Safety Update: ALTITUDE ‘unboost’

by Kazeem Olalekan MRPharmS

Early result from the ALiskiren Trial In Type 2 diabetes Using cardiovascular and renal Disease Endpoints (ALTITUDE) study has shown that:

study patients were unlikely to benefit from aliskiren; and
an increased incidence of non-fatal strokes, renal complications (including acute renal failure), hyperkalaemia and hypotension in patients randomised to the aliskiren group

Advice for healthcare professionals:

Prescribers should review the treatment of all patients taking aliskiren in combination with an ACE inhibitor or an ARB at a routine appointment
In patients who are taking an ACE inhibitor or an ARB, healthcare professionals should stop aliskiren and not initiate new treatment in:
o diabetic patients; and o non-diabetic patients with an eGFR <60 mL/min per 1.73 m²
Aliskiren in combination with ACE inhibitors or ARBs is not recommended in any other patients. The benefits versus risks of continuing aliskiren treatment should be considered carefully
If aliskiren is discontinued then alternative antihypertensive agents should be used as necessary
Use of aliskiren (either as monotherapy or in combination with other medicines) is no longer recommended in patients with severe renal impairment: ie, eGFR <30mL/min per 1.73 m²
In all patients where aliskiren treatment is continued or initiated, eGFR and glucose tolerance should be monitored at appropriate intervals
Please report suspected adverse reactions to aliskiren on a Yellow Card (www.mhra.gov.uk/yellowcard)

On March 10, 2012 / Updates / 1 Comment