Understanding treatment patterns and patient-reported outcomes associated with the use of authorized generics and corresponding independent generics across multiple therapeutic areas.

OBJECTIVES: To assess patient characteristics, treatment patterns, and patient-reported outcomes (PROs) associated with authorized generics (AGs) and independent generics (IGs) use. METHODS: Prescription claims and National Health and Wellness Survey (NHWS) data were linked. Adults with billable national drug code (AG or IG), NHWS completion from June 2015 to July 2019, AG or IG on-hand at NHWS completion, and continuous insurance eligibility in 12 months pre- and post-NHWS completion were included. To be included, all unique medication formulations had to have at least one AG and one IG observation. PRO index date was NHWS completion; claims index date was defined as the first prescription claim identified during the 180-day period prior to NHWS completion for the same active ingredient and formulation type that was on-hand at NHWS completion. RESULTS: Patients (N = 20,229; 17.2% AG users) in six therapeutic areas (attention deficit-hyperactivity disorder [ADHD], antidepressants, beta blockers [BBs], calcium channel blockers [CCBs], statins, and thyroid) were included. Generally, AG (vs. IG) users were younger and differed in regional access and insurance type (all, p < .05). In multivariable analysis, significant differences were observed for presenteeism and overall work impairment (BBs), healthcare provider visits (BBs), and indirect costs (thyroid) (all, p < .05). AG and IG users differed in persistence (ADHD and statins; both, p < .05) and switch (BBs and CCBs; both, p < .01) rates. CONCLUSIONS: PRO differences were often small in magnitude and varied by therapeutic area. The impact of switching should consider observed PRO differences, patient preferences, and market availability of AG and IG alternatives.

Findings of a U.S. national cardiometabolic screening program among 10,084 psychiatric outpatients.

OBJECTIVE: A national cardiometabolic screening program for patients in a variety of public mental health facilities, group practices, and community behavioral health clinics was funded by Pfizer Inc. between 2005 and 2008. METHODS: A one-day, voluntary metabolic health fair in the United States offered patients attending public mental health clinics free cardiometabolic screening and same-day feedback to physicians from a biometrics testing third party that was compliant with the Health Insurance Portability and Accountability Act. RESULTS: This analysis included 10,084 patients at 219 sites; 2,739 patients (27%) reported having fasted for over eight hours. Schizophrenia or bipolar disorder was self-reported by 6,233 (62%) study participants. In the overall sample, the mean waist circumference was 41.1 inches for men and 40.4 inches for women; 27% were overweight (body mass index [BMI] 25.0-29.9 kg/m(2)), 52% were obese (BMI >or=30.0 kg/m(2)), 51% had elevated triglycerides (>or=150 mg/dl), and 51% were hypertensive (>or=130/85 mm Hg). In the fasting sample, 52% had metabolic syndrome, 35% had elevated total cholesterol (>or=200 mg/dl), 59% had low levels of high-density lipoprotein cholesterol (<40 mg/dl for men or <50 mg/dl for women), 45% had elevated triglycerides (>or=150 mg/dl), and 33% had elevated fasting glucose (>or=100 mg/dl). Among the 1,359 fasting patients with metabolic syndrome, 60% were not receiving any treatment. Among fasting patients who reported treatment for specific metabolic syndrome components, 33%, 65%, 71%, and 69% continued to have elevated total cholesterol, low levels of high-density lipoprotein, high blood pressure, and elevated glucose levels, respectively. CONCLUSIONS: The prevalence of metabolic syndrome and cardiometabolic risk factors, such as overweight, hypertension, dyslipidemia, and glucose abnormalities, was substantial and frequently untreated in this U.S. national mental health clinic screening program.

Premorbid functioning in schizophrenia: relation to baseline symptoms, treatment response, and medication side effects.

Impaired premorbid functioning prior to the onset of acute psychosis has frequently been noted in schizophrenia. This study examined retrospectively the premorbid status of patients in their first episode of psychosis in order to determine relationships with baseline symptoms, treatment response, and medication side effects. One hundred eleven schizophrenic and schizoaffective patients participating in a large prospective study of first episode schizophrenia were evaluated with the Premorbid Adjustment Scale (PAS). Premorbid functioning in males became progressively worse over time. Deficit state patients exhibited worse premorbid functioning. A third of patients exhibited sustained poor premorbid functioning. At various developmental stages, lower "sociability and withdrawal" scores correlated with increased time to treatment response, more severe negative symptoms, increased drug-induced parkinsonism, and deterioration of premorbid functioning. Various mean PAS scores predicted susceptibility to tardive dyskinesia. Our findings suggest that prior to acute psychosis onset there are certain behavioral precursors reflected in premorbid functioning that may predict subsequent illness manifestations. Measures of premorbid functioning indicate that disease pathogenesis is manifest, albeit more subtly, prior to presentation of first psychotic symptoms.