Skip to main content
. 2020 Oct 1;2020(10):CD011064. doi: 10.1002/14651858.CD011064.pub2

Tepel 2008.

Study characteristics
Methods
  • Study design: prospective, double‐blind, placebo‐controlled RCT

  • study duration: 30 months

  • Study follow‐up: 30 months (median follow‐up was 19 months (8 to 30))

Participants
  • Country: Germany

  • Setting: multicentre (47 centres)

  • Inclusion criteria: patients presently existing arterial hypertension or with a history of arterial hypertension (resting BP ≥ 140/90 mmHg or antihypertensive medication), undergoing maintenance HD for at least 3 months

  • Number (analysed/randomised): treatment group (123/123); control group (128/128)

  • Median age, IQR range (years): treatment group (60, 45 to 68); control group (62, 48 to 68)

  • Sex (M/F): treatment group (78/45); control group (81/47)

  • Exclusion criteria: persistent hypotension with SBP < 90 mmHg; history of high grade aortic stenosis; history of severe heart failure NYHA stages II and IV; acute MI in the previous 4 weeks; known allergy to amlodipine; severe disorders of liver function; pregnant or breast feeding

Interventions Treatment group (dihydropyridine CCB)
  • Amlodipine (oral): 10 mg once/day for 30 months


Control group
  • Placebo (oral): once/day for 30 months

Outcomes
  • Death (any cause, including cardiovascular, sudden death, infection, cancer or other cause) assessed every 6 months during 30 months

  • Time from randomisation to first event: composite of death from any cause and cardiac events (including cardiac event including MI, need for coronary angioplasty or coronary bypass surgery, Ischaemic stroke, PVD with the need for amputation or angioplasty) assessed every 6 months during 30 months

  • Adverse events (including hypotension) assessed every 6 months during 30 months

Notes
  • Funding source: Pfizer, Karlsruhe, Germany, authors had no conflicts of interest

  • Authors contacted (number of cardiovascular death) in July 2014 and July 2020, but they did not reply

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk QUOTE: "A computer‐generated randomisation list was prepared centrally"
Allocation concealment (selection bias) Low risk QUOTE: "A computer‐generated randomisation list was prepared centrally guaranteeing that in study centres patients were assigned to one of both treatment groups"
QUOTE: "To ensure allocation concealment, sequentially numbered containers were used" No indication whether the containers were identical.
Blinding of participants and personnel (performance bias)
All outcomes Low risk QUOTE: "Double blind"
Review of the protocol on clinicaltrials.gov (NCT00124969) revealed that participants and personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk QUOTE: "Deaths were classified by the treating physician independently of the endpoint analysis"
Review of the protocol on clinicaltrials.gov (NCT00124969) revealed that the outcome assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk QUOTE: "No patient was lost to the follow‐up" (analysis was by intention‐to‐treat population)
Selective reporting (reporting bias) Low risk All outcomes prespecified were reported
Other Low risk QUOTE: "The study sponsor did not take part in collection, analysis or interpretation of data, or in the writing of the report." The study seemed to be free from other source of bias