Table 1 Change in efficacy parameters following IPE treatment in diabetes subgroups by median baseline A 1c
Parameter | All patients with diabetes mellitus | A1c<6.8% | A1c≥6.8% | All patients with diabetes mellitus | A1c<6.8% | A1c≥6.8% | |||
|---|---|---|---|---|---|---|---|---|---|
IPE dose (n = all patients, A1c<6.8%, A1c≥6.8%) | Baseline | End of treatment | Baseline | End of treatment | Baseline | End of treatment | Median placebo-adjusted change from baseline, %, p | ||
TG (mg/dL) | |||||||||
4 g/day | 262 | 217 | 262 | 228 | 268 | 203 | -23.2 | -21.0 | -24.8 |
(n=165, 78, 87) | (220-312) | (179-267) | (223-316) | (186-290) | (218-309) | (166-261) | <0.0001 | <0.0001 | <0.0001 |
2 g/day | 254 | 244 | 264 | 238 | 250 | 248 | -9.8 | -15.1 | -4.8 |
(n=171, 81, 90) | (216-303) | (199-315) | (218-325) | (196-307) | (214-297) | (203-318) | <0.01 | <0.01 | 0.39 |
Placebo | 259 | 276 | 258 | 276 | 260 | 274 | |||
(n=165, 87, 78) | (221-299) | (214-367) | (220-294) | (210-343) | (223-315) | (216-379) | |||
LDL-C (mg/dL) | |||||||||
4 g/day | 81 | 83 | 85 | 83 | 79 | 83 | -6.3 | -6.6 | -5.7 |
(n=165, 78, 87) | (70-96) | (69-98) | (70-101) | (69-96) | (70-93) | (69-100) | 0.02 | 0.08 | 0.13 |
2 g/day | 82 | 87 | 83 | 89 | 82 | 85 | -3.8 | -3.7 | -4.7 |
(n=170, 80, 90) | (73-97) | (74-100) | (76-97) | (78-99) | (69-96) | (72-102) | 0.15 | 0.33 | 0.25 |
Placebo | 84 | 88 | 84 | 85 | 84 | 93 | |||
(n=164, 87, 77) | (72-97) | (74-105) | (70-97) | (75-102) | (72-97) | (72-108) | |||
Non–HDL-C (mg/dL) | |||||||||
4 g/day | 128 | 121 | 129 | 124 | 128 | 119 | -14.4 | -11.3 | -18.0 |
(n=165, 78, 87) | (111-146) | (104-144) | (111-146) | (107-144) | (111-146) | (101-143) | <0.0001 | <0.01 | <0.0001 |
2 g/day | 125 | 135 | 128 | 135 | 124 | 136 | -4.4 | -4.6 | -4.2 |
(n=171, 81, 90) | (113-146) | (117-158) | (115-145) | (119-154) | (111-148) | (113-162) | 0.07 | 0.17 | 0.22 |
Placebo | 128 | 136 | 128 | 136 | 130 | 140 | |||
(n=165, 87, 78) | (113-147) | (123-167) | (114-142) | (121-161) | (112-154) | (126-173) | |||
VLDL-C (mg/dL) | |||||||||
4 g/day | 44 | 37 | 45 | 41 | 43 | 35 | -24.1 | -14.3 | -33.8 |
(n=165, 78, 87) | (33-54) | (29-50) | (32-53) | (31-52) | (33-56) | (28-47) | <0.0001 | 0.01 | <0.0001 |
2 g/day | 42 | 42 | 42 | 44 | 42 | 42 | -6.1 | -3.8 | -9.0 |
(n=170, 80, 90) | (32-51) | (33-58) | (32-53) | (30-60) | (33-51) | (34-55) | 0.21 | 0.57 | 0.17 |
Placebo | 42 | 49 | 42 | 45 | 43 | 53 | |||
(n=164, 87, 77) | (35-56) | (37-66) | (35-56) | (37-63) | (36-54) | (40-67) | |||
Lp-PLA 2 (ng/mL) | |||||||||
4 g/day | 180 | 160 | 179 | 166 | 180 | 153 | -19.1 | -17.9 | -20.3 |
(n=160, 75, 85) | (160-212) | (134-186) | (161-213) | (137-191) | (153-211) | (130-179) | <0.0001 | <0.0001 | <0.0001 |
2 g/day | 192 | 184 | 196 | 185 | 182 | 178 | -7.5 | -9.5 | -5.7 |
(n=163, 78, 85) | (164-219) | (159-215) | (169-237) | (163-219) | (161-212) | (153-210) | <0.001 | <0.01 | 0.08 |
Placebo | 184 | 197 | 189 | 200 | 181 | 188 | |||
(n=156, 85, 71) | (159-219) | (165-233) | (166-221) | (170-241) | (142-216) | (163-220) | |||
Apo B (mg/dL) | |||||||||
4 g/day | 91 | 89 | 91 | 90 | 91 | 88 | -9.5 | -6.1 | -12.8 |
(n=160, 75, 85) | (80-104) | (79-105) | (82-107) | (80-107) | (79-101) | (78-103) | <0.0001 | 0.02 | <0.0001 |
2 g/day | 91 | 95 | 91 | 96 | 91 | 95 | -3.4 | -2.1 | -5.1 |
