What real-world data can reveal about weight loss medications

ObesityWeek has significantly shifted its focus over the years, particularly towards pharmaceutical treatments for obesity. Initially, GLP-1s were used to treat patients with type 2 diabetes and they found it could also address patients with type 2 diabetes who were also overweight or obese.

The emphasis in obesity treatment was on lifestyle interventions, but with the advent of treatments like the once-weekly GLP-1 medications, the focus has moved towards demonstrating the effectiveness of anti-obesity medications and their clinical benefits in trials and real-world clinic settings.

More recently, while pharmaceutical companies continue to evaluate the efficacy and safety of these treatments, they are also more engaged in discussions regarding the impact of pharmacotherapy on patient health beyond just weight reduction.

In the past, there wasn't really a truly effective way to achieve significant weight reduction for a large population. Intensive lifestyle intervention results in ≥10% weight reduction for less than a third of patients, and only about 20% can maintain that weight loss long term. Bariatric surgery is effective, but it is not used by a high percentage of the eligible population. Newer anti-obesity medications are bringing about weight reduction that wasn’t typically seen with diet and lifestyle intervention alone. 

This new paradigm has created a need to explore the myriad potential benefits related to pharmacological treatment, since such a large proportion of the population qualifies for anti-obesity medications due to their risk of obesity-related health impacts. In the short term, there’s potential to reduce knee and back pain, improve activity levels and improve mental health, which has profound impact on a multitude of other conditions.

However, despite its effectiveness, adherence with GLP-1s can be challenging in the short- and long-term. There are two critical areas to address at this time:

• Understanding the root causes of poor adherence to these medications.
• Innovating on the medication dose and delivery to improve tolerability.

The trend is towards demonstrating the clinical value of these treatments in real-world settings. The short-term benefits of GLP-1s and other weight loss medications include weight reduction and improvements in metabolic health. Longer-term benefits being studied include reductions in cardiovascular events and other obesity-related complications. These studies aim to demonstrate the sustained health benefits of these medications, which is crucial for gaining support from payers and clinicians.

Real-world data can help to identify short-term and long-term effects of anti-obesity medications among patients seen in clinical practice. In a recent real-world study in Optum Health, we learned that providers do not always prioritize discussions about overweight and obesity while attending to other primary health conditions. The patient is often likely to initiate discussion and there needs to be a fair, balanced review of the options.

RWD will be crucial in documenting the changes in patients utilizing these medications outside of the rigorous trial environment. For instance, trial participants were dose-escalated to a maximum dose set by randomization, and that escalation was based on a predefined schedule irrespective of weight reduction trajectory or occurrence of side effects. In clinical practice, patients are generally titrated to the lowest effective dose on a schedule that can allow additional time at a lower dose to acclimate or adjust to side effects.

Another difference is that real-world patients commonly experienced medication interruption and discontinuation due to shortages and pharmacy coverage, so real-world data will allow us to investigate whether patients who discontinue treatment experience the same level of weight regain that was seen in the trials.

RWD may also help highlight potential benefits beyond weight reduction. These include outcomes investigated during the trials such as:

• Improvements in cardiovascular health
• Improvements in quality of life
• Reductions in obesity-related complications

Benefits may also include outcomes not measured in the trials, like workplace productivity and absenteeism — these can be important factors to consider when making decisions regarding employer-sponsored health coverage.

Optum Life Sciences are experts in the RWD we provide, and we can apply a comprehensive understanding of patient journeys through diverse data assets. By compiling de-identified data from primary data collection, surveys, clinical notes, electronic health records (EHR) data, and administrative claims data, we can demonstrate both short-term and long-term clinical benefits of anti-obesity medications.

Additionally, our analyses can address the biases and confounding factors that are not seen in clinical trials, and which may affect treatment outcomes. This data-driven approach helps pharmaceutical companies present compelling evidence of the effectiveness and additional benefits of their medications, evidence that is vital for convincing payers and employers of the value of these medications.