Correction: Advances in Therapy (2024) 42:413–426 10.1007/s12325-024-03050-1
The Results section was provided as “The descriptive analysis’ URLi-treated cohort included 17,838 patients [mean (standard deviation, SD) age 65.9 (15.7) years; 58.3% male]. The majority had type 2 diabetes (75.7%). The incidence proportion of the first severe hypoglycemia event requiring a hospital visit was 0.6% (95% CI 0.5, 0.8) and the incidence rate was 1.7 per 100 person-years (95% CI 0.7, 4.3). The comparative analysis included 10,592 URLi-treated and 52,917 comparator-treated patients. The incidence rate of severe hypoglycemia did not significantly differ between these cohorts (HR 0.8; 95% CI 0.5, 1.1; p = 0.132;.”
This section should have read as “The descriptive analysis’ URLi-treated cohort included 17,850 patients (mean [standard deviation, SD] age 65.9 [15.7] years; 58.2% male). The majority had type 2 diabetes (75.7%). The incidence proportion of the first severe hypoglycemia event requiring a hospital visit was 0.6% (95% CI: 0.5, 0.7) and the incidence rate was 1.7 per 100 person-years (95% CI: 0.6, 4.4). The comparative analysis included 10,605 URLi-treated and 52,979 comparator-treated patients. The incidence rate of severe hypoglycemia did not significantly differ between these cohorts (HR 0.8 [95% CI: 0.5, 1.1]; p = 0.170).”
In the Key Summary Points, there were a few errors.
The 95% confidence intervals for the incidence proportion of the first severe hypoglycemia event requiring a hospital visit and the incidence rate were originally provided as “0.5, 0.8” and “0.6, 4.4”, respectively. These values should have read “0.5, 0.7” and “0.6, 4.4”, respectively.
The p value provided for the last summary point regarding the incidence rate of the first severe hypoglycemia event requiring a hospital visit not differing significantly between the URLi-treated and other RAIA-treated cohorts was originally provided as “p = 0.132.” This should have been “p = 0.170.”
There were a few errors in Fig. 2. The original Fig. 2 was provided as:
The correct Fig. 2 is as follows:
In the Results, Descriptive Analyses, Patient Characteristics at Baseline section, the sentence “The final URLi-treated cohort for descriptive analysis included 17,838 patients (Fig. 2i) (mean [SD] age 65.9 [15.7] years and 58.3% male) (Table 1)” should have read “The final URLi-treated cohort for descriptive analysis included 17,850 patients (Fig. 2i) (mean [SD] age 65.9 [15.7] years and 58.2% male) (Table 1).” In this section, the percentage of patients who had a CCI ≥ 5 was incorrectly provided as 57.9% and should have read 58%.
The Results, Descriptive Analyses, Incidence proportion and incidence rate of the first severe hypoglycemia event section was originally provided as “A total of 115 events of severe hypoglycemia were observed over a follow-up period of 6792 person-years in the URLi-treated cohort (n = 17,838). The incidence proportion of the first severe hypoglycemia event requiring a hospital visit was 0.6% (95% CI: 0.5, 0.8) and the incidence rate was 1.7 per 100 person-years (95% CI: 0.7, 4.3).” This section should have read “A total of 106 events of severe hypoglycemia were observed over a follow-up period of 6360 person-years in the URLi-treated cohort (n = 17,850). The incidence proportion of the first severe hypoglycemia event requiring a hospital visit was 0.6% (95% CI: 0.5, 0.7) and the incidence rate was 1.7 per 100 person-years (95% CI: 0.6, 4.4).”
