Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

Pamlab

Status

Completed

Conditions

Diabetic Peripheral Neuropathy (DPN)

Treatments

Other: Not treated with Metanx®

Other: Metanx® (a medical food)

Study type

Observational

Funder types

Industry

Identifiers

NCT01247558

M-006

Details and patient eligibility

About

This study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria and 400 propensity score matched patients meeting the same criteria to serve as a control cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore Integrated Research Database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

Full description

The control patients will be matched at a ratio of 4:1 with the Metanx® patients. Covariates used to select the propensity matched patients will include: age; gender; health plan type and region; DCI score; presence/absence of nephropathy; ischemic heart disease; cerebrovascular disease; neoplasm; insulin use; and all-cause health plan costs in the 6-mont pre-index period.

Claims information about patients selected for the study will be followed longitudinally to the end of data availability. This data stream will be used to determine treatment patterns for Metanx®, healthcare resource utilization, and cost.

Enrollment

500 estimated patients

Sex

All

Ages

25 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients must have pharmacy claims for >120 continuous days of Metanx®. This will be defined as at least a 90-day supply dispensed within the first 120 days post-index. The first pharmacy claim for Metanx® will be the index date.
Patients must have a diagnosis of diabetes prior to or including the index date.
Patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder.
Patients must have a diagnosis of lower limb ulcer.

Exclusion criteria

Patients will be excluded if they have <18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility.
Patients will be excluded if they have taken other L-methylfolate containing products (Deplin®, Cerefolin®, Cerefolin NAC®,Neevo®) or other prescription folic acid combination products with >1mg folic acid.