Table H-2

GRADE: Ezetimibe-statin combination therapy versus statin monotherapy in participants requiring intensive lipid-lowering therapy

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 )
141randomised trialserious1,2serious2serious2serious3none6/3122 (0.2%)9/3153 (0.3%)OR 0.61 (0.22 to 1.71)1 fewer per 1000 (from 2 fewer to 2 more)VERY LOWCRITICAL
Vascular death (follow-up mean 96 weeks)
1randomised trialserious4no serious inconsistencyserious4serious4reporting bias42/357 (0.6%)1/363 (0.3%)OR 1.98 (0.21 to 19.14)53 more per 1000 (from 2 fewer to 51 more)VERY LOWCRITICAL
Participants reaching ATP III LDL-c goals (follow-up 6–24 weeks)
18randomised trialserious6very serious6,7serious6serious7none3509/4265 (82.3%)1833/3466 (52.9%)not poolednot pooledVERY LOWIMPORTANT
1

Seven trials reported no deaths.114,116,121,140,151,159,193

2

One long-term 121 and 13 short-term trials comparing different statins and different doses were included; funnel plot did not show significant asymetry.114–116,118,140,142–144,149,151,159,193,194 Six trials reported adequate allocation concealment,118,144,149,159,193,194 four reported an appropriate double-blind procedure,114–116,159 and one reported intention-to-treat analyses.140

3

Wide confidence intervals in each single trial and pooled data

4

Single 96 weeks study comparing same dose statin in both arms. 42 Study reported adequate allocation concealment and three vascular deaths.42 Double-blind, and intention-to-treat analysis procedures were not reported.42

5

Peto OR

6

Eighteen short-term trials comparing different statins and different doses were included; funnel plot did not show significant asymetry.47,112,114–118,121,140,142,144,148,149,151,167,168,193,194 Seven trials reported an adequate allocation concealment,117,118,144,148,149,193,194 four appropriate double-blind procedure,114–116,148 and four reported intention-to-treat analyses140,148,151,168

7

Results not pooled because of significant heterogeneity (I-squared 90%). Participants required intensive lipid-lowering therapy because of primary HC (8 studies), HC with CAD (3 studies), CHD risk equivalent (3 studies), and DM (4 studies)

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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