Table 1 contained a few errors. The original Table 1 was provided as below:
| URLi-treated cohort (N = 17,838) |
|
|---|---|
| Age in years, mean (SD) | 65.9 (15.7) |
| Age category, n (%) | |
| 18–49 | 2928 (16.4) |
| 50–64 | 4071 (22.8) |
| 65–69 | 2010 (11.3) |
| 70–74 | 2985 (16.7) |
| 75–79 | 2,427 (13.6) |
| 80–84 | 1836 (10.3) |
| ≥ 85 | 1581 (8.9) |
| Sex, n (%) | |
| Male | 10,395 (58.3) |
| Female | 7443 (41.7) |
| Height in cm, mean (SD)a | 160.6 (9.9) |
| Weight in kg, mean (SD)b | 61.7 (15.4) |
| BMI in kg/m2, mean (SD)c | 23.8 (4.8) |
| Hospital size (number of beds), n (%) | |
| < 200 | 1090 (6.1) |
| ≥ 200, < 500 | 9293 (52.1) |
| ≥ 500 | 7455 (41.8) |
SD standard deviation, URLi ultra-rapid lispro an = 11,797, bn = 11,884, cn = 11,761
The corrected Table 1 is as follows:
| URLi-treated cohort (N = 17,850) |
|
|---|---|
| Age in years, mean (SD) | 65.9 (15.7) |
| Age category, n (%) | |
| 18–49 | 2930 (16.4) |
| 50–64 | 4074 (22.8) |
| 65–69 | 2011 (11.3) |
| 70–74 | 2988 (16.7) |
| 75–79 | 2427 (13.6) |
| 80–84 | 1838 (10.3) |
| ≥ 85 | 1582 (8.9) |
| Sex, n (%) | |
| Male | 10,396 (58.2) |
| Female | 7454 (41.8) |
| Height in cm, mean (SD)a | 160.6 (9.9) |
| Weight in kg, mean (SD)b | 61.7 (15.4) |
| BMI in kg/m2, mean (SD)c | 23.8 (4.8) |
| Hospital size (number of beds), n (%) | |
| < 200 | 1090 (6.1) |
| ≥ 200, < 500 | 9302 (52.1) |
| ≥ 500 | 7458 (41.8) |
SD standard deviation, URLi ultra-rapid lispro an = 11,807, bn = 11,894, cn = 11,771
In the Results, Descriptive Analyses, Sensitivity Analyses section, there were a few errors.
The incidence rate in the exposure time sensitivity analysis was originally provided as 2.1 per 100 person-years (95% CI: 0.9, 5.0). The incidence rate should have been 2.0 per 100 person-years ((95% CI: 0.8, 5.0).
In the LAIA sensitivity analysis, the incidence proportion was originally provided as 0.9% (95% CI: 0.7, 1.0) and the incidence rate was 1.9 per 100 person-years (95% CI: 0.7, 5.2). The incidence proportion should have been 0.8% (95% CI: 0.6, 1.0) and an incidence rate of 1.8 per 100 person-years (95% CI: 0.6, 5.2).
For algorithm 1, the incidence proportion was provided as 7.6% (95% CI: 7.2, 8.0) and the incidence rate was 21.5 per 100 person-years (95% CI: 15.9, 29.1). This should have read as “For algorithm 1, the incidence proportion was 6.9% (95% CI: 6.5, 7.3) and the incidence rate was 20.9 per 100 person-years (95% CI: 15.2, 28.6).”
For algorithm 2, the incidence proportion was provided as 3.4% (95% CI: 3.1, 3.7) and the incidence rate was 9.4 per 100 person-years (95% CI: 6.6, 13.3). This should have read as “For algorithm 2, the incidence proportion was 3.2% (95% CI: 3.0, 3.5) and the incidence rate was 9.6 per 100 person-years (95% CI: 6.7, 13.6).”
In the URLi-treated cohort sensitivity analysis, the incidence proportion was originally provided as 1.2% (95% CI: 0.9, 1.5) and the incidence rate was 2.0 per 100 person-years (95% CI: 0.6, 6.3). This should have read as “the incidence proportion was 1.1% (95% CI: 0.9, 1.4) and the incidence rate was 1.9 per 100 person-years (95% CI: 0.5, 6.4).”
In the Results, Comparative Analyses, Patient Characteristics at Baseline section, there was an error in the patient numbers. The patient numbers provided for the unmatched URLi-treated cohort and comparator-treated cohort for comparative analysis were 10,594 and 190,095 patients, respectively. The correct patient numbers the unmatched URLi-treated cohort and comparator-treated cohort for comparative analysis should have been 10,606 and 190,243 patients, respectively.
