Chronic Pancreatitis, Diabetes, Epilepsy, Hypertension, Neuropathic Pain, Pancreatic Cancer, Renal Cancer, Renal Cell Carcinoma, Renal Pelvis Cancer, Restless Legs Syndrome
Conditions
Keywords
renal cell carcinoma, epidemiology, pancreatic cancer, renal cancer, renal pelvis cancer, GPRD, case-control, Gapabentin
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.
Interventions
The exposure of interest is gabapentin use as defined by prescriptions recorded by the GPRD general practitioner (British National Formulary codes). Data on prescriptions for gabapentin will be extracted for each case and control from entry into the study cohort up to the index date (the exposure window). Gabapentin exposure will be parameterized as follows: (1) Ever versus never exposed; (2) Number of prescriptions; (3) Duration of exposure; and (4) Cumulative dose. These parameterizations will also be examined with a 2 year lag time from the index date, limiting the exposure window from entry into the study cohort up to 2 years prior to the index date.
Sponsors
Study design
Eligibility
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | Incident renal 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 Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | 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. | Incident renal 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 Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | 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. | Incident renal 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 Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | 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. | Incident renal 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). |
Participant flow
Recruitment details
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 anonymized and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
Pre-assignment details
Actual number of patients may be less, 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.
Participants by arm
| Arm | Count |
|---|---|
| Pancreatic Cancer Cases Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded. | 3,149 |
| Pancreatic Cancer Controls Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. | 30,026 |
| Renal Cancer Cases Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded. | 1,981 |
| Renal Cancer Controls Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. | 19,046 |
| Total | 54,202 |
Baseline characteristics
| Characteristic | Total | Pancreatic Cancer Cases | Pancreatic Cancer Controls | Renal Cancer Cases | Renal Cancer Controls |
|---|---|---|---|---|---|
| Age, Customized 40-49 years | 2465 Participants | 86 Participants | 897 Participants | 134 Participants | 1348 Participants |
| Age, Customized <40 years | 706 Participants | 18 Participants | 199 Participants | 43 Participants | 446 Participants |
| Age, Customized 50-59 years | 7756 Participants | 367 Participants | 3616 Participants | 355 Participants | 3418 Participants |
| Age, Customized 60-69 years | 13709 Participants | 748 Participants | 7234 Participants | 528 Participants | 5199 Participants |
| Age, Customized 70-79 years | 17323 Participants | 1033 Participants | 10092 Participants | 594 Participants | 5604 Participants |
| Age, Customized >=80 years | 12243 Participants | 897 Participants | 7988 Participants | 327 Participants | 3031 Participants |
| Number of participants with the indicated body mass index (BMI) <18.5 kg/m^2 | 356 participants | 25 participants | 203 participants | 18 participants | 110 participants |
| Number of participants with the indicated body mass index (BMI) 18.5 to 24.99 kg/m^2 | 6610 participants | 459 participants | 3678 participants | 237 participants | 2236 participants |
| Number of participants with the indicated body mass index (BMI) 25 to 29.99 kg/m^2 | 7971 participants | 457 participants | 4250 participants | 326 participants | 2938 participants |
| Number of participants with the indicated body mass index (BMI) >=30 kg/m^2 | 4790 participants | 291 participants | 2476 participants | 250 participants | 1773 participants |
| Number of participants with the indicated body mass index (BMI) Missing | 34475 participants | 1917 participants | 19419 participants | 1150 participants | 11989 participants |
| Number of participants with the indicated duration of follow-up from GPRD registration to index date 2-3 years | 2843 participants | 173 participants | 1460 participants | 129 participants | 1081 participants |
| Number of participants with the indicated duration of follow-up from GPRD registration to index date 4-5 years | 2946 participants | 185 participants | 1509 participants | 117 participants | 1135 participants |
| Number of participants with the indicated duration of follow-up from GPRD registration to index date 6-7 years | 3665 participants | 237 participants | 2007 participants | 141 participants | 1280 participants |
| Number of participants with the indicated duration of follow-up from GPRD registration to index date >=8 years | 44748 participants | 2554 participants | 25050 participants | 1594 participants | 15550 participants |
| Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID 2-3 years | 7506 participants | 446 participants | 4121 participants | 286 participants | 2653 participants |
| Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID 4-5 years | 6400 participants | 396 participants | 3656 participants | 226 participants | 2122 participants |
| Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID 6-7 years | 7244 participants | 447 participants | 4213 participants | 246 participants | 2338 participants |
| Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID >=8 years | 33052 participants | 1860 participants | 18036 participants | 1223 participants | 11933 participants |
| Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls Diabetes | 1838 participants | 0 participants | 0 participants | 240 participants | 1598 participants |
| Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls Diuretic use | 7271 participants | 0 participants | 0 participants | 875 participants | 6396 participants |
| Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls Epilepsy | 336 participants | 0 participants | 0 participants | 33 participants | 303 participants |
| Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls Hypertension | 10272 participants | 0 participants | 0 participants | 1159 participants | 9113 participants |
| Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls Neuropathic Pain | 4446 participants | 0 participants | 0 participants | 428 participants | 4018 participants |
| Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls Chronic Pancreatitis (>=2 years prior to ID) | 30 participants | 13 participants | 17 participants | 0 participants | 0 participants |
| Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls Diabetes (>=2 years prior to index date [ID]) | 2500 participants | 363 participants | 2137 participants | 0 participants | 0 participants |
| Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls Epilepsy | 511 participants | 53 participants | 458 participants | 0 participants | 0 participants |
| Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls Neuropathic Pain | 7353 participants | 737 participants | 6616 participants | 0 participants | 0 participants |
| Number of participants with the indicated smoking status Current Smoker | 9619 participants | 731 participants | 4857 participants | 476 participants | 3555 participants |
| Number of participants with the indicated smoking status Ex-smoker | 12507 participants | 768 participants | 6626 participants | 524 participants | 4589 participants |
| Number of participants with the indicated smoking status Never Smoked | 26622 participants | 1385 participants | 15249 participants | 867 participants | 9121 participants |
| Number of participants with the indicated smoking status Status Unknown | 5454 participants | 265 participants | 3294 participants | 114 participants | 1781 participants |
| Sex: Female, Male Female | 24951 Participants | 1603 Participants | 15316 Participants | 759 Participants | 7273 Participants |
| Sex: Female, Male Male | 29251 Participants | 1546 Participants | 14710 Participants | 1222 Participants | 11773 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
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).
