Table 3.
Study/age/gender/country | T/t group | Study day for bladder cancer diagnosis | Histologyb | Smoking, other risk factors | Hematuria | Reason for bladder cancer workup | Additional clinical information | |
---|---|---|---|---|---|---|---|---|
Within 6 months prior to rand. | After rand. | |||||||
NCT00972244 [54]/75/male/Japan | DAPA 2.5 mg | 43 |
Type: class 4 malignant cells TNM classification: T2N0MX Grade: 2 |
20 cigs/day for 50 years, stopped 2007 | Yes | Yes | AE ‘occult blood positive’ on day 36 | Continued positive urine occult blood since day 215; hematuria × 6 in 1.5 months; symptoms of anorexia and weight loss; metastases to the lung at diagnosis |
NCT01031680/48/male/United States | DAPA 10 mg + MET + SU | 74 |
Type: urothelial Grade: low |
20 cigs/day for 34 years, stopped 2008 Hematuria and renal stones reported in 2008 |
Yes | No | Hospitalized for coronary artery disease; CT scan showed possibility of lesion in bladder | History of hematuria and renal stones ~2 years prior to randomization |
NCT00683878 [55]/67/male/Argentina | DAPA 5 mg + PIO | 144 |
Type: urothelial cell with areas of squamous differentiation TNM classification: T2 Grade: 3 |
Family h/o of bladder cancer PIO 45 mg used on day −223 to −16 AE of UTI reported on day 84 |
Yes | Yes | AE ‘hematuria’ on day 130 and AE ‘urinary bladder polyp’ on day 144 | Trace blood in urine on day 1; multiple positive urines for blood; UTI on day 84. Gross hematuria on day 130. Urinary urgency and frequency prior to day 144; 80 × 60 mm mass at diagnosis |
NCT01031680/55/male/Taiwan | DAPA 10 mg + MET + SU | 169 |
Type: urothelial cell Grade: 1 |
Current smoker—5 cigs/day for 36 years | Yes | Yes | Intermittent hematuria for 3 months and persistent hematospermia |
Trace blood on day 36 and day 1 Trace + blood in urine in 5 of 8 tests during the study |
NCT00673231 [56]/63/male/Austria | DAPA 5 mg + INS |
358 (AE of bladder neoplasm) 393 (SAE of bladder cancer) |
Type: G2 TNM classification: pTa Grade: unknown |
Current smoker—40 cigs/day for 50 years | No | Yes | Recurring microscopic hematuria since ~day 165 (according to the investigator) | Microscopic hematuria noted on day 165 |
NCT00673231 [56]/67/male/Hungary | DAPA 10 mg + INS | 399 |
Type: urothelial cell Grade: 2 |
Never smoked | Yes | Yes | AE ‘hematuria’ on study day 372 | Hematuria 1+ on day 13; 3+ on day 1; 7 of 9 urines positive for blood in study months 1–12 |
NCT00528879 [57]/60/male/Canada | DAPA 5 mg + MET | 512 |
Type: urothelial cell TNM classification: pTa, pN0, M0 Grade: low |
25 cigs/day for 25 years, stopped 1989 | Yes | Yes | AE ‘calculus ureteric’ on day 509 | Hematuria 2+ on day 15, trace hematuria on day 34 |
NCT00673231 [56]/66/male/United States | DAPA 10 mg + INS | 581 |
Type: urothelial Grade: low |
30 cigs/day for 42 years, stopped 2001 | No | Yes | AE ‘hematuria’ on day 577 | Hematuria on days 56, 84, 118 and 377 prior to diagnostic evaluation |
NCT00660907 [58]/76/male/Germany | DAPA 10 mga + MET | 727 |
Type: urothelial with partial squamous cell differentiation TNM classification: pT1, M0 Grade: high (G3) |
20 packs, stopped 1980 | No | Yes | AE ‘benign prostatic hyperplasia’ on day 727 |
Urine blood 3+ on day 726 Eleven prior urines negative for blood |
NCT01042977 [59]/66/male/Canada | Placebo + INS + MET | 136 |
Type: urothelial Grade: high |
20 cigs/day for 50 years; cystitis reported as AE on day 32 | Yes | Yes | Painless macroscopic hematuria for a few weeks | History of hematuria and positive dipstick results for blood in urine before and at randomization |
AE adverse event, cigs cigarettes, DAPA dapagliflozin, INS insulin, MET metformin, PIO pioglitazone, SAE serious adverse event, SU sulfonylurea, TNM tumor, node, metastasis
aThe dapagliflozin dose for this patient was up-titrated from 2.5 to 5 to 10 mg. At the time of event, the dose was 10 mg
bCurrent accepted terminology is urothelial cell carcinoma, although transitional cell carcinoma is still commonly used. These are different names for the same malignancy