A consensus statement for the clinical use of the renal sodium-glucose co-transporter-2 inhibitor dapagliflozin in patients with type 2 diabetes mellitus

Figures & data

Table 1. The online questionnaire to rate each items using a 5-point scale (1, extremely disagree; 2, disagree; 3, agree; 4, mostly agree; and 5, extremely agree). Full color available online.

	1	2	3	4	5	TOT
Statement 1: dapagliflozin mechanism of action, 5-point scale for agreement
1.1 The glycosuric effect of dapagliflozin is the main relevant mechanism of action from the clinical point of view	0	3	9	20	10	42
	7%		93%			100%
1.2 The efficacy on glycemia decreases progressively with reduced glomerular filtration rate	0	1	4	14	23	42
	2%		98%			100%
1.3 Correcting hyperglycemia with insulin-independent mechanism can be harmful in some patients with type 2 diabetes	18	15	7	2	0	42
	79%		21%			100%
1.4 Dapagliflozin is able to contrast the glucotoxicity rapidly	1	0	4	20	17	42
	2%		98%			100%
Statement 2: antihyperglycemic action of dapagliflozin, 5-point scale for agreement	1	2	3	4	5	TOT
2.1 It acts on both postprandial and fasting glucose	0	0	9	20	13	42
	0%		100%			100%
2.2 Dapagliflozin is effective regardless of the duration of the disease	0	1	8	15	18	42
	2%		98%			100%
2.3 The glucose-lowering efficacy of dapagliflozin persists over time	0	0	18	20	4	42
	0%		100%			100%
Statement 3: dapagliflozin use in clinical practice, 5-point scale for agreement	1	2	3	4	5	TOT
3.1 It is the drug of first choice in patients failing on metformin	11	22	6	2	1	42
	79%		21%			100%
3.2 It is indicated in any combination therapy	1	6	19	9	7	42
	17%		83%			100%
3.3 It is limited in its use by the current reimbursement system	3	3	17	10	9	42
	14%		86%			100%
3.4 It has to be used preferentially in combination with insulin	5	28	7	2	0	42
	79%		21%			100%
3.5 It is effective in reducing hyperglycemia in all patients with filtrate ≥60 ml/min/1.73 m^2	1	2	15	14	10	42
	7%		93%			100%
3.6 It can be used regardless of baseline glycated hemoglobin level	0	12	9	8	13	42
	29%		71%			100%
Statement 4: Blood pressure, 5-point scale for agreement	1	2	3	4	5	TOT
4.1 The blood pressure reduction of dapagliflozin in a hypertensive patient is quantitatively significant and represents a clinical advantage	0	0	16	14	12	42
	0%		100%			100%
4.2 Dapagliflozin can be used in patients on antihypertensive therapy, with normal blood pressure	0	8	15	17	2	42
	19%		81%			100%
4.3 Dapagliflozin can be used without risks of hypotension in normotensive patients	0	2	25	10	5	42
	5%		95%			100%
4.4 It should not be used in patients treated with loop diuretics	0	13	12	8	9	42
	31%		69%			100%
4.5 It should not be used in patients on any diuretic therapy	7	26	7	0	2	42
	79%		21%			100%
Statement 5: body weight, 5-point scale for agreement	1	2	3	4	5	TOT
5.1 Weight loss with dapagliflozin is clinically relevant	0	1	18	13	10	42
	2%		98%			100%
5.2 Weight loss and reduction in glycated hemoglobin with dapagliflozin are strongly correlated	1	21	9	9	2	42
	52%		48%			100%
5.3 The condition of overweight/obesity in patients with type 2 diabetes is a preferential parameter for dapagliflozin choice	0	7	21	9	5	42
	17%		83%			100%
5.4 Dapagliflozin is appropriate in a normal-weight patient	0	4	28	6	4	42
	10%		90%			100%
Statement 6: dapagliflozin tolerability, 5-point scale for agreement	1	2	3	4	5	TOT
6.1 The increase in urinary tract infections with dapagliflozin is clinically relevant	10	22	8	1	1	42
	76%		24%			100%
6.2 The increase in genital infections with dapagliflozin is clinically relevant	0	17	14	6	5	42
	40%		60%			100%
6.3 The presence of a history of recurrent genital infections precludes from the decision to prescribe dapagliflozin	0	20	16	4	2	42
	48%		52%			100%
6.4 In case of genital infection, dapagliflozin should be permanently suspended	7	31	3	1	0	42
	90%		10%			100%
Statement 7: dapagliflozin use in special populations, 5-point scale for agreement	1	2	3	4	5	TOT
7.1 Dapagliflozin is not to be used in patient with more than 75 years	1	25	8	7	1	42
	62%		38%			100%
7.2 Dapagliflozin is to be preferred in case there was a need to avoid hypoglycemia	0	7	16	12	7	42
	17%		83%			100%
7.3 The effect of dapagliflozin on long-term renal function is not negative	0	2	14	12	14	42
	5%		95%			100%
7.4 The risk of ketoacidosis with dapagliflozin is limited to the use in patients with type 1 diabetes	11	24	5	0	2	42
	83%		17%			100%
Statement 8: in reference to the cardiovascular profile, 5- point scale for agreement	1	2	3	4	5	TOT
8.1 The reduction in cardiovascular events, in secondary prevention, can influence my choice of using an SGLT2 inhibitor in patients with high cardiovascular risk with a previous event	0	3	9	12	18	42
	7%		93%			100%
8.2 The reduction in cardiovascular events, in secondary prevention, can influence my choice of treatment to use an SGLT2 inhibitor in patients with cardiovascular risk factors without a previous event	0	4	17	13	8	42
	10%		90%			100%
8.3 Using dapagliflozin for the impact on cardiovascular risk factors	0	1	15	18	8	42
	3%		97%			100%
8.4 The lipid effects of dapagliflozin can positively influence my choice of treatment	3	12	19	8	0	42
	36%		64%			100%
8.5 With dapagliflozin, the reduction of uric acid plasma levels is clinically relevant	1	7	23	9	2	42
	19%		81%			100%
8.6 The reduction of albuminuria with dapagliflozin is clinically relevant	1	9	24	5	3	42
	24%		76%			100%
Statement 9: The significance of the Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58), 5-point scale for agreement	1	2	3	4	5	TOT
9.1 The DECLARE study will provide information on the use of dapagliflozin in patients with type 2 diabetes in primary prevention	0	1	10	12	19	42
	2%		98%			100%
9.2 The DECLARE study is similar in its design and recruited people to other cardiovascular outcome studies with SGLT2 inhibitors	2	18	12	6	4	42
	48%		52%			100%
9.3 The DECLARE study will be able to give more evidence, being the study with a much larger population than other cardiovascular outcome studies with SGLT2 inhibitors	0	3	16	16	7	42
	7%		93%			100%

Consensus was considered reached if ≥66% of the panel strongly agree/disagree on the inclusion/exclusion of a given item. Items were categorized as follows: a, negative consensus: ≥66% with a score of 1 and 2; b, positive consensus: ≥66% with a score of 3, 4, and 5; and c, no consensus: ≤66% for 1 + 2 or 3 + 4 + 5.

SGLT2: sodium–glucose cotransporter-2.

Green: Consensus; Red: No consensus; Brown: Mixed.