Evidence Table 17. Description of Patient Populations in Randomized Controlled Trials on Hydroxyurea Treatment in Diseases Other than Sickle Cell Disease

Author, yearIntervention groupsNAge*Male, n (%)Race (%)Last observation
HIV
Frank, 2004104ddI 28 NR(79)White (38);6 months
HU (low dose) with/without ddI 53 Black (50);
HU (high dose) with/without ddI50White Hispanic (10 )
Havlir, 2001 189IDV, ddI, d4T + HU68NR(82)White (69);
Black (16);
White Hispanic (13)
IDV, ddI, d4T + placebo68(84)White (62);
Black (22);
White Hispanic(12)
IDV, ZDV(or d4T), 3TC66(89)White (71);
Black (23);
White Hispanic(5)
Swindells, 2005 111ABC, EFV, ddI + HU3038.1; Median, 37; [26–59]26 (87)White 16, (53)48 wks
Black 4, (13);
White Hispanic 7, (23);
Other 3, (10)
ABC, EFV, ddI2439.5; Median, 37; [29–62]21 (88)White 13, (54);
Black 8, (33);
White Hispanic 2, (8);
Other 1,(4)
Beeson, 1999 108ddI +HU 40 33.8; [26–47] 26 (65) NR40 weeks
ddI2131; [21–48]13 (62)
Bloch, 2006 191Indinavir, ritonavir, ddI and either stavudine or lamiduvine + HU 35 Median, 36; [31–39] NRNR
Indinavir, ritonavir, ddI and either stavudine or lamiduvine33Median, 34; [29–40]
Rutschmann Cluster/ HIV
Rutschmann, 1998 109ddI, stavudine + HU 72 NRNRNR24 wks
ddI, stavudine + placebo 72
Rutschmann, 1998 102ddI, stavudine + HU 72 48 weeks
ddI, stavudine + placebo 72
Rutschmann, 2000110ddI + stavudine + HU 72 24 months
ddI, stavudine + placebo72
CML
Hehlmann, 2003 114HU 308 Median, 47; [11–83] (54) NR
IFN-alpha 2a + HU 226 Median, 49; [10 – 78] (60)
no author, 1998 115HU 95 Median, 56.4; [27–84] 53
IFN and HU if needed 100 Median, 55.7; [20–83] 58
Hehlmann, 1994 113HU 194 46.9; Median, 47; [15–84] (51)
IFN 133 47.4; Median, 47; [18–85] (66)
Busulfan 186 48.5; Median, 49; [17–84] (61)
Broustet, 1991 116HU 26 58.6 16 (61.5)
IFN 24 55.6 15 (62.5)
Hehlmann, 1993 112HU 216 49.2 (unclear if mean or median reported) (52)
Busulfan22550.2 (unclear if mean or median reported)(61)
Solid Tumor
Stephens,1984 121HU69Median, 64(100)White 55, (77);
Black 15, (22);
Other 2, (3)
Adriamycin + cyclophosphamide68Median, 65(100)White 55, (84);
Black 11, (16);
Other 2 (3)
Loening, 1981 122HU 40 67.3 (100) NR23 months
Cyclophosphamide 43 68.8 (100)
Methyl-CCNU3868.5(100)
Najean Cluster/ PV
Najean, 1997 123HU 150 53.2, men; 53.6, women m/f ratio = 0.89 NRNR
Pipobroman14255.1, men; 53.3, womenm/f ratio = 1.20
Kiladjian, 2006 103HU 123 NRNRNR
Pipobroman134
ET
Harrison, 2005 103aspirin 75mg/d + HU 404 Median, 62; [21–88] 180 (45) NR
aspirin 75mg/d + Anagrelide405Median, 61; [23–88]162 (40)
Finazzi Cluster/ET
Finazzi, 2000 130HU 56 Median, 67; [40–82] 23.00 NR
No myelosuppressive agent at randomization58Median, 69; [50–85]14
Cortelazzo, 1995 129HU 56 Median, 67 23.00 NR
None58Median, 6914
*

Mean (SD) [range] unless otherwise specified.

The characteristics represent the whole population (all three arms).

This study included 30 patients that crossed over to the HU arm (regrouped the arms as received HU at some point vs. no HU), but did not report the numbers of the placebo arm. Denominators for the outcomes range from 64 to 80, because the numbers of patients at the time of the outcome event were used as denominators.

3TC = lamivudine; ABC = abacavir; CCNU = lomustine; CML = chronic myelogenous leukemia; d4T = didehydrodeoxythymidine; ddI = didanosine; EFV = efavirenz; HU = hydroxyurea; IDV = indinavir; IFN = interferon; m/f = male/female; NR = not reported; ZDV = zidovudine.

From: Appendix C: Evidence Tables

Cover of Hydroxyurea for the Treatment of Sickle Cell Disease
Hydroxyurea for the Treatment of Sickle Cell Disease.
Evidence Reports/Technology Assessments, No. 165.
Segal JB, Strouse JJ, Beach MC, et al.

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