In the Results, Comparative Analyses, Incidence proportion and incidence rate of the first severe hypoglycemia event section, the 95% CI value for the incidence proportion of the first severe hypoglycemia event requiring a hospital visit after PS-matching in the URLi-treated cohort was originally provided as 0.5 but should have read 0.4. The incidence proportion of the first severe hypoglycemia event requiring a hospital visit after PS-matching in the comparator-treated cohort was originally provided as 0.5% but should have read 0.4%. The p value provided for the incidence rate not differing significantly between the two cohorts originally read as p = 0.132 but should have read p = 0.170.
The Results, Comparative Analyses, Incidence proportion and incidence rate of the first severe hypoglycemia event, Subgroup Analysis section was originally provided as “After PS-matching, the incidence proportion among patients using combination therapy with LAIA was 0.4% (95% CI: 0.3, 0.7) in the URLi-treated cohort (n = 5030) and 0.6% (95% CI: 0.6, 0.8) in the comparator-treated cohort (n = 25,126) (Table 5). Incidence rate did not differ significantly between the URLi-treated and comparator-treated cohort (HR 0.8 [95% CI: 0.5, 1.2]; p = 0.208).” This should have read “After PS-matching, the incidence proportion among patients using combination therapy with LAIA was 0.4% (95% CI: 0.3, 0.6) in the URLi-treated cohort (n = 5033) and 0.6% (95% CI: 0.5, 0.7) in the comparator-treated cohort (n = 25,141) (Table 5). Incidence rate did not differ significantly between the URLi-treated and comparator-treated cohort (HR 0.8 [95% CI: 0.5, 1.2]; p = 0.214).”
In the Results, Comparative Analyses, Incidence proportion and incidence rate of the first severe hypoglycemia event, Sensitivity Analysis section, there were a few errors:
It was originally stated that, after PS-matching, the incidence proportion of the first severe hypoglycemia event in the URLi-treated cohort requiring a hospital visit ranged from 0.3% (95% CI: 0.2, 0.4) in the exposure time sensitivity analysis to 6.4% (95% CI: 6.0, 6.9) in the outcome sensitivity analysis. The value for the outcome sensitivity analysis should have been 5.6% (95% CI: 5.2, 6.0) instead.
The original value provided for the incidence proportion in the comparator-treated cohort in the outcome sensitivity analysis was 6.7% (95% CI: 6.5, 6.9). This should have been 6.0% (95% CI: 5.8, 6.2).
The sentence “In the comparator-treated cohort sensitivity analysis, the incidence proportion and incidence rate ranged from 0.4% (95% CI: 0.4, 0.5) and 1.4 per 100 person-years (95% CI: 0.9, 2.3) (both for insulin lispro), to 0.6% (95% CI: 0.4, 1.0) and 2.1 per 100 person-years (95% CI 0.2, 18.3) (both for Fiasp®) (Supplementary material table S10)” should have read “In the comparator-treated cohort sensitivity analysis, the incidence proportion and incidence rate ranged from 0.4% (95% CI: 0.3, 0.4) and 1.4 per 100 person-years (95% CI: 0.8, 2.3) (both for insulin lispro), to 0.6% (95% CI: 0.4, 1.0) and 2.2 per 100 person-years (95% CI 0.2, 18.9) (both for Fiasp®) (Supplementary material table S10).”
