Table 4.
Impact of the FDA Warning on Incident Second Generation Antipsychotic Drug Use, by Diagnosis
| Bipolar Disorder | Schizophrenia | |||||
|---|---|---|---|---|---|---|
| Agent-Specific Utilizationa | Risk | Risk Ratio |
95% Confidence Interval |
Risk | Risk Ratio |
95% Confidence Interval |
| Olanzapineb | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .66 | 1.00 | REF | .48 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .59 | .88 | .78–1.00 | .41 | .87 | .79–.94 |
| Advisory Period (Dec 03–Aug 04) | .44 | .66 | .56–.77 | .30 | .63 | .56–.71 |
| Initial Post-Advisory (Sept 04–Mar 05) | .24 | .37 | .29–.47 | .20 | .42 | .35–.51 |
| PDL / CATIE / Dementia Warning (April 05–Sept 05) | .12 | .17 | .12–.25 | .10 | .22 | .16–.30 |
| Post-PDL/CATIE / Dementia Warning (Oct 05–Dec 06) | .12 | .19 | .12–.29 | .08 | .17 | .11–.27 |
| Quetiapine | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .18 | 1.00 | REF | .16 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .24 | 1.38 | 1.19–1.60 | .20 | 1.21 | 1.07–1.36 |
| Advisory Period (Dec 03–Aug 04) | .26 | 1.49 | 1.27–1.75 | .23 | 1.37 | 1.19–1.57 |
| Initial Post-Advisory (Sept 04–Mar 05) | .34 | 1.91 | 1.62–2.26 | .31 | 1.86 | 1.59–2.17 |
| PDL / CATIE / Dementia Warning (April 05–Sept 05) | .37 | 2.11 | 1.77–2.52 | .31 | 1.86 | 1.55–2.23 |
| Post-PDL/CATIE / Dementia Warning (Oct 05–Dec 06) | .38 | 2.13 | 1.73–2.63 | .33 | 1.98 | 1.60–2.46 |
| Risperidone | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .06 | 1.00 | REF | .33 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .04 | .72 | .60–.86 | .25 | .77 | .70–.85 |
| Advisory Period (Dec 03–Aug 04) | .04 | .70 | .57–.86 | .27 | .83 | .74–.94 |
| Initial Post-Advisory (Sept 04–Mar 05) | .04 | .70 | .55–.89 | .26 | .81 | .69–.94 |
| PDL / CATIE / Dementia Warning (April 05–Sept 05) | .04 | .64 | .49–.85 | .31 | .94 | .79–1.11 |
| Post-PDL/CATIE / Dementia Warning (Oct 05–Dec 06) | .05 | .74 | .54–1.02 | .29 | .88 | .71–1.09 |
| Ziprasidone | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .01 | 1.00 | REF | .08 | 1.00 | REF |
| Early- Advisory (Feb 03–Nov 03) | .01 | .79 | .55–1.14 | .09 | 1.12 | .91–1.37 |
| Advisory Period (Dec 03–Aug 04) | .02 | 1.35 | .96–1.91 | .12 | 1.48 | 1.19–1.85 |
| Initial Post-Advisory (Sept 04–Mar 05) | .02 | 1.59 | 1.11–2.28 | .12 | 1.56 | 1.19–2.05 |
| PDL / CATIE / Dementia Warning (April 05–Sept 05) | .03 | 1.98 | 1.36–2.89 | .14 | 1.80 | 1.33–2.44 |
| Post-PDL/CATIE / Dementia Warning (Oct 05–Dec 06) | .01 | .59 | .27–1.28 | .16 | 1.98 | 1.39–2.82 |
| Aripiprazolec | ||||||
| Pre-Advisory Period (Jan 01–Jan 03) | .00 | -- | -- | .00 | -- | -- |
| Early- Advisory (Feb 03–Nov 03) | .01 | -- | -- | .12 | -- | -- |
| Advisory Period (Dec 03–Aug 04) | .02 | -- | -- | .13 | -- | -- |
| Initial Post-Advisory (Sept 04–Mar 05) | .02 | -- | -- | .16 | -- | -- |
| PDL / CATIE / Dementia Warning (April 05–Sept 05) | .02 | -- | -- | .16 | -- | -- |
| Post-PDL/CATIE / Dementia Warning (Oct 05–Dec 06) | .03 | -- | -- | .18 | -- | -- |
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.