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More diabetic foot amputations in those on Canagliflozin

Discussion in 'Diabetic Foot & Wound Management' started by NewsBot, May 19, 2016.

  1. NewsBot

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    Members do not see these Ads. Sign Up.
    Press reelase:
    Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
     
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    The Brits have now issued their warning:
    https://www.gov.uk/drug-safety-upda...in-trial-in-high-cardiovascular-risk-patients
     
  3. Admin2

    Admin2 Administrator Staff Member

    Canagliflozin

    Canagliflozin, sold under the brand name Invokana among others, is a medication used to treat type 2 diabetes.[2] It is used together with exercise and diet.[2] It is not recommended in type 1 diabetes.[2] It is taken by mouth.[2]

    Common side effects include vaginal yeast infections, nausea, constipation, and urinary tract infections.[2] Serious side effects may include low blood sugar, Fournier's gangrene, leg amputation, kidney problems, high blood potassium, and low blood pressure.[2] Diabetic ketoacidosis may occur despite nearly normal blood sugar levels.[2] Use in pregnancy and breastfeeding is not recommended.[1] Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor.[2] It works by increasing the amount of glucose lost in the urine.[2]

    Canagliflozin was approved for medical use in the United States, in the European Union, and in Australia in 2013.[2][3][4][5] It is on the World Health Organization's List of Essential Medicines.[6]

    1. ^ a b "Canagliflozin (Invokana) Use During Pregnancy". Drugs.com. Retrieved 6 April 2019.
    2. ^ a b c d e f g h i j "Canagliflozin Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved 6 April 2019.
    3. ^ Cite error: The named reference FDA approval was invoked but never defined (see the help page).
    4. ^ Cite error: The named reference Invokana EPAR was invoked but never defined (see the help page).
    5. ^ "Australian Public Assessment Report for Canagliflozin (as hemihydrate)" (PDF). Therapeutic Goods Administration (TGA). 31 March 2014. Retrieved 28 August 2020.
    6. ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
     
  4. NewsBot

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    Medscape are reporting:
    EMA: Amputation Warning With SGLT2 Inhibitors Must Be on Label
     
  5. NewsBot

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    New Update from gov.uk:
    SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes)

     
  6. NewsBot

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    FDA Warning:
    Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations
    [Posted 05/16/2017]
    ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

    Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.

    BACKGROUND: This information is an update to the May 18, 2016 MedWatch safety alert. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

    RECOMMENDATION: Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.

    Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    Complete and submit the report Online: www.fda.gov/MedWatch/report
    Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
     
  7. NewsBot

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    Still an effective drug:

    INVOKANA® (canagliflozin) Significantly Reduces the Combined Risk of Cardiovascular Death, Myocardial Infarction, and Stroke in the CANVAS Programme
    Study results published in the New England Journal of Medicine and discussed in special symposium at the American Diabetes Association 77th Scientific Sessions

    June 13, 2017 05:19 AM Eastern Daylight Time
    BEERSE, Belgium--(BUSINESS WIRE)--Janssen-Cilag International NV today announced results from the CANVAS Programme which showed INVOKANA® (canagliflozin) when added to standard of care significantly reduced the combined risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), and nonfatal stroke by 14%, versus placebo in patients with type 2 diabetes mellitus (T2DM) at risk for or with a history of CV disease. The results also showed canagliflozin treatment was associated with a reduced risk of hospitalisation for heart failure and demonstrated potential renal protective effects. These data from the integrated analysis of the CANVAS and CANVAS-R trials were published in the New England Journal of Medicine, and presented in a special symposium at the American Diabetes Association 77th Scientific Sessions on Monday, June 12th, in San Diego, CA.

    Canagliflozin was studied in one of the largest completed CV outcomes programme of any sodium glucose cotransporter-2 (SGLT2) inhibitor. The CANVAS Programme is the first to assess the long-term efficacy and safety of canagliflozin in more than 10,000 patients with T2DM, who had either a prior history of CV disease, or at least two CV risk factors.

