Safety and efficacy of sodium-glucose cotransporter-2 inhibitors in adults with type 2 diabetes fasting during Ramadan: A meta-analysis

Table 2 Comparison of the safety outcomes in the sodium-glucose cotransporter-2 inhibitor vs non- sodium-glucose cotransporter-2 inhibitor arms

Outcome variables (categorical)	Number of included studies	Number of participants with outcome/participants analyzed (%)		Pooled effect size	I2 (%)	P value
		SGLT2i arm	Non-SGLT2i arm
Any AE, RR (95%CI)	3	71/397	53/462	1.40 (0.83-2.39)	59	0.21
Serious AE, RR (95%CI)	2	1/220	0/211	2.74 (0.11-68.72)	Not available	0.54
Hospitalization, RR (95%CI)	2	2/135	0/129	2.84 (0.30-26.98)	0	0.36
Abdominal pain, RR (95%CI)	3	9/805	9/816	1.55 (0.62-3.88)	0	0.35
Dehydration, RR (95%CI)	5	64/1042	30/1050	1.79 (0.83-3.83)	58	0.14
Dizziness, RR (95%CI)	4	21/971	32/937	0.66 (0.10-4.21)	81	0.66
Postural dizziness, RR (95%CI)	5	65/427	4/396	6.39 (1.58-25.80)	44	0.009
Hypotension/postural hypotension, RR (95%CI)	7	61/1265	4/1195	4.43 (1.35-14.55)	31	0.01
Volume depletion, RR (95%CI)	4	40/571	33/513	1.34 (0.62-2.90)	54	0.46
Headache, RR (95%CI)	4	10/445	14/518	0.90 (0.38-2.14)	5	0.81
Hunger, RR (95%CI)	3	10/268	20/267	0.33 (0.04-2.78)	74	0.31
Sweating, RR (95%CI)	2	8/210	6/209	1.38 (0.51-3.78)	0	0.53
Generalized weakness, RR (95%CI)	4	22/326	27/319	0.58 (0.14-2.45)	54	0.46
Symptomatic hyperglycemia, RR (95%CI)	4	29/356	39/474	0.81 (0.54-1.20)	0	0.29
Increased urination, RR (95%CI)	4	23/322	14/357	2.15 (0.81-5.70)	16	0.12
Symptomatic hypoglycemia, RR (95%CI)	10	56/1640	135/1646	0.53 (0.29-0.97)	69	0.04
Severe hypoglycemia, RR (95%CI)	3	0/375	8/435	0.14 (0.02-1.11)	0	0.06
Genital infection, RR (95%CI)	4	7/326	3/319	2.03 (0.23-17.59)	47	0.52
Urinary tract infection, RR (95%CI)	5	15/1241	15/1188	1.18 (0.53-2.60)	0	0.69
Broke fast, RR (95%CI)	2	8/126	14/123	0.38 (0.03-5.26)	70	0.47
Number of days fasted, MD (95%CI)	3	252	296	-0.26 (-1.72 to 1.21)	88	0.73
Serum urea (mmol/L), MD (95%CI)	2	83	83	0.67 (-0.52 to 1.87)	86	0.27
Serum creatinine (mg/dL), MD (95%CI)	5	485	423	0.03 (-0.05 to 0.11)	64	0.43
Estimated glomerular filtration rate (mL/minute/1.73 m2), MD (95%CI)	7	1311	1189	-0.81 (-1.83 to 0.20)	0	0.12
Serum sodium (mmol/L), MD (95%CI)	3	1012	922	-1.00 (-1.34 to -0.67)	0	< 0.00001
Serum potassium (mmol/L), MD (95%CI)	3	1012	922	0.01 (-0.17 to 0.19)	51	0.89

AE: Adverse events; MD: Mean difference; RR: Risk ratio; SGLT2i: Sodium-glucose cotransporter-2 inhibitors.