Anterior Ischemic Optic Neuropathy, Ischemic Optic Neuropathy
Conditions
Keywords
Phosphodiesterase type 5 inhibitors, non-arteritic anterior ischemic optic neuropathy, descriptive epidemiology study
Brief summary
The objectives of this study were to: (1) evaluate the natural history of non-arteritic anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION; and (3) identify potential risk factors for NAION.
Detailed description
The study population consisted of members of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007, who were 18 years of age or older with at least 183 days of continuous enrollment in the database and without any doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry. From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
Interventions
OTHERNo intervention given in this observational study
No intervention given in this observational study
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Member of the Ingenix Normative Health Informatics (NHI) Database during 01/01/2003 through 12/31/2007 * 18 years of age or older * Had at least 183 days of continuous enrollment in the database * No doctor visits associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry
Exclusion criteria
* Less than 18 years of age * Less than 183 days of continuous enrollment in the database * At least one doctor visit associated with a diagnosis of ischemic optic neuropathy during the 183 days prior to cohort entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age | 01-January-2003 up to 31-December-2007 | Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years. |
| Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex | 01-January-2003 up to 31-December-2007 | Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male. |
| Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year | 01-January-2003 up to 31-December-2007 | Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007. |
| Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region | 01-January-2003 up to 31-December-2007 | Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West. |
| Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | 01-January-2003 up to 31-December-2007 | Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls. |
| Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | 01-January-2003 up to 31-December-2007 | Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes). |
| Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use | 01-January-2003 up to 31-December-2007 | Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none. |
| Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) | 01-January-2003 up to 31-December-2007 | — |
| Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | 01-January-2003 up to 31-December-2007 | Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table. |
| Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | 01-January-2003 up to 31-December-2007 | Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAION Cases Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. | 1,283 |
| Controls From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000) | 20,000 |
| Total | 21,283 |
Baseline characteristics
| Characteristic | NAION Cases | Controls | Total |
|---|---|---|---|
| Age, Customized 18 to 34 years | 43 participants | 5954 participants | 5997 participants |
| Age, Customized 35 to 44 years | 59 participants | 4937 participants | 4996 participants |
| Age, Customized 45 to 54 years | 208 participants | 4655 participants | 4863 participants |
| Age, Customized 55 to 64 years | 481 participants | 3041 participants | 3522 participants |
| Age, Customized 65 to 74 years | 247 participants | 902 participants | 1149 participants |
| Age, Customized ≥75 years | 245 participants | 511 participants | 756 participants |
| Number of participants with NAION diagnosis per calendar year Year 2003 | 285 participants | 3953 participants | 4238 participants |
| Number of participants with NAION diagnosis per calendar year Year 2004 | 236 participants | 3990 participants | 4226 participants |
| Number of participants with NAION diagnosis per calendar year Year 2005 | 284 participants | 4137 participants | 4421 participants |
| Number of participants with NAION diagnosis per calendar year Year 2006 | 231 participants | 4081 participants | 4312 participants |
| Number of participants with NAION diagnosis per calendar year Year 2007 | 247 participants | 3839 participants | 4086 participants |
| Number of participants with NAION diagnosis per region of United States Midwest | 362 participants | 5345 participants | 5707 participants |
| Number of participants with NAION diagnosis per region of United States Northeast | 100 participants | 2456 participants | 2556 participants |
| Number of participants with NAION diagnosis per region of United States South | 656 participants | 9158 participants | 9814 participants |
| Number of participants with NAION diagnosis per region of United States West | 165 participants | 3041 participants | 3206 participants |
| Sex: Female, Male Female | 595 Participants | 10669 Participants | 11264 Participants |
| Sex: Female, Male Male | 688 Participants | 9331 Participants | 10019 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,283 | 0 / 20,000 |
| serious Total, serious adverse events | 0 / 1,283 | 0 / 20,000 |
Outcome results
Primary
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.