    The International Diabetes Federation estimates that, in 2015, over 59 million people were living with diabetes in Europe.1 If left uncontrolled, T2DM can lead to serious long-term microvascular and macrovascular complications.

    Canagliflozin achieved a 14% reduction in the risk of the composite primary endpoint of CV death, nonfatal MI, or nonfatal stroke (Hazard Ratio - HR: 0.86; 95% Confidence Interval - CI: 0.75 to 0.97), and demonstrated an improved cardiovascular safety profile compared to placebo (p<0.0001 for non-inferiority) and superiority compared to placebo (p=0.0158). Each component evenly contributed to this risk reduction, including nonfatal MI by 15% (HR: 0.85; 95% CI: 0.69 to 1.05), CV death by 13% (HR: 0.87; 95% CI: 0.72 to 1.06), and nonfatal stroke by 10% (HR: 0.90; 95% CI: 0.71 to 1.15). These outcomes were broadly consistent across various patient subgroups, and across the individual components of the primary endpoint.2

    Additional analysis further revealed canagliflozin lowered the risk of hospitalization for heart failure by 33% (HR: 0.67; 95% CI: 0.52 to 0.87) and provided sustained positive effects on glycemic and blood pressure control, as well as weight reduction, demonstrating wide-ranging durability.2

    In addition, canagliflozin showed potential renal protective effects, delaying progression of albuminuria and reducing the risk of clinically important renal composite outcomes (such as 40% reduction of estimated glomerular filtration rate (eGFR), renal death, or renal replacement therapy) by 40% (HR: 0.60; 95% CI: 0.47 to 0.77). The ongoing, fully enrolled CREDENCE study, the first dedicated SGLT2 inhibitor renal outcome trial in patients with T2DM and kidney disease, is further evaluating the effects of canagliflozin on renal and CV outcomes.

    “Patients with diabetes are two to four times more likely to suffer from associated comorbidities such as heart failure and kidney disease, and the CANVAS results demonstrate the potential of canagliflozin in reducing the risk for such conditions in high-risk type 2 diabetes patients,” said David Matthews, CANVAS Steering Committee co-chair, and Professor of Diabetic Medicine and Honorary Consultant Physician, University of Oxford. “These data are promising as they suggest canagliflozin may offer potential benefits for patients with type 2 diabetes, who are also facing complications from, or are at risk for, hospitalization for heart failure or kidney disease.”

    Overall adverse events seen in the CANVAS Programme were consistent with previous findings. An increased risk of amputation with canagliflozin was seen in both the completed CANVAS study and in the CANVAS-R study. This is consistent with the observation made by the study’s Independent Data Monitoring Committee (IDMC) in 2016, and the data shared with Health Authorities and Health Care Professionals. There was an increased risk of amputation (6.3 vs. 3.4/1000 patient-years) corresponding to a hazard ratio (HR) of 1.97. The highest absolute risk of amputation occurred in patients with a prior history of amputation or peripheral vascular disease, but the relative risk for amputation with canagliflozin was comparable across these subgroups. A warning of the potential increased risk of toe amputation is being included in the prescribing information for SGLT2 inhibitors in the European Union and the risk has been included in the canagliflozin EU Summary of Product Characteristics (SmPC).

    Separately, while an increased risk of adjudicated low trauma fracture was identified in the CANVAS study, no increase was observed in the CANVAS-R study. A full assessment is ongoing to provide a complete safety review of the CANVAS and CANVAS-R results.

    “The results of the CANVAS Programme are extremely exciting for us at Janssen and the wider diabetes community,” said Jose Antonio Buron Vidal, Vice-President Medical Affairs, Janssen Europe, Middle-East and Africa. “Janssen has an ongoing commitment to address unmet needs in the treatment of type 2 diabetes and the positive and broad benefit-risk profile demonstrated here with canagliflozin reinforces our commitment to exploring the potential of canagliflozin in additional patient populations.”
     
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    What's all the fuss about canagliflozin?
     
