Effectiveness of Indapamide SR on top of Perindopril on blood pressure change: a methodological study to validate effect of anti-hypertensive drugs in CPRD Aurum.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PERINDOPRIL TERT-BUTYLAMINE

  PERINDOPRIL ARGININE

  INDAPAMIDE
• Medical condition to be studied:
  Essential 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:
  13988

Study design details

• Main study objective:
  The overall aim of this study is to assess whether and how efficacy of antihypertensive therapy can be objectivised using Blood Pressure records collected during routine clinical practice. In a main approach, the study will emulate a theoretical phase III study with the same antihypertensive treatments using the Clinical Research Practice Datalink (CPRD).
• Outcomes:
  Primary outcome will be SBP change between SBP at ID and the closest SBP value to week 8 in a window of 4 weeks to 24 weeks after ID. Change in DBP between DBP at ID and the closest DBP value to week 8 in a window of 4 weeks to 24 weeks after ID. SBP change between SBP at ID and the mean of all the SBP values recorded in a window of 4 weeks to 24 weeks after ID, instead of the closest record to week 8. Percentage of patients who reach BP control at week 8.
• Data analysis plan:
  Patients in both groups will be matched using a propensity score. The primary outcome that will be SBP change between baseline and week 8, will be assessed using a linear regression model. Missing data will be handled using multiple imputation and return-to-baseline approaches according to missing pattern. The secondary objective will further assess how BP effect of antihypertensive drugs can be measured considering real life context (less selected population, sparse BP measures). Thus, different methods like alternative definitions of population, alternative definitions of outcomes (e.g. BP control), and complementary statistical approaches (Standardized Mortality Ratio and Inverse probability censoring weighting) will be used