Table H-19

GRADE : Niacin-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 considerationsNiacin-Statin combination therapystatin monotherapyRelative (95% CI)Absolute
All cause mortality (follow-up 24–52 weeks)
4randomised trialserious 1serious1,2serious 1serious3reporting bias13/595 (0.5%)2/365 (0.5%)OR 1.08 (0.17 to 6.72)0 more per 1000 (from -4 fewer to 28 more)VERY LOWCRITICAL
Vascular death (followup 28 weeks)
1randomised trialvery serious4no serious inconsistencyserious4very serious4,3reporting bias41/114 (0.9%)1/61 (1.6%)OR 0.53 (0.03 to 8.64)7 fewer per 1000 (from 16 fewer to 108 more)VERY LOWCRITICAL
Serious Adverse Events (follow-up 24–28 weeks)
3randomised trialserious 5serious 5serious 5serious3reporting bias56/517 (1.2%)3/294 (1%)OR 1.00 (0.26 to 3.86)0 fewer per 1000 (from 7 fewer to 28 more)VERY LOWCRITICAL
Participants reaching ATPIII LDL-c goals - not measured
0-----none----IMPORTANT
1

Four 24–52 week trials comparing different statins and different statin doses reported this outcome. 105,150,171,196 Three trials reported an adequate allocation concealment,105,171,196 two had an appropriate double-blind procedure, 105,196 and intention-to-treat analysis was not performed.

2

In one study participants were diagnosed with coronary artery disease and LDL-c < 130 mg/dL,196 participants in the second trial had hyperlipidemia and were statin naive.105

3

Wide confidence interval.

4

One included trial comparing same dose of lovastatin in both arms, reported an unclear allocation concealment, an appropriate double-blind procedure and performed intention-to-treat analysis.128

5

Three 24–28 week trials comparing different statins and different statin doses reported 9 SAEs during follow up.105,150,171 Two trials described an adequate allocation concealment and an appropriate double-blind procedure,105,171 none of the trials performed an intention-to-treat analysis.

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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