Philadelphia, PA - The US Food and Drug Administration and GlaxoSmithKline have notified healthcare providers about postmarketing reports of new-onset and worsening diabetic macular edema with products containing rosiglitazone. In the majority of these cases, patients also reported concurrent peripheral edema.
The specific products are Avandia (rosiglitazone maleate), Avandamet (rosiglitazone in combination with metformin HCL), and "coming soon in some markets, Avandaryl," the GSK "Dear Health Care Provider" letter [1] notes.
The letter, signed by Dr Alexander R Cobitz (senior director, metabolism, clinical development and medical affairs, GSK), calls the reports "very rare."
"In some cases, the macular edema resolved or improved after discontinuation of therapy, and in one case, macular edema resolved after dose reduction," the letter notes.
Macular edema typically occurs along with diabetic retinopathy, although it is more likely to occur as the retinopathy progresses, the letter notes. Risk factors for its development include duration of diabetes, presence of retinopathy, hypertension, and poor glycemic control, the letter said. Symptoms suggestive of the condition include blurred or distorted vision and decreased color sensitivity or dark adaptation.
This safety information will be added to rosiglitazone product information for prescribers and patients, the GSK letter adds.
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January 7, 2006 05:00 (EST)
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side effects
Macular edema, peripheral edema, dilutional anemia, cardiac asthma,
congestive heart failure, weight gain, liver toxicity (yes, there are case reports with the non-Rezulin glitazones), and a possible link to cancer. These have all been known for some time. And I posted on this months ago. I wonder how many more drag-your-feet package insert warnings will come in the months and years ahead.
The glitazones are the most expensive and least efficacious diabetic drugs on the market. But hey, they do provide for some wonderful side effects.
Make sure to remind the drug rep of that the next time you're being treated to lunch or a "symposium."
And for those of you who continue to accuse me of being a "therapeutic nihilist" here's my Type II diabetic algorithm:
Education, weight loss, excercise, diet, metformin, glyburide/glipizide, and insulin (preferably NPH). Yeah, I know, there are several of you gasping that I try not to use lantus or whatever latest and greatest insulin is currently being promoted. (Whatever happened to Ultralente?) I reserve glitazones for those who refuse, or for some reason can't take, insulin.
Remember, there has been NO overall mortality benefit seen from the glitazones. We have only secondary endpoints. And they don't count for much. Except for sales-pitches. |
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January 7, 2006 07:24 (EST)
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Agree
David,
As I've stated previously here on the forum, the glitazones jam up my office with unnecessary consults for "CHF".It's a bit annoying when our wait list is so long for new appointments anyway.
It might be a good thing if the patient has never had a cardiovascular evaluation and they are diabetic,so it gives us an opportunity for intervention but often time, it's someone with a normal evaluation a year or two ago with new onset edema and now wondering why they have "CHF" with a normal EF and no significant valvular pathology. One patient was sent to me three times in one year for peripheral edema by her family physician, insisting she had heart failure.
I've seen at least one case of ICU admission for refractory noncardiogenic pulmonary edema and large pleural effusions. I diuresed 40 pounds off another gentleman last year.
The warnings on these drugs should be more specific, explaining that NON CARDIOGENIC pulmonary edema may occur and peripheral edema IS COMMON and exacerbation of CHF may occur, etc.
Melissa |
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January 7, 2006 11:33 (EST)
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My algorithm
Well said, David.
Here's my algoithm for prevention and treatment of atherosclerosis, DM2 and hypertension. If followed by the general pooulation, there would be almost none of these diseases to start with.
1. Education
2. Diet
3. BMI under 25 for Caucasian, 21 for Asians,
and/or waist circumference under 90 cm in men and 80 cm in women (less in Asians)
4. Exercise
5. *no* drugs or procedures until the above have been attained unless symptoms are intractable.
See my site for #1.
http://www.panaceia-or-hygeia.com |
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January 7, 2006 02:28 (EST)
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Thanks.
Thanks for the backup and contributions to this thread.
Melissa, your dedication shows through in your work. I totally agree that sometimes, getting people in for a cardiac evaluation "through the back door" is a good thing.
