An observational study in Esophagitis, sponsored by Pfizer. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-20.
Sponsored by Pfizer · Observational
The primary objective is to assess whether the risk of gastric cancer is increased in pantoprazole users compared to users of other proton pump inhibitors.
All subjects who met the inclusion criteria were included in the study.
324 studies on the registry are indexed under Esophagitis; 37 are open to participants now.
This study's enrollment of 61,864 is above the median of 100 across 93 observational studies indexed under Esophagitis.
Browse Esophagitis studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Patients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization.
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Exclusion Criteria:
Patients who received treatment with pantoprazole tablets for at least 240 days within a 12-month period from 2000 through 2003.
Other: Does not apply
Patients who received treatment with any other proton pump inhibitor for at least 240 days within a 12-month period from 1996 through 2003.
Other: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply.
This is a non-interventional study, therefore the intervention type / name do not apply.
Incidence Rate of Gastric Cancer
Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.
Time frame: 1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)
Incidence Rate of Composite Gastrointestinal Cancers
Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.
Time frame: 1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)
Incidence Rate of Overall Cancer
Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.
Time frame: 1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)
| Milestone | Pantoprazole | Other Proton Pump Inhibitors (PPI) |
|---|---|---|
| Started | 34178 | 27686 |
| Completed | 34178 | 27686 |
| Not completed | 0 | 0 |
Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.
| incidence per 100000 person-years | Pantoprazole | Other Proton Pump Inhibitors (PPI) |
|---|---|---|
| Incidence Rate of Gastric Cancer | 19.88 (14.26 to 26.96) | 23.73 (12.97 to 39.81) |
Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.
| incidence per 100000 person-years | Pantoprazole | Other Proton Pump Inhibitors (PPI) |
|---|---|---|
| Incidence Rate of Composite Gastrointestinal Cancers | 168.41 (151.13 to 187.12) | 129.25 (101.84 to 161.78) |
Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.
| incidence per 100000 person-years | Pantoprazole | Other Proton Pump Inhibitors (PPI) |
|---|---|---|
| Incidence Rate of Overall Cancer | 1465.21 (1412.12 to 1519.79) | 1369.88 (1275.12 to 1469.82) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pantoprazole | — | — | — |
| Other Proton Pump Inhibitors (PPI) | — | — | — |
Analysis population included all participants who met the inclusion criteria.
| Age, Continuous(years) | Pantoprazole | Other Proton Pump Inhibitors (PPI) | Total |
|---|---|---|---|
| Median | 59 (49 to 71) | 60 (50 to 71) | 60 (49 to 71) |
| Sex: Female, Male(Participants) | Pantoprazole | Other Proton Pump Inhibitors (PPI) | Total |
|---|---|---|---|
| Female | 19033 | 15611 | 34644 |
| Male | 15145 | 12075 | 27220 |
No study locations are listed for this record.
The record gives a start of Jul 2004, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2014, 11 months after primary completion.
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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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