From the Guidelines
Dapagliflozin (Forxiga) clinical trials did include older populations in their research, with studies like DAPA-CKD including patients with a mean age of 64 years and a range of 22-95 years 1. The DAPA-CKD trial, which examined the effect of dapagliflozin on kidney outcomes in patients with chronic kidney disease, included a substantial number of older adults, with 41% of participants being 65 years or older and 14% being 75 years or older 1. Additionally, the DECLARE-TIMI 58 trial, one of the largest cardiovascular outcome trials for dapagliflozin, included patients up to 94 years of age, with approximately 20% of participants being 75 years or older 1. When prescribing dapagliflozin for older patients, healthcare providers should consider age-related factors such as reduced renal function, risk of volume depletion, and potential for hypotension, as noted in the DAPA-CKD trial 1. Some key points to consider when treating older adults with dapagliflozin include:
- Careful monitoring of renal function and volume status
- Adjusting doses based on individual patient needs
- Considering the potential for hypotension and other age-related adverse effects
- Weighing the benefits of dapagliflozin against the potential risks in older adults, as noted in the EMPA-REG OUTCOME trial 1. Overall, the inclusion of older adults in dapagliflozin research helps provide evidence for its safety and efficacy across a broader age spectrum, though clinical judgment remains important when treating elderly patients 1.
From the FDA Drug Label
A total of 1424 (24%) of the 5936 dapagliflozin-treated patients were 65 years and older and 207 (3. 5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical trials assessing the efficacy of dapagliflozin in improving glycemic control in type 2 diabetes mellitus. In patients ≥65 years of age, a higher proportion of patients treated with dapagliflozin for glycemic control had adverse reactions of hypotension In the DAPA-CKD, DAPA-HF and DELIVER trials, safety and efficacy were similar for patients aged 65 years and younger and those older than 65.
Yes, dapagliflozin (Forxiga) was utilized in older populations in their research, with 24% of patients being 65 years and older and 3.5% being 75 years and older in clinical trials 2.
From the Research
Dapagliflozin Research Involvement of Older Population
- The provided studies do not explicitly mention the involvement of an older population in dapagliflozin (Forxiga) research 3, 4, 5, 6, 7.
- However, some studies suggest that dapagliflozin is used in the treatment of patients with type 2 diabetes, which can affect people of various age groups, including older adults 3, 4.
- One study mentions that dapagliflozin is approved for use in adults with symptomatic heart failure with reduced ejection fraction, which may include older adults, but does not provide specific information on the age range of participants 5.
- Another study discusses the benefits and limitations of dapagliflozin in improving patient outcomes, but does not provide information on the age range of participants 6.
- A study on the renal hemodynamic effects of dapagliflozin mentions that the participants were people with type 2 diabetes on metformin monotherapy, but does not provide information on the age range of participants 7.
Age-Related Considerations
- While the studies do not provide explicit information on the involvement of an older population in dapagliflozin research, it is likely that older adults were included in the studies given the prevalence of type 2 diabetes and heart failure in this age group 3, 4, 5.
- However, without specific information on the age range of participants, it is difficult to determine the extent to which older adults were represented in the studies 6, 7.