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June 14, 2007

I'm still not impressed with Tekturna (aliskiren)

One of my more popular posts has been "Do we need Tekturna (aliskiren)?". The comments have been varied, but I still stand by my doubts over its usefulness. Other medbloggers have expressed their doubts as well. And I should state right now that I think Tekturna being on the market is a Good Thing™. I am not against the drug's existence.

In fact, I'm not arguing how efficacious it is. I'm sure it works. If it didn't, it wouldn't be approved. I'm merely questioning its place in current treatment paradigms. To explain what I mean, I'm going to use a crude analogy to compare angiotensin II receptor blockers (ARBs) and aliskiren, the only direct renin inhibitor (DRI).

Think of a sink. For whatever reason, you want to keep liquid from going down the drain. Does it make more sense to keep the sink turned off, or to plug the drain directly?

Well obviously if the goal is keeping the drain dry, you'd plug the drain. This is what ARBs do. They prevent specific and non-specific binding at the angiotensin II receptor sites. Tekturna just keeps the sink from turning on and does nothing to block the drain directly. This means there's still going to be non-specific binding at the angiotensin II receptor site. (Incidentally, this non-specific binding is not merely theoretical; if it were, ACEis would be more effective as a class than the ARBs, but instead they are merely comparable.)

Back to my point: Tekturna is more expensive than the ARBs, and it will be for a long time. I don't think having aliskiren as an option is a bad thing. I just question how valuable the drug truly is with less expensive ACE inhibitors and ARBs. Sitting here, it doesn't seem to have a real niche. Would I try Tekturna if nothing else worked? Of course I would. If I were targeting the RAAS, would I reach for it as first-line therapy? Hell no I wouldn't. I'd go for an ACE inhibitor in most cases.

I'm not going to delve into the heated debates about reactive renin production and other similar topics because I suspect that the reality lies somewhere in the middle ground, as it usually does.

In the meantime, I think don't think Tekturna has a meaningful place in current drug therapy. If ARBs do not work, it is unlikely that a DRI will, either. The only time I see it perhaps being useful is if a patient cannot tolerate ACEis or ARBs.

[tags]Medicine, pharmacy, Tekturna, aliskiren, hypertension[/tags]

Comments (25) | 9:45 pm |

25 Comments »

  1. completely agree. I do drug utilization review for one of the state's medicade programs i saw a general practioner prescribe enalapril, diovan/hctz, and tekturna today. Once i looked up this drug that i had not seen yet for some reason, i was in shock that the MD would make this decision. If the combination of the ACE and the ARB wasn't enough to set bells off, and that can be useful therapy in some patient, this was 3 alarm. I understand the MOA of each drug, and i've looked at comparisons with valsarten alone and in combination and I also don't believe there is yet a place for this medication. The last thing i looked at said there were no studies with ACEs yet have you run across any? I'm willing to bet we'll see a lot of hyperk. in the future for these combinations.

    Comment by kp — June 19, 2007 @ 10:04 am

  2. I am surprised to read such negative comments. I suffered very unpleasant side effects on ACE and ARB medications which made my life miserable. Tekturna has given me my life back.

    Comment by Ian — September 26, 2007 @ 9:23 pm

  3. These are all interesting comments. JNC 7 states that almost 70% of patients who were taking meds were not "at goal". All of the aforementioned meds were already on the market and evaluated for this report. I would think that Tekturna would be a welcome addition.

    Comment by Bob — January 10, 2008 @ 9:58 am

  4. This product has much trial work underway. As per comment above many people with high BP need more than one BP lowering product. This makes Tekturna use appropriate as a 4th or 5th line drug. (There is data to show safety & efficacy in combo). Surrogate marker studies have all proved very positive so far. With referance to the "tap" & drain" analogy and drugs that work on the Renin system no drug completely inhibits the system. Thus the need to a more comprehensive approach.

    Comment by Jill — January 28, 2008 @ 6:26 am

  5. Interesting comments. As for KP's comments. There are studies with Tekturna and Ramipril. As for cost, has anyone called the local pharmacies to check, or even the insurance plans? As for outcome studies, we need to wait.

