2023-11-02 11:34:17
The most imminent, semaglutide, but there are many more in R&D. SEEN and Seedo demand the financing of treatments for equity and health benefits. GLP-1 analogs are revolutionizing the medical treatment of obesity.
Despite being described as an epidemic, obesity has for many years been considered an orphan area of treatments, with a meager arsenal due to the inability to find very effective and safe molecules. At the moment, both premises are met by GLP-1 analogues, medications that emerged for type 2 diabetes but it is because of their weight-reducing effect that they are putting the capacity of laboratories to meet demand on the ropes.
In Spain, the only medication of its class authorized for the treatment of obesity is liraglutide (marketed in this indication as Saxenda by Novo Nordisk), but the launch of semagutide (Wegovy, also from Novo Nordisk) is expected imminently. who already has their therapeutic positioning report. This drug represents another step in effectiveness and is the one that has sparked the fever for new anti-obesity drugs in the United States.
Cristóbal Morales, endocrinologist at the Virgen Macarena and Vithas Sevilla hospitals and researcher in more than 150 clinical trials in the areas of diabetes, obesity and cardiovascular, describes semaglutide with respect to liraglutide as a “revolutionary leap.” The new drug achieves weight loss of up to 15%-16%, compared to 8% for the previous one.
But research into molecules that mimic the action of incretin hormones is exploring new avenues apart from GLP-1, and the first double and triple agonists are already appearing.
The most advanced of this new generation of compounds in development for obesity is tirzepatide (Lilly), a dual GLP-1 and GIP agonist, which in the latest clinical trial results has shown average weight reductions of up to 26%. . “New generation drugs are increasingly closer to bariatric surgery and there are no longer non-responding patients: they all respond,” explains Morales.
Other dual-action compounds in development are cagrisema, the combination of the amylin analogue cagrilintide and semaglutide, and survodutide, a co-agonist of GLP-1 and glucagon. Also in development are GLP-1, GIP and glucagon triagonists, such as retatrutide, and oral drugs: the most advanced is oral semaglutide (Novo Nordisk), but there are also oral non-peptide glucagon-like peptide 1 receptor agonists ( GLP-1) such as the candidates from Lilly (orforglipron) or Pfizer (lotiglipron and danuglipron).
Financing
Faced with the possible launch of new, safe and highly effective medications for obesity, the Spanish medical societies of Endocrinology and Nutrition (SEEN) and Obesity (Seedo) agree that treatments for obesity should be financed, as is the case with medications for other diseases, and by the beneficial effect of weight loss on many comorbidities.
At the moment, GLP-1 analogues are only funded for diabetes.
A separate question is to what extent its reimbursement is sustainable for the Spanish health system, given the high prevalence of obesity. In this sense, Lillian Flores, from Seedo, explains that “a thousand ways can be studied for a drug to be financed, such as co-payment, financing exceptions for special indications, transitional financing for a specific indication, for a limited time or a certain number of attempts, among others.”
In order to avoid abuse with these drugs, it is committed to “establishing prescription indications and limiting the possibility of them being prescribed to the patient meeting a series of requirements.” Afterwards, “monitoring is easy through electronic prescription and medication withdrawal from the pharmacy.”
The announcement of results that point to a protective effect of semaglutide in the prevention of cardiovascular events in overweight and obese people may be new support for the financing of these drugs in specific patients who, in general, are considered very safe.
Today this family of drugs is only funded in type 2 diabetes. “Treatment with GLP-1 analogues in obese patients is not a question of aesthetics, but rather a question of improving many pathologies associated with this disease,” warns Flores. . “The serious thing about the situation is that, if obesity is not associated with type 2 diabetes, the patient cannot benefit from its financing by the SNS and is forced to pay for the medication in order to improve their health.”
Clinical management
GLP-1 analogues for obesity are indicated for patients with a body mass index (BMI) equal to or greater than 27 with comorbidities associated with excess weight or with a BMI equal to or greater than 30, as a complement to a low diet in calories and an increase in physical activity.
“Its use must be chronic, given that obesity is a chronic disease.” Furthermore, “its withdrawal is usually accompanied by regaining the lost weight,” warns Ínka Miñambres, from SEEN.
But they also have contraindications: “Its use is not recommended if there is a history of pancreatitis and medullary thyroid carcinoma, since it could be related to the occurrence of these two pathologies.” He adds that “caution will have to be used in patients with gastrointestinal pathology, since the main side effects are of this type,” warns Miñambres.
Gastrointestinal side effects, especially nausea, are the most common and, in some cases, may lead to discontinuation of treatment. “The ideal is to start the drug with the lowest dose and titrate it little by little, since these effects are more frequent at the beginning of treatment,” explains the SEEN spokesperson.
Regarding the shortage of GLP-1 analogues, considered in part attributable to the use of medications authorized for diabetes in obesity, the expert points out that they do not have data on off-label use, “but at SEEN we will always defend that prescriptions be made according to the indications contained in the technical sheet.”
Future of treatment
Morales understands that the development of new treatments opens a “new era” in the treatment of obesity based on the personalization of treatments: “We must stop talking about obesity and talk about obesity, and understand that there are multiple, varied and deep etiopathological causes of obesity; “You have to phenotype to really make precision medicine.”
For Flores, an era of “hope” has opened for doctors dedicated to obesity: “Having these drugs will allow us to reduce the alarming prevalence figures of this disease and the deleterious effect of obesity on all associated pathologies and the mortality, which will contribute to improving the quality of life of these patients and, in the long term, reducing health costs.”
Could they reduce bariatric surgeries? Flores explains that such striking efficiencies, such as 15% to 20%, may still be insufficient to achieve the weight loss goal of the most serious patients. Although, he sees it possible that surgeries could be reduced “as the effectiveness of the drugs improves and their chronic use can be maintained.”
Flores observes that addressing obesity is not the exclusive territory of endocrinologists: “Without the involvement of primary care physicians we will not be able to improve obesity. They are the ones called to prevent, identify the problem and initially treat obesity. On the other hand, pharmacies are key in early diagnosis and promoting self-care.”
Possible other uses
GLP-1 analogues are also being developed for other indications within the area of cardiometabolism, such as heart failure and kidney disease. But they are also being investigated for uses as different as dementia and addictions. Cristóbal Morales, from the Virgen Macarena and Vithas Sevilla hospitals, highlights the interest in research with these drugs on the consumption of addictive substances that would explain part of the benefits they obtain against obesity. Not in vain, treatment with these medications has been linked to a lower use of caloric foods, but also alcohol. Morales clarifies that this benefit would have to do with the effect of GLP-1 analogs in the central nervous system on the hedonic center, which would be complementary to its regulatory action on appetite. Naiara Brocal
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