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| ID | Type | Description | Link |
|---|---|---|---|
| N01 HC095178-19 | |||
| N01HC095178 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.
DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the United States. It is caused by damage to the blood vessels of the retina, which is the light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high blood sugar levels associated with diabetes. Older people have an increased risk of developing DR; however, DR is likely to occur earlier and be more severe in anyone who has poorly controlled diabetes. Almost everyone who has had diabetes for more than 30 years will eventually show signs of DR. Symptoms of DR include poor night vision, seeing spots in front of the eyes, blurred vision, and blindness. The ACCORD study is a study that is examining the effects of different treatments on cardiovascular disease in people with diabetes. Participants in the ACCORD study will receive one of eight different combinations of treatment, including blood sugar control, blood pressure control, and cholesterol-controlling medication. This study will enroll participants in the ACCORD study and will examine the effects of the study treatments on DR. The results from this study may be used to develop new treatments to help prevent diabetes-related blindness.
Study visits will occur at baseline and Year 4. At each study visit, participants will have an eye exam and specialized fundus photographs taken of the back of the eye and retina.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive glycemia control | Experimental | A strategy of intensive glycemia treatment to HbA1c less than 6% |
|
| Standard glycemia control | Active Comparator | A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% |
|
| Intensive BP control | Experimental | A strategy of BP treatment for SBP less than 120 mm Hg |
|
| Standard BP control | Active Comparator | A strategy of BP treatment for SBP less than 140 mm Hg |
|
| Fibrate | Experimental | Blinded fenofibrate + simvastatin 20-40 mg/d |
|
| Fibrate Placebo | Placebo Comparator | Blinded placebo + simvastatin 20-40 mg/d |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglycemic Agents | Drug | Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher. | Measured at Year 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of Visual Acuity | Measured at Year 4 | |
| Cataract Extraction | Measured at Year 4 | |
| Development or Progression of Macular Edema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter T. Ambrosius, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Emily Y. Chew, MD | National Eye Institute (NEI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Berman Center for Clinical Research | Minneapolis | Minnesota | 55404 | United States | ||
| Columbia University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17599420 | Background | Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M; ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol. 2007 Jun 18;99(12A):103i-111i. doi: 10.1016/j.amjcard.2007.03.028. Epub 2007 Apr 13. | |
| 20587587 | Result | ACCORD Study Group; ACCORD Eye Study Group; Chew EY, Ambrosius WT, Davis MD, Danis RP, Gangaputra S, Greven CM, Hubbard L, Esser BA, Lovato JF, Perdue LH, Goff DC Jr, Cushman WC, Ginsberg HN, Elam MB, Genuth S, Gerstein HC, Schubart U, Fine LJ. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010 Jul 15;363(3):233-44. doi: 10.1056/NEJMoa1001288. Epub 2010 Jun 29. |
| Label | URL |
|---|---|
| Click here for the ACCORD Study Web site | View source |
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All participants were enrolled in either the intensive or standard glycemia control arms. In addition to inclusion in the glycemia control part of the trial, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo).
Recruitment for the ACCORD Eye study was restricted to participants recruited as part of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. The ACCORD Eye study began in October 2003, with 3472 participants enrolled by February 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Glycemia Control & Intensive Blood Pressure Control | Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6% Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg |
| FG001 | Standard Glycemia Control & Intensive Blood Pressure Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard glycemia control | Drug | A strategy of glycemia drugs for HbA1c 7% - 7.9% |
|
| Intensive BP treatment | Drug | A strategy of multiple BP agents to reduce SBP less than 120 mm Hg |
|
| Standard BP control | Drug | A strategy of BP drugs for SBP less than 140 mm Hg |
|
| Fenofibrate | Drug | Blinded fenofibrate |
|
| Simvastatin | Drug | Simvastatin 20-40 mg/d |
|
| Placebo | Drug | Placebo |
|
| Measured at Year 4 |
| New York |
| New York |
| 10032 |
| United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106-4951 | United States |
| Veterans Affairs | Memphis | Tennessee | 38104-2193 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| McMaster University | Hamilton | Ontario | L8L 2X2 | Canada |
| 36975019 | Derived | Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3. |
| 27289122 | Derived | Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Eye Study Group and the Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Study Group. Persistent Effects of Intensive Glycemic Control on Retinopathy in Type 2 Diabetes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-On Study. Diabetes Care. 2016 Jul;39(7):1089-100. doi: 10.2337/dc16-0024. Epub 2016 Jun 11. |
| 25172198 | Derived | Chew EY, Davis MD, Danis RP, Lovato JF, Perdue LH, Greven C, Genuth S, Goff DC, Leiter LA, Ismail-Beigi F, Ambrosius WT; Action to Control Cardiovascular Risk in Diabetes Eye Study Research Group. The effects of medical management on the progression of diabetic retinopathy in persons with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. Ophthalmology. 2014 Dec;121(12):2443-51. doi: 10.1016/j.ophtha.2014.07.019. Epub 2014 Aug 29. |
| 22709833 | Derived | Wong TY, Simo R, Mitchell P. Fenofibrate - a potential systemic treatment for diabetic retinopathy? Am J Ophthalmol. 2012 Jul;154(1):6-12. doi: 10.1016/j.ajo.2012.03.013. |
| 20212201 | Derived | Ambrosius WT, Danis RP, Goff DC Jr, Greven CM, Gerstein HC, Cohen RM, Riddle MC, Miller ME, Buse JB, Bonds DE, Peterson KA, Rosenberg YD, Perdue LH, Esser BA, Seaquist LA, Felicetta JV, Chew EY; ACCORD Study Group. Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy. Arch Ophthalmol. 2010 Mar;128(3):312-8. doi: 10.1001/archophthalmol.2009.310. |
Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg |
| FG002 | Intensive Glycemia Control & Standard Blood Pressure Control | Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6% Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg |
