Much has happened in health related news in the past week since I have been away. In my mind, most notably news about
Singulairand
Vytorin; ironically both Merck products.
FDA looks intoSingulair, risks of suicidal thoughtsAs reported by
USATodayand other sources, last week, the
FDA announcedthis early communication about reports about possible links with the popular asthma and allergy drug and suicidal thoughts. Similar to previous post about the
Spirivawarning, and
my initial postwhen the FDA decided to release these warnings, this is another example of information that is really helpful to no one, confusing to patients, and
disastrousto physicians who will be bombarded with phone calls from concerned patients and parents. Though reports of possible suicidal though are very serious and should certainly be investigated, such a warning is premature.
Singulairis extremely common, with millions of prescriptions sold, so if there really were a link to suicidal thought and this medication, we would probably know about it by now. There is no real biologically plausible explanation for the connection.
Bottom Line:Singulairis a very clean and safe drug, and this report is no reason to stop it.
What you will not hear elsewhere:Though
Singulairis likely safe, it is ridiculously over prescribed.
Singulairis indicated for the treatment of allergies and asthma. For allergies, It has not been shown to be more effective than
Claritin(which is now generic and over-the-counter). In fact, when Merck-
Scheringwere trying to add
Singulairto
Claritin, they found it no more effective than
Claritinalone (sound familiar?). In this case, they decided not to manufacture this new pill. The most effective agents for allergic rhinitis are inhaled nasal corticosteroids.
Flonaseis now
availableas generic
fluticasone, and is much more effective then
Singulair(which is not generic),
Claritinor the combination of the two. Regarding asthma, the updated 2007 NIH guidelines recommend inhaled corticosteroids for asthmatics of all ages. The data is overwhelming, clear and convincing.
Singulair, which has much less of an effect is considered alternative therapy by the NIH. Yet,
Singulairremains one of the most commonly prescribed drugs for asthma.
More onVytorinDespite all the "shocking" headlines, from
CNNto
ABC news, there really isn't anything new here. My favorite was the video from the Today Show on NBC that titled this a "health alert." However, this story clearly hits home for many. My post on
the letter I received from Merckon this matter has
thus farbeen my most viewed post. The results that were reported in the
latestcardiology meeting and in the New England Journal simultaneously confirm what was announced in January.
Vytorin(
zetiaplus
zocor) did lower cholesterol more than
Zocoralone, but there was no difference in its ability to prevent clogging of the arteries. This is important news because this means that there continuing evidence that there may be more to the cholesterol story than just lowering "bad" cholesterol or
ldl.
Bottom Line:Though the news does reinforce not using
Vytorinas initial therapy, it does not mean that
Zetiais completely useless. Some patients have side effects from
statinmedications, and if they can not take a
statin(or take it at a dose they need to lower their cholesterol), then
Zetiacurrently the best option.
What you will not hear elsewhere:There will be
multiplecomments about how Merck promoted this drug (remember the ads with family members dressed to look very similar to cholesterol containing foods?). The
New England Journalhas a very interesting piece on the differences in use of
Vytorinand
Zetiabetween
Canadaand the US, which (correctly) suggests that much of this may be do to direct to consumer advertisement (which is not allowed in Canada). However, what is not discussed is that one major determining factor in what a physician prescribes for their patient is which drug happens
to bepreferred by their insurance company's prescription
formulary. The only patients I wrote prescriptions for
Vytorinfor were my patients who had
Aetnainsurance. Until very recently, if you were an
Aetnapatient, the only cholesterol lowering options you had were
Zocorand
Vytorin. Thus, for those patients who needed a stronger
statinthe
Zocor(such as
Lipitoror
Crestor-
Crestoris now finally on
Aetna'sformulary), I had no choice but to go with
Vytorin, despite limited data. Why would
Aetnachoose this over
Lipitor(the most popular cholesterol drug) or
Crestor(new kid on the block)? Merck had obviously given
Aetnaa much better price then the competition on their cholesterol lowering drugs.
Finally, don't throw out surrogate markers just yet. Even more evidence that
LDLcholesterol may not be the only thing that is important, just announced in the
Wall Street Journaltoday that Astra
Zenecawas stopping a
Crestortrialearly because patients clearly
benefitedfrom the drug. The Jupiter trial (which we were involved in) took patients with relatively normal
LDLcholesterol, but high
CRPlevels (which have also been associated with increased risk) and randomized them to placebo or
Crestor20mg. Though the results have not been published, clearly a significant amount of patients taking
Crestorhad fewer heart attacks or strokes.
