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%)

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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