Corrigendum

This article refers to:

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

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, table 2, table 5, 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%) (Table 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.

Table 2. Prescribed treatments.

	No. of patients (%) or mean ± SD
Safety analysis set	8505 (100.0)
Initial dose of ipragliflozin
25 mg	1152 (13.5)
50 mg	7344 (86.3)
75 mg	0 (0.0)
100 mg	9 (0.1)
Dose changes during treatment
25 mg to 25 mg	856 (10.1)
25 mg to 50 mg	263 (3.1)
50 mg to 50 mg	7168 (84.3)
50 mg to 100 mg	78 (0.9)
Other	140 (1.6)
Duration of treatment with ipragliflozin, days	277.6 ± 129.6
Concomitant antidiabetic drug
No	1257 (14.8)
Yes	7192 (84.6)
Unknown	56 (0.7)
Type of concomitant antidiabetic drug
DPP-4 inhibitor	5165 (60.7)
Sulfonylurea	3089 (36.3)
Biguanide	2400 (28.2)
α-Glucosidase inhibitor	1190 (14.0)
Insulin	914 (10.7)
Thiazolidine	898 (10.6)
Fast-acting insulin secretagogue	305 (3.6)
GLP-1 receptor agonist	143 (1.7)
Other	660 (7.8)
Concomitant diuretic drug
No	7285 (85.7)
Yes	1136 (13.4)
Unknown	84 (1.0)
Type of concomitant diuretic drug
Loop diuretic	423 (5.0)
Thiazide diuretic	346 (4.1)
Potassium-sparing diuretic	230 (2.7)
Vasopressin antagonist	5 (0.1)
Carbonate dehydratase inhibitor	2 (0.0)
Osmotic diuretic	1 (0.0)
Other	309 (3.6)
Other concomitant drugs
No	2464 (29.0)
Yes	5930 (69.7)
Unknown	111 (1.3)
Type of other concomitant drugs
Antihypertensive drugs	4031 (47.4)
ARB	2007 (23.6)
CCB	2158 (25.4)
ARB + CCB	999 (11.7)
Statin	3018 (35.5)
Antiplatelet drug	1253 (14.7)
Antipeptic ulcer drug	1181 (13.9)
Antihyperuricemia drug	447 (5.3)
Other	5704 (67.1)

ARB: angiotensin receptor blocker; CCB: calcium channel blocker; DPP-4: dipeptidyl peptidase-4; GLP-1: glucagon-like peptide-1; SD: standard deviation.

Table 5. Factors associated with the incidence of adverse drug reactions of special interest in the multivariable regression analyses.

ADR class	Factors included in the model*	Odds ratio (95% CI)
All	Female (vs. male)	1.549 (1.297–1.850)
	BMI ≥30.0 kg/m^2 (vs. ≥22.0 to <25.0 kg/m^2)	1.294 (1.003–1.669)
	Moderately impaired hepatic function (vs. normal)	2.298 (1.011–5.225)
	Mildly impaired renal function (vs. normal)	1.376 (1.097–1.725)
Hypoglycemia	BMI <18.5 kg/m^2 (vs. ≥22.0 to <25.0 kg/m^2)	9.356 (2.692–32.514)
	Concomitant insulin use (vs. no)	4.946 (2.540–9.629)
Genital infection	Female (vs. male)	5.927 (3.477–10.104)
	BMI ≥25.0 to <30.0 kg/m^2 (vs. ≥22.0 to <25.0 kg/m^2)	2.061 (1.139–3.728)
	BMI ≥30.0 kg/m^2 (vs. ≥22.0 to <25.0 kg/m^2)	2.363 (1.273–4.387)
Urinary tract infection	Female (vs. male)	5.063 (2.467–10.389)
	Duration of diabetes ≥5 years (vs. <5 years)	5.288 (1.637–17.082)
	Moderately impaired hepatic function (vs. normal)	6.652 (1.452–30.478)
Polyuria/pollakiuria	Concomitant antidiabetic drug use (vs. no)	3.679 (1.143–11.841)
Volume depletion	Age ≥75 years (vs. <75 years)	1.737 (1.209–2.497)
	Concomitant loop diuretic use (vs. no)	2.105 (1.141–3.881)
Renal disorder	Mildly impaired renal function (vs. normal)	3.203 (2.131–4.816)
	Moderately impaired renal function (vs. normal)	7.003 (3.579–13.703)
	Severely impaired renal function (vs. normal)	22.389 (5.412–92.617)
	Concomitant diuretic use (vs. no)	2.631 (1.754–3.949)
Skin complications	Female (vs. male)	1.428 (1.115–1.829)

*The final models were built using a stepwise procedure with p-values of <0.15 for entry and staying in the model. ADR: adverse drug reaction; CI: confidence interval; BMI: body mass index.

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.