Boehringer’s Micardis: Spinning Another Failure
9 CommentsBy Ed Silverman // September 9th, 2008 // 3:11 pm
For the second time this year, the drugmaker’s angiotensin receptor blocker has disappointed. Back in May, the blood pressure drug failed to reduce the risk of recurrent stroke when combined with standard antiplatelet therapy compared with a placebo.
In the latest trial, called Transcend, an 80 mg dose failed to meet statistical significance in its primary endpoint of reducing cardiovascular death, myocardial infarction, stroke and hospitalization for congestive heart failure. Micardis was again compared with placebo and combined with standard therapy, such as anti-hypertensives, blood thinners and statins, in high-risk individuals who can’t tolerate an ACE inhibitor.
What’s interesting is the way Boehringer announced the results at the end of August. The press release begins with the secondary endpoint, which met its composite goal of reducing cardiovascular death, heart attack and stroke by 13 percent compared with placebo. However, a report from MedPage Today notes that the researcher indicated the difference became “non-significant” after statistical adjustments were made for multiple comparisons. None of the endpoints were individually statistically significant. And the primary endpoint isn’t mentioned until the third paragraph.
Meanwhile, Oxford University’s Peter Sleight, who was one of three co-chairs for the trial, appears slightly sheepish when he suggests the benefit of giving Micardis may be seen in another couple of years beyond what was seen in the trial. “There’s a tantalizing possibility that (Micardis) will look better a couple of years down the line,” he says in this video clip.
We asked a Boehringer spokeswoman to explain and she wrote: “These analyses suggest that there is a delay of 6–12 months before the benefits of an angiotensin receptor blocker emerge, and that it could take several years of treatment for the full benefits to manifest.” Of course, the likelihood of something bad happening is greatest after an event, so who would wait a couple of years for a possible benefit? Maybe whoever approved the press release?
Lichtstrasse 35
Hi Ed - 3rd graf: endpoing
Batman
Ed,
Nicely explained. This appears to be classic spin from a pharma company trying to explain the terrible results from Profess Study and now really lousy results from Transcend on their primary endpoint. Seems they want the public to wait for them to make more profit and “hope” for tantalyzing and still unproven benefits!
Better Idea: Switch to a better medicine with better results.
Batman
Dan A.
micardis is one of the weaker ones in the ARB class- right down there with tevetin. while all are me-too by definition, there are notable efficacy differences, and possibly outcome differences as well. Diovan leads the pack, and benicar is stealing thier market share now. Avapro and cozaar are average, comparitively speaking.
They provide no additional benefit than an ace inhibitor- with the exception of not providing the annoying cough associated with ace inhibitors.
ARBs are believed to be beneficial with those with diabetes and kidney impariment, some have said, with this class of medications. Possibly beneficial for heart failure patients as well.
Studies have shown that diuretics and beta blockers provide better benefits that many of the name brand HTN meds from different classes (ALLHAT trial a few years ago).
See what happens when you sell these drugs for years?
Ed Silverman
Thanks, Lichstrasse. This is what happens when the copy editor - me - starts thinking about a coffee break for before finishing a post.
Cheers,
ed
BATMAN
The secondary benefits os thesw drus appear not to be so apprent with Micardis based upon these trials. Other arbs have results that look superior. This drug is beaten by placebo and that is not good. Why use it? Would you want your parent taking it?
PharmacistMike
Well this is quite simple. If your drug trial does not end with the results that you want then change what you are measuring or flaunt secondary outcomes and sub-analysis.
Bruce
Pharmacist Mike-
How very true. Its apparent they are following this pattern of diversion quite well.
Louise m. Worswick
Aloha,
I am a patient that is taking Micardis HCT and have been for over a year. Am I to understand that this is doing nothing for my blood pressure? And that I think I am preventing myself from having a stroke with this by controling my blood pressure and this med. is not able to do that? Please respond.
Thank you,
lmworswick@yahoo.com
I am also taking a low dose asprin with it on my Dr. advice.
Ray Parker
My doctor seems to think that Micardis is not working quickly enough, although he suggested that he should not be so concerned about the “quickness”, rather than that it “work”. My BP was fluctuating too much, to suit him and he gave me a prescription for a CCB! If this does not “do the trick”, what else is left, other than Vitamin D3?
I am consuming 2-3 drops of D3, morning and evening. Dr Eisenstein seems to indicate that D3 is very safe, and will lower the hypertension.