Table H-23

GRADE: BAS-statin combination therapy versus statin monotherapy in all participants

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsBAS-statin combination therapystatin monotherapyRelative (95% CI)Absolute
All cause mortality (follow-up 4–24 weeks)
3randomised trialvery serious1serious1serious1very serious2reporting bias11/195 (0.5%)1/178 (0.6%)OR 1.07 (0.11 to 10.51)0 more per 1000 (from -5 fewer to 54 more)VERY LOWCRITICAL
Vascular death - not measured
0-----None----CRITICAL
Serious Adverse Events (follow-up 6–30 weeks)
2randomised trialserious3serious3serious3very serious3reporting bias3,41/112 (0.9%)6/166 (3.6%)OR 0.39 (0.06 to 2.36)22 fewer per 1000 (from 34 fewer to 45 more)VERY LOWCRITICAL
Participants reaching ATPIII LDL-c goals (follow-up 12 weeks)
1randomised trialvery serious5no serious inconsistencyserious5no serious imprecisionreporting bias 413/28 (46.4%)5/31 (16.1%)OR 4.51 (1.34 to 15.1)348 more per 1000 (from 46 more to 734 more)VERY LOWIMPORTANT
1

Three trials comparing different statins and different statin doses were included.52,172,185 One trial reported no deaths during a 4 week follow up of 76 participants,185 and a single long term trial reported one death.52 One trial described adequate allocation concealment and appropriate double-blind procedure.172 None of the trials performed an intention-to-treat analysis.

2

Wide confidence interval.

3

Two 6–30 week trials comparing different statins and different statin doses reported 7 SAEs.172,198 One reported appropriate allocation concealment and appropriate double-blind procedure.172 None reported intention-to-treat analysis.

4

Results provided in only one out of 17 included trials

5

One trial comparing same dose of pravastatin in both arms was included. The trial reported unclear allocation concealment, no double-blind, no intention-to-treat analysis; short-term follow-up, and small sample size.108 All participants on the trial required lipid lowering therapy because of established vascular diseases.

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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