Effects of the dual peroxisome proliferator-activated receptor-α/γ agonist aleglitazar on renal function in patients with stage 3 chronic kidney disease and type 2 diabetes: a Phase IIb, randomized study

Table 5 Selected adverse events (safety analysis population)

Patients with at least one AE, n (%)	Aleglitazar 150 μg (n = 149)	Pioglitazone 45 mg (n = 152)
Peripheral edema	18 (12)	30 (20)
Heart failure (investigator-reported)	5 (3)	3 (2)
Fractures*	3 (2)	2 (1)
Renal AEs	8 (5)	6 (4)
Muscular AEs	4 (3)	5 (3)
Hepatic AEs	2 (1)	3 (2)
Hypoglycemia^†	29 (20)	22 (15)
Severe hypoglycemia	2 (1)	0
Malignancy^‡	3 (2)	1 (1)

AE = adverse event.
*The fracture sites were ankle, foot and humerus for the aleglitazar cases and clavicle, rib and scapula for the pioglitazone cases (one of the patients in the pioglitazone group had two fractures).
^†In both groups, approximately 90% of hypoglycemic events occurred in patients on sulfonylureas. The total number of hypoglycemic events was 100 in the aleglitazar group and 56 in the pioglitazone group.
^‡Malignancies were not considered to be related to study medication, including one case of bladder cancer in the aleglitazar group with first symptoms reported 3 weeks after start of treatment. The other cases in the aleglitazar group related to breast cancer and metastases to neck, and in the pioglitazone group to squamous cell carcinoma of skin.

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