GLP-1 and dual GIP/GLP-1 receptor agonists

Glucagon-like peptide-1 (GLP-1) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonists are well-established as effective options for treating type 2 diabetes and overweight or obesity, and for chronic weight management.1-3 Building upon these benefits, a robust body of evidence demonstrates the additional cardiorenal benefits of GLP-1 receptor agonists, including a reduction in major adverse cardiovascular events, kidney disease and cardiovascular (CV) death.1,4 There is growing interest in the potential benefits of GLP-1 and GIP/GLP-1 receptor agonists in several other therapeutic areas, such as addiction, liver disease, Alzheimer’s disease, and chronic kidney disease (CKD), among others.1,4-5The excitement of emerging new indications and broad benefits of GLP-1 and GIP/GLP-1 agonist therapies is tempered by cholelithiasis and cholecystitis adverse events, potential risks such The excitement of emerging new indications and broad benefits of GLP-1 and GIP/GLP-1 agonist therapies is tempered by cholelithiasis and cholecystitis adverse events, potential risks such as pancreatitis, and concerns of thyroid cancer risks; safety signals related to potential adverse events continue to be monitored. As these therapies have experienced extensive uptake and media coverage, drug shortages and significant cost have also become limiting factors, leading to questions regarding the long-term management of drug supply and drug reimbursement policies.6,7This article provides pharmacists with an update on the current and evolving dialogue regarding the benefits, emerging indications, safety and pharmacoeconomic considerations for GLP-1 and GIP/GLP-1 receptor agonists.GLP-1 receptors: beyond the pancreasThe expression of the GLP-1 receptor in pancreatic beta cells forms the basis of the benefits of GLP-1 and GIP/GLP-1 agonist therapies in type 2 diabetes. However, the effects of GLP-1 in the body are wide-ranging, facilitated by the expression of GLP-1 receptors in many organs and tissues, including the heart, brain, kidney, intestinal tract, eyes, vascular smooth muscles and immune system.4,5,8 The presence of GLP-1 receptors in multiple body systems has spurred interest in exploring additional benefits of GLP-1 receptor agonists beyond the currently approved indications, as well as their potential anti-inflammatory and immunomodulatory benefits.4,5,9Established benefits of GLP-1 receptor agonistsType 2 diabetesThe use of GLP-1 and GIP/GLP-1 receptor agonists for the treatment of type 2 diabetes is well-documented, with a significant reduction in glycated hemoglobin (A1C, ~ 1.5% reduction depending on the drug and dose). As a result, these agents are included as standard therapy in guideline-based care.10-12 A person-centred approach to diabetes management is preferred; therefore, guidelines also recommend these agents be included in the type 2 diabetes therapy management of patients with atherosclerotic CV disease, CV risk factors and overweight, or those who would benefit from chronic weight management.10-12 Along with indications for use in type 2 diabetes management, some agents carry additional indications for reduction of CV risk or for chronic weight management (Table 1).Obesity and weight managementGLP and GIP/GLP-1 medications are perhaps even more well-known by the general public for producing weight loss by inducing satiety and delaying gastric emptying, with semaglutide and tirzepatide demonstrating mean body weight reductions ranging from approximately 15%–20% in clinical trials.13,14 The highly publicized use of these medications by celebrities for successful weight loss has brought these drugs into the public eye, contributing to greatly increased demand.15Cardiorenal benefitsAs people with type 2 diabetes are at high risk for developing CV and renal disease, the discovery of the cardiorenal benefits of GLP-1 receptor agonists further increased their appeal in this population. GLP-1 receptor agonists have been shown to reduce major adverse CV events and the progression of albuminuria, among other cardiorenal benefits, and a recent retrospective cohort study demonstrated tirzepatide is also effective in reducing these risks.16,17For the latest literature regarding cardiovascular outcome data for GLP-1 receptor agonists, see Arden Barry’s “Cardiovascular issues” column in the January/February issue of Pharmacy Practice+Business.18 (For digital version: canadianhealthcarenetwork.ca/rising-star-glp-1-receptor-agonists-keeping-cardiovascular-outcomes)Emerging therapeutic areas of interestMetabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitisNo GLP-1 receptor agonist therapies are currently indicated in Canada for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) or metabolic dysfunction-associated steatohepatitis (MASH). However, their benefits in comorbid conditions (e.g., type 2 diabetes and overweight) commonly associated with MASLD and MASH, as well as demonstrated improvements in liver parameters in this patient population, have prompted their inclusion in some treatment guidelines, such as those of the American Association of Clinical Endocrinology.19-21The use of GLP-1 receptor agonists has been shown to improve steatohepatitis, decrease fibrosis progression, and lead to MASH resolution, with some studies demonstrating a reduction in liver fat content ranging from 19%–39%.19 This is an active area of research as Novo Nordisk announced key results from the phase III ESSENCE trial in November 2024. The findings of this study demonstrated a significant improvement in liver fibrosis and resolution of steatohepatitis, compared with placebo, in patients with MASH and moderate to advanced liver fibrosis treated with semaglutide plus standard