Efficacy and safety of vildagliptin in clinical practice-results of the PROVIL-study

Table 1 Baseline demographic and clinical characteristics

	Vildagliptin add-on to metformin		Vildagliptin + metformin (SPC)		Other OADs
	n	mean ± SD or n (%)	n	mean ± SD or n (%)	n	mean ± SD or n (%)
Sex
Male		338 (56.1)		1247 (56.7)		436 (51.5)
Female		263 (43.6)		938 (42.7)		404 (47.7)
Age (yr)
Total	578	63.0 ± 11.1	2115	62.4 ± 10.6	819	63.2 ± 11.0
Male	324	62.1 ± 10.8	1200	61.4 ± 10.2	422	62.5 ± 11.0
Female	252	64.1 ± 11.5	902	63.7 ± 11.0	392	64.0 ± 11.0
Weight (kg)
Total	601	89.3 ± 16.8	2183	90.6 ± 17.5	836	87.9 ± 16.5
Male	337	93.7 ± 16.3	1239	95.1 ± 17.0	432	92.3 ± 15.6
Female	262	83.7 ± 15.7	931	84.6 ± 16.3	397	83.0 ± 16.0
BMI (kg/m²)
Total	601	30.6 ± 5.3	2181	31.1 ± 5.5	836	30.3 ± 5.2
Male	337	30.4 ± 5.0	1239	30.7 ± 5.1	432	29.8 ± 4.7
Female	262	30.9 ± 5.6	929	31.6 ± 6.0	397	30.8 ± 5.6
Underweight/normal weight (BMI < 25)		70 (11.6)		174 (8.0)		90 (10.8)
Overweight/obese (BMI ≥ 25)		531 (88.4)		2007 (92.0)		746 (89.2)
Mean (Median) duration of type II diabetes mellitus (yr)	556	6.2 ± 5.3 (median: 5.0)	2010	6.2 ± 5.1 (median: 5.0)	588	5.9 ± 5.2 (median: 4.5)
< 1		78 (14.0)		235 (11.7)		93 (15.8)
≥ 1 and < 5		197 (35.4)		771 (38.4)		215 (36.6)
≥ 5		281 (50.5)		1004 (50.0)		280 (47.6)
HbA1c (%)	597	7.8 ± 1.2	2186	7.9 ± 1.3	832	7.6 ± 1.2
< 6.5		43 (7.2)		150 (6.9)		91 (10.9)
≥ 6.5 and < 7.5		222 (37.2)		747 (34.2)		357 (42.9)
≥ 7.5 and < 10		300 (50.3)		1119 (51.2)		353 (42.4)
≥ 10		32 (5.4)		167 (7.6)		31 (3.7)
Fasting plasma glucose (mg/dL)	560	158.6 ± 47.2	2091	160.4 ± 49.0	797	151.3 ± 46.5
Serum creatinine (μmol/L)	552	82.4 ± 21.4	2053	82.2 ± 19.0	769	84.4 ± 22.8

The number of patients (n) given in this table constitutes the number of patients who had data available for the respective parameters and thus differ from the number of patients in the cohorts given in Figure 1. BMI: Body mass index; HbA1c: Glycosylated hemoglobin; OADs: Oral antidiabetic drugs; SPC: Single pill combination.

Table 2 Oral antidiabetic therapy

Type of therapy	n (%)
Total number of patients	3648
Metformin + vildagliptin	603 (16.5)
Metformin + vildagliptin (SPC)	2198 (60.3)
Metformin + sulfonylureas	370 (10.1)
Glibenclamide/metformin	96 (2.6)
Glimepiride/metformin	241 (6.6)
Gliquidone/metformin	1 (< 0.1)
Nateglinide/metformin	2 (0.1)
Repaglinide/metformin	30 (0.8)
Metformin + glitazones	123 (3.4)
Pioglitazone/metformin	99 (2.7)
Rosiglitazone/metformin	24 (0.7)
Metformin + other DPP-4 inhibitors	99 (2.7)
Saxagliptin/metformin	7 (0.2)
Sitagliptin/metformin	92 (2.5)
Other1	255 (7.0)

¹The group “other” also included patients for whom data were documented in this observational study without the physician recording information on the medication given and patients for whom the physician recorded only one medication although only patients receiving dual therapy were to be documented in this study. SPC: Single pill combination; DPP-4: Dipeptidyl peptidase-4.

Table 3 Change in HbA1c in patients with an HbA1c-value of ≥ 6.5% at initial visit n (%)

Changes	Vildagliptin add-on to metformin	Vildagliptin + metformin (SPC)	Other OADs
Patients with an HbA1c-value of ≥ 6.5% at initial visit	n = 553	n = 2033	n = 741
Patients with improvement in HbA1c at the last control visit compared to baseline	319 (57.7)	1242 (61.1)	336 (45.3)
Of these, patients with HbA1c value of < 6.5% at the last control visit	140 (25.3)	477 (23.5)	147 (19.8)

OADs: Oral antidiabetic drugs; SPC: Single pill combination.

Table 4 Summary of adverse events n (%)

	Events
	Vildagliptin add-on to metformin	Vildagliptin + metformin (SPC)	Other OADs
Total adverse events	77 (100.0)	336 (100.0)	77 (100.0)
Adverse events with suspected causal relationship1	34 (44.2)	151 (44.9)	31 (40.3)
Serious adverse events	20 (26.0)	118 (35.1)	16 (20.8)
Serious adverse events with suspected causal relationship1	1 (1.3)	22 (6.5)	6 (7.8)
Most common adverse events (preferred terms)
Glycosylated haemoglobin increased	18 (23.4)	102 (30.4)	26 (33.8)
Blood glucose increased	11 (14.3)	34 (10.1)	6 (7.8)
Blood pressure increased	5 (6.5)	16 (4.8)	9 (11.7)
Blood pressure systolic increased	5 (6.5)	16 (4.8)	7 (9.1)
Treatment noncompliance	4 (5.2)	18 (5.4)	1 (1.3)
Hypertension	3 (3.9)	13 (3.9)	7 (9.1)
Selected hepatic adverse events (preferred terms)
Transaminases increased	0 (0.0)	2 (0.6)	1 (1.3)
Alanine aminotransferase increased	0 (0.0)	1 (0.3)	0 (0.0)
Aspartate aminotransferase increased	1 (1.3)	1 (0.3)	0 (0.0)

¹Following a conservative approach, in addition to events with definite, likely and possible causal relationship all events with missing causality assessments or causality indicated as “not assessable” were also classified as events with suspected causal relationship. OADs: Oral antidiabetic drugs; SPC: Single pill combination.