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
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (without 2 year lag) | 3093 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (without 2 year lag) | 28 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (without 2 year lag) | 14 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (without 2 year lag) | 14 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (with 2 year lag) | 3125 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (with 2 year lag) | 11 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (with 2 year lag) | 7 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (with 2 year lag) | 6 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (with 2 year lag) | 50 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (without 2 year lag) | 29773 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (with 2 year lag) | 29883 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (without 2 year lag) | 88 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (with 2 year lag) | 47 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (without 2 year lag) | 74 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (with 2 year lag) | 46 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (without 2 year lag) | 91 participants |
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
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).
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
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (without 2 year lag) | 3093 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (without 2 year lag) | 28 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (without 2 year lag) | 14 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (without 2 year lag) | 14 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (with 2 year lag) | 3125 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (with 2 year lag) | 13 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (with 2 year lag) | 4 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (with 2 year lag) | 7 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (with 2 year lag) | 52 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (without 2 year lag) | 29773 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (with 2 year lag) | 29883 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (without 2 year lag) | 83 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (with 2 year lag) | 47 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (without 2 year lag) | 79 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (with 2 year lag) | 44 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (without 2 year lag) | 91 participants |
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
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).
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
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (without 2 year lag) | 56 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (without 2 year lag) | 3093 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (with 2 year lag) | 24 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (with 2 year lag) | 3125 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (with 2 year lag) | 29883 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (without 2 year lag) | 253 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (with 2 year lag) | 143 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (without 2 year lag) | 29773 participants |
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
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).
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
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (without 2 year lag) | 3093 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (without 2 year lag) | 30 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (without 2 year lag) | 12 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (without 2 year lag) | 14 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (with 2 year lag) | 3125 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (with 2 year lag) | 14 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (with 2 year lag) | 3 participants |
| Cases | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (with 2 year lag) | 7 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (with 2 year lag) | 46 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (without 2 year lag) | 29773 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (with 2 year lag) | 29883 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (without 2 year lag) | 99 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (with 2 year lag) | 49 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (without 2 year lag) | 64 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (with 2 year lag) | 48 participants |
| Controls | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (without 2 year lag) | 90 participants |
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Incident renal 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).
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.
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (without 2 year lag) | 1949 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (without 2 year lag) | 9 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (without 2 year lag) | 17 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (without 2 year lag) | 6 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (with 2 year lag) | 1968 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (with 2 year lag) | 5 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (with 2 year lag) | 5 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (with 2 year lag) | 3 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (with 2 year lag) | 26 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (without 2 year lag) | 18880 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Never (with 2 year lag) | 18970 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (without 2 year lag) | 45 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (with 2 year lag) | 26 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 2 (without 2 year lag) | 63 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 1 (with 2 year lag) | 24 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Tertile 3 (without 2 year lag) | 58 participants |
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Incident renal 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).
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.
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (without 2 year lag) | 1949 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (without 2 year lag) | 15 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (without 2 year lag) | 10 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (without 2 year lag) | 7 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (with 2 year lag) | 1968 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (with 2 year lag) | 6 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (with 2 year lag) | 3 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (with 2 year lag) | 4 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (with 2 year lag) | 22 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (without 2 year lag) | 18880 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Never (with 2 year lag) | 18970 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (without 2 year lag) | 44 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (with 2 year lag) | 31 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 2 (without 2 year lag) | 67 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 1 (with 2 year lag) | 23 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Tertile 3 (without 2 year lag) | 55 participants |
Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Incident renal 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).
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.
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (without 2 year lag) | 32 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (with 2 year lag) | 13 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (without 2 year lag) | 1949 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (with 2 year lag) | 1968 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (with 2 year lag) | 18970 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (without 2 year lag) | 166 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Never (without 2 year lag) | 18880 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Ever (with 2 year lag) | 76 participants |
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Incident renal 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).
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.
Population: Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (without 2 year lag) | 1949 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (without 2 year lag) | 16 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (without 2 year lag) | 11 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (without 2 year lag) | 5 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (with 2 year lag) | 1968 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (with 2 year lag) | 6 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (with 2 year lag) | 4 participants |
| Cases | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (with 2 year lag) | 3 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (with 2 year lag) | 21 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (without 2 year lag) | 18880 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Never (with 2 year lag) | 18970 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (without 2 year lag) | 58 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (with 2 year lag) | 28 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 2 (without 2 year lag) | 55 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 1 (with 2 year lag) | 27 participants |
| Controls | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Tertile 3 (without 2 year lag) | 53 participants |