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    Risks of Diabetic Foot Syndrome and Amputation associated with Sodium Glucose Co-transporter 2 Inhibitors: A Meta-analysis of Randomized Controlled Trials
    Li. Dandan et al
    Diabetes & Metabolism; 3 February 2018
     
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    Risk of Amputations Associated with SGLT2 Inhibitors Compared to DPP-4 Inhibitors: A Propensity-Matched Cohort Study.
    Adimadhyam S et al
    Diabetes Obes Metab. 2018 Jul 3.
     
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    SGLT2 inhibitors in Type 1 diabetes: is this the future?
    Herring R et al
    Diabet Med. 2018 Aug 8. doi: 10.1111/dme.13791.
     
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    Association Between Sodium-Glucose Cotransporter 2 Inhibitors and Lower Extremity Amputation Among Patients With Type 2 Diabetes.
    Chang HY et al
    JAMA Intern Med. 2018 Aug 13. doi: 10.1001/jamainternmed.2018.3034.
     
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    PUBLIC RELEASE: 31-DEC-2018
    Canagliflozin not associated with increased risk for fracture
    Abstract: http://annals.org/aim/article/doi/10.7326/M18-0567
    Editorial: http://annals.org/aim/article/doi/10.7326/M18-3550
    Compared with a glucagon-line peptide-1 (GLP-1) agonist, canagliflozin was not associated with an increased risk for fracture in patients with type 2 diabetes at relatively low risk for fracture. Findings from a multidatabase cohort study are published in Annals of Internal Medicine.

    Sodium-glucose cotransporter-2 (SGLT2) inhibitors promote glycosuria, resulting in possible effects on calcium, phosphate, and vitamin D homeostasis. Some studies suggest that canagliflozin, an SGLT2 inhibitor, is associated with decreased bone mineral density and a potential increased risk for fracture, which is important because people with type 2 diabetes are already at higher risk. These conflicting study results raise challenges in counseling patients prescribed canagliflozin about the risk for fracture.

    Researchers from Brigham and Women's Hospital reviewed two U.S. commercial health care databases providing data on more than 70 million patients from March 2013 to October 2015 to estimate risk for nonvertebral fracture among new users of canagliflozin. Dr Mike Fralick, the study's lead author, indicated that the overall rate of fracture was similarly low among patients with type 2 diabetes who were treated with canagliflozin or a GLP-1 agonist. Findings were robust across multiple sensitivity and subgroup analyses and the study population is representative of a meaningful proportion of commercially insured patients with diabetes in the U.S. population.

    According to the researchers, these results should be reassuring to patients and physicians who are considering the potential risks and benefits of canagliflozin. An accompanying editorial from the University of Manitoba supports this conclusion and stresses the importance of these real-world findings. However, the editorialists write that caution may still be appropriate when using canagliflozin in older patients who have high fracture risk, with particular attention given to hydration status and fall risk.
     
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    Effects of canagliflozin on amputation risk in type 2 diabetes: the CANVAS Program.
    Matthews DR et al
    Diabetologia. 2019 Mar 12
     
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    Canagliflozin and Amputation Risk: Evidence So Far.
    Papadokostaki E et al
    Int J Low Extrem Wounds. 2019 Nov 8
     
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    The Effect of Canagliflozin on Amputation Risk in the CANVAS Program and the CREDENCE Trial
    Clare Arnott et al
    Diabetes Obes Metab. 2020 May 21
     
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    NEWS RELEASE 16-NOV-2020
    SCORED and SOLOIST trials add to evidence for treating diabetes with SGLT2 inhibitors
    SCORED trial of patients with diabetes and chronic kidney disease is first trial of an SGLT2 inhibitor to show benefit across the full range of albuminuria; SOLOIST shows an SGLT2 inhibitor is safe to start in patients hospitalized with heart failure


    Boston, MA -- Less than a decade ago, the Food and Drug Administration approved drugs for treating type 2 diabetes in an entirely new way. Since that time, evidence in favor of the use of sodium/glucose cotransporter 2 (SGLT2) inhibitors has been mounting, with studies showing better blood glucose control, cardiovascular benefits, weight loss and more for patients with diabetes taking SGLT2 inhibitors. Now, two large clinical trials, conducted by investigators at Brigham and Women's Hospital and sponsored by Lexicon Pharmaceuticals, add new evidence about the benefits for patients with diabetes and chronic kidney disease as well as those with diabetes and recent worsening heart failure. In these two paired trials, teams of investigators led by Brigham cardiologist Deepak L. Bhatt, MD, MPH, evaluated sotagliflozin, a drug that inhibits SGLT2 and SGLT1. Results of the trials are both published in The New England Journal of Medicine and presented by Bhatt simultaneously at the Late-Breaking Clinical Trial Sessions of the American Heart Association Scientific Sessions.