And it's good that you're willing to do that. Even if the yogurt has to spoil. (Sorry folks, inside joke.)
And Mr. Rose/Dr. Rose (apologies, I don't know how to address you), I love your lifestyle approach (tough-love, in a way). Syndrome X/Metaboic syndrome (or the term-du-jour) would barely exist if
not for the foothold we give it.
(Eat, drink, smoke, don't exercise, and be merry. . .for now.)
One of the largest challenges we face in medicine is convincing people that the negative consequences of not caring for themselves NOW can equate to really bad problems in the future.
We all have human failings, and I would never "blame the victim," but I do do a lot of cheerleading, and scare-tactics, and congratulating when they do quit smoking, lose 10 lbs, start a walking program, join AA, etc. |
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January 7, 2006 03:21 (EST)
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Tough love in Japan
David,
I am a cardiologist. Spent many years in a cath lab watching atherosclerosis progress inexorably and decided there was a better way. I hope my site helps even a little. There's an email address on the home page if you want to discuss things more privately.
I am told the Japanese doctors don't even think about using pills for lifestyle diseases until patients have changed. And they have the longest life expectancy of any industrailzed society. |
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January 7, 2006 05:03 (EST)
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Dr. Rose
Cool site.
Very radical.
Sad to call it that, but it defies the "conventional wisdom,' that we've all had thrown at us. I would advise anyone who reads these discussions -- all 12 of us :) -- to take a look at Dr. Rose's site.
BTW:
Where is the e-mail address? |
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January 7, 2006 05:05 (EST)
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never mind
never mind.
found it.
thanks. |
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January 7, 2006 05:35 (EST)
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As a third or fourth-line agent
Glitazones, as third or fourth line agents (behind Metformin, sulfonylureas and other OHG's), can still be useful for controlled diabetes. Lifestyle intervention is great but tell that to a doublely amputated end-stage diabetic on hemodialysis with phantom limb pain in both knees. Also, many patients refuse to exercise or moderate their diet. |
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January 8, 2006 02:31 (EST)
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to be honest
If someone is on dialysis, and is a double amputee, "tight" control of blood sugar isn't going to do much good. It's too late.
Most reasonable diabetic texts that I have read state that a hga1c <8.0 in this situation is acceptable.
Perhaps we should deny people "lifestyle" medications unless they earn it. No viagra for you unless you stop smoking, drinking, and lose weight. Yes, it's a free country, and you can do whatever you want, but I think a little heartburn in an alcoholic is a warning sign to be heeded, rather than covered up by Nexium. Just something to think about.
In this profession, there are days when I wonder if I am helping or just enabling. "Fix me, but don't ask me to change in any way, shape, or form." Or in the immortal words of the 'Dilbert' comic strip: "Shut up and just give me a pill you quack." I'm not sure that acquiesing to patient demands all the time helps anyone. |
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January 8, 2006 11:24 (EST)
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Panacea pays well!
Dave writes regarding patient expectations and the concept of enabling -- "In this profession, there are days when I wonder if I am helping or just enabling. "Fix me, but don't ask me to change in any way, shape, or form."
An additional problem with allowing patients to continute to indulge in poor dietary/exercise habits (because they don't want to change) and then "fixing" them with drug therapy is the widely underappreciated fact that the NNT to prevent adverse CV events in primary prevention is very high. If the NNT is 20, that means that 95% of drug-treated patients cannot expect any benefit from the drug therapy, and they are not really "fixed" by taking drugs. Unfortunately, the financial burden of treating 95% of patients with drug therapy (that cannot possibly benefit them) is placed on society- at-large via an overall increase in health care insurance costs.
I think that the medical profession is primarily responsible for perpetuating this untenable situation by an attitude that favors financially rewarding elective procedures and the use of high NNT-drugs, and an attitude that disfavors lifestyle change recommendations.
In other words, doctors maximise their earnings by "panacea" rather than "hygea" (to use Colin's words), and they apparently have no real incentive to change the situation!
Jeff. |
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