Time frame: 01-January-2003 up to 31-December-2007
Population: Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years \[(NAION cases n, Controls n) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age | Age 18 to 34 (n=43, 5,954) / 8,042,997 | 0.01 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age | Age 35 to 44 (n=59, 4,937) / 6,669,176 | 0.01 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age | Age 45 to 54 (n=208, 4,655) / 6,288,235 | 0.03 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age | Age 55 to 64 (n=481, 3,041) / 4,107,953 | 0.12 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age | Age 65 to 74 (n=247, 902) / 1,218,472 | 0.20 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age | Age ≥75 (n=245, 511) / 690,287 | 0.35 incidence rate per 1000 person-years |
Comparison: Incidence rate Age 18 to 3495% CI: [0.01, 0.01]
Comparison: Incidence rate Age 35 to 4495% CI: [0.01, 0.01]
Comparison: Incidence rate Age 45 to 5495% CI: [0.03, 0.04]
Comparison: Incidence rate Age 55 to 6495% CI: [0.07, 0.09]
Comparison: Incidence rate Age 65 to 7495% CI: [0.11, 0.14]
Comparison: Incidence rate Age ≥7595% CI: [0.15, 0.21]
Comparison: Odds ratio Age 18 to 3495% CI: [0.06, 0.13]
Comparison: Odds ratio Age 35 to 4495% CI: [0.08, 0.16]
Comparison: Odds ratio Age 45 to 5495% CI: [0.3, 0.45]
Comparison: Odds ratio Age 65 to 7495% CI: [2.68, 5.47]
Comparison: Odds ratio Age ≥7595% CI: [4, 8.22]
Primary
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.
Time frame: 01-January-2003 up to 31-December-2007
Population: Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\]. Only the covariates selected by the step wise regression procedure were summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | Diabetes (n=349, 1,131) / 1,527,818 | 0.23 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | Smoking (n=48, 232) / 313,399 | 0.15 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | Obesity (n=25, 273) / 368,784 | 0.07 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | Nitrates (n=71, 171) / 230,996 | 0.31 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | Anti-platelet agents (n=127, 182) / 245,856 | 0.52 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | Diuretics (n=134, 296) / 399,853 | 0.34 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors | Recent PDE-5 inhibitors use (n=17, 202) / 272,873 | 0.06 incidence rate per 1000 person-years |
Comparison: Incidence rate Diabetes95% CI: [0.08, 0.1]
Comparison: Incidence rate Smoking95% CI: [0.08, 0.14]
Comparison: Incidence rate Obesity95% CI: [0.03, 0.06]
Comparison: Incidence rate Nitrates95% CI: [0.06, 0.09]
Comparison: Incidence rate Anti-platelet agents95% CI: [0.12, 0.18]
Comparison: Incidence rate Diuretics95% CI: [0.09, 0.17]
Comparison: Incidence rate Recent PDE-5 inhibitors use95% CI: [0.01, 0.04]
Comparison: Odds ratio Diabetes95% CI: [1.47, 2.25]
Comparison: Odds ratio Smoking95% CI: [0.63, 2.85]
Comparison: Odds ratio Obesity95% CI: [0.23, 0.81]
Comparison: Odds ratio Nitrates95% CI: [0.42, 0.94]
Comparison: Odds ratio Anti-platelet agents95% CI: [1.53, 2.94]
Comparison: Odds ratio Diuretics95% CI: [1.46, 3.43]
Comparison: Odds ratio Recent PDE-5 inhibitors use95% CI: [0.31, 1.04]
Primary
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.
