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Thiazolidinediones Contraindicated in Patients at Risk for Heart Failure CME News Author: Laurie Barclay, MD CME Author: Charles Vega, MD Authors and Disclosures Dec. 8, 2003 - A joint statement from the American Heart Association (AHA) and the American Diabetes Association (ADA), published in the Dec. 9 issue of Circulation, urges physicians not to prescribe thiazolidinediones (TZDs) to patients at risk for congestive heart failure (CHF). The statement will also be published in the January 2004 issue of Diabetes Care. "There is now widespread use of TZDs in a broad group of patients with type 2 diabetes," lead author Richard W. Nesto, MD, from the Lahey Clinic in Burlington, Massachusetts, says in a news release. "At the same time there have been reports of CHF associated with their use." The TZDs rosiglitazone maleate (Avandia) and pioglitazone hydrochloride (Actos) are indicated as monotherapy or as combination therapy for type 2 diabetes. Although these drugs help control blood glucose and may improve other cardiovascular risk factors including hypertension, high cholesterol, and inflammatory biomarkers, some patients treated with these drugs develop edema. "It is sometimes difficult to know whether such swelling is a benign side effect of the drugs or a more ominous sign of heart failure," Dr. Nesto says. "It is this common association that concerns both cardiologists and diabetologists." To balance improved glycemic control achieved with TZDs against potential risk, the joint statement writing committee reviewed existing trials to identify diabetic patients who are at increased risk for CHF and who may not be ideal candidates for TZDs. Recommendations of the consensus statement include avoidance of TZDs in patients with advanced heart disease or severe CHF. In patients with depressed ejection fraction but without symptoms of CHF, TZDs should be prescribed only if glycemic control cannot be achieved with other drugs, and in these cases TZDs should be started at low doses. The statement also recommends a "start low, go slow" regimen of TZDs for diabetics with mild to moderate CHF, and in those with one or more risk factors for CHF. Because diabetes is a cardiovascular risk factor, many patients given TZDs for diabetes could also have underlying heart disease. "But at this point we don't know the real risk because we don't know either the actual number of patients with diabetes who are taking a TZD and develop CHF, compared to the total number of patients who are taking a TZD," Dr. Nesto says. "This risk is probably quite low, but without solid data that's just guesswork." According to the statement, patients receiving TZD treatment should report weight gain of more than 3 kg (6.6 lb), sudden onset of pedal edema, dyspnea, or fatigue. For CHF diagnosed after initiation of TZD therapy, "dosage change and temporary or permanent discontinuance are the obvious options, but no one of these is preferred for all patients," the authors write. Circulation. 2003;108:2941-2948 Learning Objectives Upon completion of this activity, participants will be able to: List the nonhypoglycemic benefits of TZDs. Describe how TZDs should and should not be used in the presence of CHF and CHF risk factors. Clinical Context TZDs have emerged as a treatment option for patients with diabetes in part due to effects beyond their ability to lower serum glucose. In a review by Parulkar and colleagues appearing in the Jan. 2, 2001, issue of the Annals of Internal Medicine, the authors cite reduced blood pressure, correction of diabetic dyslipidemia, improvement in fibrinolysis, and a decrease in carotid artery intima-media thickness as other benefits associated with TZDs. However, the authors tempered their enthusiasm for TZDs in a discussion of the weight gain associated with the drugs. Weight gain and fluid retention are known adverse events associated with TZD use. In a retrospective analysis by Tang and colleagues of diabetic patients with known heart failure using TZDs, 17.1% of subjects developed fluid retention that resolved after the TZD was discontinued. The research, which appeared in the April 16, 2003, issue of the Journal of the American College of Cardiology, demonstrated that female sex and insulin use predisposed patients to weight gain with TZDs. To reconcile the risks and benefits of TZDs in diabetic patients who either currently have CHF or have significant CHF risk factors, the AHA and ADA released the current consensus statement based on available evidence. Study Highlights Weight gain is common with both rosiglitazone and pioglitazone and may be due to both increased caloric retention as well as fluid retention. When combined with a sulfonylurea, weight gain may vary between 1.8 to 2.9 kg. Weight gain is even more significant when TZDs are combined with insulin (average gain, 2.3 - 5.4 kg). Edema is also frequently found in patients taking TZDs, occurring in 3% to 5% of patients using TZDs as monotherapy. Rates of edema are higher if TZDs are used in combination with other hypoglycemic agents. 