title: Aldosterone Antagonists or Renin-Guided Therapy for Treatment-Resistant Hypertension: A Comparative Effectiveness Pilot Study in Primary Care.
abstract: Uncontrolled treatment-resistant hypertension (TRH), i.e., blood pressure (BP, mm Hg) ≥140/≥90mm Hg in and out of office on ≥3 different BP medications at optimal doses, is common and has a poor prognosis. Aldosterone antagonist (AA) and renin-guided therapy (RGT) are effective strategies for improving BP control in TRH but have not been compared.
  
  
  
  A comparative effectiveness TRH pilot study of AA vs. RGT was conducted in 4 primary care clinics with 2 each randomized to AA or RGT. The primary outcome was change in clinic BP defined by means of 5 automated office BP values. Eighty-nine patients with apparent TRH were screened and 44 met criteria for true TRH.
  
  
  
  Baseline characteristics of 20 patients in the AA (70% Black, 45% female, mean age: 57.4 years) and 24 patients in RGT (79% Black, 50% female, 57.8 years) arms were similar with baseline BP 162±5/90±3 vs. 153±3/84±3, respectively, P = 0.11/0.20. BP declined to 144±5/86±4 in AA vs. 132±4/75±3 in RGT, P = 0.07/0.01; BP was controlled to JNC7 (Seventh Joint National Committee Report) goal in 25% vs. 62.5%, respectively, P < 0.01. Although BP changes from baseline, the primary outcome, were not different (-17.6±5.1/-4.0±3.0 AA vs. -20.4±3.8/-9.7±2.0 RGT, P = 0.65/0.10.), more BP medications were added with AA than RGT (+0.9±0.1 vs. +0.4±0.1 per patient, P < 0.01).
  
  
  
  In this TRH pilot study, AA and RGT lowered BP similarly, although fewer additional medications were required with RGT. A larger comparative effectiveness study could establish the utility of these treatment strategies for lowering BP of uncontrolled TRH patients in primary care.
authors.affiliation: Care Coordination Institute, Greenville Health System, Greenville, South Carolina, USA; University of South Carolina School of Medicine-Greenville, Greenville, South Carolina, USA; began@ccihealth.org.
authors.forename: Brent M
authors.initials: BM
authors.lastname: Egan
authors.affiliation: College of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA;
authors.forename: Marilyn A
authors.initials: MA
authors.lastname: Laken
authors.affiliation: Care Coordination Institute, Greenville Health System, Greenville, South Carolina, USA;
authors.forename: Susan E
authors.initials: SE
authors.lastname: Sutherland
authors.affiliation: College of Nursing, Medical University of South Carolina, Charleston, South Carolina, USA;
authors.forename: Suparna
authors.initials: S
authors.lastname: Qanungo
authors.affiliation: Care Coordination Institute, Greenville Health System, Greenville, South Carolina, USA; University of South Carolina School of Medicine-Greenville, Greenville, South Carolina, USA;
authors.forename: Douglas O
authors.initials: DO
authors.lastname: Fleming
authors.affiliation: Department of Family Medicine, AnMed Health, Anderson, South Carolina, USA;
authors.forename: Anne G
authors.initials: AG
authors.lastname: Cook
authors.affiliation: Department of Family Medicine, McLeod Regional Medical Center, Florence, South Carolina, USA;
authors.forename: William H
authors.initials: WH
authors.lastname: Hester
authors.affiliation: Department of Family Medicine, McLeod Regional Medical Center, Florence, South Carolina, USA;
authors.forename: Kelly W
authors.initials: KW
authors.lastname: Jones
authors.affiliation: Department of Family Medicine, McLeod Regional Medical Center, Florence, South Carolina, USA;
authors.forename: Gerard C
authors.initials: GC
authors.lastname: Jebaily
authors.affiliation: Carolina Medical Affiliates, Spartanburg, South Carolina, USA;
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Valainis
authors.affiliation: Family Diagnostic Associates, Holly Hill, South Carolina, USA.
authors.forename: Charles F
authors.initials: CF
authors.lastname: Way
authors.affiliation: Department of Family Medicine, AnMed Health, Anderson, South Carolina, USA;
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Wright
authors.affiliation: Care Coordination Institute, Greenville Health System, Greenville, South Carolina, USA;
authors.forename: Robert A
authors.initials: RA
authors.lastname: Davis
mesh_terms: D000803:Angiotensin I / Q000097:blood; D005260:Female; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage*; D010865:Pilot Projects; D011320:Primary Health Care; D012083:Renin / Q000378:metabolism
chemical_list: D000451:Mineralocorticoid Receptor Antagonists; D000803:Angiotensin I; D012083:Renin
keywords: aldosterone antagonists; blood pressure; clinical effectiveness; renin-guided therapy; treatment-resistant hypertension.