Thanks so much jonzobot,... sorry for my bad memory,... it's bad and getting bag badder!

So for 48 patients,.. 35 on Apabetalone,.. 13 placebo,... increase in eGFR of 3.4% and in placebo decrease of 5.8%,... sounds good to me.

Was curious,.... did they announce yet the results of the ALP for the CKD gropup in BetonMACE,...

They looked good here:

Six months of apabetalone treatment yielded a reduction in ALP versus baseline of 14.0% (12.0 U/L) (p<0.0001 vs baseline) compared to a reduction of 6.3% (4.5 U/L) (p=0.9 vs baseline) in the placebo group. The difference between groups was significant (p = 0.02) (Table 2)

Six months of apabetalone treatment yielded a reduction in ALP versus baseline of 14.0% (12.0 U/L) (p<0.0001 vs baseline) compared to a reduction of 6.3% (4.5 U/L) (p=0.9 vs baseline) in the placebo group. The difference between groups was significant (p = 0.02) (Table 2). eGFR in the apabetalone group increased by 3.4% (1.7 mL/min/1.73 m2) (p=0.04 vs baseline) and decreased by 5.8% (2.9 mL/min/1.73 m2) (ns vs baseline) in the placebo group (Table 2). 

Results

A total of 48 CKD patients were included in the post-hoc analysis, 35 who received apabetalone treatment and 13 on placebo (Fig. 1). One patient from the placebo group was lost due to death and one patient in the apabetalone group discontinued the study.

Fig. 1.

Disposition of Patients Eligible for Post-hoc Analysis

Baseline clinical characteristics and concomitant medication use are summarized in Table 1. Due to the small sample size of each treatment group, there were some differences in baseline characteristics between apabetalone and placebo groups. Patients treated with apabetalone were more likely to have higher levels of creatinine (1.3 mg/dL vs 1.1 mg/dL; p=0.002). Although this difference was observed, the baseline eGFR measurements between the two treatment groups were similar (p=0.7). Patients in the apabetalone treatment group were more likely to be male (77.1% vs 30.8%; p=0.003). The concomitant statin allocation was different between treatment groups as apabetalone treated patients were more likely to be co-administered rosuvastatin (77.1% vs. 38.5%; p=0.02) while placebo treated patients were more likely to be co-administered atorvastatin (61.5% vs 22.9%; p=0.02).

Table 1.

Patient demographics, concomitant medications, and baseline laboratory values in placebo- and apabetalone treated patients with baseline eGFR<60 mL/min/1.73 m2 from the pooled SUSTAIN and ASSURE studies. Categorical variables are summarized using frequencies N(%), while laboratory parameters are reported as median (min, max); eGFR estimated glomerular filtration rate, hsCRP high-sensitivity C-reactive protein, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol

Six months of apabetalone treatment yielded a reduction in ALP versus baseline of 14.0% (12.0 U/L) (p<0.0001 vs baseline) compared to a reduction of 6.3% (4.5 U/L) (p=0.9 vs baseline) in the placebo group. The difference between groups was significant (p = 0.02) (Table 2). eGFR in the apabetalone group increased by 3.4% (1.7 mL/min/1.73 m2) (p=0.04 vs baseline) and decreased by 5.8% (2.9 mL/min/1.73 m2) (ns vs baseline) in the placebo group (Table 2). Reductions in blood urea nitrogen (BUN) were similar between the two groups, and did not differ statistically (data not shown). Changes in additional markers of bone metabolism and liver function such as serum calcium, serum phosphate, serum lactate dehydrogenase, serum alanine aminotransferase, serum aspartate transaminase, and serum gamma-glutamyl transferase did not show any differences between treatment groups (data not shown).

Table 2.

Effects of Apabetalone on ALP and eGFR in the subgroup of patients with baseline eGFR<60 mL/min/1.73 m2 from the pooled SUSTAIN and ASSURE studies

Apabetalone was well tolerated with fewer patients in the apabetalone group experiencing an SAE compared to the placebo group (5/35, 14.3% compared to 2/13, 15.4%) (Table 3). In the apabetalone group, all of the SAEs were assessed by the Investigator unrelated to treatment with the study drug.