Study Design
  • TALENT was a 16-week multicenter, prospective, randomized, double-blind trial that included 327 high CV risk patients from 40 centers in Italy and Spain


  • It compared the effect of two general treatment strategies on 24h blood pressure: initiating therapy with the combination of nifedipine GITS 20 mg/telmisartan 80 mg versus initiating therapy with one drug and then adding the second

    • The first 8-week period consisted of three treatment arms:

      • - Nifedipine GITS 20 mg/telmisartan 80 mg combination (n=164)
      • - Telmisartan 80 mg monotherapy (n=74)
      • - Nifedipine GITS 20 mg monotherapy (n=89)

    • Starting from 8 weeks, all patients received nifedipine GITS 20 mg/telmisartan 80 mg combination


  • In the optional 8-week extension period, all patients continued to receive GITS 20 mg/telmisartan 80 mg combination, with an open-label up-titration of nifedipine GITS to 30 mg or addition of medication (e.g. a diuretic) for patients whose SBP was ≥120 mmHg and whose physicians recommended it
study_design.jpg
Figure 1. TALENT study design
Patients
  • Patients were age 18-75 years of age with untreated or poorly controlled hypertension (office SBP >135 mmHg) following a stable antihypertensive regimen for ≥4 weeks


  • Participants also had to have an additional CV risk factor: type 2 diabetes, target-organ damage or metabolic syndrome, defined as the presence of at least two of the following:

    • a. Impaired glucose tolerance (fasting plasma glucose 110-125 mg/dL)
    • b. Raised serum triglycerides (≥150 mg/dL)
    • c. Low HDL cholesterol (men: <40 mg/dL, women: <50 mg/dL)
    • d. Waist circumference of >102 cm (men) or >88 cm (women)
 
Endpoints
  • The primary endpoint was change from baseline in 24-hour mean systolic BP (SBP) after 16 weeks of treatment as measured by ambulatory blood pressure monitoring (ABPM)


  • Secondary endpoints included:

    • A number of measures of the homogeneity of blood pressure control throughout the 24h period, including morning BP increase/surge, smoothness index (ratio between the average of 24-hour hourly changes from baseline and the corresponding standard deviation), trough-peak ratio and whether nocturnal BP fall is dipping or non-dipping (>10% or <10% of daytime values)
    • Markers of inflammation
    • Reduction of microalbuminuria (in a subgroup of patients)
 
 

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Cardiometabolism
Cardiometabolism