Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)

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Brief Title

Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)

Official Title

Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research Database

Brief Summary

      High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there
      has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by
      spontaneous reports in the Adverse Events Reporting System or in the published literature. In
      a published case-control screening study of the association of gabapentin with 55 cancers,
      the only cancer that met the screening criteria for possibly increased cancer risk with
      gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to
      be likely due to or substantially accentuated by confounding by cigarette smoking,
      hypertension, and lifestyle (Cancer Causes Control 2009;20:1821-1835).

      The primary objective of this study is to determine whether exposure to gabapentin is
      associated with an increased risk of developing pancreatic cancer or renal cancer in the
      United Kingdom (UK) General Practice Research Database (GPRD). Almost all members of the UK
      population are registered with a General Practice, which centralizes the medical information
      not only from the general practitioners themselves but also from specialist referrals and
      hospital attendances. Over 487 General Practices contribute data to the GPRD.

      The study cohort from which cases and controls are drawn is all subjects in the GPRD
      1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins
      Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of
      registration if later than Jan 1, 1993. Patients with a first diagnosis of the respective
      cancer 1995-2008 are risk set matched with up to 10 controls within the same General Practice
      for age at cohort entry (within two years), sex, and year of entry into the study cohort
      (within one year). For cases, the index date is the date of first diagnosis of the respective
      cancer. The index date for controls is set as the date at which the follow-up time from
      cohort entry is the same as the case. The index date is chosen so as to give the control
      equal follow-up time to that of the case for ascertainment of use of gabapentin. Cases and
      controls will be required to have at least 2 years of follow-up in the study cohort before
      their index date. Data on gabapentin prescriptions are obtained for cases and controls from
      study cohort entry to the index date.

      Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from
      conditional logistic regression models, with additional analyses evaluating for latency and
      dose-response. For pancreatic cancer, covariates are smoking, body mass index, diabetes,
      epilepsy, neuropathic pain, and chronic pancreatitis. For renal cancer, covariates are
      smoking, body mass index, diabetes, hypertension, diuretic use, epilepsy, and neuropathic
      pain.
    

Detailed Description

      Patients were not recruited for nor enrolled in this study. This study is a retrospective
      observational study. Data from medical records or insurance claims databases are anonymised
      and used to develop a patient cohort. All diagnoses and treatment are recorded in the course
      of routine medical practice. Actual number of patients could be less than , as it is possible
      for a patient to be represented in more than one of the four arms (See "Participant Flow:
      Overall Study" Table) because of the risk set sampling.
    


Study Type

Observational


Primary Outcome

Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin


Condition

Renal Pelvis Cancer

Intervention

Gabapentin prescriptions

Study Arms / Comparison Groups

 UK GPRD 1993-2008
Description:  The study cohort from which cases and controls are drawn is all subjects in the United Kingdom (UK) General Practice Research Database (GPRD) 1993-2008. Each member of the UK population is registered with a General Practice, which centralizes the medical information not only from the general practitioners themselves but also from specialist referrals and hospital attendances. Over 487 General Practices contribute data to the GPRD. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

54202

Start Date

March 2010

Completion Date

August 2010

Primary Completion Date

August 2010

Eligibility Criteria

        Inclusion Criteria:

          -  The study cohort from which cases and controls are drawn is all subjects in the UK
             GPRD 1993-2008. Entry into the study cohort begins Jan 1, 1993 for all those who are
             registered in GPRD before that time, and at the time of registration if later than Jan
             1, 1993. Follow-up ends Dec 31, 2008, or earlier if the respective cancer is
             diagnosed, or if the subject leaves the GPRD for any reason including death.

        Exclusion Criteria:

          -  Cases and controls will be required to have at least 2 years of follow-up in the study
             cohort before their index date (For cases, the index date is the date of first
             diagnosis of the respective cancer. The index date for controls is set as the date at
             which the follow-up time from cohort entry is the same as the case.)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

GSK Clinical Trials, , 



Administrative Informations


NCT ID

NCT01138124

Organization ID

114427

Secondary IDs

EPI40634

Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline


Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline


Verification Date

May 2017