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Original Research

Risk of Bladder Cancer Among Diabetic Patients Treated With Pioglitazone

Interim report of a longitudinal cohort study

  1. James D. Lewis, MD, MSCE1,2,3⇓,
  2. Assiamira Ferrara, MD, PHD4,
  3. Tiffany Peng, MA4,
  4. Monique Hedderson, PHD4,
  5. Warren B. Bilker, PHD1,2,
  6. Charles P. Quesenberry Jr., PHD4,
  7. David J. Vaughn, MD3,
  8. Lisa Nessel, MSS, MLSP1,
  9. Joseph Selby, MD4 and
  10. Brian L. Strom, MD, MPH1,2,5
  1. 1Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania
  2. 2Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania
  3. 3Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
  4. 4Division of Research, Kaiser Permanente Northern California, Oakland, California
  5. 5Department of Pharmacology, University of Pennsylvania, Philadelphia, Pennsylvania
  1. ↵Corresponding author: James D. Lewis, lewisjd{at}mail.med.upenn.edu.
Diabetes Care 2011 Apr; 34(4): 916-922. https://doi.org/10.2337/dc10-1068
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Article Figures & Tables

Tables

  • Table 1

    Demographics of the study cohort according to ever use of pioglitazone: the KPNC diabetes registry, 1997–2008

    Ever use of pioglitazone*Never use of pioglitazone*
    N30,173162,926
    Age (years)
     40–498,612 (28.5)36,452 (22.4)
     50–599,945 (33.0)41,962 (25.8)
     60–697,799 (25.8)42,691 (26.2)
     ≥703,817 (12.7)41,821 (25.7)
    Sex (female)14,157 (46.9)75,686 (46.5)
    Race/ethnicity
     White14,768 (48.9)80,777 (49.6)
     Black2,823 (9.4)16,731 (10.3)
     Asian3,834 (12.7)18,877 (11.6)
     Hispanic3,320 (11.0)14,430 (8.9)
     Other1,691 (5.6)8,876 (5.4)
     Missing3,737 (12.4)23,235 (14.3)
    Current smoker6,052 (20.1)28,023 (17.2)
    Renal function
     Normal creatinine23,174 (76.8)125,879 (77.3)
     Elevated creatinine†1248 (4.1)13,993 (8.6)
     Missing5,751 (19.1)23,054 (14.2)
    Bladder condition‡3,686 (12.2)25,581 (15.7)
    Congestive heart failure969 (3.2)11,038 (6.8)
    Income
     Low§14,413 (47.8)82,270 (50.5)
     High12,825 (42.5)66,133 (40.6)
     Missing2,935 (9.7)14,523 (8.9)
    Baseline A1C (%)
     <74,873 (16.2)46,407 (28.5)
     7–7.95,455 (18.1)31,517 (19.3)
     8–8.93,921 (13.0)17,060 (10.5)
     9–9.92,979 (9.9)11,524 (7.1)
     ≥107,330 (24.3)28,017 (17.2)
     Missing5,615 (18.6)28,401 (17.4)
    Newly diagnosed with diabetes at the start of follow-up¶14,687 (48.7)94,739 (58.1)
    Duration of diabetes (years)
     0–517,363 (57.5)102,916 (63.2)
     5–92,983 (9.9)9,671 (5.9)
     ≥102,956 (9.8)17,432 (10.7)
     Missing6,871 (22.8)32,907 (20.2)
    Other cancer prior to baseline1,186 (3.9)8,762 (5.4)
    Other diabetes medications
     Other TZDs2,754 (9.1)2,470 (1.5)
     Metformin24,797 (82.2)70,956 (43.6)
     Sulfonylureas26,311 (87.2)95,429 (58.6)
     Other oral hypoglycemic drugs1,482 (4.9)1,865 (1.1)
     Insulin13,123 (43.5)41,337 (25.4)
    Pioglitazone use during follow-up
     Time since starting pioglitazone (months)39.5 (1–102)N/A
      <187,245 (24.0)N/A
      18–366,681 (22.1)N/A
      >3616,247 (53.8)N/A
     Duration of therapy (months)24.1 (1–102)N/A
      <127,332 (24.3)N/A
      12–247,677 (25.4)N/A
      >2415,164 (50.3)N/A
     Cumulative dose (mg)17,670 (450–179,000)N/A
      1–10,50010,281 (34.1)N/A
      10,501–28,0009,667 (32.0)N/A
      >28,00010,225 (33.9)N/A
    • Data are n (%) or median (range) unless otherwise indicated. N/A, not applicable.

