Table H-16

GRADE - Fibrate-statin combination therapy versus statin monotherapy in all participants

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsany statins plus fibratesstatins monotherapyRelative (95% CI)Absolute
All cause mortality (follow-up 12–92 weeks)
3randomised trialvery serious1Serious1,2Serious1,2very serious3reporting bias41/202 (0.5%)2/137 (1.5%)OR 0.28 (0.03 to 2.97)511 fewer per 1000 (from 15 fewer to 28 more)VERY LOWCRITICAL
Vascular death - not measured
0-----none----CRITICAL
Serious Adverse Events (follow-up 12–52 weeks)
2randomised trialserious6serious6,7serious6serious7reporting bias712/428 (2.8%)5/224 (2.2%)OR 1.2 (0.42 to3.46)4 more per 1000 (from 13 fewer to 50 more)VERY LOWCRITICAL
Participants reaching ATPIII LDL-c goals (follow-up 18–24 weeks)
2randomised trialvery serious8very serious8,9,10.serious8very serious10reporting bias11124/153 (81%)75/90 (83.3%)not poolednot pooledVERY LOWIMPORTANT
1

Three 12–92 week trials comparing different statins and different statin doses were included,125,134,188 one trial reported no deaths.188 All trials described an unclear allocation concealment and did not perform intention-to-treat analysis, one trial described an appropriate double-blind procedure.134

2

Participants in two trials diagnosed with hypercholesterolemia and DM.125,188 No specific risk reported in a third trial.134

3

Wide confidence intervals (individual trials and pooled data).

4

Only 3 out of 11 included trials provided data on all cause mortality

5

Peto OR

6

Two trials comparing different statins and different statin doses were included,120,123 but one reported no serious adverse events.123 One trial reported an adequate allocation concealment,120 and one trial reported and appropriate double-blind procedure and performed an intention-to-treat analysis.123

7

Data analyzed for a single study on which participants had hypercholestoremia.120

8

Two trials comparing different statins and different statin doses were included,125,161 none reported adequate allocation concealment or an appropriate double-blind procedure, one reported intention-to-treat analyses.161

9

All participants in both trials had diabetes mellitus.125,161

10

Results based on two short-term trials, with significant heterogeneity (I-squared = 84%)

11

Results provided in only two out of 11 included trials

Three 12–92 week trials comparing different statins and different statin doses were included,125,134,188 one trial reported no deaths.188 All trials described an unclear allocation concealment and did not perform intention-to-treat analysis, one trial described an appropriate double-blind procedure.134

Wide confidence intervals (individual trials and pooled data).

Only 3 out of 11 included trials provided data on all cause mortality

Peto OR

Two trials comparing different statins and different statin doses were included,120,123 but one reported no serious adverse events.123 One trial reported an adequate allocation concealment,120 and one trial reported and appropriate double-blind procedure and performed an intention-to-treat analysis.123

Data analyzed for a single study on which participants had hypercholestoremia.120

Two trials comparing different statins and different statin doses were included,125,161 none reported adequate allocation concealment or an appropriate double-blind procedure, one reported intention-to-treat analyses.161

All participants in both trials had diabetes mellitus.125,161

Results based on two short-term trials, with significant heterogeneity (I-squared = 84%)

Results provided in only two out of 11 included trials

From: Appendix H, GRADE Tables, Assessing the Evidence

Cover of Comparative Effectiveness of Lipid-Modifying Agents
Comparative Effectiveness of Lipid-Modifying Agents [Internet].
Comparative Effectiveness Reviews, No. 16.
Sharma M, Ansari MT, Soares-Weiser K, et al.

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