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

This study has been completed.

First Received on June 3, 2010.  
Last Updated on June 23, 2011  
History of Changes
This Clinical Trial Sponsored By: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01138124
 

Purpose for Clinical Trial

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.

Condition Study Intervention
Renal Pelvis Cancer
Restless Legs Syndrome
Epilepsy
Neuropathic Pain
Chronic Pancreatitis
Hypertension
Pancreatic Cancer
Diabetes
Renal Cancer
Renal Cell Carcinoma
Drug: Gabapentin prescriptions

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research Database

Resource links provided by NLM:

Genetics Home Reference related topics:
6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics:
Cancer
Diabetes
Epilepsy
High Blood Pressure
Kidney Cancer
Pancreatic Cancer
Pancreatitis
Restless Legs
Smoking and Youth
Drug Information available for:
Gabapentin
Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures For Clinical Trial:

  • Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [ Time Frame: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case ] [ Designated as safety issue: Yes ]
    Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).

  • Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions [ Time Frame: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case ] [ Designated as safety issue: Yes ]
    Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).

  • Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [ Time Frame: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case ] [ Designated as safety issue: Yes ]
    Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 – 1.55 months), Tertile 2 (1.56 – 6.44 months), and Tertile 3 (6.45 – 78.36 months). Tertile’s with 2 year lag: Tertile 1 (0.01 – 1.78 months), Tertile 2 (1.79 – 7.20 months), and Tertile 3 (7.21 – 64.13 months).

  • Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [ Time Frame: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case ] [ Designated as safety issue: Yes ]
    Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 – 33.6 grams), Tertile 2 (33.7 – 185.0 grams), and Tertile 3 (185.1 – 7500.2 grams). Tertile’s with 2 year lag: Tertile 1 (0.01 – 39.0 grams), Tertile 2 (39.1 – 210.0 grams), and Tertile 3 (210.1 – 5623.8 grams).

  • Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [ Time Frame: The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. ] [ Designated as safety

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