Muñaro, a new drug for diabetes and obesity, arrived in Spain

Muñaro (tirzepatide), Lilly’s drug for the treatment of type 2 diabetes (T2D) or for weight control in obese people, is now available in Spain. This preparation for weekly subcutaneous administration will be available from July 1 in Spanish pharmacies, always with a doctor’s prescription, in doses of 5 and 10 mg.

Due to its proven effectiveness, tirzepatide has been approved for two indications. On the one hand, as a treatment for T2DM, and on the other, for weight control in people with overweight (BMI) >27 kg/m2 and at least one complication associated with overweight or obesity (BMI > 30 kg/m2) .

It is the first drug in a new therapeutic family that targets the GIP and GLP-11 receptors. Its mechanism of action, in addition to promoting glycemic control, reduces appetite, increases the feeling of fullness and reduces excess fat, including visceral fat around the waist. In addition, in people with T2DM, glycemic control is improved through several mechanisms, including increased insulin secretion, decreased glucagon secretion, and improved insulin sensitivity.

In clinical studies in people with T2DM, tirzepatide demonstrated excellent glycemic control (up to 87% of patients achieved glycated hemoglobin (HbA1c) levels of 6.5% or lower compared with 66.2% of patients receiving semaglutide 1 mg), and even about Togo. 50% achieve levels similar to those of a person without diabetes (HbA1c ≤5.7%) compared to 19.7% who achieve it with semaglutide, with an average weight loss of up to 12.4 kg with tirzepatide compared with 6. 2 kg with semaglutide, all with favorable safety. profile.

In overweight and obese people without diabetes, tirzepatide showed a mean weight reduction of up to 22.5% (23.6 kg) at week 72 and, in addition, 4 out of 10 patients achieved an equal or greater weight reduction of 25%. And all this with a high response rate: 96% of patients achieved a reduction equal to or greater than 5% after 72 weeks of treatment.

The clinical development of tirzepatide included a large program of clinical studies known as SURPASS (in people with T2DM) and SURMOUNT (in obese and overweight people without diabetes), “in which the molecule’s powerful effects in terms of glycemic control even reaching normalization HbA1c levels in 51% of people with T2DM treated, and weight loss with an approximately 20% reduction at 10 and 15 mg/week in obesity. These data are close to what is achieved after bariatric surgery. Along with this, beneficial effects on various cardiovascular risk factors are observed, although the specific results of the cardiovascular effects will be known later,” says Javier Escalada, President of the Foundation of the Spanish Society of Endocrinology and Nutrition (FSEEN).

Tirzepatide is the first molecule in its therapeutic class approved for the treatment of T2DM when adequate control is not achieved with diet and exercise alone, and has demonstrated reductions in HbA1c and weight superior to other therapeutic classes (including receptor agonists). GLP-1) at all doses studied.

Information on the effectiveness and safety of the treatment of T2DM comes from the SURPASS clinical trial program, which studied its use both as monotherapy and in combination with other drugs used to control T2DM. The phase 3 SURPASS-2 clinical trial was a head-to-head comparison study with semaglutide 1 mg over 40 weeks. The SURPASS-2 study enrolled 1,879 patients with a mean baseline HbA1c level of 8.28% and diabetes diagnosis for an average of 8.6 years.

weight control

The SURMOUNT program clinic studied the use of tirzepatide as a weight control agent in adults with overweight (BMI >27 kg/m2) and at least one weight-related complication or obesity (BMI >30 kg/m2).

SURMOUNT-1 was a multicenter, randomized, double-blind, parallel, placebo-controlled, phase 3 clinical trial that compared the efficacy and safety of tirzepatide 5 mg, 10 mg, and 15 mg with placebo, both as an add-on to an ineffective treatment. high-calorie diet and increased physical activity in obese or overweight adults with at least one of the following complications: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

In addition to the already mentioned weight control, participants included in this clinical trial showed improvements in key cardiometabolic parameters with tirzepatide, resulting in a decrease in waist circumference ranging from 14.6 to 19.9 cm, a decrease in triglyceride levels (24.3 – 31 ,4%). , lower blood pressure (both systolic and diastolic) and a positive effect on cholesterol levels (with improved HDL levels and decreased LDL levels).

According to various medical reviews, weight loss equal to or greater than 15% is associated with a reduced risk of cardiovascular mortality and with benefits in complications associated with excess weight.

Mar Malagon, President of the Spanish Society for the Fight against Obesity (SEEDO), “Obesity is a chronic, relapsing disease that affects more than 18% of the adult population in Spain. Scientific evidence shows that it is a complex and multifactorial disease, influenced by everything from biological and genetic factors to socioeconomic and environmental factors, as well as sleep patterns. The research has also been fundamental in identifying the intrinsic factors that regulate food intake and body weight, which has provided the basis for the development of therapeutic compounds that open the door of optimism for people suffering from this disease.”

In addition, obese people have an increased risk of more than 200 complications, such as “cardiovascular disease, type 2 diabetes, lipid disorders, metabolic liver disease (the number one cause of liver cirrhosis in our country), and various chronic respiratory diseases. pathologies, infertility, without forgetting the very common cancers: breast, colorectal, kidney, liver, ovarian, etc.,” adds Dr. Alfredo Michan Doña, specialist in internal medicine and coordinator of the diabetes group, Obesity and Nutrition of the Spanish Society of Doctors. Internal Medicine (SEMI).

The expert emphasizes that “knowing your approach and treatment is essential for every clinician,” since, in addition, obesity increases the risk of premature death, and compared with adults with a healthy weight, obese people have a 12-fold higher risk of developing 4 or more comorbidities7.

“The commercialization of tirzepatide represents an important milestone in the treatment of people with type 2 diabetes and obesity. This is a revolutionary innovation that reflects Lilly’s passion for researching and developing medicines that represent quantum leaps in the treatment of diseases that impact the hopes and quality of life of patients,” said Dr. José Antonio Sacristán, Medical Director of Lilly Spain. . “We are very proud of Spain’s participation in the clinical research programs for Tirzepatide. Of the more than 10,000 patients who took part in the clinical development of Tirzepatide, 95 centers (35 of them involved in obesity research) and 1,128 patients participated in Spain, reflecting the enormous quality of our healthcare system and researchers.”