13.1% to 16.2% of patients taking TZDs with insulin may experience edema. CHF is not frequently encountered with TZD use. Rosiglitazone, either alone or in combination with other oral hypoglycemic agents, is associated with an incidence of CHF of less than 1%. However, CHF incidence rises to 2% to 3% if rosiglitazone is combined with insulin. Pioglitazone has been associated with an incidence of CHF of 1.1%. In reviewing case reports of CHF associated with the use of TZDs, the authors of the consensus statement caution that TZDs may unmask previously asymptomatic cardiac insufficiency by increasing plasma volume. The recommendations of the consensus panel are as follows: Before prescribing a TZD, the physician should perform a thorough history and physical for risk factors, such as previous myocardial infarction or significant valvular disease, that could predispose a patient to CHF. Baseline dyspnea and edema should be recorded. Physicians should also pay attention to other medications, such as vasodilators, which may also contribute to fluid retention. Peripheral edema is not a contraindication for TZD use, but it should be monitored during TZD therapy. Patients should be instructed to report any weight gain more than 3 kg, new pedal edema, dyspnea, or fatigue after starting a TZD. In patients without known heart disease but with 1 or more cardiac risk factors, TZDs should be started at the lowest possible dose and advanced cautiously with special attention to possible fluid overload. TZDs should be avoided if possible when the patient has a known reduced ejection fraction (<40%) but is asymptomatic. Again, if TZDs must be used, the patient should be started on the lowest possible dose and advanced cautiously. TZDs also may be used with close patient supervision if the patient has known class I or II New York Heart Heart Association (NYHA) CHF. TZDs should be avoided in cases of class III or IV NYHA CHF. If evidence of fluid overload manifests itself during TZD therapy, especially in the first few months of treatment, the physician should mount a thorough investigation for CHF. This should include an electrocardiogram, echocardiogram, and, possibly, serum evaluation for brain natriuretic peptide. If CHF is not present in a patient receiving TZDs with evidence of fluid overload, other drugs that may contribute to increased intravascular volume should be reconsidered. The TZD also may be discontinued or modified to a lower dose. Angiotensin-converting enzyme inhibitors with or without a thiazide diuretic may help to reduce edema. Any treatment-emergent CHF should prompt a reconsideration of the use of a TZD. If the TZD is discontinued, symptoms of volume overload should be expected to resolve fairly quickly, and diuretic therapy may be needed for only a short time. Pearls for Practice TZDs offer diabetic patients benefits beyond lowering serum glucose. TZDs frequently lead to fluid retention. All patients receiving TZDs should be monitored for symptoms and signs of fluid retention. TZDs should be avoided in patients with moderate to severe CHF or evidence of an ejection fraction less than 40%.
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Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia?
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Electromatic said this... Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia? someone will probably correct me on this but here goes.... Avandia is containdicated for people with a history of heart disease. Hypertension (high BP) is NOT a heart issue. It's a vascular issue. Basically constriction of the blood vessels, which means the heart has to work harder to push blood round. Hence increased pressure! So Avandia isn't necessarily dangerous to someone with high BP on medication. Any other thoughts anyone? ratty -- www.flyingrat.net
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"Electromatic" <groupbm~extramayo.com wrote in message news:x%PDb.529$zv4.416~newssvr27.news.prodigy.com... Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia? I would show this information to my doctor and follow his advice.
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I'm also taking 4mg of Avandia per day but my MD (cardiologist/general) has me split it and take 1/2 in the morning and 1/2 in the evening. Wonder if that has anything to do with a risk? I also take 80mg Zocor, 50mg Vioxx ,100mg Pletal and an 81mg aspirin. Haven't had any heart problems that I know of and my blood pressure is great (knock on wood) but will run this by my MD on next visit in February. Rob Mills "Electromatic" <groupbm~extramayo.com wrote in message news:x%PDb.529$zv4.416~newssvr27.news.prodigy.com... Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia?
