Table H-1

GRADE: Ezetimibe-lower dose simvastatin combination therapy versus higher dose simvastatin monotherapy in participants requiring intensive lipid-lowering therapy

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsLower dose simvastatin- ezetimibe combination therapyhigher dose simvastatin monotherapyRelative (95% CI)Absolute
All cause mortality (follow-up 12–24 weeks)
2 randomised trialvery serious1no serious inconsistency2no serious indirectnessvery serious1reporting bias10/214 (0%)0/225 (0%)not poolednot pooledVERY LOWCRITICAL
Vascular death - not measured
0-----none0/0 (0%)0/0 (0%)--CRITICAL
Participants reaching ATP III LDL-c goals (follow-up 12–24 weeks)
3randomised trial3very serious4serious5no serious indirectnessvery serious5reporting bias4198/256 (77.3%)188/396 (47.5%)not poolednot pooledVERY LOWIMPORTANT
1

Two trials reporting no deaths during a 12–24 weeks followup.121,151 One of the trials reported an appropriate method of randomization,151 no trial described method of allocation concealment, double-blind procedure and intention-to-treat analysis.

2

Participants with T2DM on stable medication, some of whom had previously completed a simvastatin trial, with LDL-c > 100 mg/dl

3

Fixed and/or conditional titration

4

Three trials included.47,121,151 One 12-week trial described appropriate method of randomization, and performed an intention-to-treat analysis for ATP III target outcome.151 None of the trials described double-blind procedure. Participants required intensive lipid-lowering therapy because of T2DM121,151 and/or CHD risk equivalent.47,151

5

Data could not be pooled because of significant heterogeneity (I-squared = 60%)

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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