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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)

Go to MHRA site for more information.

1 Comment
  1. Review of Aliskiren prescribing (MeReC): http://bit.ly/H4r0RR

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