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Electromatic wrote: Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia? I note the original warning says contra-indicated IF you a HISTORY or OTHER RISK. So it seems to me like a high-protein diet damageing kidneys - panic (quite understandable) leading to assuming that starting something off is the same as making worse something already started. jmo, but avandia/actos are perfectly safe if used correctly. Like everything else they unsafe if used incorrectly. -- Al. Idiopathic t1 HbA1c 5.95 Total Chol 2.7 Blood Pressure 105/70 Beef Lente 1x Beef Neutral 2x
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Flying Rat wrote in message ... Electromatic said this... Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia? someone will probably correct me on this but here goes.... Avandia is containdicated for people with a history of heart disease. Hypertension (high BP) is NOT a heart issue. It's a vascular issue. Basically constriction of the blood vessels, which means the heart has to work harder to push blood round. Hence increased pressure! So Avandia isn't necessarily dangerous to someone with high BP on medication. Any other thoughts anyone? ratty -- www.flyingrat.net The docs lump the various forms of heart disease into "heart disease" in the press releases, then separate them in the discussion. If you have diabetes then you are prone to ischemic heart disease, i.e. the diabetes causes damage which encourages the plugging of arteries. The TZD's like Actos and Avandia "fight" ischemic heart disease in diabetics and therefore: For many diabetics, Actos and Avandia are life-saving drugs. However, the TZD's encourage fluid retention. If you are prone to Congestive Heart Failure, (a "heart disease" different than Ischemic Heart Disease) then: For "you", the TZD's have a dangerous side effect. The docs fling the buzz words around and don't make it easy for us amateurs to pick out the differences. Note how they use "heart failure" all through this quoted report but don't mention infarction which is the death-dealing result of ischemic heart disease. There is a bit of gallows humor in this whole subject. a. In my family, folks die young from infarctions caused by ischemic heart disease. However, we don't have problems with Congestive Heart Failure. Therefore, we notice the life-saving effects of the anti-ischemic meds and recommend them to everybody (e.g. I am always pushing the TZD's in the newsgroups) b. In some families, Congestive Heart Failure is a problem. Folks with this genetic heritage notice the edema effects of the TZD's and are quick to point out how dangerous they are. Annette has relatives who suffer form congestive heart failure but don't seem to suffer from ischemic heart disease. For her, Actos and Avandia are dangerous drugs with unnecessary anti-ischemic heart disease benefits. My wife has a pre-school grandchild. The "other" grandmother is a T2 diabetic. The "other" grandmother has congestive heart failure and therefore is barred from the life-saving benefits of Actos and Avandia. My wife will enjoy her grandchild's exeriences as he progresses through school. I don't think the "other" grandmother will live long enough to watch her grandchild graduate from high school, perhaps not from middle school, perhaps even not from kindergarden. That part is not humorous, only sad. Now, we must think about high blood pressure. AFAIK, damage from high blood pressure can cause congestive heart failure. Insulin Resistance produces high levels of circulating insulin which damages arteries which causes high blood pressure. Actos and Avandia are anti-Insulin Resistance meds. Therefore, they fight high blood pressure, and thus also fight congestive heart failure. Therefore: Actos and Avandia have anti-heart disease effects in that: c. They fight the high blood pressure which causes congestive heart failure d. They improve the lipid profiles/bG excursions which lead to ischemic heart disease. However, it you don't "catch" the congestive heart disease problem/tendency/genetic predisposition?? soon enough, then you are prohibited from enjoying the life-saving effects of Actos and Avandia. Thus the doctors' dilemma. e. If they avoid prescribing TZD's, they may exacerbate heart disease tendencies, . f. If they prescribe TZD's, they may exacerbate undiscovered heart disease One answer is to fight Insulin Resistance tooth and nail before getting into that dilemma. The "other" grandmother lost that race. That's why cardiologists refer to T2 as a cardiovascular disease marked by occasional high blood sugars. Regards Old Al (Say. . .there's this med called metformin which the Brits have been using for 40 years and. . . .)
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Al, These drugs are pretty new to the market, and it is only in the last couple months that evidence of their damaging side effects has come to light. The after-marketing procedure is tilted in the direction of letting the drug manufacturers continue to market their drugs. Doctors must report the drug side effect to the FDA (a cumbersome process) for it to get attention. But doctors who give a patient Actos or Avandia and then saw them develop congestive heart failure may not have connected the two--after all these patients tend to be older and in poor health. And many doctors do not report. I know that mine did not when I developed permanent tinnitus from Clinoril. So many people must die before the FDA takes another look. Look at how in the US, antidepressants are still being prescribed to teenagers, though in Britain it has become evident that they cause a much higher than expected incidence of suicide and agitation. (I just saw a neighbor's friend have exactly this reaction to one of the drugs banned for teens in the UK, alas. Then they put her on the anti-psychotic that causes diabetes. She gained 40 lbs in 3 months, and I suspect that at 15 because of the initial mis-presciption, they've just ruined her life. <sigh) So this is a situation where you have to be a bit paranoid about the possibility of side effects because the chances are that the true incidence of these new