Table H-17

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

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsNiacin-statin combination therapystatins monotherapyRelative (95% CI)Absolute
All cause mortality (follow-up 52 weeks)
1randomised trialvery serious1no serious inconsistency2serious1very serious1reporting bias12/78 (2.6%)1/71 (1.4%)OR 1.84 (0.16 to 20.76)11 more per 1000 (from 12 fewer to 215 more)VERY LOWCRITICAL
Vascular death (follow-up 12 weeks)
1randomised trialvery serious3no serious inconsistency2serious3very serious3reporting bias30/27 (0%)0/27 (0%)--VERY LOWCRITICAL
Participants reaching ATPIII LDL-c goals (follow-up 16 weeks)
1randomised trialvery serious4no serious inconsistencyserious4very serious5reporting bias421/32 (65.6%)19/34 (55.9%)OR 1.51 (0.56 to 4.08)185 more per 1000 (from 205 fewer to 699 more)VERY LOWIMPORTANT
1

Single study comparing mixed statins in both arms, with adequate allocation concealment and double-blind procedure, no intention-to-treat analysis reported, long-term follow-up, and 3 deaths196

2

All participants had established vascular diseases

3

Single study comparing mixed statins in both arms, with unclear allocation concealment and double-blind procedure, no intention-to-treat analysis reported, short-term follow-up, and reporting no deaths197

4

One 16 week trial comparing different statins and different doses was included.49 This trial described an unclear allocation concealment, unclear double-blind procedure, and no intention-to-treat analysis.49

5

Wide confidence interval.

Single study comparing mixed statins in both arms, with adequate allocation concealment and double-blind procedure, no intention-to-treat analysis reported, long-term follow-up, and 3 deaths196

All participants had established vascular diseases

Single study comparing mixed statins in both arms, with unclear allocation concealment and double-blind procedure, no intention-to-treat analysis reported, short-term follow-up, and reporting no deaths197

One 16 week trial comparing different statins and different doses was included.49 This trial described an unclear allocation concealment, unclear double-blind procedure, and no intention-to-treat analysis.49

Wide confidence interval.

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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