    • ↵*All comparisons have P values <0.01 except female sex (P = 0.46).

    • ↵†Creatinine ≥1.4 mg/dL for women and ≥1.5 mg/dL for men.

    • ↵‡History of urinary tract infections, urolithiasis, incontinence, and other bladder or urethral conditions.

    • ↵§Low income defined as median household income in census block below the cohort average ($59,000).

    • ↵¶Includes newly diagnosed patients and patients who newly enrolled in KPNC with an existing diagnosis of diabetes.

  • Table 2

    Incidence rate and HR of bladder cancer with pioglitazone use: the KPNC diabetes registry, 1997–2008

    Median (range) bladder cancer incidence rate (per 100,000 person-years)HR (95% CI) adjusted for age and sexFully adjusted HR (95% CI)*
    Never use of pioglitazone68.8 (64.1–73.6)Ref.Ref.
    Ever use of pioglitazone†81.5 (64.7–98.4)1.2 (0.9–1.5)‡1.2 (0.9–1.5)
    Time since starting pioglitazone (months)†
     <1867.1 (41.8–92.4)1.1 (0.8–1.6)1.2 (0.8–1.7)
     18–3685.2 (51.8–118.6)1.3 (0.9–2.0)1.4 (0.9–2.1)
     >3693.1 (63.5–122.7)1.3 (0.9–1.8)1.3 (0.9–1.8)
     Ptrend—0.040.07
    Duration of therapy (months)†
     <1248.4 (29.0–67.8)0.8 (0.5–1.2)0.8 (0.6–1.3)
     12–2486.7 (52.0–121.4)1.3 (0.9–2.0)1.4 (0.9–2.1)
     >24102.8 (71.7–133.8)1.5 (1.1–2.0)1.4 (1.03–2.0)
     Ptrend—0.020.03
    Cumulative dose (mg)†
     1–10,50059.7 (39.0–80.4)1.0 (0.7–1.4)1.0 (0.7–1.5)
     10,501–28,00076.8 (48.3–105.2)1.1 (0.8–1.6)1.2 (0.8–1.8)
     >2,8000105.9 (68.0–143.8)1.5 (1.1–2.2)1.4 (0.96–2.1)
     Ptrend—0.050.08
    • ↵*Includes all potential confounders listed in Table 1 in the statistical model.

    • ↵†Never use of pioglitazone was the reference group for the calculation of the HR associated with ever use of pioglitazone and time, duration, and dose of pioglitazone use.

    • ↵‡Also adjusted for use of other diabetes medications.

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Risk of Bladder Cancer Among Diabetic Patients Treated With Pioglitazone
James D. Lewis, Assiamira Ferrara, Tiffany Peng, Monique Hedderson, Warren B. Bilker, Charles P. Quesenberry, David J. Vaughn, Lisa Nessel, Joseph Selby, Brian L. Strom
Diabetes Care Apr 2011, 34 (4) 916-922; DOI: 10.2337/dc10-1068

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Risk of Bladder Cancer Among Diabetic Patients Treated With Pioglitazone
James D. Lewis, Assiamira Ferrara, Tiffany Peng, Monique Hedderson, Warren B. Bilker, Charles P. Quesenberry, David J. Vaughn, Lisa Nessel, Joseph Selby, Brian L. Strom
Diabetes Care Apr 2011, 34 (4) 916-922; DOI: 10.2337/dc10-1068
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