care.22In addition to direct improvements in liver histology, effects such as weight loss, cardiorenal protection, and decreased blood pressure and insulin resistance are of added benefit in this population.19,21Chronic kidney diseaseData from studies on the effect of GLP-1 receptor agonists on reducing CV risk in patients with type 2 diabetes also showed a reduction in albuminuria, and potential nephroprotective benefits, perhaps achieved by the pleiotropic anti-inflammatory, antioxidant and vasodilatory properties of these drugs. The FLOW study stimulated further research to determine a direct nephroprotective link, and ended early when semaglutide 1 mg weekly demonstrated a 24% reduction in the risk of major kidney disease events and slowed the decline in kidney function in patients with type 2 diabetes and chronic kidney disease.23,24 The major kidney disease events assessed were the onset of kidney failure, a ≥ 50% reduction in estimated glomerular filtration rate from baseline, or death from kidney-related or CV causes. The REMODEL trial hopes to clarify the details of the nephroprotective mechanism of action of semaglutide and provide further information on the utility of GLP-1 receptor agonists in slowing or preventing the progression of chronic kidney disease in patients with type 2 diabetes.25AddictionGLP-1 receptors are found in the ventral tegmental area and the nucleus accumbens, key parts of the brain involved in reward behaviour. A growing area of interest in the application of GLP-1 receptor agonists is their association with reward-related behaviour, in particular, smoking and alcohol use disorder.26-28A reduction in nicotine-seeking behaviour has been observed anecdotally in patients using GLP-1 receptor agonists for indications such as type 2 diabetes; studies are currently underway to examine the effects of GLP-1 receptor agonists, combined with the nicotine patch and counselling, on rates of smoking cessation and post-cessation weight gain.29,30Decreased desire and consumption of alcohol have also been observed anecdotally, and studies in rodents and monkeys have shown a reduction in alcohol intake while receiving GLP-1 receptor agonists.31 One randomized controlled trial examined the effects of exenatide (no longer marketed in Canada) on reducing alcohol consumption in people drinking at least 60 g (male) or 48 g (female) of alcohol on at least five days in the past month. While no difference in number of heavy drinking days was found in the study population as a whole, the number of heavy drinking days was significantly reduced in a subgroup of patients with obesity.32Neuroprotection and Alzheimer’s diseaseAnother emerging area of interest for GLP-1 receptor agonists is their use in treating Alzheimer’s disease and other dementias. Analysis of trial data studying GLP-1 receptor agonists in people with type 2 diabetes showed the trend of decreased reports of cognitive impairment or dementia.28,33 While there is no evidence of a direct effect on the clearance of amyloid-β plaques or tau neurofibrillary tangles, metabolic effects (e.g., glucose regulation) may be neuroprotective. The EVOKE and EVOKE+ trials, currently underway, are examining the potential benefits of oral semaglutide in early Alzheimer’s disease.34Other potential therapeutic usesGLP-1 and GIP/GLP-1 receptor agonists are also under study or show promise in several other therapeutic areas. For example, tirzepatide has recently been approved in the United States for treatment of moderate to severe obstructive sleep apnea in adults with obesity.35 Other indications under active study include heart failure with preserved ejection fraction,36,37 obesity-related cancers,38 and polycystic ovarian syndrome.39 Ongoing research continues to identify potential new indications.Safety concernsAdverse events and contraindicationsGastrointestinal-related effects (e.g., nausea, diarrhea, vomiting, constipation) are the most commonly reported adverse events with GLP-1 and GIP/GLP-1 receptor agonists. They are often dose-related and commonly subside following the dose escalation period.2,5Acute events of cholelithiasis and cholecystitis have also been observed with GLP-1 receptor agonists, perhaps related to a slowing of gallbladder emptying.4,16 The risk may be greater with higher doses and longer duration of therapy, although the overall risk is low; one systematic review reported an additional 27 cases per 10,000 persons treated per year.40Due to hyperplasia of thyroid gland C cells seen in rodents, GLP-1 and GIP/GLP-1 receptor agonists are contraindicated in patients with a history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, or those with a family history of medullary thyroid cancer. Real-world assessment of the risk of thyroid cancer shows an inconsistent association and investigation is ongoing.4,8,1Pancreatitis and pancreatic cancerEarly concerns for pancreatitis, supported by reports to adverse event databases, led to scrutiny of the risk of pancreatitis and pancreatic cancer with GLP-1 receptor agonists.42,43 Much analysis of these risks has been conducted, particularly in trials assessing GLP-1 receptor agonists and CV benefits. Based on this further analysis, no association has been found linking these drugs to increased risks of pancreatitis or pancreatic cancer.4,42,43 While an increased risk has not been identified, GLP-1 and GIP/GLP-1 receptor agonists should be discontinued if pancreatitis develops and alternate therapies considered in those with a history of pancreatitis.8,41Perioperative managementPulmonary aspiration, resulting from delayed gastric emptying despite routine preoperative fasting, has been reported in patients taking GLP-1 receptor agonists who are undergoing procedural sedation