In August this year, the FDA updated the manual of the Cag Grid, involving multiple important updates. Recently, we invited the Judicong Professor of Peking University People’s Hospital to interpret the FDA Came Grid’s net descriptive update. Below, let’s listen to the idea of ??professor.
– Interview with Professor Ji Peng, Peking University People’s Hospital
“International Diabetes”:Recently, the US FDA has updated the Cam Ge Lie (Yi Kean) ? The manual, made a major change in the black box warning of the amputation risk. Please analyze the cause of the FDA to make such an update and what is evidence? Can this relieve clinical concerns about amputation risk? What impact will the clinical application of Camigre?
Professor Ji Pean:The US FDA is a pharmaceutical regulator that has a very strict supervision of the drug specification. Previous CANVAS research accidents, the risk of acupuncture-related diabetes patients with Goglie net treatment has increased significantly, from the perspective of protecting diabetic patients, FDA added a black box warning It is suggested that diabetic patients taking card GE GEO is likely to increase amputation risk.
Last month, FDA removed this black box warning, which is also based on gradually accumulating clinical evidence. for example:
CREDENCE research mainly verifies whether the Card Lelens has a kidney protection. In its incorporated in the large-scale risk of kidney high-risk risks, it is not found to increase the risk of amputation in Phaffron.
In addition, in the real world analysis, the amputation risk of taking the type 2 diabetes patients who take the card gel and taking other hypoglycemic drugs, nor did the jean net treatment will additionally increase the risk of amputation.
- In addition, the use of SGLT2 inhibitors in the clinical study of SGLT2 inhibitors is found to be related to the increase in amputation risks.
Therefore, the FDA believes that there is currently no sufficient evidence to support the increase in Caglite net treatment and amputation risk, so the black box warning is removed, which is also a great relief for clinicians.
- In Canvas Research, for type 2 diabetes patients with cardiovascular disease or cardiovascular risk factors, the use of Carrier net treatment can significantly reduce cardiovascular hard end – main cardiovascular adverse events compared to placebo MACE, including cardiovascular death, non-lethal stroke, non-lethal myocardial infarction), reducing cardiovascular death or heart failure hospital risk 22% (Figure 1), and continuously reducing protein urine.
Figure 1. Canvas Study: Confirmed the cardiocarian hard end of Kagli
- In Credence Research, KG GL is proven to have a very strong protective effect on the kidneys, significantly reducing kidney hard end (end-stage nephropathy, serum creatinine multiplication, kidney or cardiovascular death) is 30% (Figure 2).
Figure 2. Credence studies with the main endpoint with the kidney hard end point to confirm the kid-ranking is the first kidney hard end-beneficial hypoglycemic drug
Therefore, the clinician is very willing to use the Cagli net to protect the heart and kidneys of diabetic patients and reduce the risk of heart failure. After the black box is warned, the clinician is more confident that this kind of heart-protected drug is very strong to provide better treatment for diabetic patients, thereby further improving their cardiovascular and kidney disease risk and heart failure.
“International Diabetes”:This Card Lele-net manual update also relaxes the requirements of renal function, not only allow EGFR ≥ 30 ml / min / 1.73 m 2 Patient starts 100 mg card collections, and suggests EGFR <30 mL / min / 1.73 m 2 Patients continue to treat 100 mg to reduce the risk of cardiovascular and kidney disease. We know that KG Grid has been confirmed by CredenCe to confirm that there is a kidney hard end, and the update is also mainly due to this study. Please talk about the research results to talk about the net in different EGFR level diabetic nephropathy patients. Application, and actual clinical significance after relaxing EGFR use limited?
Professor Ji Pean:Koglie is developed as a new hypoglycemic mechanism. Early clinical study found that EGFR <45 ml / min / 1.73 m2 At the time, the Cagli net hypoglycemic effect was significantly weakened. However, the Canvas study found that the NG columns had a significant kidney protection, so the CRedENCE studied EGFR 30 to 90 mL / min / 1.73 m. 2 And there are a large number of proteinuria type 2 diabetes patients to verify that the Net of the Kid Column has a protective role in the kidney. The results confirmed that Kagli net treatment can significantly improve the kidney ending of diabetic patients, suggesting that it has a strong kidney protection.
With the support of CRedence research evidence, the FDA relaxed the use restrictions of the Cag Grid’s EGFR, mainly from the kidney protection perspective EGFR at 30 ~ 45 mL / min / 1.73 m2 Type 2 diabetes patients with large amounts of protein urine (urobellopenin / creatinine ratio of more than 300 mg / g) can be used to protect the kidney.
In addition, Credence studies have also found that EGFR ≥ 30 mL / min / 1.73 m occurs when entering the group.2 Patient, if the EGFR level is reduced to 30 mL / min / 1.73 m during the india news in english study2 Hereinafter, the use of Koglie net treatment still has strong kidney protection. So, FDA recommends that such patients can continue to use Kogli net treatment to maintain their protective effects on the kidneys.
“International Diabetes”:The effectiveness of SGLT2 inhibitors in type 2 diabetes treatment has been fully confirmed, and good safety is important for improving the long-term use and improving compliance. This Card GrizEx Report also includes a warning for acute renal injury and hypotension, which is mainly focused on security issues. Please contact your experience in clinical practice to talk about the experience of Gogli net safety applications?
Professor news section Ji Pean:When the SGLT2 inhibitor initially entered the clinical use, there was a case that it could increase the risk of acute renal injury, but did not find this in large randomized controlled clinical studies, particularly CREDENCE studies. In addition, after a large number of clinical studies have confirmed that SGLT2 inhibitors such as Kogli net do not increase hypotension.
These warnings are released, allowing clinicians to be more assured using SGLT2 inhibitors such as Kogli net to perform high blood sugar control in diabetic patients and to prevent their risk of cardiovascular and nephropathy and heart failure in the future. For clinicians, this is a very good news that the some news SGLT2 inhibitor can protect the heart and kidneys of diabetic patients in the clinic, and achieve better blood glucose control.
Heavy centering pill! FDA removes the black frame of the Camigre Puebled to warn, relax the EGFR use restriction
(Source: “International Diabetes” Editorial Department)
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