    Comment by Bob — January 30, 2008 @ 10:56 am

  6. I have recently been taking Tekturna. After I take it, I have nausea, slow uneven heart rate, and a weak pulse for a couple of hours or more. I have some info from the net that these symptoms should be reported to my doctor at once. I went to the doctor, and told her about this, but on that day my heart rate was normal. It had been a couple of hours since I tool the tekturna. She didn't seem concerned about the problem I'm having daily since my heart rate was normal at the time I visited her. I would like to know if these side effects are common, and how serious they really are. I didn't take my Tekturna today, and had no side effects. I'm also on Rhythmol SR, 225, but have been taking it without these side effects previous to taking the Tekturna.

    Comment by Sarah Frizzell — February 13, 2008 @ 10:54 pm

  7. It sounds like you have some cardiac rhythm issues. Do you see a Cardiologist? I don't think Tekturna has any "electric" properties like beta blockers might. It might be worth speaking to a specialist.

    Comment by Bob — February 14, 2008 @ 10:57 pm

  8. I failed on ACEs and ARBs. I have had miserable side effects for the drugs I have taken. I've cycles through just about all the classes. I've run out of options. Will Tekturna work? Who knows? I'll let you know in a few weeks. I will say this: There needs to be MORE blood pressure drug choices, not less.

    Comment by Rick Bradley — March 16, 2008 @ 8:31 pm

  9. I took Tekturna for about 4 months and had to stop taking the drug for hypertension.
    I experienced the following health problems.
    Vomiting, severe diarrhea, my intestines were inflamed from a esophagus to my Colin. I experience severe stomach and intestinal pains especially in the middle of the night. I lost over 30 pounds because I could not eat food. In my opinion this dangerous drug and should be taken off the market.

    Comment by Martin Kelemen — April 3, 2008 @ 12:54 pm

  10. I finally stopped Tekturna (see Feb. post). I got a big gut despite being in shape and vigorous workouts. I also washed out on Bystolic a few weeks earlier. I couldn't take the daily nausea, exhaustion and hair loss. So I'm back to square one, having not been able to tolerate something like 15 drugs or drug combos. I had combined Tekturna with Bystolic because I had run out of drugs and these were newly approved. ARBs make me fat; ACEs give the cough. I'm screwed. I may try another calcium channel blocker but if history is any indication I am going to fail on these, too, due to side effects. Time for serious alternative treatment options, plus C-PAP breathing device.

    Comment by Rick Bradley — June 1, 2008 @ 11:15 am

  11. Rick, of the ACE inhibitor, fosinopril has the lowest incidence of cough. You may want to try it, if you haven't.

    Comment by RJS — June 1, 2008 @ 12:21 pm

  12. Once you fail on an ACE from cough, that's it, you're done. Thanks though.

    Comment by Rick Bradley — June 7, 2008 @ 7:37 am

  13. Once you fail on an ACE from cough, that’s it, you’re done. Thanks though.

    I don't know who told you that, but they are wrong. People can and do switch ACE inhibitors due to the cough. It doesn't always work, but it also doesn't hurt to try.

    Comment by RJS — June 7, 2008 @ 9:06 am

  14. ACE Inhibitor cough has to do with bradykinin which has to do with cough. Every ACE works the same way. Maybe try an ARB or another RAAS blocker.

    Comment by Bowtie Bob — June 7, 2008 @ 10:46 am

  15. Yes, I know how the RAAS works, how Tekturna works, and also how the interplay of ACEis and ARBs work. That said, some ACEis have lower incidence of cough.

    Now, you can continue to argue with me, but there's really no point.

    Comment by RJS — June 8, 2008 @ 9:11 am

  16. No blood pressure medication works well.

    The average person needs 3 blood pressure medications at least if you are going to try for a "normal " blood pressure of 120/70.

    Blood pressure medications have a lot of side effects.

    Thus having new blood pressure medications, with different mechanisms of action is welcome.

    The increase in Renin with ACEs and ARBs limit their effectiveness. Blocking this system is important since the increase in sympathetic nervous system activity from angiotensin II leads to other problems aside from further increasing blood pressure.

    I am not impressed with ANY blood pressure medication.

    I heartily welcome Tekturna in my tool kit.

