Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials

Table 3 Summary of clinical AEs and hypoglycemia (treated set)

% Subjects	Linagliptin 5 mg (n = 366)	Placebo (n = 146)
*Clinical AEs*
Any AE	62.6	62.3
Investigator-defined drug-related AE	10.4	8.2
Any AEs classified by system organ class*
Gastrointestinal disorders	11.5	15.8
Infections and infestations	21.6	22.6
Nasopharyngitis	5.7	4.8
Injury, poisoning and procedural complications	7.4	8.2
Metabolism and nutrition disorders	21.0	20.5
Musculoskeletal and connective tissue disorders	11.2	11.0
Nervous system disorders	8.2	12.3
Respiratory, thoracic and mediastinal disorders	4.6	5.5
Vascular disorders^†	7.1	4.8
AEs leading to study drug discontinuation	1.4	3.4
Serious AEs	4.1	6.2
Deaths	0.0	0.0
*Hypoglycemia*
Subjects with hypoglycemia	9.3	2.1
Subjects with hypoglycemia by study
Studies without sulfonylurea^‡	0.5	0.0
Studies with sulfonylurea^§	19.8	5.9
Severe hypoglycemia^¶	0.3	0.0

*Medical Dictionary for Regulatory Activities, version 14.0.
^†Individual AEs (preferred terms; %) were accelerated hypertension (linagliptin 0.0, placebo 0.7), arteriosclerosis (linagliptin 0.5, placebo 0.0), hypertension (linagliptin 5.2, placebo 4.1), hypertensive crisis (linagliptin 1.1, placebo 0.0), temporal arteritis (linagliptin 0.3, placebo 0.0). 2 of these events were considered drug-related (2 cases of hypertension; 1 with linagliptin and 1 with placebo).
^‡Linagliptin, n = 199; placebo, n = 95.
^§Linagliptin, n = 167; placebo, n = 51.
^¶Event requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitation.

ISSN: 1475-2840