(n=166, 79, 87) | (84-104) | (86-107) | (84-105) | (87-106) | (83-103) | (85-112) | 0.08 | 0.46 | 0.07 |
Placebo | 93 | 98 | 93 | 96 | 93 | 103 | |||
(n=158, 86, 72) | (82-105) | (88-113) | (82-104) | (86-109) | (82-106) | (90-117) | |||
TC (mg/dL) | |||||||||
4 g/day | 167 | 160 | 173 | 166 | 165 | 157 | -12.7 | -10.7 | -15.1 |
(n=165, 78, 87) | (147-188) | (142-181) | (150-189) | (143-184) | (145-187) | (140-177) | <0.0001 | 0.0001 | <0.0001 |
2 g/day | 166 | 176 | 170 | 177 | 164 | 175 | -4.0 | -4.1 | -4.1 |
(n=171, 81, 90) | (150-185) | (154-198) | (156-184) | (162-196) | (146-185) | (151-201) | 0.04 | 0.10 | 0.15 |
Placebo | 167 | 181 | 167 | 181 | 168 | 184 | |||
(n=165, 87, 78) | (151-190) | (166-211) | (154-189) | (168-206) | (147-191) | (160-216) | |||
HDL-C (mg/dL) | |||||||||
4 g/day | 36 | 36 | 38 | 38 | 36 | 35 | -5.0 | -5.9 | -4.3 |
(n=165, 78, 87) | (31-43) | (30-43) | (32-45) | (30-43) | (30-42) | (30-44) | <0.01 | 0.02 | 0.05 |
2 g/day | 39 | 40 | 40 | 41 | 39 | 39 | -2.3 | -1.6 | -2.9 |
(n=171, 81, 90) | (32-46) | (33-45) | (32-46) | (34-47) | (31-45) | (32-45) | 0.17 | 0.51 | 0.18 |
Placebo | 38 | 39 | 41 | 40 | 37 | 38 | |||
(n=165, 87, 78) | (32-45) | (34-48) | (33-47) | (34-50) | (32-42) | (32-47) | |||
VLDL-TG (mg/dL) | |||||||||
4 g/day | 186 | 145 | 189 | 163 | 185 | 140 | -28.9 | -23.5 | -34.1 |
(n=165, 78, 87) | (147-245) | (113-200) | (147-238) | (111-214) | (140-249) | (113-177) | <0.0001 | <0.001 | <0.0001 |
2 g/day | 181 | 168 | 186 | 172 | 177 | 163 | -10.8 | -10.9 | -10.7 |
(n=170, 80, 90) | (143-232) | (136-236) | (145-243) | (136-239) | (143-230) | (136-236) | 0.02 | 0.12 | 0.11 |
Placebo | 186 | 202 | 176 | 196 | 197 | 209 | |||
(n=164, 87, 77) | (145-238) | (146-277) | (142-224) | (142-275) | (146-243) | (146-283) | |||
Ox-LDL (U/L) | |||||||||
4 g/day | 54 | 52 | 55 | 52 | 52 | 53 | -16.1 | -13.8 | -17.4 |
(n=60, 29, 31) | (46-60) | (44-59) | (49-58) | (44-63) | (44-66) | (45-59) | <0.0001 | <0.01 | <0.001 |
2 g/day | 55 | 56 | 55 | 57 | 53 | 56 | -8.9 | -10.3 | -8.2 |
(n=59, 24, 35) | (48-66) | (49-71) | (49-59) | (49-62) | (48-69) | (49-74) | 0.03 | 0.07 | 0.15 |
Placebo | 52 | 60 | 52 | 60 | 53 | 61 | |||
(n=64, 34, 30) | (45-62) | (51-70) | (46-63) | (51-66) | (42-62) | (47-73) | |||
hsCRP (mg/L) | |||||||||
4 g/day | 2.5 | 2.1 | 1.8 | 2.0 | 2.9 | 2.1 | -21.5 | -4.0 | -34.6 |
(n=160, 75, 85) | (1.3-4.1) | (1.0-4.4) | (1.1-3.6) | (0.9-4.4) | (1.4-4.9) | (1.1-4.3) | <0.01 | 0.74 | <0.001 |
2 g/day | 2.1 | 2.7 | 1.5 | 1.7 | 2.5 | 3.2 | -8.2 | -8.4 | -8.7 |
(n=166, 79, 87) | (1.0-4.6) | (1.1-4.5) | (0.9-3.1) | (0.9-3.9) | (1.3-5.8) | (1.5-5.0) | 0.26 | 0.41 | 0.41 |
Placebo | 2.5 | 3.1 | 2.1 | 2.7 | 2.7 | 3.4 | |||
(n=158, 86, 72) | (1.2-5.1) | (1.3-6.0) | (1.1-5.0) | (1.2-6.1) | (1.4-5.2) | (1.4-5.9) | |||
RLP-C (mg/dL) | |||||||||
4 g/day | 13.0 | 10.0 | 14.0 | 11.5 | 12.5 | 9.0 | -25.0 | -26.7 | -21.3 |
(n=60, 28, 32) | (11.0-17.0) | (8.0-13.6) | (11.0-16.6) | (8.0-14.5) | (10.0-18.0) | (8.0-11.5) | <0.01 | 0.05 | 0.04 |
2 g/day | 15.0 | 11.0 | 16.0 | 13.0 | 12.0 | 10.5 | -16.6 | -27.8 | -3.0 |
(n=62, 32, 30) | (11.0-18.0) | (9.0-16.0) | (13.0-18.5) | (10.0-16.0) | (10.0-18.0) | (8.0-14.0) | 0.06 | 0.02 | 0.84 |
Placebo | 14.0 | 13.0 | 14.0 | 15.5 | 14.0 | 12.0 | |||
(n=61, 34, 27) | (11.0-17.0) | (9.0-20.0) | (11.0-18.0) | (11.0-22.0) | (11.0-16.0) | (9.0-16.0) | |||