"ADA diagnosis and treatment standards" ushered in advance update: involving 3 chapters, 1 new drug under development and multiple hypoglycemic new stars

Yimaitong compiles and organizes, please do not reprint without authorization
.

Guide: According to the past rules, the full version of the 2022 version of the ADA diagnosis and treatment standards will be released at the end of the year
.

However, two months after the "prescribed date", the ADA diagnosis and treatment standards ushered in a minor update in advance
.

This update involves 3 chapters: "Chapter 2: Classification and Diagnosis of Diabetes", "Chapter 10: Cardiovascular Disease and Risk Management", "Chapter 11: Microvascular Complications and Foot Care", involving 1 The research drug teplizumab and dapagliflozin, idogliflozin, Sotagliflozin, fennelrone, etc.
, which have attracted much attention in recent years
.

The update content is as follows
.

Chapter 2: Classification and Diagnosis of Diabetes 1.
[Update] "Recommendation 2.
4" has been adjusted to the following content: At present, GAD autoantibodies are recommended in research trials to screen for the risk of type 1 diabetes.
This plan may also be considered Used in first-degree family members of probands with type 1 diabetes
.

B 2.
[Added] The following content was added to the last paragraph of the "Type 1 Diabetes Risk Screening" section: In 2019, the use of anti-CD3 antibodies (teplizumab) in high-risk relatives of type 1 diabetes significantly delayed the development of diabetes.
In 2021, extended trials were carried out
.

The research data has been submitted to the FDA to apply for indications for delaying or preventing clinical type 1 diabetes in high-risk populations
.

However, currently, this drug and other drugs in this category are not available for clinical use
.

 Chapter 10: Cardiovascular Disease and Risk Management 1.
[Added] The following content has been added to the "SGLT2 Inhibitor Trial" section: ➤Etogliflozin related: The VERTIS CV study is a randomized, double-blind trial with 8246 participants To evaluate the effect of etogliflozin on cardiovascular outcomes in patients with type 2 diabetes and ASCVD compared with placebo
.

In the context of standard care, participants were randomly assigned to the etogliflozin 5 mg group, the etogliflozin 15 mg group, and the placebo group
.

The average age of study participants at baseline was 64.
4 years, the average duration of diabetes was 13 years, and the median follow-up time was 3.
0 years
.

 In terms of the main outcome of MACE, etogliflozin was not inferior to placebo [11.
9% in the etogliflozin group and 11.
9% in the placebo group; HR 0.
97 (95%CI 0.
85-1.
11); P< 0.
001]
.

 In terms of secondary outcomes (death from cardiovascular causes or hospitalization due to heart failure, death from cardiovascular disease, death from kidney causes, renal replacement therapy, or doubling of serum creatinine levels) Etogliflozin was not superior to placebo
.

The hazard ratio for the secondary outcome of hospitalization for heart failure (etogliflozin vs.
placebo) was 0.
70 (95% CI 0.
54-0.
90), which is consistent with the results of other cardiovascular outcome trials of SGLT2 inhibitors
.

 ➤Sotagliflozin related: Sotagliflozin is an experimental SGLT1 and SGLT2 inhibitor.
It reduces glucose by delaying intestinal glucose absorption while increasing urinary glucose excretion.
It has been evaluated in the SCORED trial
.

A total of 10,584 patients with type 2 diabetes, chronic kidney disease and additional cardiovascular risk were enrolled in the study, randomized to 200mg, qd group (if tolerated, the dose was increased to 400mg, qd) or placebo group
.

The primary endpoint of the trial is the total number of deaths due to cardiovascular causes, hospitalizations due to heart failure, and emergency medical visits due to heart failure
.

 After a median follow-up time of 16 months, the incidence of primary endpoint events in the Sotagliflozin group was significantly reduced (HR 0.
74, 95% CI 0.
63-0.
88, P<0.
001])
.

Sotagliflozin also reduced the secondary end point risk of the total number of hospitalizations due to heart failure and the total number of emergency visits due to heart failure (3.
5% vs.
5.
1%; HR 0.
67, 95% CI 0.
55-0.
82, P <0.
001), but did not reduce the cause The secondary end point risk of death from cardiovascular causes
.

 There were no significant differences between the groups in terms of all-cause mortality or the first occurrence of long-term dialysis, kidney transplantation, or the compound renal outcome of continuous reduction in estimated glomerular filtration rate (eGFR)
.

In general, the side effects of Sotagliflozin are similar to the side effects of using SGLT2 inhibitors, but also include an increase in the rate of diarrhea that may be related to the inhibition of SGLT1
.

