| Title |
Treatment |
Disease Area |
Type
of
Decision |
Adherence and Effectiveness
An observational study found that while inhaled corticosteroids were associated with a lower risk of in-patient admissions and emergency room visits for adherent patients, users of oral controllers derived greater benefit from treatment due to increased adherence. (more)
|
Corticosteroids |
Asthma |
 |
Support for Expanded Indication in a Drug
An observational study that found that clozapine reduced suicide risk was used to support an expanded indication. (more)
|
Clozapine |
Schizophrenia |
 |
Support for Modified Label
A pregnancy registry provided data to support a labeling change from Pregnancy Category C (risk cannot be ruled out) to Pregnancy Category B (no evidence of risk in humans). (more)
|
Acyclovir |
Herpes virus infections |
|
Determining Optimal Dose
Data from large linked registries demonstrated that physicians were more likely to administer high-dose corticosteroids for COPD exacerbations, but that low-dose oral corticosteroids were equally effective and had fewer side effects. (more)
|
Corticosteroids |
COPD |
 |
Support for Coverage Decisions
A registry demonstrated that PET scans changed physicians' intended management strategies in cancer patients, leading to expanded Medicare coverage. (more)
|
PET scans |
Cancer |
|
Support for Expanded Indication in a Device
Data from a registry were used to support an expanded indication for IOLs to include patients younger than 65 years of age. (more)
|
Intraocular lenses |
Cataracts |
|