side effects is not known. Nor can you trust that your doctor is up-to-date with the latest information about side effects. I have learned this the hard way! I have been misprescribed several drugs that are contraindicated for people with my drug reaction history though I have spelled it out very clearly each time I go to the doctor. Only be reading the prescribing info myself have I found how inappropriate these prescriptions were. The problem with Actos/Avandia as I see it is that there's some latitude in discovering who is, in fact, "at risk" for heart failure (a terrible, irreversible and eventually fatal condition.) If your doctor has run all the tests mentioned in the article, perhaps you are safe. But if your doctor (and HMO) is like mine, they haven't run those tests and won't until you develop symptoms. So it isn't known if you are truly at risk for heart failure Plus, there is going to be a small number of people who develop the side effect with no obvious warning. Maybe it's only 1 in 200,000 but if you're that one, it means you die a lot earlier than necessary. From what I've read on Medscape, my suggestion would be that anyone who experiences sudden or swift weight gain of any type on these drugs should stop taking them rather than gamble with their heart's ability to pump. Also, these same drugs are also now associated with an increase macular edema (swelling in the retina) and that can lead to blindness! What's really sad, is that the people I know who are on Actos/Avandia (including some relatives) were never told to try carbohydrate restriction before committing to these potentially damaging drugs. At the big family get together they sit shoveling down low fat potato salad and pasta which they are convinced is healthy because their doctors told them to eat a low fat diet. This past year I've watched one cousin (in her early 30s) gain 40 lbs on Avandia. <sigh -- Jenny Cut the carbs to respond to my new email address! New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm Weight: 168.5/137 Diabetes Type II diagnosed 8/1998 - HBa1c 5.2 10/03 Low Carb 9/1998 - 8/2001 and 11/10/02 - Now http://www.geocities.com/jenny_the_bean How to calculate your need for protein * How much people really lose each month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings * Characteristics of Successful Dieters * Indispensible Low Carb Treats * Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes "Al Hardy" <a.hardy2~ntlworld.com wrote in message news:brp97v$5seld$1~ID-191168.news.uni-berlin.de... Electromatic wrote: Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia? I note the original warning says contra-indicated IF you a HISTORY or OTHER RISK. So it seems to me like a high-protein diet damageing kidneys - panic (quite understandable) leading to assuming that starting something off is the same as making worse something already started. jmo, but avandia/actos are perfectly safe if used correctly. Like everything else they unsafe if used incorrectly. -- Al. Idiopathic t1 HbA1c 5.95 Total Chol 2.7 Blood Pressure 105/70 Beef Lente 1x Beef Neutral 2x
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Jenny wrote: Al, I am not sure if you are responding to me in person, looking at the thread it seems that you are. Please to forgive if I got that wrong. These drugs are pretty new to the market, and it is only in the last couple months that evidence of their damaging side effects has come to light. Is it not the case that extensive safety testing is done by the FDA before marketing is allowed? Sometimes here in the UK we are as much as a year behind America in allowing new drugs. Sometimes an advantage, sometimes a disadvantage. Here, we don`t have just one ageny involved, but at least two, MAHRA and NICE, sometimes MAFF gets involved as well. The after-marketing procedure is tilted in the direction of letting the drug manufacturers continue to market their drugs. Doctors must report the drug side effect to the FDA (a cumbersome process) for it to get attention. But doctors who give a patient Actos or Avandia and then saw them develop congestive heart failure may not have connected the two--after all these patients tend to be older and in poor health. And many doctors do not report. I know that mine did not when I developed permanent tinnitus from Clinoril. Older and in poor health is, imho, an excellent reason to exercise care with any new drug for any health problem. So many people must die before the FDA takes another look. No offence intended, but FDA is utterly irrelevant in the UK, just as MAHRA and NICE are irrelevant in the US. Look at how in the US, antidepressants are still being prescribed to teenagers, though in Britain it has become evident that they cause a much higher than expected incidence of suicide and agitation. (I just saw a neighbor's friend have exactly this reaction to one of the drugs banned for teens in the UK, alas. Then they put her on the anti-psychotic that causes diabetes. She gained 40 lbs in 3 months, and I suspect that at 15 because of the initial mis-presciption, they've just ruined her life. <sigh) So this is a situation where you have to be a bit paranoid about the possibility of side effects because the chances are that the true incidence of these new side effects is not known. Aah, but I, personally am not willing to take any medication except salbutamol, beclomethazone, insulin: without them I`m dead very quickly. Nor can you trust that your doctor is up-to-date with the latest information about side effects. I have learned this the hard way! I have been misprescribed several drugs that are contraindicated for people with my drug reaction history though I have spelled it out very clearly each time I go to the doctor. Only be reading the prescribing info myself have I found how inappropriate these prescriptions were. If I couldn`t trust my doctor, then I would find a different one. I got through 5 GPs in the past 7 years, but now I am satisfied. The problem with Actos/Avandia as I see it is that there's some latitude in discovering who is, in fact, "at risk" for heart failure (a terrible, irreversible and eventually fatal condition.) If your doctor