From the Guidelines
Orfoglipron (Gliflozin) is not currently an FDA-approved medication for type 2 diabetes mellitus, and therefore, there is no established recommended dosage or usage regimen for this specific medication name. Patients with type 2 diabetes should instead use established FDA-approved medications such as metformin, SGLT-2 inhibitors (like empagliflozin, dapagliflozin, or canagliflozin), GLP-1 receptor agonists, DPP-4 inhibitors, sulfonylureas, or insulin as prescribed by their healthcare provider 1. It's essential for patients to consult with their healthcare provider for appropriate medication selection and dosing based on their specific health status, diabetes control, and other individual factors. Using unapproved medications could pose significant health risks and should be avoided outside of properly conducted clinical trials. The recommended dosages for FDA-approved SGLT-2 inhibitors are as follows:
- Empagliflozin: 10 mg PO daily
- Dapagliflozin: 10 mg PO daily
- Canagliflozin: 100 mg PO daily These medications have been shown to improve glycemic control and reduce the risk of cardiovascular events in patients with type 2 diabetes 1. However, the use of these medications should be individualized based on patient-specific factors, such as kidney function, cardiovascular risk, and other comorbidities. Healthcare providers should carefully evaluate the benefits and risks of each medication and select the most appropriate treatment regimen for each patient. Regular monitoring of kidney function, blood pressure, and cardiovascular risk factors is also crucial to ensure the safe and effective use of these medications. In summary, while Orfoglipron (Gliflozin) is not an approved medication for type 2 diabetes, established FDA-approved medications like SGLT-2 inhibitors can be effective in improving glycemic control and reducing cardiovascular risk, but their use should be individualized and carefully monitored by healthcare providers.
From the Research
Dosage and Usage of Orfoglipron
- The recommended dosage of Orfoglipron (Gliflozin) for patients with type 2 diabetes mellitus is not explicitly stated in the provided studies, but the studies suggest that doses of 12 mg or greater once daily may be effective in reducing HbA1c and body weight 2, 3.
- A Phase 1b trial evaluated the safety, pharmacokinetics, and pharmacodynamics of Orfoglipron in patients with type 2 diabetes, with daily doses ranging from 3 to 45 mg 3.
- A Phase 2 trial compared the efficacy and safety of Orfoglipron versus placebo or dulaglutide in patients with type 2 diabetes, with Orfoglipron doses ranging from 3 to 45 mg once daily 2.
Efficacy of Orfoglipron
- Orfoglipron has been shown to be effective in reducing HbA1c and body weight in patients with type 2 diabetes, with significant reductions in HbA1c and body weight compared to placebo or dulaglutide 2, 3.
- A systematic review and meta-analysis of randomized controlled trials found that Orfoglipron led to significant reductions in HbA1c and body weight in patients with type 2 diabetes or obesity 4.
Safety of Orfoglipron
- The most common adverse events associated with Orfoglipron are gastrointestinal-related, and occur early in treatment, similar to findings with other GLP-1 receptor agonists 2, 3.
- Orfoglipron has been shown to have a neutral effect on the odds of severe hypoglycemia or serious adverse events, but significantly higher odds of gastrointestinal, treatment-emergent adverse events and adverse events leading to discontinuation 4.
Cardiovascular Risk Markers
- Orfoglipron treatment has been associated with beneficial changes in cardiovascular risk markers, including significant decreases in blood pressure, low-density lipoprotein (LDL) cholesterol, triglycerides, and high-sensitivity C-reactive protein (hsCRP) 5.