Table 2 contained a few errors. The original Table 2 was provided as below:
| URLi-treated cohort (N = 17,838) |
|
|---|---|
| Diagnosis of diabetes, n (%) | |
| T1D | 4339 (24.3) |
| T2D | 13,499 (75.7) |
| Duration of diabetes in years, mean (SD) | 3.0 (3.4) |
| History of severe hypoglycemia requiring a hospital visit, n (%) | 152 (0.9) |
| History of complications related to diabetes, n (%) | |
| Diabetic nephropathy | 3285 (18.4) |
| Diabetic retinopathy | 2892 (16.2) |
| Diabetic neuropathy | 1263 (7.1) |
| Duration of antidiabetic drugs in years, mean (SD) | 2.6 (3.3) |
| Antidiabetic drugs other than insulin, n (%) | |
| DPP4i | 4444 (24.9) |
| SGLT2i | 3426 (19.2) |
| Biguanide | 2982 (16.7) |
| Alpha glucosidase inhibitor | 1482 (8.3) |
| GLP-1 RA | 1474 (8.3) |
| Sulfonylurea | 675 (3.8) |
| Glinide | 669 (3.8) |
| Thiazolidine | 372 (2.1) |
| Imeglimin | 80 (0.4) |
| Duration of insulin use in years, mean (SD) | 2.1 (3.0) |
| Insulin use, n (%) | |
| Rapid-acting insulin | 17,838 (100) |
| Basal insulin | 11,597 (65.0) |
| Regular insulin | 4314 (24.2) |
| Biphasic insulin | 669 (3.8) |
| Intermediate-acting insulin | 105 (0.6) |
| Use of LAIAs, n (%) | 11,387 (63.8) |
| Number of types of RAIAs used prior to index date, n (%) | |
| 0 | 11,329 (63.5) |
| 1 | 6200 (34.8) |
| ≥ 2 | 309 (1.7) |
| Administration route of rapid-acting insulin including URLi at index date, n (%) | |
| Injection | 17,728 (99.4) |
| CSII | 110 (0.6) |
| CGM use, n (%) | 2674 (15.0) |
| Charlson Comorbidity Index, n (%) | |
| 0 | 630 (3.5) |
| 1–2 | 2684 (15.0) |
| 3–4 | 4194 (23.5) |
| ≥ 5 | 10,330 (57.9) |
| Comorbidities, n (%) | |
| Diabetes without chronic complication | 8554 (48.0) |
| Diabetes with chronic complication | 6980 (39.1) |
| Any malignancies | 3874 (21.7) |
| Cerebrovascular disease | 3598 (20.2) |
| Congestive heart failure | 3052 (17.1) |
| Mild liver disease | 2584 (14.5) |
| Peptic ulcer disease | 2522 (14.1) |
| Chronic pulmonary disease | 2035 (11.4) |
| Renal disease | 1896 (10.6) |
| Peripheral vascular disease | 1596 (8.9) |
| Myocardial infarction | 904 (5.1) |
| Dementia | 918 (5.1) |
| Metastatic solid tumor | 830 (4.7) |
| Rheumatic disease | 702 (3.9) |
| Liver dysfunction | 273 (1.5) |
| Hemiplegia or paraplegia | 179 (1.0) |
| AIDS/HIV | 10 (0.1) |
The corrected Table 2 is as follows:
| URLi-treated cohort (N = 17,850) |
|
|---|---|
| Diagnosis of diabetes, n (%) | |
| T1D | 4341 (24.3) |
| T2D | 13,509 (75.7) |
| Duration of diabetes in years, mean (SD) | 3.0 (3.4) |
| History of severe hypoglycemia requiring a hospital visit, n (%) | 152 (0.9) |
| History of complications related to diabetes, n (%) | |
| Diabetic nephropathy | 3288 (18.4) |
| Diabetic retinopathy | 2893 (16.2) |
| Diabetic neuropathy | 1264 (7.1) |
| Duration of antidiabetic drugs in years, mean (SD) | 2.6 (3.3) |
| Antidiabetic drugs other than insulin, n (%) | |
| DPP4i | 4446 (24.9) |
| SGLT2i | 3427 (19.2) |
| Biguanide | 2984 (16.7) |
| Alpha glucosidase inhibitor | 1483 (8.3) |
| GLP-1 RA | 1474 (8.3) |
| Sulfonylurea | 675 (3.8) |
| Glinide | 669 (3.7) |
| Thiazolidine | 373 (2.1) |
| Imeglimin | 80 (0.4) |
| Duration of insulin use in years, mean (SD) | 2.1 (3.0) |
| Insulin use, n (%) | |
| Rapid-acting insulin | 17,850 (100) |
| Basal insulin | 11,600 (65.0) |
| Regular insulin | 4314 (24.2) |
| Biphasic insulin | 669 (3.7) |