has run all the tests mentioned in the article, perhaps you are safe. But if your doctor (and HMO) is like mine, they haven't run those tests and won't until you develop symptoms. So it isn't known if you are truly at risk for heart failure Plus, there is going to be a small number of people who develop the side effect with no obvious warning. Maybe it's only 1 in 200,000 but if you're that one, it means you die a lot earlier than necessary. From what I've read on Medscape, my suggestion would be that anyone who experiences sudden or swift weight gain of any type on these drugs should stop taking them rather than gamble with their heart's ability to pump. Also, these same drugs are also now associated with an increase macular edema (swelling in the retina) and that can lead to blindness! What's really sad, is that the people I know who are on Actos/Avandia (including some relatives) were never told to try carbohydrate restriction before committing to these potentially damaging drugs. At the big family get together they sit shoveling down low fat potato salad and pasta which they are convinced is healthy because their doctors told them to eat a low fat diet. This past year I've watched one cousin (in her early 30s) gain 40 lbs on Avandia. <sigh May I ask (not sarcastically, I do actually want to know) what is *carbohydrate restriction*, how low is *low-carb*? I am 5` 10" tall, weigh 139 lbs, physically active (on my feet at least 8 hours a day), no statins or Met or Actos or anything has ever been prescribed or even hinted at, and I am t1. And why would low-carb prevent the need for Actos/Avandia? Nearly forgot, I do have a *slight* heart issue, enlarged left ventricle, maternally inherited, predates diabetes by over 4 decades. -- Al. Idiopathic t1 HbA1c 5.95 Total Chol 2.7 Blood Pressure 105/70 Beef Lente 1x Beef Neutral 2x
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oldal4865 wrote: Flying Rat wrote in message ... Electromatic said this... Ok, I'm on 4mg daily of avandia and 5mg daily of elanapril for high blood pressure. Does this mean that I should discontinue the avandia because I'm in grave danger of having a heart attack due to the avandia? someone will probably correct me on this but here goes.... Avandia is containdicated for people with a history of heart disease. Hypertension (high BP) is NOT a heart issue. It's a vascular issue. Basically constriction of the blood vessels, which means the heart has to work harder to push blood round. Hence increased pressure! So Avandia isn't necessarily dangerous to someone with high BP on medication. Any other thoughts anyone? ratty -- www.flyingrat.net The docs lump the various forms of heart disease into "heart disease" in the press releases, then separate them in the discussion. If you have diabetes then you are prone to ischemic heart disease, i.e. the diabetes causes damage which encourages the plugging of arteries. The TZD's like Actos and Avandia "fight" ischemic heart disease in diabetics and therefore: For many diabetics, Actos and Avandia are life-saving drugs. However, the TZD's encourage fluid retention. If you are prone to Congestive Heart Failure, (a "heart disease" different than Ischemic Heart Disease) then: For "you", the TZD's have a dangerous side effect. The docs fling the buzz words around and don't make it easy for us amateurs to pick out the differences. Note how they use "heart failure" all through this quoted report but don't mention infarction which is the death-dealing result of ischemic heart disease. There is a bit of gallows humor in this whole subject. a. In my family, folks die young from infarctions caused by ischemic heart disease. However, we don't have problems with Congestive Heart Failure. Therefore, we notice the life-saving effects of the anti-ischemic meds and recommend them to everybody (e.g. I am always pushing the TZD's in the newsgroups) b. In some families, Congestive Heart Failure is a problem. Folks with this genetic heritage notice the edema effects of the TZD's and are quick to point out how dangerous they are. Annette has relatives who suffer form congestive heart failure but don't seem to suffer from ischemic heart disease. For her, Actos and Avandia are dangerous drugs with unnecessary anti-ischemic heart disease benefits. My wife has a pre-school grandchild. The "other" grandmother is a T2 diabetic. The "other" grandmother has congestive heart failure and therefore is barred from the life-saving benefits of Actos and Avandia. My wife will enjoy her grandchild's exeriences as he progresses through school. I don't think the "other" grandmother will live long enough to watch her grandchild graduate from high school, perhaps not from middle school, perhaps even not from kindergarden. That part is not humorous, only sad. Now, we must think about high blood pressure. AFAIK, damage from high blood pressure can cause congestive heart failure. Insulin Resistance produces high levels of circulating insulin which damages arteries which causes high blood pressure. Actos and Avandia are anti-Insulin Resistance meds. Therefore, they fight high blood pressure, and thus also fight congestive heart failure. Therefore: Actos and Avandia have anti-heart disease effects in that: a. They fight the high blood pressure which causes congestive heart failure b. They improve the lipid profiles/bG excursions which lead to ischemic heart disease. However, it you don't "catch" the congestive heart disease problem/tendency/genetic predisposition?? soon enough, then you are prohibited from enjoying the life-saving effects of Actos and Avandia. Thus the doctors' dilemma. a. If they avoid prescribing TZD's, they may exacerbate heart disease tendencies, . b. If they prescribe TZD's, they may exacerbate undiscovered heart disease One answer is to fight Insulin Resistance tooth and nail before getting into that dilemma. The "other" grandmother lost that race. That's why cardiologists refer to T2 as a cardiovascular disease marked by occasional high blood sugars. Regards Old Al (Say. . .there's this med called metformin which the Brits have been using for 40 years and. . . .) My thanks for this clear logical treatise.