    "With the results of these large two trials, adding to other recent data about drugs in this class, it is now clear that most patients with type 2 diabetes and either kidney disease or heart failure should be on an SGLT2 inhibitor," said Bhatt, the executive director of Interventional Cardiovascular Programs at the Brigham. "SCORED provides further randomized clinical trial evidence that SGLT2 inhibitors should be part of the standard of care for patients with type 2 diabetes mellitus and kidney disease. And SOLOIST demonstrates that early, in-hospital initiation of SGLT2 inhibitors is safe, effective, and should become the standard of care in patients with type 2 diabetes mellitus and heart failure."

    Sotagliflozin, developed by Sanofi and transferred to Lexicon Pharmaceuticals, inhibits not only SGLT2 but also SGLT1. SGLT2 inhibition helps the body eliminate blood sugar via urine, while SGLT1 inhibition leads to blood sugar reduction via the digestive tract.

    In the Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) trial, investigators evaluated whether sotagliflozin could prevent cardiovascular events in patients with diabetes with chronic kidney disease. They performed a multicenter, double-blind trial, which enrolled 10,584 patients who were followed for an average of 16 months. The trial ended early due to COVID-related loss of funding. While blinded to data, the authors changed the primary endpoint; however, the initial endpoint also reached statistical significance.

    Unlike previous trials, SCORED enrolled patients across the full range of albuminuria -- leakage of protein into the urine that can happen when a person has diabetes. Sotagliflozin significantly reduced the primary endpoint of total occurrences of cardiovascular deaths, hospitalizations for heart failure, or urgent visits for heart failure regardless of the patient's degree of albuminuria by about 26 percent. As well, sotagliflozin reduced the rate of cardiovascular death, myocardial infarction, or stroke, with an early benefit potentially mediated by the SGLT1 action. There was also a reduction in the total number of fatal or non-fatal heart attacks and the total number of fatal or non-fatal strokes by 32 percent and 34 percent, respectively.

    "SCORED is the first trial to show the benefits of SGLT2 inhibitors across the full range of albuminuria," said Bhatt. "It is also the first trial of an SGLT2 inhibitor to show a beneficial effect on stroke."

    The Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trial enrolled 1,222 patients with type 2 diabetes mellitus and recent worsening heart failure requiring hospitalization. Patients were randomized to sotagliflozin or placebo and followed for an average of nine months. The trial was ended early due to loss of funding from the sponsor during the COVID-19 pandemic. Data from the patients who took part in the trial showed a significant 33 percent reduction in the study's primary endpoint -- the total occurrences of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure -- for patients with either heart failure with reduced or preserved ejection fraction. Taking the drug prior to hospital discharge was safe and effective.

    "SOLOIST is the first large randomized trial to show the safety and efficacy of SGLT2 inhibitors when initiated in patients hospitalized with acute heart failure," said Bhatt. "Thus, it really changes the field and supports early initiation of this class of drugs."

    ###

    Limitations of SCORED and SOLOIST include premature cessation due to loss of funding that led to an inability to complete the intended duration of follow-up. However, both trials found statistically significant declines in rates of total cardiovascular events for their respective patient populations.

    The original sponsor of SCORED and SOLOIST was Sanofi. Sponsorship was transferred to Lexicon Pharmaceuticals as of January 30, 2020.

    Bhatt receives research funding paid to Brigham and Women's Hospital from Sanofi and Lexicon for his role as the study chairman of SCORED and SOLOIST.

    Papers cited:

    Bhatt DL et al. "Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease" NEJM DOI: 10.1056/NEJMoa2030186

    Bhatt DL et al. "Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure" NEJM DOI: 10.1056/NEJMoa2030183

    Brigham Health, a global leader in creating a healthier world, consists of Brigham and Women's Hospital, Brigham and Women's Faulkner Hospital, the Brigham and Women's Physicians Organization and many related facilities and programs. With more than 1,000 inpatient beds, approximately 60,000 inpatient stays and 1.7 million outpatient encounters annually, Brigham Health's 1,200 physicians provide expert care in virtually every medical and surgical specialty to patients locally, regionally and around the world. An international leader in basic, clinical and translational research, Brigham Health has nearly 5,000 scientists, including physician-investigators, renowned biomedical researchers and faculty supported by over $700 million in funding. The Brigham's medical preeminence dates back to 1832, and now, with 19,000 employees, that rich history is the foundation for its commitment to research, innovation, and community. Boston-based Brigham and Women's Hospital is a teaching affiliate of Harvard Medical School and dedicated to educating and training the next generation of health care professionals. For more information, resources, and to follow us on social media, please visit brighamandwomens.org.
     
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    SGLT2 inhibitors and lower limb complications: an updated meta-analysis
    Chu Lin et al
    Cardiovasc Diabetol. 2021 Apr 28;20(1):91
     
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    Effect of SGLT2 inhibitors versus DPP4 inhibitors or GLP-1 agonists on diabetic foot-related extremity amputation in patients with T2DM: A meta-analysis
    YapingDuLeiBaiBinggeFanHaixiaDingHaiyanDingLinHouHongfangMaNaXingFujunWang
    Primary Care Diabetes; 18 December 2021
     
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    News Release 1-Jun-2022
    Newer class of type 2 diabetes drugs decreased risk for hospitalization for heart failure
    In cardiovascular outcome trials among adults with type 2 diabetes (T2D), sodium-glucose co-transporter 2 inhibitors (SGLT-2i) have shown therapeutic promise, including reduced risk of hospitalization for heart failure compared to placebo. However, SGLT-2i have mainly been evaluated as a second-line treatment — metformin is generally given as a first-line, antidiabetic treatment. In a new study, researchers from the Brigham compared cardiovascular outcomes among adults with T2D who initiated first-line treatment with either metformin or SGLT-2i. For the study, 8,613 patients treated with SGLT-2i were matched to 17,226 patients treated with metformin. The authors found that patients receiving SGLT-2i showed a similar risk for myocardial infarction, stroke, and all-cause mortality, and a lower risk for hospitalization for heart failure compared with patients who received metformin. The risk for adverse events was similar except for an increased risk for genital infections compared with those receiving metformin.

    “Our results suggest that SGLT-2i may be considered as first-line treatment for patients with T2D and cardiovascular disease or who are at increased risk for cardiovascular events,” said lead author HoJin Shin, BPharm, PhD, of the Division of Pharmacoepidemiology and Pharmacoeconomics. “However, more evidence from randomized clinical trials or observational studies will help us to identify patients who would benefit most from using SGLT-2i as first-line type 2 diabetes treatment.”
     
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    The unexpected benefits of sodium glucose co-transporter 2 (SGLT2) Inhibitors
    Chok G Chan, Ralph Stewart
    N Z Med J. 2022 Aug 19;135(1560):99-104.
     
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    Effects of SGLT2 inhibitors and GLP1-receptor agonists on cardiovascular and limb events in peripheral artery disease: A review
    Nedaa Skeik et al
    Source
     
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    Risk of lower limb amputation in diabetic patients using SGLT2 inhibitors versus DPP4 inhibitors or GLP-1 agonists: a meta-analysis of 2 million patients
    Yang Lu, Caiyun Guo
    Ther Adv Drug Saf. 2023 Jun 10
     
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    The effects of canagliflozin on gout in type 2 diabetes: a post-hoc analysis of the CANVAS Program
    JingWei Li et al
    Lancet Rheumatol. 2019 Dec;1(4):e220-e228.
     
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