Conscious use

Diabetes obesity: slimming drugs boom, Aifa guide on use and risks

President Nisticò: 'Beware of misuse and illegal purchases, new molecules are not an easy and risk-free solution for slimming'

by Ernesto Diffidenti

Weight-loss drugs: Capture the positive lifestyle changes in individuals benefiting from revolutionary weight-loss medications Natchaya - stock.adobe.com

4' min read

Translated by AI
Versione italiana

4' min read

Translated by AI
Versione italiana

Here comes guidance from the Italian Medicines Agency (Aifa) on the use of new drugs to combat type 2 diabetes and obesity that are experiencing a real boom in consumption. These are GLP-1 analogues (liraglutide, dulaglutide and semaglutide), GLP-1 receptor agonists (exenatide) and GIP/GLP-1 receptor agonists (tirzepatide), molecules that mimic the action of natural hormones produced by the intestine. The way they work is simple: they increase insulin production by the pancreas in response to food, slow down gastric emptying and act on the central nervous system by reducing hunger. In this way, they help the patient not only keep glycaemia under control, but also to eat less food, leading to significant weight loss. "However, these drugs," Aifa emphasises, "always require a doctor's prescription and should never be considered an easy and risk-free solution for weight loss. They must be used consciously, in accordance with the authorised indications and under appropriate monitoring by the prescribing doctor'.

Aware use of new medicines

The guide 'New drugs for diabetes and obesity: what to know for informed use' (also in the form of a leaflet version), published on the Aifa website, offers an updated and comprehensive overview of the safety profile, authorised therapeutic indications, consumption trends and correct clinical use of these drugs. Particular attention is paid to the risks associated with misuse, self-administration without medical supervision and illegal purchase through unauthorised channels.

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"With this initiative," says Aifa president Robert Nisticò, the Agency intends to strengthen correct information for citizens and health workers, support pharmacovigilance, and contribute to the protection of public health by encouraging responsible access to innovative therapies of increasing clinical relevance. Medicines are a valuable tool, but should never be understood as risk-free shortcuts to a correct lifestyle. The AIFA guide is also an opportunity to emphasise once again that health also and above all depends on prevention and conscious behaviour'.

'The document,' states the technical scientific director, Pierluigi Russo, 'stems from the growing popularity of GLP-1 analogues and GIP/GLP-1 dual agonists in the treatment of type 2 diabetes and obesity, and the need to promote their appropriate, safe and evidence-based use.

The differences between drugs

All new drugs for diabetes and obesity require a prescription, but have different therapeutic indications.

For the treatment of type 2 diabetes mellitus, drugs such as Ozempic and Rybelsus (semaglutide), Mounjaro (tirzepatide), Victoza (liraglutide), Trulicity (dulaglutide) and Byetta/Bydureon (exenatide) are reimbursed by the National Health Service (Class A/PHT), according to Aifa Note 100. They can be prescribed by general practitioners and specialists.

For the management of body weight (obesity and overweight with comorbidity), drugs such as Wegovy (semaglutide), Saxenda (liraglutide) and Mounjaro (tirzepatide, prescribed for this specific indication) are not reimbursed by the SSN and are classified in class C, with costs paid by the citizen.

The consumption boom

Consumption data show a very marked growth of these medicines in recent years (2020-2024), both in the channel reimbursed by the NHS and in private purchasing. The overall trend also shows a progressive concentration towards the fastest growing drugs. For semaglutide alone, the number of packages reimbursed by the SSN rose from approximately 322,000 in 2020 to over 4 million in 2024 (+48.9% in one year). A very significant increase was also recorded in private purchases paid for by the citizen, with semaglutide packages rising from about 29.7 thousand in 2020 to over 326 thousand in 2024 (+78.4% compared to 2023), while tirzepatide, in its first year on the market, exceeded 30 thousand packages.

'Moreover, in 2024, in the context of private purchasing,' Aifa reports, 'there was a particularly marked increase (+142.8%) in drugs authorised for weight management compared to those without this indication, which could reflect a use more in line with the authorised indications.

Misuse for slimming and medical supervision

The Agency points out that the use of these drugs for weight loss should not be considered a 'shortcut' to the goal of losing weight. The drug must always be part of an integrated strategy that includes, among other things, a calorie-restricted diet and physical activity. Its use must also always be supervised by the prescribing doctor, who can assess the patient's clinical response in the light of his or her overall health, any concomitant pathologies, age and the medication he or she is taking. Recent studies also show that discontinuing the therapy without a radical and well-established change in lifestyle leads to a rapid regaining of lost weight (the so-called 'rebound' or 'yo-yo' effect).

Safety profile and interactions not to be underestimated

Like all medicines, they have a safety profile that needs to be monitored. The most common undesirable effects are gastrointestinal (nausea, vomiting, abdominal pain, diarrhoea and constipation), especially in the early stages of treatment and during dose escalation; headache, dizziness and fatigue are also common. Less frequent but clinically relevant events include acute pancreatitis, which requires discontinuation of treatment, and an increased risk of gallbladder disease, including cholelithiasis. For some drugs in the class, particularly semaglutide, epidemiological studies suggest a possible increased risk of non-arteritic anterior ischaemic optic neuropathy (Naion), which can cause loss of vision and requires discontinuation of treatment if diagnosed. In addition, the Agency draws attention to drug interactions: concomitant use with insulin or other antidiabetics increases the risk of hypoglycaemia. These drugs are also not recommended during pregnancy.

Avoiding DIY and illegal web shopping

Lastly, Aifa points out that DIY and the use of these drugs outside the authorised therapeutic indications ('off-label'), without a doctor's supervision, for purely cosmetic purposes, exposes people to health risks and can lead to shortages of life-saving drugs for diabetic patients. Moreover, as they are subject to prescription, these products cannot be purchased online. Fake versions of pre-filled pens (e.g. fake Ozempic) sold on social networks have already been found in Europe, which are extremely dangerous to health. "These products have not affected the Italian legal supply chain, which uses well-established vigilance and control systems," concludes Aifa. "This is why it is essential to purchase medicines through legal channels and to be wary of offers that may come from the Web.

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