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In alt.support.diabetes Al Hardy <a.hardy2~ntlworld.com wrote: If I recall correctly, about 5 years ago there were three drugs onthe market , Actos, Avandia and ? (don't remember the name). They all were insulin resistance reducers. ? was pulled from the market because of, I believe it was liver problems, but at any rate, there was too high incidence of death from a side effect. There has been discussion before on this group about people getting edema with these drugs and being taken off them. THis warning is quite specific to a particular group of individuals, as bigAl has pointed out and certainly is contraindicated if it results in any edema or unusual weight gain, particularly from water retention. Isn't Metformin also supposed to have some insulin reduction effect without the edema, as well as its primary action of reducing glucagon release from the liver? Wendy
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Al, Years ago before the AIDS epidemic when drugs were only marketed to doctors, not the public, the FDA was more rigorous in testing drugs. Unfortunatley, in response to the dire need of AIDS patients to try experimental drugs, the whole process got speeded up and drugs now hit the market with short term studies done in a couple thousand people which cannot catch any long term effects. In addition, the drug companies pretty much run the FDA since they fund it, and the current administration is not interested in any more regulation of huge corporate campaign donors. There's an excellent book called _Bitter Pills: Inside the hazardous world of legal drugs_ by Stephen Fried which anyone who takes pharmaceuticals should read. Fried was a mainstream investigative journalist whose wife suffered irreversible brain damage from a Floxin drug prescribed for a minor urinary tract infection. He was able to document the way that the manufacturer had kept the drug on the market despite mounting evidence that it caused this side effect in a small number of people. His expose of how the approval and aftermarket process works is must reading! May I ask (not sarcastically, I do actually want to know) what is *carbohydrate restriction*, how low is *low-carb*? I am 5` 10" tall, weigh 139 lbs, physically active (on my feet at least 8 hours a day), no statins or Met or Actos or anything has ever been prescribed or even hinted at, and I am t1. And why would low-carb prevent the need for Actos/Avandia? As a thin T1, Actos or Avandia would not be of use to you. Your problem isn't insulin resistance (i.e. an inability for cells to respond to insulin) it's not making insulin, which is something else entirely. These insulin resistance drugs are prescribed for Type IIs who still make insulin but who are believed to be insulin resistant (usually without any actual testing.) The drugs work on PPAR-gamma receptors in muscle tissue to help those tissues take in blood sugar with the help of the body's own insulin. According to the endocrinologist I saw, this tends to pack on weight in these muscle tissues (arms and legs in particular). A low carb diet would help a young person with Type II diabetes because many people in the earlier stages of type II diabetes still make enough insulin to handle a modest load of carbohydrate--12 - 15 grams a meal but not the 200 - 300 grams that old fashioned dieticians and doctors recommend. When overweight people with type II diabetes go on a low carb diet, their weight loss can also be very dramatic. I know many people who have lost as much as 100 pounds over a year of low carbing. That kind of weight loss itself reduces insulin resistance too, which makes blood sugar much easier to control. Unfortunately here in the US we are bombarded with TV and magazine ads for these very expensive drugs which are advertised with all the subtlety (and logic) of new cars. The message they give is that these drugs take care of diabetes without the person having to make any changes in their diet. Since drug manufacturers fund most medical research nowadays, most of the articles doctors read about diabetes are about how drugs control it. Sad . . . --Jenny Cut the carbs to respond to my new email address! New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm Weight: 168.5/137 Diabetes Type II diagnosed 8/1998 - HBa1c 5.2 10/03 Low Carb 9/1998 - 8/2001 and 11/10/02 - Now http://www.geocities.com/jenny_the_bean How to calculate your need for protein * How much people really lose each month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings * Characteristics of Successful Dieters * Indispensible Low Carb Treats * Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes "Al Hardy" <a.hardy2~ntlworld.com wrote in message news:brpt6f$5nmv2$1~ID-191168.news.uni-berlin.de... Jenny wrote: Al, I am not sure if you are responding to me in person, looking at the thread it seems that you are. Please to forgive if I got that wrong. These drugs are pretty new to the market, and it is only in the last couple months that evidence of their damaging side effects has come to light. Is it not the case that extensive safety testing is done by the FDA before marketing is allowed? Sometimes here in the UK we are as much as a year behind America in allowing new drugs. Sometimes an advantage, sometimes a disadvantage. Here, we don`t have just one ageny involved, but at least two, MAHRA and NICE, sometimes MAFF gets involved as well. The after-marketing procedure is tilted in the direction of letting the drug manufacturers continue to market their drugs. Doctors must report the drug side effect to the FDA (a cumbersome process) for it to get attention. But doctors who give a patient Actos or Avandia and then saw them develop congestive heart failure may not have connected the two--after all these patients tend to be older