Nephrology Dialysis Transplantation, Vol 13, Issue 6 1430-1437, Copyright © 1998 by Oxford University Press
C Coggins, J Lewis, A Caggiula, L Castaldo, S Klahr, S Wang and G Beck
Background: The purpose of the present study was to
compare the participation of women and men in the protocols of the
Modification of Diet in Renal Disease (MDRD) study, a multicentrer
prospective randomized clinical trial, and to assess gender differences in
their renal outcomes. Methods: Of the 840 participants
in the MDRD study, 332 (39.5%) were women who were assigned randomly to the
dietary protein and blood pressure groups and followed for a median of 2.2
years. A subgroup analysis of the MDRD study database was carried out to
compare women and men participants in recruitment, baseline
characteristics, adherence to protocol requirements, safety and outcomes,
and progression of renal disease and its response to dietary and blood
pressure interventions. Results: Adherence by women to
the requirements of the protocol including diet, record keeping, office
visits, glomerular filtration rate (GFR) measurements and urine collections
was equivalent to that of men. Women had different renal diagnoses, less
proteinuria and lower serum creatinine levels for given GFRs than men. When
participants were grouped above and below age 52, the younger women had
lower mean arterial pressure than did the men. Older women compared with
younger had higher mean arterial pressure, body weight and body mas index,
and total low density lipoprotein cholesterol. These differences were not
seen between males of the same two age groups. During follow-up, the rate
of GFR fall was slower in women, especially in the younger group. However,
the association between gender and the rate of fall in GFR was attenuated
and became non-significant after adjusting for differences in blood
pressure, proteinuria and high density lipoprotein cholesterol. In analyses
of the full cohort, there were no significant differences between women and
men in the effects of the low protein or low blood pressure intervention in
patients with either moderate (study A) or advanced (study B) renal
disease. However, in subgroup analyses of patients in study A, there was
some evidence of a lesser effect in women than in men.
Conclusions: This exploratory analysis of the MDRD
study indicates a slower mean GFR decline in women as compared with men.
The slower mean GFR decline and suggestive evidence of a lesser beneficial
effect of the low protein diet and low blood pressure interventions in
women suggest that gender differences should be considered in trials of the
effects of these interventions on the progression of renal disease. Also,
the participation of women in the MDRD study was excellent and equivalent
to that of men. Key words: gender; glomerular
filtration rate; progression; renal disease
ORIGINAL ARTICLES
Differences between women and men with chronic renal disease
Massachusetts General Hospital and Harvard Medical School, USA; Vanderbilt University, USA; University of Pittsburgh, USA; Massachusetts General Hospital, USA; Washington University School of Medicine, USA; The Cleveland Clinic Foundation, USA; Corresponding author at: MDRD Study Data Coordinating Center, Department of Biostatistics and Epidemiology, P888, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA
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