Dose-dependent efficacy of olezarsen in high-risk hypertriglyceridemia: A meta-analysis

Table 3 Certainty of evidence assessment using Grading of Recommendations, Assessment, Development, and Evaluation

No of studies	Study design	Certainty assessment					No of patients		Effect		Certainty	Importance
		Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Change in triglyceride level	Placebo	Relative (95%CI)	Absolute (95%CI)
Change in triglyceride level
3	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	845	333	-	SMD 0.72 lower (1.55 lower to 0.12 higher)	High	Critical
Change in HDL
2	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	823	312	-	SMD 0.05 higher (0.08 lower to 0.18 higher)	High	Critical
Change in VLDL
2	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	823	312	-	SMD 0.09 lower (0.22 lower to 0.04 higher)	High	Critical
Change in apolipoprotein C-III level
3	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	845	333	-	SMD 0.26 lower (0.51 lower to 0.01 lower)	High	Critical
Change in apolipoprotein B level
2	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	823	312	-	SMD 0.91 SD lower (2.7 lower to 0.88 higher)	High	Critical
Any adverse events
3	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	695/911 (76.3%)	261/355 (73.5%)	RR = 1.04 (0.96-1.11)	29 more per 1000 (from 29 fewer to 81 more)	High	Critical
Any serious adverse events
3	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	123/911 (13.5%)	34/355 (9.6%)	RR = 1.40 (0.97-2.02)	38 more per 1000 (from 3 fewer to 98 more)	High	Critical
Hypersensitivity reaction
3	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	45/911 (4.9%)	14/355 (3.9%)	RR = 1.71 (0.51-5.75)	28 more per 1000 (from 19 fewer to 187 more)	High	Critical
Renal dysfunction
2	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	44/889 (4.9%)	16/334 (4.8%)	RR = 1.13 (0.62-2.04)	6 more per 1000 (from 18 fewer to 50 more)	High	Critical
Liver dysfunction
3	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	32/911 (3.5%)	15/355 (4.2%)	RR = 1.07 (0.55-2.09)	3 more per 1000 (from 19 fewer to 46 more)	High	Critical
Thrombocytopenia
2	Randomized trials	Not serious	Not serious	Not serious	Not serious	None	29/889 (3.3%)	9/334 (2.7%)	RR = 1.57 (0.28-8.75)	15 more per 1000 (from 19 fewer to 209 more)	High	Critical

RR: Relative risk; HDL: High-density lipoproteins; VLDL: Very low-density lipoproteins; SMD: Standardized mean difference.