Time frame: 01-January-2003 up to 31-December-2007
Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year | Year 2003 (n=285, 3953) / 5,339,934 | 0.05 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year | Year 2004 (n=236, 3,990) / 5,389,915 | 0.04 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year | Year 2005 (n=284, 4,137) / 5,588,491 | 0.05 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year | Year 2006 (n=231, 4,081) / 5,512,843 | 0.04 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year | Year 2007 (n=247, 3,839) / 5,185,936 | 0.05 incidence rate per 1000 person-years |
Comparison: Incidence rate Year 200395% CI: [0.04, 0.05]
Comparison: Incidence rate Year 200495% CI: [0.04, 0.05]
Comparison: Incidence rate Year 200595% CI: [0.04, 0.05]
Comparison: Incidence rate Year 200695% CI: [0.04, 0.05]
Comparison: Incidence rate Year 200795% CI: [0.04, 0.05]
Comparison: Odds ratio Year 200495% CI: [0.61, 0.96]
Comparison: Odds ratio Year 200595% CI: [0.58, 0.91]
Comparison: Odds ratio Year 200695% CI: [0.68, 1.12]
Comparison: Odds ratio Year 200795% CI: [0.72, 1.19]
Primary
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).
Time frame: 01-January-2003 up to 31-December-2007
Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Other retinal disorders (n=337, 240) / 324,205 | 1.04 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Glaucoma (n=161, 353) / 476,852 | 0.34 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Cataract (n=245, 405) / 547,097 | 0.45 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Visual disturbances (n=291, 130) / 175,611 | 1.66 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Blindness and low vision (n=103, 11) / 14,859 | 6.93 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Other disorders of eye (n=143, 201) / 271,522 | 0.53 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Occlusion / Stenosis (n=98, 75) / 101,314 | 0.97 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Acute sinusitis (n=92, 1,123) / 1,517,011 | 0.06 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Other dermatoses (n=114, 536) / 724,059 | 0.16 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Bone and cartilage (n=114, 504) / 680,831 | 0.17 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Head and neck (n=181, 771) / 1,041,510 | 0.17 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses | Ill defined / Unknown causes (n=71, 183) / 247,207 | 0.29 incidence rate per 1000 person-years |
Comparison: Incidence rate Other retinal disorders95% CI: [0.28, 0.39]
Comparison: Incidence rate Glaucoma95% CI: [0.11, 0.16]
Comparison: Incidence rate Cataract95% CI: [0.08, 0.41]
Comparison: Incidence rate Visual disturbances95% CI: [0.83, 1.17]
Comparison: Incidence rate Blindness and low vision95% CI: [1.6, 2.46]
Comparison: Incidence rate Other disorders of eye95% CI: [0.16, 0.23]
Comparison: Incidence rate Occlusion and stenosis of precerebral arteries95% CI: [0.18, 0.27]
Comparison: Incidence rate Acute sinusitis95% CI: [0.05, 0.08]
Comparison: Incidence rate Other dermatoses95% CI: [0.05, 0.08]
Comparison: Incidence rate Other disorders of bone and cartilage95% CI: [0.06, 0.1]
Comparison: Incidence rate Symptoms involving head and neck95% CI: [0.1, 0.14]
Comparison: Incidence rate Other ill defined and unknown causes of morbidity and mortality95% CI: [0.1, 0.18]
Comparison: Odds ratio Other retinal disorders95% CI: [4.72, 9.38]
Comparison: Odds ratio Glaucoma95% CI: [1.77, 3.81]
Comparison: Odds ratio Cataract95% CI: [1.02, 1.68]
Comparison: Odds ratio Visual disturbances95% CI: [10.4, 19.3]
Comparison: Odds ratio Blindness and low vision95% CI: [6.6, 34.5]
Comparison: Odds ratio Other disorders of eye95% CI: [1.44, 2.82]
Comparison: Odds ratio Occlusion and stenosis of precerebral arteries95% CI: [0.64, 2.31]
Comparison: Odds ratio Acute sinusitis95% CI: [0.96, 1.74]
Comparison: Odds ratio Other dermatoses95% CI: [1.02, 1.77]
Comparison: Odds ratio Other disorders of bone and cartilage95% CI: [0.98, 1.77]
Comparison: Odds ratio Symptoms involving head and neck95% CI: [1.02, 1.84]
Comparison: Odds ratio Ill defined and unknown causes of morbidity and mortality95% CI: [1.08, 2.49]
Primary
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.
