Table 4.
Summary of mean (SD) changes in lipid parameters
PF-05231023 | ||||||||
---|---|---|---|---|---|---|---|---|
Placebo | 0.5 mg | 1.5 mg | 5 mg | 15 mg | 50 mg | 100 mg | 200 mg | |
Lipid panel | n = 13* | n = 10 | n = 10 | n = 10 | n = 10 | n = 5* | n = 10 | n = 10 |
LDL-C | ||||||||
Baseline (mg dl–1) | 135.7 (34.7) | 111.1 (41.2) | 127.2 (36.9) | 110.3 (16.2) | 109.2 (24.6) | 132.8 (35.1) | 115.5 (32.6) | 107.1 (39.3) |
Maximum change from baseline (%) | –6.6 (15.0) | –6.5 (8.2) | –4.5 (12.1) | –7.6 (6.6) | –9.1 (17.7) | –5.3 (18.2) | –7.2 (23.5) | –7.5 (24.3) |
Time of maximum change (days postdose) | 4 | 1 | 6 | 2 | 6 | 6 | 6 | 6 |
HDL-C | ||||||||
Baseline (mg dl–1) | 48.7 (14.0) | 53.3 (12.7) | 40.3 (10.4) | 37.9 (8.9) | 44.8 (12.4) | 43.6 (8.5) | 41.4 (10.0) | 41.8 (10.2) |
Maximum change frombaseline (%) | 7.7 (31.0) | -3.4 (6.7) | 6.2 (7.8) | 2.8 (7.7) | 5.6 (8.1) | 11.7 (3.8) | 13.0 (10.3) | 17.4 (7.6) |
Time of maximum change (days postdose) | 1 | 2 | 6 | 4 | 1 | 2 | 6 | 2 |
Triglyceride | ||||||||
Baseline (mg dl–1) | 210.2 (74.9) | 148.4 (65.1) | 187.0 (74.4) | 213.0 (129.6) | 207.6 (114.5) | 290.8 (176.8) | 193.8 (120.0) | 182.4 (72.2) |
Maximum change from baseline (%) | –19.1 (26.4) | –6.8 (18.6) | –13.2 (26.8) | –14.0 (19.8) | –30.2 (18.8) | –37.0 (13.8) | –36.7 (15.9) | –48.5 (10.0) |
Time of maximum change (days postdose) | 6 | 6 | 6 | 4 | 6 | 6 | 4 | 4 |
Total cholesterol | ||||||||
Baseline (mg dl–1) | 208.8 (39.0) | 174.2 (42.7) | 192.7 (47.6) | 178.9 (29.7) | 177.6 (21.8) | 216.8 (43.0) | 186.1 (41.1) | 169.5 (40.7) |
Maximum change from baseline (%) | –4.9 (17.5) | –0.3 (11.2) | –0.3 (10.4) | –5.3 (10.3) | –8.9 (9.9) | –10.1 (8.2) | –11.4 (13.4) | –6.5 (18.6) |
Time of maximum change (days postdose) | 6 | 6 | 6 | 4 | 6 | 6 | 6 | 6 |
Data presented as maximum decreases from baseline for LDL-C, triglyceride and total cholesterol, and maximum increases from baseline for HDL-C. Abbreviations are as follows: HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SD, standard deviation.
*Baseline measurements were missing for one subject in the placebo group and five subjects in the 50 mg group. Data from these subjects are excluded.