US EXTERNAL STANDBY STATEMENT FOR POSTING ON:
pharma.us.novartis.com (US Website)
FINAL — December 19, 2011 at 5:48 PM
IMPORTANT INFORMATION REGARDING TEKTURNA AND ALISKIREN-BASED PRODUCTS
Patient safety is the highest priority for Novartis. Based on new safety findings related to its blood pressure treatment Tekturna® (aliskiren) and aliskiren based products, Novartis is recommending that the treatment not be used in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) – two commonly prescribed high blood pressure medications. This includes Tekturna and all combination products containing aliskiren such as Tekturna® HCT, Valturna®, TekamloTM, and AmturnideTM.
This is based on a recommendation from an independent data monitoring committee responsible for overseeing the ALTITUDE trial. The committee recommended stopping the trial because patients were unlikely to benefit from treatment, and there was a higher incidence of adverse events compared to placebo in these high-risk patients. Specifically, Tekturna was associated with an increased risk of non-fatal stroke, renal complications, abnormally high levels of potassium (hyperkalemia) and low blood pressure (hypotension) in this study population.
ALTITUDE was the first trial to study Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. These patients are known to be at high risk of cardiovascular and renal events. In the study, Tekturna was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
In view of the unexpected study findings, a decision was taken immediately to terminate the ALTITUDE study. In addition, we are working with health authorities worldwide, including the US Food and Drug Adminisration (FDA).
Patients taking Tekturna, Tekturna HCT, Tekamlo, Amturnide or Valturna should contact their healthcare professional to review their high blood pressure medicines. In the meantime, patients should not stop their treatment in view of the importance of controlling high blood pressure.
Novartis is advising healthcare professionals not to combine an aliskiren containing product with an ACE or an ARB. Healthcare professionals are being asked to switch patients taking Tekturna or any aliskiren-based products in combination with an ACE or an ARB to another appropriate therapy for hypertension. This change should take place as soon as medically feasible, consistent with patient safety and the prescribing physician’s clinical judgment.
Patients in ALTITUDE should contact their study site for guidance on medication and should not stop treatment until they have seen their physician in view of the importance of controlling high blood pressure.
If consumers or healthcare professionals have questions, they can call the Company toll free at 877-263-6725.