more weight is lost but it is not funded

Mounjaro, Lilly’s innovative medicine

The 5 milligram treatment will cost 271 euros per month and the 10 milligram treatment will cost 358 euros.

Four out of 10 patients achieved weight loss equal to or greater than 25%

Mounjaro® (tirzepatide), Lilly’s innovative medicine to treat type 2 diabetes (T2DM) or for weight control in people with obesity, is now available in Spain. This drug, for weekly subcutaneous administration, will be available starting July 1 in Spanish pharmacies, always under medical prescription, with the doses of 5 and 10 milligrams. The first dose will cost 271 euros and in the second case 358 euros.

Due to its demonstrated efficacy, tirzepatide has been approved for two indications. On the one hand, as a treatment for DM2 and, on the other, for weight control in Overweight people with a body mass index (BMI) >27kg/m2 and at least one complication derived from excess weight, or with obesity (BMI >30 kg/m2). In this way, a direct competitor to the Novo Nordisk treatment is born, Ozempic.

In the case of Mounjaro, it is the first drug in a new therapeutic family that acts on the GIP and GLP-11 receptors. Its mechanism of action, in addition to promoting glycemic control, reduces appetite, increases the feeling of satiety and reduce excess fat, including visceral fat around the waist. Furthermore, in people with DM2, glycemic control improves through multiple mechanisms that include greater insulin secretion, lower glucagon secretion and better insulin sensitivity.

In clinical studies in people with T2DM, tirzepatide has demonstrated excellent glycemic control (up to 87% of patients achieved glycated hemoglobin (HbA1c) levels of 6.5% or lower compared to 66.2% of patients). treated with semaglutide 1mg), and even around 50% reaches levels similar to those of a person without diabetes (HbA1c ≤5.7%) compared to 19.7% who achieve this with semaglutide, with average weight losses of up to 12.4 kg with tirzepatide compared to 6.2 kg with semaglutide, all with a favorable safety profile.

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

The clinical development of tirzepatide has had a robust program of clinical trials, known as SURPASS (in people with DM2) and SURMOUNT (in people with obesity and overweight, without diabetes), “in which the powerful effect of the molecule in terms of control glycemic, even achieving normalization of HbA1c levels in up to 51% of people with DM2 treated, and weight loss with decreases of around 20% with doses of 10 and 15 mg/week in obesity. These data are close to what is achieved after bariatric surgery. Along with this, beneficial effects on different cardiovascular risk factors are observed, although the specific results of the cardiovascular effects will be known later,” indicates the Dr. Javier Escalada, president of the Foundation of the Spanish Society of Endocrinology and Nutrition (FSEEN).

Indicated in type 2 diabetes

Tirzepatide is the first molecule in its therapeutic class approved for the treatment of DM2 when sufficient control is not achieved with treatment alone. diet and exerciseand has demonstrated a reduction in HbA1c and weight superior to treatments from other therapeutic classes (including GLP-1 receptor agonists) at all doses studied.

The information on efficacy and safety as a treatment for T2DM comes from the SURPASS clinical trial program, which studied its use both in monotherapy and in combination with other drugs used to control T2DM. The phase 3 SURPASS-2 clinical trial was a direct comparison study with semaglutide 1 mg, lasting 40 weeks. In SURPASS-2, 1879 patients participated with a mean baseline HbA1c of 8.28% and a diagnosis of diabetes for an average of 8.6 years.

Indicated for weight control

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

SURMOUNT-1 is 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 versus placebo, both as a complement to a low-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 weight control already mentioned, in the participants included in this clinical trial, a benefit in parameters was observed with tirzepatide. key cardiometabolicgenerating reductions in waist circumference ranging from 14.6 to 19.9 cm, reductions in triglycerides (24.3 – 31.4%), reduction in blood pressure (both systolic and diastolic) and a positive impact on cholesterol levels (with improvements in HDL and reductions in LDL).

weight losses equal to or greater than 15% They are associated with a reduction in the risk of cardiovascular mortality and with benefits in complications related to excess weight, as different medical reviews have concluded.

The impact of obesity

As remembers the Dr. Mar Malagón, president of the Spanish Obesity Society (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 biological and genetic factors to socioeconomic and environmental factors or hours of sleep. “Research has also been fundamental to identify the intrinsic factors that regulate intake and body weight, which has served as a basis for the development of compounds with therapeutic use that open a door of optimism for people suffering from this disease.”

Besides, people with obesity They have a higher risk of suffering more than 200 complications such as “cardiovascular diseases, type 2 diabetes mellitus, lipid disorders, metabolic liver disease (the first cause of cirrhosis in our country), as well as various chronic respiratory pathologies, infertility, without forgetting highly prevalent cancers: breast, colorectal, kidney, liver, ovary, etc.,” adds the Dr. Alfredo Michan Doña, specialist in Internal Medicine and coordinator of the Diabetes, Obesity and Nutrition group of the Spanish Society of Internal Medicine (SEMI).

The expert emphasizes that “knowledge of its approach and treatment is essential for every clinical doctor,” since, in addition, obesity increases the risk of early death and compared to adults with a healthy weight, people with obesity have 12 times the risk of developing 4 or more related diseases.

«The commercialization of tirzepatide represents a milestone in the treatment of people with type 2 diabetes and obesity. “This is a disruptive innovation, which reflects Lilly’s vocation to research and develop medicines that represent a qualitative leap in the treatment of diseases that impact the hope and quality of life of patients,” says Dr. José Antonio Sacristán, medical director of Lilly Spain. «We are very proud of Spain’s participation in Tirzepatide clinical research programs. Of the more than 10,000 patients who have participated in the clinical development of Tirzepatide, in Spain 95 centers (35 of them in obesity studies) and 1,128 patients have participated, which reflects the enormous quality of our health system and researchers. Spanish people”.