Ambulatory versus clinic blood pressure for the assessment of antihypertensive efficacy in clinical trials: Insights from the Val-Syst study

Paolo Palatini, Francesca Dorigatti, Amedeo Mugellini, Vitaliano Spagnuolo, Natale Var, Roberto Ferrara, Federico Bertocchi

Research output: Contribution to journalArticlepeer-review


Several studies have found that measurement of blood pressure (BP) in the clinical setting may lead to overestimation of hypertension and may yield inaccurate assessments of the efficacy of antihypertensive treatment. The aim of this study was to determine whether the use of clinic BP in the Valsartan and Amlodipine for the Treatment of Isolated Systolic Hypertension in the Elderly (Val-Syst) study accurately identified those elderly outpatients with systolic hypertension who had true 24-hour elevations in BP, as well as those who required dose increases in antihypertensive therapy during follow-up. In Val-Syst, patients aged between 60 and 80 years with a clinic sitting systolic BP (SBP) of 160 to 220 mm Hg and a diastolic BP -140 mm Hg after 8 weeks of double-blind treatment, doses were titrated upward to valsartan 160 mg or amlodipine 10 mg once daily (level 2). If clinic SBP was >-140 mm Hg after a further 8 weeks, hydrochlorothiazide 12.5 mg was added for an additional 8 weeks (level 3). Clinical decisions during the active-treatment period were based on clinic BP measurements. Thirteen of the 35 participating centers assessed ambulatory BP as well as clinic BP at baseline and the end of the treatment, making it possible to compare the results of the 2 modes of measurement. The Student test was used to compare drug-induced changes in clinic and ambulatory BP in individual patients. Differences between the decreases in clinic and ambulatory BP at the 3 treatment levels were tested using repeated-measures analysis of covariance (ANCOVA), with baseline as the covariate. One hundred sixty-four elderly patients (age range, 60-80 years; 85 men, 79 women) were included in the study (79 valsartan, 85 amlodipine), and valsartan and amlodipine were reported to have comparable effects on the level and rhythm of 24-hour BP In the present study, 22 of 164 patients had white-coat hypertension at baseline (clinic SBP >-160 mm Hg and mean 24-hour SBP -160 mm Hg and mean 24-hour SBP

Original languageEnglish
Pages (from-to)1436-1445
Number of pages10
JournalClinical Therapeutics
Issue number9
Publication statusPublished - Sep 2004


  • ambulatory blood pressure
  • clinical trials
  • hypertension
  • white-coat

ASJC Scopus subject areas

  • Pharmacology


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