title: Chart review of patients on valsartan-based single-pill combinations vs. ARB-based free combinations for BP goal achievement.
abstract: OBJECTIVE
  To compare blood pressure (BP) goal achievement associated with the use of valsartan-based single pill combinations (SPCs) vs. angiotensin II receptor blocker (ARB)-based free combinations (FCs) among adult hypertension patients.
  
  
  METHODS
  Data were collected from physician-administered chart review of adult hypertension patients in the South Central region. All patients had uncontrolled BP before initiating one of the index therapies (SPCs: valsartan/amlodipine or valsartan/hydrochlorothiazide [HCTZ], FCs: ARB + calcium channel blocker [CCB] or ARB + HCTZ) between 07/2008 and 06/2009. Up to three BP measures were collected starting from 45 days after the therapy initiation. BP goal was <130/80 mmHg for patients with diabetes, chronic renal disease or coronary heart disease; or <140/90 mmHg for patients without these comorbidities. The Kaplan-Meier method with log-rank test was used to compare rates of BP goal achievement associated with valsartan-based SPCs vs. ARB-based FCs over time. Cox proportional hazard models were used to estimate the likelihood of BP goal achievement associated with SPCs vs. FCs, controlling for demographics, baseline BP, hypertension history, comorbidities, prior and concurrent use of anti-hypertensive medications, and physician specialty.
  
  
  RESULTS
  The study included 812 patients: 414 on valsartan-based SPCs (209 on valsartan/amlodipine and 205 on valsartan/HCTZ) and 398 on ARB-based FCs (200 on ARB + CCB and 198 on ARB + HCTZ). The ARBs in the FC group included valsartan, losartan, olmesartan, telmisartan, irbesartan and candesartan. In the ARB FC group, the most commonly used ARB and CCB were valsartan (29.1%) and amlodipine (81.5%), respectively. During the observation period (81 days for valsartan SPC patients and 90 days for ARB FC patients), 65.9% of valsartan SPC patients and 55.8% of the ARB FC patients achieved BP goal. Over time, the rates of BP goal achievement were consistently higher among valsartan SPC vs. ARB FC patients (p = 0.01): 31.1% vs. 28.9% and 69.1% vs. 59.2% at month 3 and 6 after therapy initiation, respectively. Cox regression confirmed that valsartan SPC patients were more likely to achieve BP goal (HR = 1.22; p = 0.05). A similar trend was observed in the subgroup analyses comparing SPC of valsartan/amlodipine vs. FCs of ARB + CCB and SPC of valsartan/HCTZ vs. FCs of ARB + HCTZ.
  
  
  CONCLUSIONS
  Non-randomization of treatments, limited generalizability, and no records of BP measures within 45 days.
  
  
  CONCLUSIONS
  Patients using valsartan-based SPCs were significantly more likely to achieve BP goal than those treated with ARB-based FCs in the real-world clinical practice in the South Central region. The significance was achieved at two-sided alpha = 0.05.
authors.affiliation: Novartis Pharmaceuticals Corporation Medical, East Hanover NJ, USA.
authors.forename: Joanne
authors.initials: J
authors.lastname: Chang
authors.forename: Weiyi
authors.initials: W
authors.lastname: Yang
authors.forename: Thomas
authors.initials: T
authors.lastname: Fellers
authors.forename: Kristijan H
authors.initials: KH
authors.lastname: Kahler
authors.forename: John
authors.initials: J
authors.lastname: Orloff
authors.forename: Jipan
authors.initials: J
authors.lastname: Xie
authors.forename: Magda
authors.initials: M
authors.lastname: Tsaneva
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Yu
authors.forename: Eric Q
authors.initials: EQ
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D057911:Angiotensin Receptor Antagonists / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage; D001794:Blood Pressure / Q000187:drug effects* / Q000502:physiology; D015897:Comorbidity; D015536:Down-Regulation / Q000187:drug effects; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013607:Tablets; D013777:Tetrazoles / Q000008:administration & dosage*; D016896:Treatment Outcome; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000068756:Valsartan
chemical_list: D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents; D004338:Drug Combinations; D013607:Tablets; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine