Table 3.
Impact of the FDA Warning on Agent-Specific Use among Prevalent Antipsychotic Users, by Diagnosis
| Bipolar Disorder | Schizophrenia | |||||
|---|---|---|---|---|---|---|
| Agent-Specific Utilizationa | Risk | Risk Ratio |
95% Confidence Interval |
Risk | Risk Ratio |
95% Confidence Interval |
| Olanzapine Useb | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .41 | 1.00 | REF | .43 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .37 | .90 | .84–.95 | .42 | .96 | .95–.98 |
| Advisory Period (Dec 03–Aug 04) | .33 | .80 | .74–.87 | .38 | .88 | .86–.90 |
| Initial Post-Advisory (Sept 04–Mar 05) | .27 | .66 | .59–.74 | .32 | .74 | .72–.76 |
| PDL/CATIE/Dementia Warning (April 05–Sept 05) | .22 | .52 | .46–.60 | .23 | .54 | .52–.56 |
| Post-PDL/CATIE/Dementia Warning (Oct 05–Dec 06) | .17 | .41 | .34–.50 | .16 | .36 | .34–.38 |
| Quetiapine Use | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .14 | 1.00 | REF | .16 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .17 | 1.15 | 1.06–1.26 | .20 | 1.20 | 1.16–1.25 |
| Advisory Period (Dec 03–Aug 04) | .19 | 1.28 | 1.15–1.43 | .21 | 1.28 | 1.23–1.34 |
| Initial Post-Advisory (Sept 04–Mar 05) | .21 | 1.47 | 1.30–1.66 | .23 | 1.41 | 1.34–1.47 |
| PDL/CATIE/Dementia Warning (April 05–Sept 05) | .24 | 1.63 | 1.44–1.87 | .27 | 1.65 | 1.58–1.73 |
| Post-PDL/CATIE/Dementia Warning (Oct 05–Dec 06) | .24 | 1.64 | 1.44–1.87 | .30 | 1.83 | 1.74–1.92 |
| Risperidone Use | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .45 | 1.00 | REF | .42 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .44 | .98 | .92–1.04 | .38 | .91 | .89–.92 |
| Advisory Period (Dec 03–Aug 04) | .41 | .90 | .82–.98 | .37 | .89 | .86–.91 |
| Initial Post-Advisory (Sept 04–Mar 05) | .41 | .89 | .81–.99 | .39 | .92 | .89–.95 |
| PDL/CATIE/Dementia Warning (April 05–Sept 05) | .42 | .92 | .83–1.03 | .40 | .95 | .92–.98 |
| Post-PDL/CATIE/Dementia Warning (Oct 05–Dec 06) | .42 | .92 | .82–1.04 | .41 | .97 | .94–1.00 |
| Ziprasidone Use | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .02 | 1.00 | REF | .05 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .04 | 1.65 | 1.31–2.08 | .10 | 1.85 | 1.71–1.99 |
| Advisory Period (Dec 03–Aug 04) | .04 | 2.00 | 1.52–2.68 | .11 | 2.06 | 1.88–2.25 |
| Initial Post-Advisory (Sept 04–Mar 05) | .05 | 2.31 | 1.73–3.26 | .13 | 2.46 | 2.24–2.71 |
| PDL/CATIE/Dementia Warning (April 05–Sept 05) | .06 | 2.67 | 2.03–3.71 | .15 | 2.76 | 2.51–3.04 |
| Post-PDL/CATIE/Dementia Warning (Oct 05–Dec 06) | .06 | 2.58 | 1.88–3.58 | .15 | 2.76 | 2.50–3.06 |
| Aripiprazole Usec | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .00 | -- | -- | .00 | -- | -- |
| Early- Advisory (Feb 03–Nov 03) | .03 | -- | -- | .08 | -- | -- |
| Advisory Period (Dec 03–Aug 04) | .05 | -- | -- | .12 | -- | -- |
| Initial Post-Advisory (Sept 04–Mar 05) | .07 | -- | -- | .15 | -- | -- |
| PDL/CATIE/Dementia Warning (April 05–Sept 05) | .09 | -- | -- | .17 | -- | -- |
| Post-PDL/CATIE/Dementia Warning (Oct 05–Dec 06) | .12 | -- | -- | .20 | -- | -- |
Models were estimated using PROC GENMOD (SAS, 9.1) with a Poisson distribution and log link. Control variables included sex, age, race, Medicaid eligibility status, and the presence of the following during the 6 months prior to the index prescription date: receipt of care from a psychiatrist, inpatient mental health treatment, dementia, alcohol or substance abuse, epilepsy, complicating conditions, diabetes, hyperlipidemia, hypertension, heart disease, or obesity. PDL / CATIE / Dementia Warning = Period including the Medicaid Preferred-Drug List policy change, publication of the CATIE trial results, and the FDA’s black box warning for the risk of mortality among elderly patients with dementia.
High metabolic risk agent = Olanzapine. All other agents classified as lower metabolic risk agents.
Risk ratios are not provided for aripiprazole since it was introduced late in the pre-advisory period.