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sigmund
Member
Reged: 07/29/03
Posts: 181
Loc: Vienna
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Healthcare professionals are finding that there are potentially dangerous health risks with the Second Generation anti-psychotics, such as respiridone, respiridol,
xyprexia, etc. Ironically, these were developed among other reasons, to eliminate the tardive dyskynesia (shuffling, motor problems, confusion) which was the major side effect of the First Generation meds. Politically, it's noteworthy that this coference was organized by the very companies that manufacture them!
Joint Panel Urges Increased Surveillance for Adverse Effects of Antipsychotic Drugs
A consensus statement published in the February issue of Diabetes Care reviews the association of weight gain and risk of diabetes related to newer antipsychotic medications. The joint panel of the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity gives recommendations for monitoring, management, and counseling. They also note that not all second-generation antipsychotics (SGAs) are associated with increased risk.
"The SGAs are of great benefit to a wide variety of people with psychiatric disorders," write panel chair Eugene Barrett, MD, PhD, from the University of Virginia Health System in Charlottesville, and colleagues. "As with all drugs, SGAs are associated with undesirable side effects. One constellation of adverse effects is an increased risk for obesity, diabetes, and dyslipidemia."
After reviewing all the available literature and hearing presentations from the U.S. Food and Drug Administration and from several manufacturers of SGAs, the joint panel recommended careful screening and monitoring of patients receiving these medications for signs of rapid weight gain or other precursors of diabetes, obesity, and heart disease, with specialist referral as needed.
The panel noted a dramatic increase in the use of SGAs in recent years for schizophrenia spectrum disorders, bipolar disorder, dementia, psychotic depression, autism, and developmental disorders; and, to a lesser extent, delirium, aggressive behavior, personality disorders, and posttraumatic stress disorder.
"Considerable evidence" links treatment with SGAs to rapid weight gain and fat deposition. There is also a documented association between SGA use and the development of prediabetes, diabetes, and elevated blood lipid levels. SGA use may also in some cases be associated with diabetic ketoacidosis.
However, the SGAs vary in their risk profiles. Some SGAs, such as clozapine and olanzapine, are effective but carry a greater risk of weight gain, diabetes, and dyslipidemia.
Before physicians prescribe antipsychotic drugs, the panel recommended that they first screen patients for personal and family history of obesity, diabetes, dyslipidemia, hypertension, and cardiovascular disease; weight and height; waist circumference; blood pressure; fasting plasma glucose; and fasting lipid profile.
Frequent follow-up monitoring is indicated for all patients receiving SGA therapy. Referral to specialists should be considered if problems arise with significant weight gain, new onset diabetes, or other cardiovascular risk factors. All patients who are taking antipsychotic medications and who are overweight or obese should receive counseling regarding nutrition and physical activity.
Pending the results of additional research to more clearly define the risks of SGAs, the known adverse effects of SGAs should guide therapy. Individuals at greatest risk for these complications should be prescribed SGAs least likely to cause them.
Although risks of SGAs should influence management decisions, the panel suggests tailoring treatments to individual patients by weighing the benefits against the risks. "Even for those medications associated with an increased risk of metabolic side effects, the benefits to specific patients could outweigh the potential risks," they conclude.
The consensus development conference was supported in part by an educational grant from AstraZeneca, Bristol-Myers Squibb Co., Janssen Pharmaceutical Products, Eli Lilly and Co., and Pfizer Inc. These pharmaceutical companies also have various financial arrangements with several of the panel members.
Diabetes Care. 2004;27:596-601
Learning Objectives
Upon completion of this activity, participants will be able to:
Evaluate the benefits of SGAs compared with those of older antipsychotics.
List the potential consequences of weight gain and diabetes with respect to particular SGAs.
Clinical Context
The SGA drug class includes clozapine, risperidone, olanzapine, aripiprazole, quetiapine, and ziprasidone. As a class, SGAs offer some definite advantages over their predecessor agents such as haloperidol and chlorpromazine. First, they have been shown to improve not only the positive symptoms of psychosis, but they can aid negative symptoms, such as withdrawal and apathy, as well. They can also help cognitive and affective symptoms in patients with severe psychiatric disease. Finally, this class of drugs does not cause extrapyramidal symptoms at nearly the rate of older medications.
