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

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.