Time frame: 01-January-2003 up to 31-December-2007
Population: Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years \[(n=NAION cases, Controls) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use | Recent use (n=17, 187) / 254,239 | 0.05 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use | Any use (n=32, 322) / 437,780 | 0.06 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use | Chronic use (n=16, 162) / 220,249 | 0.06 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use | Non-chronic use (n=16, 160) / 217,530 | 0.07 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use | Never use (n=631, 5,234) / 7,115,962 | 0.09 incidence rate per 1000 person-years |
Comparison: Incidence rate Recent use95% CI: [0.03, 0.07]
Comparison: Incidence rate Any use (includes chronic and non-chronic use)95% CI: [0.04, 0.08]
Comparison: Incidence rate Chronic use95% CI: [0.03, 0.08]
Comparison: Incidence rate Non-chronic use95% CI: [0.03, 0.11]
Comparison: Incidence rate Never use95% CI: [0.08, 0.1]
Primary
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.
Time frame: 01-January-2003 up to 31-December-2007
Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region | Northeast (n=100, 2,456) / 3,317,702 | 0.03 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region | Midwest (n=362, 5,345) / 7,220,325 | 0.05 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region | South (n=656, 9,158) / 12,371,139 | 0.05 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region | West (n=165, 3,041) / 4,107,953 | 0.04 incidence rate per 1000 person-years |
Comparison: Incidence rate Northeast95% CI: [0.04, 0.06]
Comparison: Incidence rate Midwest95% CI: [0.04, 0.05]
Comparison: Incidence rate South95% CI: [0.05, 0.06]
Comparison: Incidence rate West95% CI: [0.04, 0.05]
Comparison: Odds ratio Northeast95% CI: [0.31, 0.56]
Comparison: Odds ratio Midwest95% CI: [0.56, 0.84]
Comparison: Odds ratio West95% CI: [0.57, 0.93]
Primary
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex
Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.
Time frame: 01-January-2003 up to 31-December-2007
Population: Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years \[(n=NAION cases, Controls) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex | Female (n=595, 10,669) / 14,412,283 | 0.04 incidence rate per 1000 person-years |
| Combined NAION Cases and Controls | Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex | Male (n=688, 9,331) / 12,604,837 | 0.05 incidence rate per 1000 person-years |
Comparison: Incidence rate Female95% CI: [0.04, 0.05]
Comparison: Incidence rate Male95% CI: [0.05, 0.06]
Comparison: Odds ratio Male95% CI: [1.5, 2.22]
Primary
Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Time frame: 01-January-2003 up to 31-December-2007
Population: Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years \[(n=NAION cases) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Age 18 to 64 years (n=2) / 66.63 | 1.00 incidence rate ratio |
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Age ≥65 years (n=1) / 57.39 | 0.62 incidence rate ratio |
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Female (n=1) / 66.05 | 1.00 incidence rate ratio |
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Male (n=2) / 57.97 | 2.03 incidence rate ratio |
Primary
Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Time frame: 01-January-2003 up to 31-December-2007
Population: Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years \[(n=NAION cases) / person-years\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Age ≥65 years (n=9) / 29.94 | 0.56 incidence rate ratio |
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Female (n=14) / 31.69 | 1.00 incidence rate ratio |
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Male (n=13) / 23.77 | 1.22 incidence rate ratio |
| Combined NAION Cases and Controls | Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Age 18 to 64 years (n=18) / 25.53 | 1.00 incidence rate ratio |
Primary
Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
Time frame: 01-January-2003 up to 31-December-2007
Population: Participants from the NAION cases population adjudicated by medical record review.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined NAION Cases and Controls | Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) | Acute | 35 participants |
| Combined NAION Cases and Controls | Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) | Intermittent | 3 participants |
| Combined NAION Cases and Controls | Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) | Chronic | 1 participants |
| Combined NAION Cases and Controls | Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) | Unknown | 35 participants |