and in poor health. And many doctors do not report. I know that mine did not when I developed permanent tinnitus from Clinoril. Older and in poor health is, imho, an excellent reason to exercise care with any new drug for any health problem. So many people must die before the FDA takes another look. No offence intended, but FDA is utterly irrelevant in the UK, just as MAHRA and NICE are irrelevant in the US. Look at how in the US, antidepressants are still being prescribed to teenagers, though in Britain it has become evident that they cause a much higher than expected incidence of suicide and agitation. (I just saw a neighbor's friend have exactly this reaction to one of the drugs banned for teens in the UK, alas. Then they put her on the anti-psychotic that causes diabetes. She gained 40 lbs in 3 months, and I suspect that at 15 because of the initial mis-presciption, they've just ruined her life. <sigh) So this is a situation where you have to be a bit paranoid about the possibility of side effects because the chances are that the true incidence of these new side effects is not known. Aah, but I, personally am not willing to take any medication except salbutamol, beclomethazone, insulin: without them I`m dead very quickly. Nor can you trust that your doctor is up-to-date with the latest information about side effects. I have learned this the hard way! I have been misprescribed several drugs that are contraindicated for people with my drug reaction history though I have spelled it out very clearly each time I go to the doctor. Only be reading the prescribing info myself have I found how inappropriate these prescriptions were. If I couldn`t trust my doctor, then I would find a different one. I got through 5 GPs in the past 7 years, but now I am satisfied. The problem with Actos/Avandia as I see it is that there's some latitude in discovering who is, in fact, "at risk" for heart failure (a terrible, irreversible and eventually fatal condition.) If your doctor has run all the tests mentioned in the article, perhaps you are safe. But if your doctor (and HMO) is like mine, they haven't run those tests and won't until you develop symptoms. So it isn't known if you are truly at risk for heart failure Plus, there is going to be a small number of people who develop the side effect with no obvious warning. Maybe it's only 1 in 200,000 but if you're that one, it means you die a lot earlier than necessary. From what I've read on Medscape, my suggestion would be that anyone who experiences sudden or swift weight gain of any type on these drugs should stop taking them rather than gamble with their heart's ability to pump. Also, these same drugs are also now associated with an increase macular edema (swelling in the retina) and that can lead to blindness! What's really sad, is that the people I know who are on Actos/Avandia (including some relatives) were never told to try carbohydrate restriction before committing to these potentially damaging drugs. At the big family get together they sit shoveling down low fat potato salad and pasta which they are convinced is healthy because their doctors told them to eat a low fat diet. This past year I've watched one cousin (in her early 30s) gain 40 lbs on Avandia. <sigh May I ask (not sarcastically, I do actually want to know) what is *carbohydrate restriction*, how low is *low-carb*? I am 5` 10" tall, weigh 139 lbs, physically active (on my feet at least 8 hours a day), no statins or Met or Actos or anything has ever been prescribed or even hinted at, and I am t1. And why would low-carb prevent the need for Actos/Avandia? Nearly forgot, I do have a *slight* heart issue, enlarged left ventricle, maternally inherited, predates diabetes by over 4 decades. -- Al. Idiopathic t1 HbA1c 5.95 Total Chol 2.7 Blood Pressure 105/70 Beef Lente 1x Beef Neutral 2x
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Wendy, The earlier drug was Rezulin. One of the things that came out before it was pulled off the market was that even though the manufacturers included a "black box warning" i.e. the most strongly worded warning about fatal side effects, doctors continued to prescribe it to people in the group at risk for fatal reactions and did not do the periodic liver testing that the drug companies recommended. There is some evidence that these new drugs also cause occasional liver failure (i.e. death!) but they'll have to kill a lot more people before they get pulled off the market. Unfortunately, if a drug only kills 30 or 40 people a year, it will continue to be marketed. This is only a problem, of course, if you are one of the forty! -- Jenny Cut the carbs to respond to my new email address! New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm Weight: 168.5/137 Diabetes Type II diagnosed 8/1998 - HBa1c 5.2 10/03 Low Carb 9/1998 - 8/2001 and 11/10/02 - Now http://www.geocities.com/jenny_the_bean How to calculate your need for protein * How much people really lose each month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings * Characteristics of Successful Dieters * Indispensible Low Carb Treats * Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes "W. Baker" <wbaker~panix.com wrote in message news:brqkg1$dgp$1~reader2.panix.com... In alt.support.diabetes Al Hardy <a.hardy2~ntlworld.com wrote: If I recall correctly, about 5 years ago there were three drugs onthe market , Actos, Avandia and ? (don't remember the name). They all were insulin resistance reducers. ? was pulled from the market because of, I believe it was liver problems, but at any rate, there was too high incidence of death from a side effect. There has been discussion before on this group about people getting edema with these drugs and being taken off them. THis warning is quite specific to a particular group of individuals, as bigAl has pointed out and certainly is contraindicated if it results in any edema or unusual weight gain, particularly from water retention. Isn't Metformin also supposed to have some insulin reduction effect without the edema, as well as its primary action of reducing glucagon release from the liver? Wendy
