CKD: Progression and Diabetes (2001)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

The purpose of this meta-analysis was to assess the effect of antilipemic agents on nephropathy.

Inclusion Criteria:

1. Studies published as full articles in peer-reviewed journals, or as abstracts.

2. Prospective

3. Parallel or cross-over design control group

4. Studies that were greater than 3 months in length.

 

Exclusion Criteria:

1. Uncontrolled or used historical controls

2. Subjects treated for less than 3 months.

3. Studies that evaluated only diet or dietary supplements on renal function or proteinuria.

4. Studies that examined the effects of fish oil or other dietary fatty acid supplements.

Description of Study Protocol:

Recruitment:

Studies were located through three methods: A Medline search to July 1, 1999 was conducted to locate trials examining the effects of lipid-lowering therapy on the progression of renal disease. Bibliographies from these Medline articles and other recent articles were reviewed. In addition abstracts from major nephrology meetings in the previous 10 years were included that met inclusion and exclusion criteria.

Design:

1. Authors of papers identified for inclusion were contacted and asked to provide patient specific data for calculating endpoints and variances.

2. Two investigators extracted data independently and differences were resolved with conferencing.

3.  Quality index used to assess effect of study quality on results for quality assignment of individual papers: 2 points: random assignment to study group; 2 points: parallel group design; 1 point: cross-over design; 1 point: inclusion & exclusion criteria clearly delineated; 1 point: subjects masked to treatment; 1 point: investigators masked to treatment;

4. Other data collected: age, gender, cause of renal disease (diabetes, glomerulonephritis or other), change in serum cholesterol, change in blood pressure.

5. Homogeneity of treatment effects was evaluated.

Blinding Used (if applicable): not applicable

Intervention Used (if applicable): not applicable

Statistical Analysis:

Weighted means and confidence intervals were calculated for combined differences between treatment and control groups using a fixed-effects model.

Data Collection Summary:

Timing of Measurements: varied by study

Dependent Variables:

  • GFR was major endpoint of interest
  • Change in proteinuria or urine albumin excretion

Independent Variables: varied by study

Control Variables: varied by study

 

Description of Actual Data Sample:

Initial N:  13 studies met the inclusion and exclusion criteria and 12 studies provided complete information needed for data analysis and in 11 studies with information on proteinuria, 94% had follow-up information.  Subject numbers ranged from 15 to 118.

Attrition (Final N):  13 studies

Age: mean age 49 years, subjects aged 36 - 65 years

Ethnicity: not specified

Other Relevant Demographics: Males, mean was 61%, studies varied from 25 to 80%

7 studies: all subjects had diabetes

3 studies: all subjects had glomerulonephritis

2 studies: 76-81% of subjects had glomerulonephritis

1 study: cause of kidney disease was not indicated

10 studies were randomized controlled trials.

Anthropometrics: not specified

Location: not specified

 

 

Summary of Results:

Effect of lipid-lowering treatment on GFR:

The effect of treatment on the change in GFR was 0.156 (0.026 to 0.285) mL/min/month (P=0.008) indicating that treatment with lipid-reducing agents had a favorable effect on GFR.

Effect of lipid-lowering treatment on urine albumin excretion:

The effect of treatment on change in urine albumin excretion was –0.283 (-0.427 to –0.139, P<0.001), however, chi square test for heterogeneity between the studies was statistically significant (P<0.001) questioning the validity of combining the results for proteinuria. When only studies of >6 months duration were analyzed, the effect of treatment was –0.450 (- 0.783 to –0.116, P<0.001) but was not significant for studies of <6 months duration.

Author Conclusion:

The results of this meta-analysis suggest that lipid-lowering therapy in patients with renal insufficiency may help slow the rate of renal disease progression. This meta-analysis lends further support to the argument that hyperlipidemia should be treated in patients with nephrotic syndrome and/or renal insufficiency.

This meta-analysis may have important implications for therapy of patients with renal disease, because large, multicenter, randomized controlled trials to determine definitively whether lipidlowering agents slow the rate of renal disease progression may never be carried out.

Funding Source:
University/Hospital: University of Pittsburgh, University of Pittsburgh School of Medicine, Hennepin County Medical Center
Reviewer Comments:

This study showed a small but significantly lower decline in GFR in subjects with renal insufficiency who were treated with lipid lowering medications.

This meta-analysis did not include studies in which dietary modification was a part of treatment. However, patients with diabetes would be expected to follow a diet low in total and saturated fat.

Quality Criteria Checklist: Review Articles
Relevance Questions
  1. Will the answer if true, have a direct bearing on the health of patients? Yes
  2. Is the outcome or topic something that patients/clients/population groups would care about? Yes
  3. Is the problem addressed in the review one that is relevant to dietetics practice? Yes
  4. Will the information, if true, require a change in practice? Yes
 
Validity Questions
  1. Was the question for the review clearly focused and appropriate? Yes
  2. Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described? Yes
  3. Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased? Yes
  4. Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible? Yes
  5. Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined? Yes
  6. Was the outcome of interest clearly indicated? Were other potential harms and benefits considered? Yes
  7. Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described? Yes
  8. Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included? Yes
  9. Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed? Yes
  10. Was bias due to the review's funding or sponsorship unlikely? Yes