ALTITUDE Study - Aliskiren Use?

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Sandra H Counts
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ALTITUDE Study - Aliskiren Use?

This is a weekly in-house memo I do weekly for our fam med residents and faculty.  I didn't have time to rewrite it for clinical pharmacists/iforum members but wanted to throw it out there for discussion.  BTW, if any one wants to be added to my email group list to receive my 'Phriday Pharm Phlags" ie little casual writeups of something I learned during the week, drop me an email at PLSandra@aol.com

Sandra Harley Counts, PharmD

AnMed HEalth Family Medicine Residency program

Faculty

 

1.13.12 Phriday Pharm Phlag

Should we be using the BP med, Tekturna?

 

Do you have any patients on Tekturna?  If they also have DM,CKD and are on an ACE or ARB, according to recent interim results from the ALTITUDE study, they should be taken off.

Tekturna is an antihypertensive agent in the class of “direct renin inhibitors’… kind of a “fancy” ACE or ARB for those of you not familiar with the class of Direct Renin inhibitors.  A recent Medical Letter review comments on this class of meds:”

“Whether Tekturna offers any advantage over ACE or ARBs remains to be determined and no outcomes data are available.” 

And now a recent study reveals that Tekturna could actually be harmful in certain hi risk patients.  On Dec 20, Novartis reported that the ongoing “ALTITUDE” study was being terminated due to an increase in the number of adverse events, including nonfatal stroke, renal complications, hyperkalemia, and hypotension.  (http://www.novartis.com/newsroom/media-releases/en/2011/1572562.shtml)

 The study looked at 8,606 patients from 36 countries, and was the first longer-term (more than a year) investigation of Tekturna to involve higher risk patients

The Data Safety and Monitoring Board concluded that patients in the study were unlikely to benefit from Tekturna on top of standard BP therapy.  As a result, Novartis reps will stop promoting Tekturna (and the combo products Valturna, Tekturna HCT, & Amturnide) for use in combination with an ACE inhibitor or ARB.  The company is also recommending that physicians not prescribe drugs containing Tekturna with either an ACE or an ARB. 

These study results prompted me to do a quick EMR search for any of our patients on Tekturna or related combo products.  I found 7 pts who had Tekturna in their active med lists, and 4 of the 7 had been prescribed by specialists vs by us.  Two of the remaining 3 met the criteria of DM + CKD + on an ACE or ARB. I’ll be alerting these prescribers by flag so they can contact their patients.

Other studies have looked at Tekturna, but they were surrogate marker studies, and not outcome based like ALTITUDE. In the AVOID trial, Tekturna reduced diabetic albuminuria when added to the ARB losartan (Cozaar).  Patients with moderate albuminuria and moderate renal impairment were allowed into the study, and follow-up was only six months.

Another trial, ACCELERATE, found that combining Tekturna with amlodipine (Norvasc) resulted in improved long-term (six months) BP control compared with treatment with either drug alone.  But the results from ALTITUDE trump these.

John Osborne, a cardiologist in Dallas, TX, sent the following comment to CardioBrief:

The Novartis hypertension franchise is now DOA, obviously.  Furthermore, this class of DRIs (direct renin inhibitors) has died with the death of this drug.  There may be the very rare patient on an Tekturna-based product for hypertension that are not on an ACEI or ARB, but that population is going to be very, very small.  Furthermore, given this data, why would one use this molecule anyway?  In a larger sense, this is also the final nail in the coffin of any kind of a dual RAAS inhibiting/blocking strategy.  This also kills off the idea of Plasma Renin Activity as a useful biomarker in hypertensive patients.  These study results are quite remarkable and unexpected and will be one of the top CV stories of 2011

Even though our residents and faculty have been “lunched and detailed” on Tekturna we have tried to stick to outcomes-based evidence and therefore rarely prescribed Tekturna.  It’s reassuring that our EMR can be used to easily and quickly identify patients when news like this breaks.  Yay Centricity!

Have a good weekend…

Sandra