 2.
[Update] The last paragraph of the "SGLT2 Inhibitor Trial" subsection is revised as follows: The DAPA-HF study and the EMPEROR-Reduced study evaluated the efficacy of dapagliflozin and empagliflozin in patients with heart failure, respectively.
It is described in the section on treatment and heart failure
.

The specific content is described in the section "Glucose-lowering therapy and heart failure"
.

 Chapter 11: Microvascular Complications and Foot Care 1.
[Added] The following content has been added to the subsection "The choice of hypoglycemic drugs for patients with chronic kidney disease": The DAPA-CKD study (dapagliflozin) is to evaluate drugs in advanced diabetes The second trial of the therapeutic effect of kidney disease
.

The included cohort population was similar to CREDENCE, but the study endpoints were slightly different
.

 The main result of the study is the time to the first appearance of any component in the composite endpoint (eGFR sustained decline ≥50%, ESRD, cardiovascular death, kidney-related death)
.

Secondary findings include the time to the first appearance of a composite renal outcome (continuous decrease in eGFR ≥50%, ESRD, renal death), the time to the first appearance of any component of the cardiovascular composite endpoint (cardiovascular death, hospitalization due to heart failure), and Time of death from all causes
.

 The results of the study showed that dapagliflozin had a significant benefit on the primary endpoint (HR 0.
61, 95%CI 0.
51~0.
72; P＜0.
001); the renal composite endpoint was significantly reduced (HR 0.
56, 95%CI 0.
45~0.
68; P＜0.
001) ; The composite endpoint composed of cardiovascular death and heart failure hospitalization risk was significantly reduced (HR 0.
71, 95%CI 0.
55~0.
92; P=0.
009); compared with placebo group, dapagliflozin group had a reduction in all-cause mortality (P=0.
004)
.

 2.
[Added] After the subsection "Choice of hypoglycemic drugs for patients with chronic kidney disease", a new subsection titled "Renal and cardiovascular outcomes of mineralocorticoid receptor antagonists in diabetic nephropathy" was added, and the following was added Text: Considering the risk of hyperkalemia, mineralocorticoid receptor antagonists have not been well studied in diabetic nephropathy
.

However, current data shows that the benefits of reduced proteinuria are sustained
.

 At the end of 2020, the FIDELIO-DKD trial tested a new type of non-steroidal mineralocorticoid receptor antagonist-fenelidone.
The results showed that patients with advanced diabetic nephropathy had significantly reduced CKD progression and cardiovascular events
.

 The primary endpoint of the trial is the first occurrence of a composite endpoint event (renal failure, continuous decline in eGFR from baseline by ≥40% for at least 4 weeks, and kidney-related death)
.

The pre-set secondary outcome is the first occurrence of a composite end point event [cardiovascular death or non-fatal cardiovascular event (myocardial infarction, stroke, heart failure hospitalization)]
.

 Compared with placebo, fennelrone reduced the primary study endpoint (HR 0.
82, 95%CI 0.
73-0.
93, P=0.
001) and key secondary comprehensive outcomes (HR 0.
86, 95%CI 0.
75-0.
99, P=0.
03 )
.

2.
3% of participants in the fenelrone group withdrew from the study due to hyperkalemia, compared with 0.
9% in the placebo group
.

No deaths related to hyperkalemia occurred
.

 3.
[Deleted] The following text has been deleted from the "Cardiovascular Diseases and Blood Pressure" section: Mineralocorticoid receptor antagonists (spironolactone, eplerenone and fennelrone) combined with ACEI or ARB are still very important Areas of concern
.

Mineralocorticoid receptor antagonists are effective in the treatment of refractory hypertension.
Short-term studies of CKD have been shown to reduce proteinuria and may have additional cardiovascular benefits
.

However, in patients receiving combination therapy, the incidence of hyperkalemia has increased.
Before this treatment is recommended, a larger-scale, longer-term clinical outcome trial is required
.

Yimaitong compiled and compiled from: [1]Addendum.
2.
Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2021.
Diabetes Care 2021;44(Suppl.
1):S15–S33.
Diabetes Care 2021 Sep; 44 (9): 2182-2182.
https://doi.
org/10.
2337/dc21-ad09[2]Addendum.
10.
Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2021.
Diabetes Care 2021;44(Suppl .
1):S125–S150.
Diabetes Care 2021 Sep; 44(9): 2183-2185.
https://doi.
org/10.
2337/dc21-ad09a[3]Addendum.
11.
Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes--2021: Diabetes Care 2021;44(Suppl.
1):S151--S167.
Diabetes Care 2021 Sep; 44(9): 2186-2187.
https://doi.
org/10.
2337/dc21-ad09bMaitong Endocrine Group Scan the QR code to join the "Yi Maitong-Endocrine Group", you can enjoy the benefits of lecture review, Q&A and free guides~