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  ["project_title"]=>
  string(141) "Do SGLT2 inhibitors reduce the risk of knee and hip replacements for osteoarthritis compared to placebo: a secondary analysis of SGLT2 Trials"
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  string(784) "A major driver of osteoarthritis (OA) pain is inflammation. While some anti-inflammatory drugs have been tested for osteoarthritis, these drugs have mostly targeted a single path within a complex inflammatory cascade. Some drugs that are currently used for other diseases have broader anti-inflammatory effects. Among these is SGLT2 drugs. This class of drugs developed for diabetes has been found to be effective in preventing progressive kidney disease, in lessening the risk of heart disease, and in preventing a related arthritis disorder, gout. The goal of the proposed study is to see if SGLT2 drugs reduce the risk of end stage osteoarthritis by seeing if patients on these drugs in a randomized trial get fewer knee and hip replacement for OA than those randomized to placebo."
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    ["first_name"]=>
    string(5) "David"
    ["last_name"]=>
    string(6) "Felson"
    ["degree"]=>
    string(7) "MD, MPH"
    ["primary_affiliation"]=>
    string(17) "Boston University"
    ["email"]=>
    string(14) "dfelson@bu.edu"
    ["state_or_province"]=>
    string(2) "MA"
    ["country"]=>
    string(13) "United States"
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      ["p_pers_f_name"]=>
      string(17) "Yuqing (Angelica)"
      ["p_pers_l_name"]=>
      string(2) "Li"
      ["p_pers_degree"]=>
      string(3) "MPH"
      ["p_pers_pr_affil"]=>
      string(17) "Boston University"
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      ["requires_data_access"]=>
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    ["label"]=>
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  ["project_funding_source"]=>
  string(16) "NIH P30 AR072571"
  ["project_date_type"]=>
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  ["property_scientific_abstract"]=>
  string(1635) "Background: Osteoarthritis is a common inflammatory disorder with no disease-modifying therapies. Whether SGLT2 inhibition can reduce the consequences of large joint osteoarthritis is unclear

Objective: To determine whether SGLT2 inhibition reduces incident total hip or knee replacement (THR/TKR) for osteoarthritis

Design: Secondary analysis of SGLT2 vs placebo trials with at least 2 year median follow-up

Participants: Deidentified participants in SGLT2 trials (active treatment and placebo) who had THR/TKR noted in trial database

Outcome Measures: The primary outcome measure will be TKR. THR will be a secondary outcome

Statistical analysis: Our first step is to assess whether this project is feasible by determining whether the trials have data on THR/TKR and its date. If the data show this effort is feasible, we will carry out a Cox proportional hazards models to estimate hazard ratios (HRs) and 95% CIs for the primary analysis of time to first incident THR/TKR for all SGLT2 doses combined vs. placebo. All analyses will be performed on an intention-to-treat basis. Individual participant follow-up time will be censored at the time of death, loss to follow-up, or withdrawal of consent; participants who had THR/TKR due to acute fracture or in a joint with previous arthroplasty will not be censored because other joints are still at risk. In addition to the primary analysis including the full trial cohort, sensitivity analyses will be performed that exclude participants with a history of gout, gouty arthritis, psoriatic arthritis or rheumatoid arthritis at baseline if identified"
  ["project_brief_bg"]=>
  string(3228) "Osteoarthritis (OA) is the most common form of arthritis with joint pain from OA affecting roughly 600 million persons worldwide. It affects mostly older persons and is a leading cause of disability. Non-surgical treatment for OA of the knees/hips, the most commonly symptomatic joints, has been disappointing, and there are no approved treatments that reduced disease progression and also diminish pain. Affected patients seek knee/hip replacements when pain is severe and non-surgical treatments have failed. Rates of knee/hip replacements are rising rapidly in both US and European countries because of the aging populations, increasing rates of obesity, and because of the paucity of effective nonsurgical treatments. New treatments are urgently needed.

The goal of the proposed study is to see if SGLT2i drugs reduce the risk of end stage osteoarthritis by seeing if patients on these drugs in a randomized trial get fewer knee and hip replacement for osteoarthritis than those randomized to placebo.

