Table H-22

GRADE: BAS-statin combination therapy versus statin monotherapy in all participants followed for more than 24 weeks

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsBAS-statin combination therapystatin monotherapyRelative (95% CI)Absolute
All cause mortality (follow-up 24 weeks)
1randomised trialvery serious1no serious inconsistencyserious1very serious1reporting bias10/73 (0%)1/77 (1.3%)OR 0.35 (0.01 to 8.9)8 fewer per 1000 (from 51 fewer to 119 more)VERY LOWCRITICAL
Vascular death - not measured
0-----None----CRITICAL
Serious Adverse Events (follow-up 30 weeks)
1randomised trialvery serious2no serious inconsistencyserious2very serious2reporting bias21/44 (2.3%)5/92 (5.4%)OR 0.40 (0.05 to 3.6)32 fewer per 1000 (from 51 fewer to 119 more)VERY LOWCRITICAL
Participants reaching ATP III LDL-c targets - not measured
0-----None----IMPORTANT
1

One 24 week trial comparing same dose of fluvastatin in both arms, reported one death.52 This trial described an unclear allocation concealment, unclear double-blind procedure and no intention-to-treat analysis was performed.52

2

One 30 week trial comparing different statins reported six SAEs.198 This trial described an unclear allocation concealment, unclear double-blind procedure and no intention-to-treat analysis was performed.198

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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