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 |
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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Number randomised: 166 participants Number lost to follow‐up/withdrawn: "reasons for not completing the study in the amlodipine group (n = 24) were: adverse events (14), withdrawal of informed consent (6), violation of procedure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
Exclusion criteria:
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Interventions |
Intervention: amlodipine 5 to 10 mg Comparison: lisinopril 10 to 20 mg Concomitant medications: no details given Excluded medications: no details given |
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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" |
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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 |
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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 |