Friday, March 31, 2023

Type 2 diabetes: FDA approves tirazeptide

  • The Food and Drug Administration (FDA) has approved a novel first-in-class drug for the treatment of type 2 diabetes. The drug is called tirazeptide.
  • A person gets it as a once weekly injection under the skin.
  • This has a dual effect, lowering blood sugar and supporting weight loss better than currently available medications for the condition.
  • The most common side effects are nausea, diarrhea, and vomiting, which tend to subside over time. There were also some reports of severe low blood sugar in clinical trials.

Insulin is a hormone made by the pancreas that allows blood sugar to enter cells and provide fuel.

The body of someone with type 2 diabetes either doesn’t produce enough insulin or doesn’t respond to insulin the way it should.

insulin resistance Occurs when the body’s cells are unable to take up blood sugar easily. In response, the pancreas produces more insulin until the cells respond. Over time, the pancreas may not be able to meet the increased demands. this leads to prediabetes and diabetes.

all in, 11.3% The number of people in the United States who have diabetes, and 90–95% of these cases are diabetes type 2,

Uncontrolled high blood sugar can lead to serious complications, such as chronic kidney disease, blindnessAnd the strokes,

A variety of medicines can lower blood sugar in people with type 2 diabetes. Some examples include:

  • oral medications
    • alpha-glucosidase inhibitor
    • biguanides
    • bile acid sequestrant
    • dopamine-2 agonist
    • DPP-4 inhibitor
    • meglitinides
    • SGLT2 inhibitor
    • sulfonylurea
    • thiazolidinediones
  • injectable drugs

The 2022 American Diabetes Association guidelines state that first-line treatment is usually metformin, a biguanide, and healthy lifestyle changes,

But initial treatment options also depend on the presence or risk of other health conditions, including heart failure, coronary artery disease, or chronic kidney disease. A doctor also considers the individual’s preferences, their access to the drug, and its cost, effectiveness, side effects, and impact on weight.

Often, combination therapy, which includes two or more drugs, is needed to keep blood sugar within a reasonable range to delay or prevent complications related to diabetes,

But some people with type 2 diabetes may not reach blood sugar targets with currently available combination therapies.

The need for new, more effective treatment options is the basis for the FDA’s approval of tirzepatide, a new drug for type 2 diabetes.

Tirzepatide is the first drug in a new class of diabetes drugs. It is a dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist.

GLP-1 and GIP are gut hormones called incretins, and release them when we eat. Incretins stimulate the secretion of insulin from the insulin-producing cells of the pancreas, called beta cells.

GLP-1 enhances the release of insulin from the pancreas. It also lowers levels of glucagon, a hormone that prevents blood sugar from getting too low.

another role of GLP-1 is increasing the number and quantity of beta cells in the pancreas. It also promotes a feeling of satiety by delaying the emptying of the stomach and controlling appetite in the brain.

Like GLP-1, GIP enhances insulin release. It also improves beta cell production and reduces beta cell destruction. Additionally, GIP reduces fat accumulation, enhances bone formation, increases glucagon production and decreases stomach acid secretion.

People with type 2 diabetes do not respond as strongly to the incretin hormone as other people. Tirzepatide overcomes this deficiency by activating GLP-1 and GIP receptors in the body.

In a video, clinical endocrinologist at Rockwood Clinic in Spokane, WA, and clinical professor of medicine at the University of Washington, Dr. Carol Wisham speaks about tirazeptide’s dual GLP-1 and GIP actions. she explains:

“They both have somewhat different activities, but they have [greater activities in combination]Stimulates insulin secretion, improves glucose tolerance, and reduces body weight.”

in a clinical trial called Sarpas-1The researchers found that tirazeptide is effective in adults with diabetes that is inadequately controlled by diet and exercise interventions alone.

Participants received one of three tirzepatide doses: 5 milligrams (mg), 10 mg, or 15 mg, or a placebo injection under the skin once weekly for 40 weeks.

