Comparison of the medication adherence of patients treated with telmisartan/hydrochlorothiazide or telmisartan/amlodipine FDC versus double-pill combination therapy in real-world Japanese therapeutic practice

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Assessment of risk minimisation measure implementation or effectiveness

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TELMISARTAN

  AMLODIPINE

  HYDROCHLOROTHIAZIDE
• Medical condition to be studied:
  Hypertension

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3275

Study design details

• Main study objective:
  The primary objective of this study is to compare the medication adherence measured by PDC (Proportion of Days Covered) of patients with FDC (fixed dose combination) or double-pill combination therapy in real-world Japanese therapeutic practice.
• Outcomes:
  PDC of patients treated with single- and double- combination therapy, Demographic and clinical characteristics of patients treated with single- and double- combination therapy
• Data analysis plan:
  Caliculate and compare the medication adherence (PDC) of patients with FDC or double-pill combination therapy in the following groups:1) • Telmisartan+ hydrochlorothiazide double-pill combination • Telmisartan/hydrochlorothiazide single-pill combination (Micombi®) 2) • Telmisartan+amlodipine double-pill combination • Telmisartan/amlodipine single-pill combination (Micamlo®) Data are shown as the mean ±SD. Variables were compared by using Student’s t-test, or χ2 test, as appropriate. A p value less than 0.05 was accepted as indicative of statistical significance.To compare adjusted differences among single- and double-pill cohorts with respect to medication adherence (PDC≧80%), logistic regression model was applied.