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Jenny wrote: Al, Years ago before the AIDS epidemic when drugs were only marketed to doctors, not the public, There is more difference than I thought between your system and ours. Here drugs are not marketed to doctors or piblic, only advertised, and not even supplied by the doctor, but the pharmacist. But there is possibly a linguisic difference between my undestanding of the word *marketing* and yours. the FDA was more rigorous in testing drugs. Unfortunatley, in response to the dire need of AIDS patients to try experimental drugs, the whole process got speeded up and drugs now hit the market with short term studies done in a couple thousand people which cannot catch any long term effects. In addition, the drug companies pretty much run the FDA since they fund it, and the current administration is not interested in any more regulation of huge corporate campaign donors. A definite difference there, NICE and MAHRA are funded by the govt but totally autonomous in every other way. There's an excellent book called _Bitter Pills: Inside the hazardous world of legal drugs_ by Stephen Fried which anyone who takes pharmaceuticals should read. Fried was a mainstream investigative journalist whose wife suffered irreversible brain damage from a Floxin drug prescribed for a minor urinary tract infection. Oh, that is so sad! He was able to document the way that the manufacturer had kept the drug on the market despite mounting evidence that it caused this side effect in a small number of people. His expose of how the approval and aftermarket process works is must reading! May I ask (not sarcastically, I do actually want to know) what is *carbohydrate restriction*, how low is *low-carb*? I am 5` 10" tall, weigh 139 lbs, physically active (on my feet at least 8 hours a day), no statins or Met or Actos or anything has ever been prescribed or even hinted at, and I am t1. And why would low-carb prevent the need for Actos/Avandia? As a thin T1, Actos or Avandia would not be of use to you. Your problem isn't insulin resistance (i.e. an inability for cells to respond to insulin) it's not making insulin, which is something else entirely. These insulin resistance drugs are prescribed for Type IIs who still make insulin but who are believed to be insulin resistant (usually without any actual testing.) The drugs work on PPAR-gamma receptors in muscle tissue to help those tissues take in blood sugar with the help of the body's own insulin. According to the endocrinologist I saw, this tends to pack on weight in these muscle tissues (arms and legs in particular). Thank you for that, a very clear explanation. A low carb diet would help a young person with Type II diabetes because many people in the earlier stages of type II diabetes still make enough insulin to handle a modest load of carbohydrate--12 - 15 grams a meal but not the 200 - 300 grams that old fashioned dieticians and doctors recommend. Goodness gracious, are there still doctors recommending such a huge carb load? I eat 85gm to 95gm per day, but then I wish to put on another 7lbs or slightly more. When overweight people with type II diabetes go on a low carb diet, their weight loss can also be very dramatic. I know many people who have lost as much as 100 pounds over a year of low carbing. That kind of weight loss itself reduces insulin resistance too, which makes blood sugar much easier to control. Unfortunately here in the US we are bombarded with TV and magazine ads for these very expensive drugs which are advertised with all the subtlety (and logic) of new cars. The message they give is that these drugs take care of diabetes without the person having to make any changes in their diet. Since drug manufacturers fund most medical research nowadays, most of the articles doctors read about diabetes are about how drugs control it. Sad . . . Thank you for your help, Jenny. Al.
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In article <brqkg1$dgp$1~reader2.panix.com, W. Baker <wbaker~panix.com wrote: In alt.support.diabetes Al Hardy <a.hardy2~ntlworld.com wrote: If I recall correctly, about 5 years ago there were three drugs onthe market , Actos, Avandia and ? (don't remember the name). The other drug was Rezulin. They all were insulin resistance reducers. ? was pulled from the market because of, I believe it was liver problems, but at any rate, there was too high incidence of death from a side effect. The incidence of death from liver problems was NOT that high; about 1 in 50,000, and this was without carrying out liver tests. It would not have been withdrawn if Actos and Avandia, slightly different drugs believed not to have the liver problem, were not already going through the approval process. There has been discussion before on this group about people getting edema with these drugs and being taken off them. THis warning is quite specific to a particular group of individuals, as bigAl has pointed out and certainly is contraindicated if it results in any edema or unusual weight gain, particularly from water retention. Apparently the problem with edema was not caught during drug testing. There are NO "safe effective drugs". Isn't Metformin also supposed to have some insulin reduction effect without the edema, as well as its primary action of reducing glucagon release from the liver? Slight. Metformin also has its risks, including liver problems and lactic acidosis, I believe. -- This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin~stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558