Hg from baseline in the intervention group to a mean 123.8 mm Hg. For those in the control group, the reduction in systolic BP was 7.2 mm Hg, to a mean 147.4 mm Hg. This 20.8-point difference between the two groups was highly statistically significant (P less than .0001).
“These new 12-month efficacy data are statistically indistinguishable from our previously reported 6-month data,” wrote Ciantal Blyler, PharmD, a clinical pharmacist at Cedars-Sinai Medical Center, Los Angeles, and her coauthors.
Diastolic BP, a secondary outcome measure, fell in the intervention group by 14.5 mm Hg more than in the active controls. In the intervention arm, 68% of participants reached the prespecified goal blood pressure of less than 130/80 mm Hg, while just 11% of the control group hit this target, a significant difference.
No trial participants experienced treatment-related adverse events or deaths during the 6-month extension phase.
Compared with men in the active control arm, those receiving the intervention were on a greater number of antihypertensive classes per regimen. Also, patients receiving the intervention were more likely to receive first-line drugs as add-on therapy. At the end of the 12-month period, all participants in the intensive arm were on antihypertensives, up from 57% at baseline. For the control group, antihypertensive medication use went from 53% at baseline to 65% at 6 months (P less than .001).
The intervention group saw their PCP more frequently than did the control group during the study; there was no difference in PCP visit frequency at baseline. “This suggests that the pharmacist intervention did not interfere with the patient-PCP relationship, and perhaps influenced the increase in PCP visits,” noted Dr. Blyler and her colleagues.
The investigators noted that the pharmacists’ ability to begin, titrate, and change hypertension medication under a collaborative agreement with physicians was an essential part of the program’s initial and continued success. “Perhaps the most critical first step toward widespread dissemination of our model is the expansion of collaborative practice between pharmacists and physicians, or the elimination of the requirement altogether (as in Canada and the UK),” wrote Dr. Blyler and her coauthors.
Beyond that, Dr. Blyler and her colleagues said that scalability will depend on the ability to adapt the model to create operational efficiencies while maintaining intervention potency. The time it took pharmacists to get to and from barbershops was significant, and some form of telemonitoring may work well going forward as “an appropriate means of maintaining/sustaining the intervention effect whilst also addressing this logistical inefficiency,” they said.
The study was funded by the National Institutes of Health, the California Endowment, the Lincy Foundation, the Harriet and Steven Nichols Foundation, the Smidt Heart Institute, and the Division of Community Relations and Development at Cedars-Sinai Medical Center, Los Angeles. One coauthor reported being a consultant for Recor Medical; other authors reported that they had no disclosures.
SOURCE: Blyler C et al. Circulation. 2018 Dec 17.