Case-Control Study on Analgesics and Nephropathy (SAN)
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The objective of the international, multicenter case-control study was to evaluate the
      association between end-stage renal disease (ESRD) and use of non-phenacetin-containing
      analgesics with particular emphasis on combined formulations.
    

Detailed description: 
      Background:

      The association between intake of non-phenacetin-containing analgesics and the occurrence of
      chronic renal failure is still controversially discussed. A new epidemiologic study was
      planned and conducted in Germany and Austria.

      Methods/design:

      The objective of the international, multicenter case-control study was to evaluate the
      association between end-stage renal disease (ESRD) and use of non-phenacetin-containing
      analgesics with particular emphasis on combined formulations. A targeted sample of 1000 new
      (incident) dialysis patients, aged less than 50 years, was planned to recruit between January
      1, 2001 and December 31, 2004. The age limit was chosen to avoid contamination of the study
      population with phenacetin-containing analgesics to the extent possible. Four control
      subjects per ESRD case, matched by age, sex, and region were selected from the population
      living in the region the case came from.

      Lifetime exposure to analgesics and potential renal risk factors were recorded in a single
      face-to-face interview. A set of aids was introduced to reinforce the memory of study
      participants.

      A standardized, pre-tested interview questionnaire (participants), a medical documentation
      sheet (physicians in dialysis centres), a logbook for all activities (dialysis centres) were
      used to collect the necessary data.

      Quality management consisted of the standardized procedures, (re-) training and supervision
      of interviewers, regular checks of all incoming data for completeness and plausibility.

      The study is scientifically independent and governed by a international Scientific Advisory
      Committee that bridged the gap between the sponsoring companies and the investigators. Also
      other advisory groups assisted the managing committee of the study. All relevant German and
      Austrian nephrological associations supported the study, and the study design was carefully
      reviewed and approved by the Kidney Foundation of Germany.

      Discussion:

      The study is expected to answer the main research question by end 2005. There is however a
      high potential for various biases that we tried to address with adequate measure. One
      limitation however cannot be overcome: The methodologically needed age-limitation of the
      study will make it not easy to generalize the results to age groups over 50 years. It might
      be suggested to repeat the study for persons over 50 years in 10 years when contamination
      with phenacetin use early in life is likely to be outgrown.
    

Intervention name(s): non-phenacetin containing analgesics
Intervention type(s): Drug
Intervention MeSH terms: Analgesics
Observational model: Case-Control
Time perspective: Retrospective
Keywords: Analgesics; Chronic Kidney Failure