Table H-4

GRADE: Ezetimibe-statin combination therapy versus statin monotherapy in participants with diabetes mellitus

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsEzetimibe- statin combination therapystatin monotherapyRelative (95% CI)Absolute
All cause mortality (follow-up 6–24 weeks)
6randomised trialserious1serious1serious1serious2reporting bias12/1509 (0.1%)4/1507 (0.3%)OR 0.40 (0.08 to 2.09)2 fewer per 1000 (from 3 fewer to 3 more)VERY LOWCRITICAL
Vascular death - not measured
0-----None----CRITICAL
Participants reaching ATP III LDL-c goals (follow-up 6–24 weeks)
9randomised trialserious3very serious3,4serious3serious4reporting bias32055/2474 (83.1%)1074/1866 (57.6%)not poolednot pooledVERY LOWIMPORTANT
1

A 24-week trial with unclear allocation concealment, double-blind procedure and no intention-to-treat analysis reported no deaths.121 Data from five 6–12 week trials reporting 6 deaths were pooled.118,144,149,193,194 All 6–12 week trials reported adequate allocation concealment, none reported double-blind procedure or intention-to-treat analysis. Included trials compared different statins and different doses.

2

Wide confidence intervals in each single trial and pooled data

3

Nine 6–24 week trials comparing different statins and different doses were included.115,117,118,121,144,149,167,193,194 Six trials reported adequate allocation concealment,117,118,144,193,194,259 one reported appropriate double-blind procedure,115 and none performed intention-to-treat analysis.

4

Short-term trials with significant heterogeneity (I-squared = 91%)

A 24-week trial with unclear allocation concealment, double-blind procedure and no intention-to-treat analysis reported no deaths.121 Data from five 6–12 week trials reporting 6 deaths were pooled.118,144,149,193,194 All 6–12 week trials reported adequate allocation concealment, none reported double-blind procedure or intention-to-treat analysis. Included trials compared different statins and different doses.

Wide confidence intervals in each single trial and pooled data

Nine 6–24 week trials comparing different statins and different doses were included.115,117,118,121,144,149,167,193,194 Six trials reported adequate allocation concealment,117,118,144,193,194,259 one reported appropriate double-blind procedure,115 and none performed intention-to-treat analysis.

Short-term trials with significant heterogeneity (I-squared = 91%)

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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