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Table 2 Estimated glomerular filtration rate change

From: Renal safety of lithium in HIV-infected patients established on tenofovir disoproxil fumarate containing antiretroviral therapy: analysis from a randomized placebo-controlled trial

eGFR MDRD changed

Treatment arm

Week 4 % (n)

Week 8 % (n)

Week 12 % (n)

Week 16 % (n)

Week 20 % (n)

Week 24 % (n)

Increased

Lithium

30.4% (7/23)

39.1% (9/23)

39.1% (9/23)

34.8% (8/23)

39.1% (9/23)

56.5% (13/23)

Placebo

40% (12/30)

50% (15/30)

43.3% (13/30)

33.3% (10/30)

43.3% (13/30)

46.7% (14/30)

 

p = 0.518a

p = 0.621a

p = 0.095a

p = 0.012a

p = 0.095a

p = 0.506a

Grade 1

Decreased 0.1% to <10% from baseline

Lithium

34.8% (8/23)

13% (3/23)

8.7% (2/23)

26.1% (6/23)

17.4% (4/23)

8.7% (2/23)

Placebo

23.3% (7/30)

16.7% (5/30)

20% (6/30)

23.3% (7/30)

30% (9/30)

20% (6/30)

 

p = 0.495a

p = 0.264b

p = 0.229b

p = 0.817a

p = 0.233b

p = 0.229b

Grade 2

Decreased 10 to <30% from baseline

Lithium

26.0% (6/23)

26.1% (9/23)

43.5% (10/23)

21.7% (5/23)

34.8% (8/23)

23% (6/23)

Placebo

26.7% (8/30)

13.3% (5/30)

30% (9/30)

33.3% (10/30)

13.3% (4/30)

30% (9/30)

 

p = 0.971a

p = 0.164a

p = 0.765a

p = 0.484a

p = 0.145a

p = 0.814b

Grade 3

Decreased ≥30 to <50% from baseline

Lithium

8.7% (2/23)

8.7% (2/23)

8.7% (2/23)

8.7% (2/23)

8.7% (2/23)

8.7% (2/23)

Placebo

0%

0%

3.3% (1/30)

0%

13.3% (4/30)

3.3% (1/30)

 

p = 0.202b

p = 0.202b

p = 0.418b

p = 0.202b

p = 0.493b

p = 0.418b

Grade 4

Decreased ≥50% from baseline

Lithium

0%

0%

0%

0%

0%

0%

Placebo

0%

0%

0%

3.3% (1/30)

0%

0%

    

p = 574b

  

Creatinine not measuredc

Lithium

0%

0%

0%

4.3% (1/23)

0%

0%

Placebo

0%

10% (3/30)

3.3% (1/30)

3.3% (1/30)

0%

0%

  

p = 0.197b

p = 0.574b

p = 0.687b

  
  1. eGFR estimated glomerular filtration rate, MDRD modification of diet in renal disease formula
  2. aChi-squared test
  3. bOne-sided Fisher’s exact test
  4. cParticipants did not attend the specific study visit
  5. dGrading according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 2.0 November 2014)