or general anesthesia. Recommendations for perioperative management of GLP-1 receptor agonists have continued to evolve, recognizing the practical difficulties in extended preoperative discontinuation to restore gastric motility (i.e., for 3–5 half-lives and potentially 4 weeks for most agents). Building on past recommendations, in December 2024, multiple specialty societies released a statement of guidance, recommending a shared decision-making approach to assess the risk of delayed gastric emptying preoperatively; factors contributing to increased risk include higher or escalating doses, weekly dosing and some comorbid conditions.44 If risk factors warrant holding the patient’s GLP-1 receptor agonist, the guidance document recommends holding daily formulations on the day of the procedure and weekly formulations for one week prior to the procedure.44Other potential safety concernsSafety signals related to GLP-1 and GIP/GLP-1 receptor agonists continue to be monitored and evaluated. For example, the FOCUS trial is currently underway to study the long-term risks of semaglutide on the development and progression of diabetic retinopathy, after the SUSTAIN-6 trial showed significantly higher rates of retinopathy complications in the semaglutide group.4,45,46 As well, Health Canada has conducted a safety review of GLP-1 receptor agonists following international case reports of suicidal thoughts and self-harm in patients using these medications. The review did not find a causal link between GLP-1 receptor agonists and suicide, self-harm or suicidal/self-harm ideation in the general type 2 diabetes population. However, evidence was inconsistent and inconclusive for patients with obesity regardless of type 2 diabetes status. Health Canada will continue to monitor this issue.47As GLP-1 and GIP/GLP-1 receptor agonists have experienced rapid and widespread uptake, and are relatively new classes of drugs, pharmacists should be alert for any newly reported safety issues and are encouraged to report any adverse reactions associated with these medications to the Canada Vigilance Program (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html).Pharmacoeconomic considerationsCost and drug coverageGLP-1 receptor agonists offer a multitude of benefits, particularly to those with type 2 diabetes and those seeking weight loss and chronic weight management, while also contributing cardiorenal advantages. Their therapeutic success has led to a significant increase in the prescribing of these drugs, resulting in a huge cost impact to public and private insurers. A review by Canada’s Drug Agency found that the national expenditures on GLP-1 receptor agonists by public provincial and territorial drug plans increased from approximately $12 million in 2016 to $227 million in 2021, led overwhelmingly by subcutaneous semaglutide.6 Extrapolating forward, an American report calculates that if the publicly funded US Medicare program were to cover GLP-1 receptor agonists for those with an elevated body mass index and 10-year atherosclerotic CV risk (irrespective of established type 2 diabetes or CV disease), this could result in an increased cost to Medicare of $34–$145US billion annually.7The cost implications of the broader use of GLP-1 receptor agonists raise challenging questions for public and private insurers related to approved indications, reimbursement criteria and long-term sustainability of funding of these therapies.Accessibility: drug shortagesThe immense popularity of GLP-1 receptor agonist therapies has resulted in worldwide shortages of these agents, with Canada recently experiencing shortages of semaglutide (subcutaneous), dulaglutide and tirzepatide.48 As pharmacists are well aware, drug shortages risk interruption of ongoing therapy, cause anxiety and concern for the patient, and result in a time-consuming search for medication supply or alternate therapies. Shortages of GLP-1 receptor agonists have led patients to seek out compounded formulations of these medications, resulting in the US Food and Drug Administration issuing statements to clarify policies related to compounding these drugs and the American Diabetes Association issuing a statement recommending against the use of compounded products due to uncertainty about safety and quality.49,50 Health Canada also recently recalled a semaglutide compounded product with an unauthorized active pharmaceutical ingredient.51Future directionsGLP-1 and GIP/GLP-1 receptor agonists have become major players in the treatment of type 2 diabetes and offer a significant advancement in drug therapy options for people with overweight and obesity. In addition, the number of novel indications for these agents continues to grow as researchers discover new potential benefits. Navigating consumer marketing, media coverage, and the challenges of drug shortages and drug coverage can be complex for patients. By staying up to date on new research and developments, guidelines and drug coverage policies, pharmacists can play an important role in helping patients understand current issues and recommendations related to these exciting therapies.Sarah Snobelen (sarah.snobelen@icloud.com) writes continuing education content for pharmacists and is a clinical pharmacist at St. Michael’s Hospital, Unity Health Toronto, in Toronto, Ont.References:Ferro EG, Elshazly MB, Bhatt DL. New antidiabetes medications and their cardiovascular and renal benefits. Cardiol Clin 2021;39:335-51. doi:10.1016/j.ccl.2021.04.007.Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med 2021;385:503-515. doi:10.1056/NEJMoa2107519.Yao H, Zhang A, Li D, et al. 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GLP-1 and dual GIP/GLP-1 receptor agonists

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