    Comment by James Katt — April 13, 2009 @ 11:49 pm

  17. I have been taking Tekturna for about 6 months. When I started taking it i was taking 150mg and was doinfg fine then my doctor increased the dosage to 300mg and I am losing my hair terribly, is this the reason? Does Tekturna cause hair loss ???

    Comment by Ada Ward — May 11, 2009 @ 10:03 am

  18. I have been taking Tekturna for about 6 months. When I started taking it I was taking 150mg and was doing fine then my doctor increased the dosage to 300mg and I am losing my hair terribly, is this the reason? Does Tekturna cause hair loss ???

    Comment by Ada Ward — May 11, 2009 @ 10:05 am

  19. Tekturna in my area is very affordable. It now has better coverage than MANY of the other ARB's on the market including Benicar, Cozaar and Micardis. It is preferred on the vast majority of commercial plans at tier 2 status, all major mail-order as well as Med-D plans, and Florida Medicaid w/o prior auth. Tekturna certainly has a purpose and was a needed introduction into this market. Last time I checked there are still ALOT of patients dying on ACE"S and ARBS. This is the ONLY drug that can pharmocologically directly inhibit the culprit thats ailing the body-RENIN. It offers BP reduction without side effect and actually helps reduce side effects of other agents when used in combo therapy. Hypertension is known as the "silent killer" because most times it is asymptomatic. In clinical trials patients on Tekturna felt BETTER than placebo! More patients discontinued treatment with placebo than Tekturna. This is going to be a very important treatment option in Diabetic patients that need BP control b/c of the proteinuria data as well as the studies that have found renal vasodilation far exceeds that seen with ACE's and ARB's.

    Comment by Janine — July 15, 2009 @ 12:53 pm

  20. Janine. Are you a rep for the company that makes Tekturna?

    Comment by Bob — July 16, 2009 @ 6:27 am

  21. I started using Tekturna about 7 months ago and my hair has gradually been thinning and is now coming out in my comb and brush….. I noticed that Ada Ward had a similiar problem. Has anyone else experienced this???

    Comment by B.J. — January 4, 2010 @ 11:34 pm

  22. I've been using Tekturna 300 mg for about 1 1/2 years and it works fairly well on BP. However, like Ada and B.P., I started noticing thinning hair 6 months ago and it's gotten much worse. (I've had big hair all my life.) My doc says hair loss isn't listed as a side effect, not even a rare one…but I wonder if that's because people don't report it. Is there a web site or other source where we can find out more?

    Comment by E.S.L. — January 5, 2010 @ 3:21 am

  23. I have been on Tekturna for about three months.It seems to be managing my blood pressure well enough but my hair has been deteriorating in volume, amount and texture. My hair comes out in copious amounts when I shampoo, brush my hair, or simply run my fingers through my hair. All my life I have had extremely healthy, thick, shiny hair It is now horribly thin, weak and dull. I actually have patches on my scalp where there my hair has noticeably fallen out. It is extremely disturbing. All my doctor can say is, "Tekturna does not cause hair loss." I will see him in ten days and I will INSIST that Tekturna IS causing my hair loss. If there are others out there besides ESL, Ada Ward, BP and myself who can support the connection of hairloss to Tekturna, please join this discussion. There has to be an alternative to Tekturna for us.

    Comment by mvt — January 15, 2010 @ 10:44 pm

  24. Re: Tekturna hair loss. If everyone who experiences this side effect calls the manufacturer, maybe they will acknowledge and list it. Then the docs will believe us. Side effects are listed post-marketing ONLY if someone reports them. For example, it took years for ACE-inhibitors to have coughing listed – It didn't show up in their small clinical trials with healthy subjects! Has anyone STOPPED Tekturna and had their hair loss reversed?

    Comment by E.S.L. — February 16, 2010 @ 12:48 am

  25. I experienced a lot of hair loss after starting Tekturna. I started taking it around August 2009. I slowly started noticing an increase in hairloss but didn't think it was due to Tekturna. I went from 150mg to 300 and the hairloss increased significantly until I was basically bald in the front. I went back down to 150 and the hairloss has slowed some, but I probably won't be taking Tekturna anymore.

    Comment by Jacqueline — February 26, 2010 @ 2:19 pm

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