The study showed that the participants taking tirazepetide had a significantly greater reduction in A1C, a measure of blood sugar, than the placebo group. A1C fell from 1.87 to 2.07%, depending on the dose.

In addition, compared to the placebo group, participants taking tirazeptide lost more weight: 7 to 9.5 kilograms (kg), or 15.4 to 20.9 pounds (lb).

In the SURPASS-2 trials, participants with type 2 diabetes received the same dose of tirazeptide as in the previous trial or a 1-mg dose of semaglutide once weekly for 40 weeks. Semaglutide is an FDA-approved GLP-1 agonist used to treat type 2 diabetes.

Tirzepatide decreased A1C from 2.01 to 2.3%, depending on the dose, while semaglutide decreased it by 1.86%.

The trial also reported a significantly greater weight loss in the tyrazepatide group than in the semaglutide group. Formerly, weight loss ranged from 1.9 kg (4.2 lb) to 5.5 kg (12.1 lb).

SURPASS-3 TESTING Compared tirazepetide with insulin degludec, another injectable diabetes drug that is already approved by the FDA.

The study recruited people with type 2 diabetes who had not previously used insulin and had not responded adequately to treatment with metformin alone or in combination with SGLT2 inhibitors.

After 52 weeks, participants who received tirazeptide had a significantly greater reduction in A1C than those receiving insulin degludec. The first group also experienced significantly greater weight loss.

In the next test, called Sarpas-4The scientists recruited adults with type 2 diabetes and overweight or obese who were at high risk of heart disease or cardiovascular events.

These participants were already using one or more diabetes medications and had inadequate blood sugar control at the start of the study.

Participants received weekly doses of another injectable diabetes drug, tyrazepetide or insulin glargine, for 52 weeks.

Once again, participants who received tyrazepetide achieved better A1C reductions and weight loss than those who received insulin glargine.

The SURPASS-5 trial evaluated tirzepatide as an add-on drug for people with type 2 diabetes who were already taking insulin glargine with or without metformin. The trial measured A1C and weight loss in participants who received a placebo and others once a week in addition to their previous treatment for 40 weeks.

Those taking tirzepatide as an add-on treatment achieved greater A1C reductions and weight loss than those receiving placebo.

Dr. Laurie A. Kane talks to Endocrinologist at Providence St. John’s Health Center in Los Angeles, CA medical news today About tirzepetide he explained:

“Tirzepatide is unique because it is combining GLP-1 plus a GIP agent in a single injection, and the efficacy we are seeing in glucose-lowering weight [loss] That’s beyond anything we have available right now. […] A lot of agents on the market give us a reduction of around 1% of A1C or less depending on the level of A1C at the time of starting treatment.”

Among study participants, the most commonly reported side effects of tirazeptide were nausea, diarrhea, vomiting, and constipation. Severe low blood sugar also occurred, but only occasionally.

Dr. Visham explains: “Gastrointestinal side effects from tirazeptide are very similar” […] GLP-1 agent. […] As in the studies done with GLP-1 receptor agonists, nausea was greatest at the beginning of dosing and with increasing dose, and then [decrease] with time.”

Researchers continue to investigate the long-term safety of tirzepatide and its potential effects on cardiovascular outcomes, such as heart attack, stroke, and cardiovascular death.

Dr Kane commented: “As long as we are using agents that have no hypoglycemic risk, which is the case [tirzepatide]Aiming for a low A1C [people with type 2 diabetes] In a better position to prevent long-term complications. Reducing A1C to 5.7% is pretty incredible. ,

“It’s probably going to be agent costs and coverage by insurance that will be a constraint in some cases, so we’ll have to wait and see how that plays out,” she said.

MNT Robert Gubbe, Chief Science and Medical Officer of the American Diabetes Association. Looking to the future, he is interested in knowing whether the drug could also help ward off complications related to type 2 diabetes, he said:

“We are curious to know whether tirazeptide may provide any benefit in heart disease, NASH [a form of nonalcoholic fatty liver disease]and other complications, such as retinopathy, nephropathy, and neuropathy.”

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