Issue 43 May 2012
7. Diabetes Medicine Updates

New Data on Risks When Renin Inhibitor Aliskiren is Used With ARBs, ACE Inhibitors

The US Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with angiotensin converting enzyme(ACE) inhibitors and angiotensin receptor blockers (ARBs) in patients with diabetes or renal impairment.

These drug combinations should not be used in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with renal impairment.

The labels for aliskiren-containing drugs are being updated based on preliminary data from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE) study. In ALTITUDE, the risks of renal impairment, hypotension, and hyperkalaemia in a group of patients taking aliskiren plus an ARB or ACE inhibitor increased relative to a group of patients taking an ARB or ACE plus placebo.

The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke) in the aliskiren group. However, the FDA has reached no definite conclusion regarding an actual link between these drugs and death or stroke.
FDA rejects diabetes drug Alogliptin
Takeda Pharmaceutical’s diabetes drug Alogliptin failed to secure U.S. Food and Drug Administration approval. Takeda did not disclose what concerns the FDA raised about the drug. But the company said the most common adverse events observed in phase 3 studies for Alogliptin were headache, urinary tract infection, nasopharyngitis and upper respiratory tract infection. Adverse events reported in studies of the combination of Alogliptin and Actos (Pioglitazone) included nasopharyngitis, back pain, urinary tract infection and influenza. Alogliptin is already approved in Japan, where it is marketed under the name Nesina. The combination of Nesina and Actos is approved in Japan as a drug called Liovel.
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