Wednesday, June 11, 2008

ADA: Metabolic Monitoring Guidelines for Antipsychotics Largely Unheeded

By Crystal Phend
SAN FRANCISCO, 11 june 2008-- Recommendations for lipid and glucose monitoring for patients on atypical antipsychotic drugs have made scarcely a dent on clinical practice, researchers found.Metabolic screening and monitoring rates rose by 5% or less since 2004, when the FDA warned of increased diabetes and cardiovascular risk with antipsychotic medications, according to two separate analyses of large insurance claim databases reported here at the American Diabetes Association meeting.Only about 20% of patients on second-generation antipsychotics received recommended glucose monitoring and just 10% had lipids monitored, reported Dan W. Haupt, M.D., of Washington University in St. Louis, and colleagues in one of the studies.
Changes in screening rates were no better than, and in some cases worse, for patients starting antipsychotics than for other commercially-insured patients, found Elaine Morrato, Dr.P.H., M.P.H., of the University of Colorado in Denver, and colleagues in the other study.
In 2004, the FDA asked manufacturers of atypical antipsychotics to add a warning of the risk of hyperglycemia and diabetes with these medications.
Around the same time, the ADA, American Psychiatric Association, and other groups issued a joint consensus statement recommending that doctors screen and monitor patients on second-generation antipsychotics for signs of rapid weight gain or other problems that could lead to diabetes, obesity, and heart disease.
Surveys have found relatively high awareness of risk, intentions to screen, and self-reported screening rates, Dr. Morrato said. "So there's a disconnect between what's happening and what they say is happening."
Her study included 18,176 adults initiating aripiprazole (Abilify), clozapine (Clozaril, FazaClo), olanzapine (Zyprexa, Zydis), quetiapine (Seroquel), risperidone (Risperdal), or ziprasidone (Geodon) from 2001 through 2006 compared with 56,522 adults likewise at high risk because of diabetes.
For patients on antipsychotics, blood sugar screening rates in 2006 in the month prior to or after initiation was 25.6% and 45.5% within 61 days. Lipid screening rates were 8.9% and 26.9%, respectively.
Glucose screening rose 0.8% per quarter among antipsychotic-treated patients before the guidelines compared with a decrease of 0.6% per quarter afterward (P=0.07 for trend).
Among diabetic control group patients, laboratory glucose screening rates rose 1.2% per quarter before the statement and decreased 1.3% per quarter afterward (P<0.01 for trend).
Likewise, lipid screening decreased 0.6% per quarter after the consensus statement among antipsychotic-treated patients (P<0.001 for trend) compared with a decrease of 1.3% per quarter (P=0.37 for trend) among control group patients.
"Whatever we're observing is just sort of background rates happening," Dr. Morrato said.
Dr. Haupt's retrospective cohort study similarly used a large national insurance database. It included 5,787 patients pre-guideline (2000 to 2003) and 17,832 post-guideline (2004 to 2006) followed from 40 days prior to and 130 days after atypical antipsychotic prescription.
Monitoring rates were:
For lipid screening, 8.25% before guidelines and 10.08% afterward (P<0.01).
For lipid monitoring, 6.78% before guidelines and 8.63% after (P<0.05).
For glucose screening, 17.23% before guidelines and 21.37% after (P<0.01).
For glucose monitoring, 14.03% before guidelines and 17.61% afterward (P<0.01).
Part of the reason for low screening and monitoring rates may be that patients don't follow up on doctor's orders, particularly because many psychiatrists offices are not set up to do onsite blood draws, Dr. Morrato said.
Adding to this challenge is an "identity crisis" in psychiatry, Dr. Haupt said. "Historically these are people who have gone to medical school but have not viewed themselves as physicians in the same way as an internist would."
After the de-institutionalization of psychiatry in the late '60s and '70s, he said, "psychiatrists have been practicing really kind of separated from the rest of the medical field."
Even when screening is done, interpreting the findings of lab results and treating based on them has been problematic, as well, Dr. Morrato noted.
"Many psychiatrists don't necessarily consider these kinds of metabolic complications associated with mental illness and its treatment to be their responsibility," Dr. Haupt said.
The APA is completing a report on these issues that should be similar to existing ADA recommendations, said Dr. Haupt, who was a member of the work group for the report.
Changing clinical behavior for any guideline is not easy, Dr. Morrato said. A disease management approach may help, she said, but Dr. Haupt saw the real shift in the future as reimbursement linked to this kind of quality of care measures comes down the pipeline.
Dr. Morrato's study was supported by Pfizer. Dr. Haupt's study was supported by funding by Bristol-Myers Squibb and Otsuka Pharmaceutical.
Dr. Morrato reported no conflicts of interest. Dr. Haupt reported receiving research support from Abbott and the National Institutes of Health; consulting for Abbott, Bristol-Myers Squibb, Pfizer, Organon, and Wyeth; and receiving royalties from Compact Clinicals for a metabolic reporting form.
Primary source: American Diabetes Association meetingSource reference:Morrato EH, et al "Metabolic screening before and after the ADA consensus statement on antipsychotic drugs and risk of diabetes and dyslipidemia" ADA Meeting 2008; Abstract 967-P. Additional source: American Diabetes Association meetingSource reference: Haupt DW, et al "Prevalence and predictors of lipid and glucose monitoring among commercially insured patients treated with atypical antipsychotic agents" ADA Meeting 2008; Abstract 1216-P.

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