The Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators (Nonusers of Regranex [Becaplermin])
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to compare the risk of cancers in patients who have used
      REGRANEX (becaplermin) to that of patients with similar characteristics and health issues who
      have not used REGRANEX (becaplermin). REGRANEX (becaplermin) is topical medication used to
      treat non-healing neuropathic foot ulcers in patients with diabetes.
    

Detailed description: 
      This is an observational retrospective study where data will be collected from a medical
      claims database derived from a large national managed care organization with over five
      million members. Members enrolled in a Medicare supplement program will also be included. The
      objective of this study is to determine the incidence of cancer among patients who have used
      REGRANEX (becaplermin) compared to patients who have not used REGRANEX (becaplermin).
      REGRANEX (becaplermin) is an FDA-approved prescription medicine that contains a
      platelet-derived growth factor that is used for the treatment of foot ulcers in patients with
      diabetes. Patients who were treated with REGRANEX (becaplermin) between January 1998 and June
      2003 will be identified in a health insurance claims database. Another group of patients who
      have not been treated with REGRANEX (becaplermin) but have similar characteristics to
      patients treated with REGRANEX (becaplermin) will also be identified during the same time
      frame in the database. Medical record abstraction and review will be conducted to verify all
      incident cancers identified. Follow-up for study outcomes will be conducted from the date of
      accrual through termination of health-plan membership or December 2003 (whichever comes
      first). The date of accrual is the date of REGRANEX (becaplermin) exposure for each exposed
      patient and his or her matched unexposed comparison patients. Any incidence of death from
      cancer will also be identified. The primary outcome measure in the study will be the
      incidence rate of cancers of all kinds, grouped by organ site in patients who have used
      REGRANEX (becaplermin) and patients who have not used REGRANEX (becaplermin). A secondary
      objective is a similar comparison of the incidence of death from cancer. This is an
      observational study; no investigational drug will be administered.
    

Intervention name(s): REGRANEX (becaplermin); REGRANEX (becaplermin) comparators
Intervention type(s): Drug; Other
Intervention description(s): A cohort of REGRANEX (becaplermin) users (ie, patients treated with REGRANEX (becaplermin), a topical medication used to treat non-healing neuropathic foot ulcers in patients with diabetes).; A cohort of REGRANEX (becaplermin) nonusers (ie, patients who are not treated with REGRANEX [becaplermin]) but are similar in characteristics to patients in the REGRANEX [becaplermin] user cohort)
Intervention MeSH terms: Becaplermin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with similar characteristics who were treated or who were not treated with
        REGRANEX (becaplermin) between January 1998 and June 2003 identified in a health insurance
        claims database.
      
Keywords: REGRANEX (becaplermin); Platelet-derived growth factor BB; Cancer; Cancer incidence; Cancer mortality