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. 2023 Aug 4;2023(8):CD013573. doi: 10.1002/14651858.CD013573.pub2

Terpstra 2004.

Study characteristics
Methods Study design: prospective, randomised, double‐blind, single‐centre trial
Total duration of study: 2 years
Details of any 'run‐in' period: "participants with hypertension and aged between 60 and 75 years were selected for the study and advised to restrict their salt intake (low‐salt diet). After another period of 4 weeks, blood pressure was measured for the fifth time and hypertensive patients who met the inclusion criteria received placebo treatment for 2 weeks. If blood pressure remained stable during this run‐in period, the patients were randomly assigned to the double‐blind treatment phase."
Number of study centres and location: 1 centre in the Netherlands
Study setting and date of study: outpatients; no details given
Participants Number randomised: 166 participants
Number lost to follow‐up/withdrawn: "reasons for not completing the study in the amlodipine group (n = 24) were: adverse events (14), withdrawal of informed consent (6), violation of procedure (2), death (1), and other (1). Reasons for not completing the study in the lisinopril group (n = 22) were: adverse events (11), withdrawal of informed consent (4), violation of procedure (4), and other (3)"
Number analysed: 166 participants
Number of interest: 166 participants
Mean age: 67+/‐4 years
Age range: 60 to 75 years old
Gender: 92 men and 74 women
Severity of condition: untreated mild to moderate hypertension
Diagnostic criteria: "four measurements of DBP were between 95 and 115 mmHg or SBP was between 160 and 220 mmHg (or both), derived from several measurements made on three occasions over a period of 4 weeks"
Smoking history: 68 current smokers
Inclusion criteria
  • "Diastolic blood pressure between 95 and 115 mmHg or systolic blood pressure between 160 and 220 mmHg, or both

  • Aged between 60 and 75 years"


Exclusion criteria:
  • "office blood pressure > 220/115 mmHg;

  • unstable blood pressure after the period of placebo treatment, defined as differences in DBP or SBP readings before placebo treatment of > 10 mmHg or > 20 mmHg, respectively;

  • secondary hypertension of any aetiology;

  • angina pectoris;

  • manifest coronary artery disease;

  • current or recent history of congestive heart failure;

  • haemodynamically significant valvular heart disease;

  • cardiac arrhythmia;

  • renal insufficiency;

  • insulin‐dependent diabetes mellitus."

Interventions Intervention: amlodipine 5 to 10 mg
Comparison: lisinopril 10 to 20 mg
Concomitant medications: no details given
Excluded medications: no details given
Outcomes Primary outcome: change from baseline of the combined mean maximum far wall IMT of carotid and femoral arteries
Secondary outcome: changes in maximum far wall IMT of the common carotid artery and the common femoral artery
Time points reported: "before and after 1 and 2 years of treatment, IMT was measured in three carotid and two femoral arterial sites by B‐mode ultrasound"
Notes Funding for trial: "the study was sponsored by an unrestricted grant of Pfizer BV"
Notable conflicts of interest of trial authors: no details given
Protocol: no details given
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the patients were randomly assigned to the double‐blind treatment phase."
Allocation concealment (selection bias) Low risk Quote: "166 patients were allocated randomly to groups to receive amlodipine or lisinopril."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "the patients were randomly assigned to the double‐blind treatment phase."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "All images were saved on S‐VHS tape and analysed off‐line throughout the study by an analyst who was unaware of the patients’ characteristics."
Incomplete outcome data (attrition bias)
All outcomes Low risk All prespecified outcomes reported
Selective reporting (reporting bias) Low risk All outcome measures have been reported in the results section
Other bias Low risk No other source of bias detected