| FG003 | Standard Glycemia Control & Standard Blood Pressure Control | Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg |
| FG004 | Intensive Glycemia Control & Fibrate | Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6% Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d |
| FG005 | Standard Glycemia Control & Fibrate | Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d |
| FG006 | Intensive Glycemia Control & Fibrate Placebo | Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6% Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d |
| FG007 | Standard Glycemia Control & Fibrate Placebo | Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Glycemia Control | A strategy of intensive glycemia treatment to HbA1c less than 6% |
| BG001 | Standard Glycemia Control | A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% |
| BG002 | Intensive BP Control | A strategy of BP treatment for SBP less than 120 mm Hg |
| BG003 | Standard BP Control | A strategy of BP treatment for SBP less than 140 mm Hg |
| BG004 | Fibrate | Blinded fenofibrate + simvastatin 20-40 mg/d |
| BG005 | Fibrate Placebo | Blinded placebo + simvastatin 20-40 mg/d |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Count of Participants | Participants |
| ||||||||||
| Duration of diabetes | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | year |
| |||||||||
| Previous cardiovascular event | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Count of Participants | Participants |
| ||||||||||
| Race | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Count of Participants | Participants |
| ||||||||||
| Glycated hemoglobin | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | percent |
| |||||||||
| Cholesterol (HDL) | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | mg/dl |
| |||||||||
| Cholesterol (LDL) | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | mg/dl |
| |||||||||
| Triglycerides | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | mg/dl |
| |||||||||
| Systolic Blood pressure | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | mm Hg |
| |||||||||
| Diastolic Blood Pressure | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | mm Hg |
| |||||||||
| Urinary albumin:creatinine ratio | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | albumin (mg/dL): creatinin (g/dL) |
| |||||||||
| BMI | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | kg/m^2 |
| |||||||||
| Visual acuity | Visual acuity is defined as a mean of the acuity scores for both eyes of 74 to 78 letters (the approximate Snellen equivalent of 20/30) | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Mean | Standard Deviation | letters |
| ||||||||
| Smoking status | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Count of Participants | Participants |
| ||||||||||
| Severity of Diabetic Retinopathy | Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher. | All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy | Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher. | The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses. | Posted | Number | participants | Measured at Year 4 |
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| Secondary | Loss of Visual Acuity | Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity. | Posted | Count of Participants | Participants | Measured at Year 4 |
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| Secondary | Cataract Extraction | Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction. | Posted | Count of Participants | Participants | Measured at Year 4 |
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| Secondary | Development or Progression of Macular Edema | Posted | Count of Participants | Participants | Measured at Year 4 |
|
Entire duration of the study
Adverse events were collected as part of the ACCORD main trial (NCT00000620). No adverse events were collected as part of the ACCORD-Eye Study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Glycemia Control | A strategy of intensive glycemia treatment to HbA1c less than 6% | 0 | 0 | 0 | 0 | ||
| EG001 | Standard Glycemia Control | A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% | 0 | 0 | 0 | 0 | ||
| EG002 | Intensive BP Control | A strategy of BP treatment for SBP less than 120 mm Hg | 0 | 0 | 0 | 0 | ||
| EG003 | Standard BP Control | A strategy of BP treatment for SBP less than 140 mm Hg | 0 | 0 | 0 | 0 | ||
| EG004 | Fibrate | Blinded fenofibrate + simvastatin 20-40 mg/d | 0 | 0 | 0 | 0 | ||
| EG005 | Fibrate Placebo | Blinded placebo + simvastatin 20-40 mg/d | 0 | 0 | 0 | 0 |
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The glycemia trial was stopped early, potentially underestimating the reported effect of glycemia treatment on diabetic retinopathy.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Walter Ambrosius, PhD | Wake Forest University School of Medicine | 336-716-6281 | wambrosi@wakehealth.edu |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007004 | Hypoglycemic Agents |
| D011345 | Fenofibrate |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Blood Pressure and Lipid Studies |
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| Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control | Regression, Logistic | Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis | 0.29 | Odds Ratio (OR) | 1.23 | 2-Sided | 95 | 0.84 | 1.79 | Superiority or Other |
| Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone | Regression, Logistic | Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis | 0.006 | Odds Ratio (OR) | 0.60 | 2-Sided | 95 | 0.42 | 0.87 | Superiority or Other |
| OG005 | Placebo + Simvastatin Therapy | Blinded placebo + simvastatin 20-40 mg/d |
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| OG005 | Placebo + Simvastatin Therapy | Blinded placebo + simvastatin 20-40 mg/d |
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Blinded placebo + simvastatin 20-40 mg/d |
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| Male |
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| No previous cardiovascular event |
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| White race |
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| Former Smoker |
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| Current Smoker |
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| Missing |
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| Mild |
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| Moderate Nonproliferative Diabetic Retinopathy |
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| Severe Nonproliferative Diabetic Retinopathy |
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| Proliferative diabetic retinopathy |
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| Missing |
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