| Intermediate-acting insulin | 105 (0.6) |
| Use of LAIAs, n (%) | 11,390 (63.8) |
| Number of types of RAIAs used prior to index date, n (%) | |
| 0 | 11,341 (63.5) |
| 1 | 6200 (34.7) |
| ≥ 2 | 309 (1.7) |
| Administration route of rapid-acting insulin including URLi at index date, n (%) | |
| Injection | 17,740 (99.4) |
| CSII | 110 (0.6) |
| CGM use, n (%) | 2675 (15.0) |
| Charlson Comorbidity Index, n (%) | |
| 0 | 629 (3.5) |
| 1–2 | 2672 (15.0) |
| 3–4 | 4194 (23.5) |
| ≥ 5 | 10,355 (58.0) |
| Comorbidities, n (%) | |
| Diabetes without chronic complication | 8559 (47.9) |
| Diabetes with chronic complication | 6984 (39.1) |
| Any malignancies | 3874 (21.7) |
| Cerebrovascular disease | 3599 (20.2) |
| Congestive heart failure | 3054 (17.1) |
| Mild liver disease | 2873 (16.1) |
| Peptic ulcer disease | 2523 (14.1) |
| Chronic pulmonary disease | 2035 (11.4) |
| Renal disease | 1897 (10.6) |
| Peripheral vascular disease | 1597 (8.9) |
| Myocardial infarction | 906 (5.1) |
| Dementia | 918 (5.1) |
| Metastatic solid tumor | 830 (4.6) |
| Rheumatic disease | 702 (3.9) |
| Liver dysfunction | 273 (1.5) |
| Hemiplegia or paraplegia | 179 (1.0) |
| AIDS/HIV | 13 (0.1) |
Table 3 contained a few errors. The original Table 3 was provided as below:
| CSII (n = 110) | Combination therapy with LAIAs (n = 11,387) | T1D (n = 4339) |
T2D (n = 13,499) |
|
|---|---|---|---|---|
| Number of events | 0 | 99 | 63 | 52 |
| Follow-up period duration (person-years) | 66 | 5080 | 2484 | 4308 |
| Incidence proportion (95% CI) (%) | 0.0 (–, –) | 0.9 (0.7, 1.1) | 1.5 (1.1, 1.9) | 0.4 (0.3, 0.5) |
| Incidence rate (95% CI) (per 100 person-years) | 0.0 (–, –) | 1.9 (0.7, 5.2) | 2.5 (0.5, 12.3) | 1.2 (0.4, 4.0) |
The corrected Table 3 is as follows:
| CSII (n = 110) | Combination therapy with LAIAs (n = 11,390) | T1D (n = 4341) |
T2D (n = 13,509) |
|
|---|---|---|---|---|
| Number of events | 0 | 92 | 59 | 47 |
| Follow-up period duration (person-years) | 66 | 4875 | 2,448 | 3912 |
| Incidence proportion (95% CI) (%) | 0.0 (–, –) | 0.8 (0.7, 1.0) | 1.4 (1.1, 1.8) | 0.4 (0.3, 0.5) |
| Incidence rate (95% CI) (per 100 person-years) | 0.0 (–, –) | 1.9 (0.7, 5.2) | 2.4 (0.5, 12.8) | 1.2 (0.3, 4.2) |
Table 4 contained a few errors. The original Table 4 was provided as below:
| Unmatched cohorts | Matched cohorts | |||
|---|---|---|---|---|
| URLi-treated (n = 10,594) |
Comparator-treated (n = 190,095) |
URLi-treated (n = 10,592) |
Comparator-treated (n = 52,917) |
|
| Number of events | 34 | 855 | 34 | 239 |
| Follow-up period duration (person-years) | 2614 | 58,174 | 2614 | 15,566 |
| Incidence proportion (95% CI) (%) | 0.3 (0.2, 0.5) | 0.5 (0.4, 0.5) | 0.3 (0.2, 0.5) | 0.5 (0.4, 0.5) |
| Incidence rate (95% CI) (per 100 person-years) | 1.3 (0.2, 7.9) | 1.5 (1.0, 2.1) | 1.3 (0.2, 7.9) | 1.5 (0.8, 2.9) |
| HR (95% CI) | – | – | 0.8 (0.5, 1.1) | |
| p value | – | – | 0.132 | |
The corrected Table 4 is as follows:
| Unmatched cohorts | Matched cohorts | |||
|---|---|---|---|---|
| URLi-treated (n = 10,606) |
Comparator-treated (n = 190,243) |
URLi-treated (n = 10,605) |
Comparator-treated (n = 52,979) |
|
| Number of events | 31 | 748 | 31 | 223 |
| Follow-up period duration (person-years) | 2290 | 51,962 | 2290 | 14,203 |
| Incidence proportion (95% CI) (%) | 0.3 (0.2, 0.4) | 0.4 (0.4, 0.4) | 0.3 (0.2, 0.4) | 0.4 (0.4, 0.5) |