FDA looks intoSingulair, risks of suicidal thoughts
As reported byUSATodayand other sources, last week, theFDA announcedthis early communication about reports about possible links with the popular asthma and allergy drug and suicidal thoughts. Similar to previous post about theSpirivawarning, andmy initial postwhen the FDA decided to release these warnings, this is another example of information that is really helpful to no one, confusing to patients, anddisastrousto physicians who will be bombarded with phone calls from concerned patients and parents. Though reports of possible suicidal though are very serious and should certainly be investigated, such a warning is premature.Singulairis extremely common, with millions of prescriptions sold, so if there really were a link to suicidal thought and this medication, we would probably know about it by now. There is no real biologically plausible explanation for the connection.
Bottom Line:Singulairis a very clean and safe drug, and this report is no reason to stop it.
What you will not hear elsewhere:ThoughSingulairis likely safe, it is ridiculously over prescribed.Singulairis indicated for the treatment of allergies and asthma. For allergies, It has not been shown to be more effective thanClaritin(which is now generic and over-the-counter). In fact, when Merck-Scheringwere trying to addSingulairtoClaritin, they found it no more effective thanClaritinalone (sound familiar?). In this case, they decided not to manufacture this new pill. The most effective agents for allergic rhinitis are inhaled nasal corticosteroids.Flonaseis nowavailableas genericfluticasone, and is much more effective thenSingulair(which is not generic),Claritinor the combination of the two. Regarding asthma, the updated 2007 NIH guidelines recommend inhaled corticosteroids for asthmatics of all ages. The data is overwhelming, clear and convincing.Singulair, which has much less of an effect is considered alternative therapy by the NIH. Yet,Singulairremains one of the most commonly prescribed drugs for asthma.
More onVytorin
Despite all the "shocking" headlines, fromCNNtoABC news, there really isn't anything new here. My favorite was the video from the Today Show on NBC that titled this a "health alert." However, this story clearly hits home for many. My post onthe letter I received from Merckon this matter hasthus farbeen my most viewed post. The results that were reported in thelatestcardiology meeting and in the New England Journal simultaneously confirm what was announced in January.Vytorin(zetiapluszocor) did lower cholesterol more thanZocoralone, but there was no difference in its ability to prevent clogging of the arteries. This is important news because this means that there continuing evidence that there may be more to the cholesterol story than just lowering "bad" cholesterol orldl.
Bottom Line:Though the news does reinforce not usingVytorinas initial therapy, it does not mean thatZetiais completely useless. Some patients have side effects fromstatinmedications, and if they can not take astatin(or take it at a dose they need to lower their cholesterol), thenZetiacurrently the best option.
What you will not hear elsewhere:There will bemultiplecomments about how Merck promoted this drug (remember the ads with family members dressed to look very similar to cholesterol containing foods?). TheNew England Journalhas a very interesting piece on the differences in use ofVytorinandZetiabetweenCanadaand the US, which (correctly) suggests that much of this may be do to direct to consumer advertisement (which is not allowed in Canada). However, what is not discussed is that one major determining factor in what a physician prescribes for their patient is which drug happensto bepreferred by their insurance company's prescriptionformulary. The only patients I wrote prescriptions forVytorinfor were my patients who hadAetnainsurance. Until very recently, if you were anAetnapatient, the only cholesterol lowering options you had wereZocorandVytorin. Thus, for those patients who needed a strongerstatintheZocor(such asLipitororCrestor-Crestoris now finally onAetna'sformulary), I had no choice but to go withVytorin, despite limited data. Why wouldAetnachoose this overLipitor(the most popular cholesterol drug) orCrestor(new kid on the block)? Merck had obviously givenAetnaa much better price then the competition on their cholesterol lowering drugs.
Finally, don't throw out surrogate markers just yet. Even more evidence thatLDLcholesterol may not be the only thing that is important, just announced in theWall Street Journaltoday that AstraZenecawas stopping aCrestortrialearly because patients clearlybenefitedfrom the drug. The Jupiter trial (which we were involved in) took patients with relatively normalLDLcholesterol, but highCRPlevels (which have also been associated with increased risk) and randomized them to placebo orCrestor20mg. Though the results have not been published, clearly a significant amount of patients takingCrestorhad fewer heart attacks or strokes.