It's very challenging to identify drugs that may be effective in treating OA. Animal models of disease have identified promising treatments but testing these treatments in humans has required large studies with long follow-ups (cartilage loss occurs slowly), and these studies have been frustratingly negative. The greatest promise has emerged recently from a large trial of GLP1 agonists which causes major weight loss reducing the obesity that is a major risk factor for disease. GLP1 agonists not only cause weight loss that also serve as pleiotropic anti-inflammatory medications which may account for some of their efficacy.

SGLT2 inhibitors have promise as a treatment for osteoarthritis. While they cause modest weight loss, they have pleiotropic effects on inflammation and also promote the conversion of monocytes to the M2 antiinflammatory macrophage phenotype. There is evidence that they are effective in gout, a related disorder. In recent work, it's reported that persons starting SGLT2 inhibitors have a modestly lower risk of new total knee/hip replacements than persons starting GLP1 agonists. The subset of GLP1 users starting semaglutide had a roughly equivalent risk of THR and TKR compared with SGLT2 inhibitors. Those on earlier GLP1 agonists which caused much less weight loss had a higher risk of THR and TKR than those starting SGLT2 inhibitors. These findings suggest that SGLT2 inhibitors may have therapeutic efficacy for OA.

The outcomes we propose for this study are THR and TKR, not reports of osteoarthritis. In our experience 1st Claims for OA do not usually represent incident disease. Since OA is a slowly evolving disorder, the date of incidence is very hard to estimate or define. By using THR and TKR outcomes, we can use outcomes that are not only clinically relevant but can be dated precisely. Given the high burden of OA in the community and the paucity of effective treatments, the identification of a treatment already approved and widely used that may have an additional indication would be of substantial significance. For frustrated patients who have been unable to find effective treatments for their pain, SGLT2i could provide a valuable option."
  ["project_specific_aims"]=>
  string(611) "The overall objective of this project is to determine if, based on trial data, those randomized to SGLT2 drugs have a lower rate of THR/TKR for osteoarthritis than those randomized to placebo.

Aim 1. To determine if data available from trial datasets will identify participants undergoing THR or TKR surgeries with the date and will provide information about indication for the surgery.  H1: The trial data sets will provide information on THR/TKR in the adverse events files.

Aim 2. To determine if rates of THR/TKR were lower on SGLT2 trial participants than those randomized to placebo.

"
  ["project_study_design"]=>
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    ["label"]=>
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      ["label"]=>
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  string(262) "All trials will be from the YODA project. All patients randomized in these trials will be included with no exclusions. 

The 3 trials of interest for this project are:

NCT01032629

NCT02065791

NCT01989754







"
  ["project_main_outcome_measure"]=>
  string(172) "The primary outcome will be total knee replacement (TKR) surgery and its date

The secondary outcome will be total hip replacement (THR) surgery and its date.

"
  ["project_main_predictor_indep"]=>
  string(122) "The main predictor for these analysis will be treatment, whether the patient was randomized to SGLT2 inhibitor or placebo."
  ["project_other_variables_interest"]=>
  string(319) "In addition to the primary analysis including the full trial cohort, sensitivity analyses will be performed that exclude participants with a history of gout, gouty arthritis, psoriatic arthritis or rheumatoid arthritis at baseline if identified. 



No covariates will be added to the model.



"
  ["project_stat_analysis_plan"]=>
  string(1447) "Our first step is to assess whether this project is feasible by determining whether the trials have data on THR/TKR and its date. 



If the data show this effort is feasible, for each trial, we will carry out a Cox proportional hazards models to estimate hazard ratios (HRs) and 95% CIs for the primary analysis of time to first TKR for all SGLT2 doses combined vs. placebo. All analyses will be performed on an intention-to-treat basis. Individual participant follow-up time will be censored at the time of death, loss to follow-up, or withdrawal of consent. After the analysis of the primary outcome, TKR, we will carry out a similar analysis of THR, the secondary outcome. If the indication for the surgery is available from the datasets, we will restrict all analyses above to surgery for osteoarthritis. The central outcome measure will be the hazard ratio of risk of TKR in those randomized to SGLT2 vs. placebo. If addition, we will construct Kaplan-Meier curves to display the results over time. 



