Yokote K, Terauchi Y, Nakamura I, et al. Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study. Expert Opin Pharmacother. 2006;17:1–9.
http://dx.doi.org/10.1080/14656566.2016.1219341
When the article was first published online, errors were found in paragraph 3.2, , , and paragraph 5. These have now been corrected in the online and print versions, and they have also been provided below.
3.2. Prescribed treatments
The initial dose of ipragliflozin was 50 mg in 86.3% of patients, 25 mg in 13.5% of patients, and 100 mg in 0.1% of patients. The dose was increased from 25 mg to 50 mg in 3.1% of patients and from 50 mg to 100 mg in 0.9% of patients. In 84.3% of patients, ipragliflozin was initially prescribed at 50 mg and this dose was continued unchanged. Ipragliflozin was prescribed in combination with other antidiabetic drugs in 84.6% of patients. The most commonly used antidiabetic drugs were dipeptidyl peptidase-4 (DPP-4) inhibitors (60.7%), sulfonylureas (36.3%), and biguanides (28.2%) (). Antihypertensive drugs, statins, antiplatelet drugs, antipeptic ulcer drugs, and diuretics were prescribed to 47.4%, 35.5%, 14.7%, 13.9%, and 13.4% of patients, respectively.
5. Conclusions
In conclusion, this 1-year PMS has demonstrated the safety profile, in terms of the ADRs that might occur when prescribing ipragliflozin to elderly Japanese patients with T2DM. This PMS is important in that it provides evidence regarding the use of ipragliflozin in real-world clinical practice and there were no safety concerns that were not previously observed in the preapproval clinical trials. The most common types of ADRs were related to skin complications, volume depletion, polyuria/pollakiuria, genital infection, urinary tract infection, and renal disorders. Overall, 38.99% of ADRs occurred within 30 days and 65.69% within 90 days of starting treatment. The majority of ADRs resolved or were in remission at the time the case report form was completed. The risk factors for ADRs varied among the different categories, and could be rationalized based on the results of prior studies. The observed risk factors for hypoglycemia were BMI (<18.5 kg/m2 vs. ≥22.0 to <25.0 kg/m2; OR, 9.356) and concomitant insulin use (vs. no; OR, 4.946), while those for volume depletion were age (≥75 years vs. <75 years; OR, 1.737) and concomitant loop diuretic use (vs. no; OR, 2.105). The results of this PMS should help guide physicians in Japan, and other countries, identify possible treatment-emergent ADRs in patients treated with ipragliflozin.