| Incidence rate (95% CI) (per 100 person-years) | 1.4 (0.2, 8.6) | 1.4 (1.0, 2.1) | 1.4 (0.2, 8.6) | 1.6 (0.8, 3.2) |
| HR (95% CI) | – | – | 0.8 (0.5, 1.1) | |
| p value | – | – | 0.170 | |
Table 5 contained a few errors. The original Table 5 was provided as below:
| Matched cohorts | ||
|---|---|---|
| URLi-treated (n = 5,030) |
Comparator-treated (n = 25,126) |
|
| Number of events | 22 | 162 |
| Follow-up period duration (person-years) | 1268 | 7932 |
| Incidence proportion (95% CI) (%) | 0.4 (0.3, 0.7) | 0.6 (0.6, 0.8) |
| Incidence rate (95% CI) (per 100 person-years) | 1.7 (0.2, 13.4) | 2.0 (1.1, 3.8) |
| HR (95% CI) | 0.8 (0.5, 1.2) | – |
| p value | 0.208 | – |
The corrected Table 5 is as follows:
| Matched cohorts | ||
|---|---|---|
| URLi-treated (n = 5,033) |
Comparator-treated (n = 25,141) |
|
| Number of events | 21 | 155 |
| Follow-up period duration (person-years) | 1148 | 7240 |
| Incidence proportion (95% CI) (%) | 0.4 (0.3, 0.6) | 0.6 (0.5, 0.7) |
| Incidence rate (95% CI) (per 100 person-years) | 1.8 (0.2, 14.0) | 2.1 (1.0, 4.6) |
| HR (95% CI) | 0.8 (0.5, 1.2) | – |
| p value | 0.214 | – |
In the Discussion section, there were a few errors:
The sentence “Nevertheless, the current study’s results did not show a statistically significant increase in the incidence and risk of the first severe hypoglycemia event requiring a hospital visit in URLi-treated patients, compared with a PS-matched cohort of other RAIA-treated patients (HR 0.8 [95% CI: 0.5, 1.1]; p = 0.132)” should have read “Nevertheless, the current study’s results did not show a statistically significant increase in the incidence and risk of the first severe hypoglycemia event requiring a hospital visit in URLi-treated patients, compared with a PS-matched cohort of other RAIA-treated patients (HR 0.8 [95% CI: 0.5, 1.1]; p = 0.170).”
The sentence “In the descriptive analysis, the incidence rate of the main analysis (1.7 per 100 person-years) and the incidence rates of the outcome sensitivity analyses (algorithm 1: 21.5 per 100 person-years and algorithm 2: 9.4 per 100 person-years) were quite different…” should have read “In the descriptive analysis, the incidence rate of the main analysis (1.7 per 100 person-years) and the incidence rates of the outcome sensitivity analyses (algorithm 1: 20.9 per 100 person-years and algorithm 2: 9.6 per 100 person-years) were quite different…”.
The sentence “Consistent with the trials’ results, incidence proportion and incidence rate in the T1D subgroup of the current study (1.5% and 2.5 per 100 person-years)…” should have read “Consistent with the trials’ results, incidence proportion and incidence rate in the T1D subgroup of the current study (1.4% and 2.4 per 100 person-years)…”.
The sentence “Lak et al. [30] reported the incidence rate of severe hypoglycemia in patients with T1D to be 0.4–0.9 per 100 person-years, which is numerically lower than that of URLi-treated patients with T1D in the current study (2.5 per 100 person-years)” should have read “Lak et al. [30] reported the incidence rate of severe hypoglycemia in patients with T1D to be 0.4–0.9 per 100 person-years, which is numerically lower than that of URLi-treated patients with T1D in the current study (2.4 per 100 person-years).”
The electronic supplementary (where relevant) and the original article have been updated.
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