Nonetheless, it has become increasingly clear that these benefits may be derived at some risk in terms of weight gain and diabetes. In a retrospective analysis of data from health plans, Gianfresco and colleagues found that olanzapine, clozapine, and high- and low-potency conventional antipsychotic drugs raised the risk of diabetes in patients with psychosis compared with untreated patients with psychosis. Their research, which appeared in the October 2002 issue of the Journal of Clinical Psychiatry, also demonstrated no increased risk of diabetes associated with risperidone treatment.
Interesting commentary of the validity of the clinical trials that are carried out by the drug comapanies themselves.
anna22
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how can you tell the Dreamer from the one who dreams the dream?
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Trampy
Pooh-Bah
Reged: 04/02/02
Posts: 1216
Loc: Southwest U.S.
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Quote:
...Interesting commentary of the validity of the clinical trials that are carried out by the drug comapanies themselves.
The diabetes is probably a consequence of the weight gain and while it is a more serious side effect than obesity, diabetes can take quite a while to develop and would probably not be found in any Phase III trials prior to drug approval. FDA's Phase IV is monitoring for adverse side effects while a drug is in use. That is where they should notice the diabetes risk. Weight gain was observed in the Phase III trials.
The FDA often accepts known side effects in approved medications by balancing harm against benefit. I was told by a M.D. in 1999 that Respirdal causes less weight gain than Zyprexa ... which matches what this article says. If the diabetes risk is confirmed, FDA will probably change the product insert warnings and advise doctors to screen these patients for diabetes. Diabetes is a slow-developing side effect. Weight gain would usually be a warning signal. These side effects are much less of a health threat than things that can cause sudden death. The second generation antipsychotics will stay on the market because weight gain and an increased risk of diabetes are nothing compared to the irreversible neurological damage that was often seen with the first generation antipsychotics, and the new drugs have allowed many people with schizophrenia to hold steady jobs instead of sitting at home on disability as they did with Thorazine.
Compare this to the phen-fen situation where drugs used to treat obesity were found to sometimes cause sudden death. That was unacceptable from a harm/benefit perspective.
Here the benefits almost surely outweigh the risks, which are slow-developing in any case and possibly preventable. It's a simple matter to monitor the weight gainers for diabetes and try to prevent diabetes with diet and exercise. Unlike the laboratory blood tests for liver function needed for many drugs, diabetes screening can be performed with simple tests in most any doctor's office.
There are surely very few drugs with no known adverse side effects. I can't think of one.
Trampy
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Your mileage may vary ...
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sigmund
Member
Reged: 07/29/03
Posts: 181
Loc: Vienna
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Trampy,
Your posts always elicit thoughts for further discourse and raise important questions. I appreciate that as well as your knowledge and critical thinking on this one.
Having seen patients through both generations of anti-psychotic meds, the picture has changed dramatically. As you indicated, those on the thorazine, haldol, etc. seemed to become "treated psychotics" rather than experiencing a better quality of life. The tardive dyskenesia (even with med to counteract it) seemed to lower their stature in society and appeared like treated psychotics/schizophrenics(without the florid symptoms) and no longer dangerous.
The most frustrating problem in working with patients on the second generation anti-psychotics is the weight gain which ends up leading to non-compliance. Could you please clarify if the reason for the weight gain is that the meds over-stimulate the appetite center? Some articles on the topic suggested that these patients be given a low dose of topomax, the anti-seizure medication, because it suppresses appetite. If this were sound phamacologically, it might keep more people on their medication regimens to allow them to live functional lifes or get through periods of traumatic stress.
Lastly, thanks for the description of the Phases of FDA-monitored drug trials. I have seen some private-sector trials that were so poorly designed that it was impossible to ascertain with validity whether the experimental protocol made a difference or whether it was due to chance.
If diabetes does run in families, do you think it would be possible to rule out those with a genetic propensity? This would not of course eliminate those subjects who develop the diabetes secondary to obesity. Thanks for any more light you can shed on this. It's too late to get into the issue of diet meds to counteract the weight gain because of the complex metabolic problems created...however, this seems to come up often.
anna22
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how can you tell the Dreamer from the one who dreams the dream?
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