Participants who had THR/TKR due to acute fracture or in a joint with previous arthroplasty will not be censored because other joints are still at risk. In addition to the primary analysis including the full trial cohort, sensitivity analyses will be performed that exclude participants with a history of gout, gouty arthritis, psoriatic arthritis or rheumatoid arthritis at baseline if identified.



"
  ["project_software_used"]=>
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      ["label"]=>
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      ["label"]=>
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    [2]=>
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      ["label"]=>
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  ["project_timeline"]=>
  string(37) "January 31, 2026 – January 30, 2027"
  ["project_dissemination_plan"]=>
  string(494) "The deliverable will be abstracts presented at scientific meetings, especially the American College of Rheumatology (ACR) and the Osteoarthritis Research Society International (OARSI). We will target presentations at these meetings in 2027 at the latest.

The manuscript reporting main findings will be submitted to a general medical journal such as the Annals of Internal Medicine and secondarily to Arthritis and Rheumatology, the leading Rheumatology journal in the US.



"
  ["project_bibliography"]=>
  string(1788) "

Schieker M, Conaghan PG, Mindeholm L, et al. Effects of interleukin-1β inhibition on incident hip and knee replacement: Exploratory analyses from a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2020;173(7):509-515. doi:10.7326/M20-0527
Baker K, Grainger A, Niu J, et al. Relation of synovitis to knee pain using contrast-enhanced MRIs. Ann Rheum Dis. 2010;69(10):1779-1783. doi:10.1136/ard.2009.121426
Felson DT, Niu J, Neogi T, et al. Synovitis and the risk of knee osteoarthritis: The MOST Study. Osteoarthritis Cartilage. 2016;24(3):458-464. doi:10.1016/j.joca.2015.09.013
Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of osteoarthritis: latest findings and interpretations. Ther Adv Musculoskelet Dis. 2013;5(2):77-94. doi:10.1177/1759720X12467868
Clementi E, Corbi G, Boccardi V, Scisciola L. Anti-Inflammatory Role of SGLT2 Inhibitors as Part of Their Anti-Atherosclerotic Activity: Data from Basic Science and Clinical Trials.
McCormick N, Yokose C, Lu N, et al. Sodium-Glucose Cotransporter-2 Inhibitors vs Sulfonylureas for Gout Prevention Among Patients With Type 2 Diabetes Receiving Metformin. JAMA Intern Med. 2024;184(6):650-660. doi:10.1001/jamainternmed.2024.0376
Denoble AE, Huffman KM, Stabler T V., et al. Uric acid is a danger signal of increasing risk for osteoarthritis through inflammasome activation. Proc Natl Acad Sci U S A. 2011;108(5):2088-2093. doi:10.1073/pnas.1012743108
Bliddal H, Bays H, Czernichow S, et al. Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis. N Engl J Med. 2024;391(17):1573-1583. doi:10.1056/NEJMoa2403664

 
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    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
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  ["project_review_link"]=>
  array(21) {
    ["ID"]=>
    int(18761)
    ["id"]=>
    int(18761)
    ["title"]=>
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    ["filename"]=>
    string(38) "YODA-Project-Review-2026-0036_site.pdf"
    ["filesize"]=>
    int(1331955)
    ["url"]=>
    string(87) "https://yoda.yale.edu/wp-content/uploads/2026/01/YODA-Project-Review-2026-0036_site.pdf"
    ["link"]=>
    string(80) "https://yoda.yale.edu/data-request/2026-0036/yoda-project-review-2026-0036_site/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(34) "yoda-project-review-2026-0036_site"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(18605)
    ["date"]=>
    string(19) "2026-02-13 15:03:22"
    ["modified"]=>
    string(19) "2026-02-13 15:03:22"
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    int(0)
    ["mime_type"]=>
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    ["type"]=>
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    ["subtype"]=>
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    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_highlight_button"]=>
  string(0) ""
  ["request_data_partner"]=>
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}
data partner
array(1) {
  [0]=>
  string(0) ""
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(0) {
}


num of trials
array(1) {
  [0]=>
  string(1) "0"
}


res
array(1) {
  [0]=>
  string(1) "3"
}