Table 1.
Overview of empirical examples
| Drug of interest |
Comparator | Outcome(s) | Follow-up period | Data source(s)* | Signal expected? |
|---|---|---|---|---|---|
| Cerivastatin | Atorvastatin | Rhabdomyolysis | Duration of index treatment | (1) New Jersey Medicare data linked to pharmacy assistance program; (2) Pennsylvania Medicare data linked to pharmacy assistance program | Yes |
| Paroxetine | Tricyclic antidepressants with low affinity for serotonin receptors | Gastrointestinal bleed | 90 days following treatment initiation | HealthCore Integrated Research Database (HIRD) | Yes |
| Lisinopril | Angiotensin receptor blockers | Angioedema | Duration of index treatment plus 30 days | HIRD | Yes |
| Ciprofloxacin | Macrolide antibiotics | Achilles tendon rupture | 183 days following treatment initiation | HIRD | Yes |
| Rofecoxib | Non-selective non-steroidal anti-inflammatory drugs | Myocardial infarction | 180 days following treatment initiation | (1) New Jersey Medicare data linked to pharmacy assistance program; (2) Pennsylvania Medicare data linked to pharmacy assistance program; (3) Medicaid Analytic eXtract (MAX) (covering Medicaid beneficiaries in 48 states). | Yes |
| Telithromycin | Azithromycin | Hepatotoxicity | 60 days following treatment initiation | (1) HIRD; (2) New Jersey Medicare data linked to pharmacy assistance program; (3) Pennsylvania Medicare data linked to pharmacy assistance program | Uncertain |
| Rosuvastatin | Atorvastatin | Diabetes | Duration of index treatment | (1) HIRD; (2) New Jersey Medicare data linked to pharmacy assistance program; (3) Pennsylvania Medicare data linked to pharmacy assistance program | Uncertain |
| Rosuvastatin | Atorvastatin | Rhabdomyolysis | Duration of index treatment plus 60 days | (1) HIRD; (2) New Jersey Medicare data linked to pharmacy assistance program; (3) Pennsylvania Medicare data linked to pharmacy assistance program | No |
| Celecoxib | Non-selective non-steroidal anti-inflammatory drugs | Myocardial infarction | 180 days following treatment initiation | (1) New Jersey Medicare data linked to pharmacy assistance program; (2) Pennsylvania Medicare data linked to pharmacy assistance program | No |
*
All data sources comprise administrative claims data including demographic data, medical claims from healthcare providers and facilities, and outpatient pharmacy dispensing records.