Colesevelam was shown to be effective in significantly lowering low-density-lipoprotein cholesterol (LDL-C) over 10% in patients with type 1 diabetes, according to a poster presented at the American Diabetes Association’s 70 Scientific Sessions today in Orlando.
The study was a double-blind, randomized, investigator-initiated, single-center, 12-week pilot study. The investigators, led by author Satish K. Garg, MD, professor of medicine and pediatrics at the Regents of the University of Colorado, followed 40 adult patients with type 1 diabetes who also had hyperlipidemia. The participants were randomized to take 3.75 g/day of colesevelam or a placebo for 12 weeks; the groups were evenly distributed, with 20 people in each and similar demographics. There were no significant differences between the groups for fasting glucagon, insulin dose, or weight.
The investigators then measured both A1C levels and LDL-C at initial screening, at baseline, and then once every four weeks until the end of the study period. But of the 40 initially enrolled, only 36 were able to complete the 12-week study; the groups were even again though, with 18 in each arm. The compliance ratio for both groups was above 88%.
The results presented in the poster abstract were from the intent-to-treat population with the “last observation carried forward.” Four weeks into the study, those in the colesevelam group saw a mean reduction of -16.1% in their LDL-C; the mean reduction was statistically significant and was maintained throughout the study’s length, though it did increase a little to -14.0%. Four weeks into the study those in the colesevelam arm also saw a statistically significant change in their A1C levels. However, this was not maintained through the duration of the study and was therefore not statistically significant.
Despite the relatively small size of the study population, the results from the study suggest that colesevelam lowers LDL-C in type 1 patients, a result also seen in patients with type 2 diabetes. With a reduction of over 10% in type 1 diabetes patients, the results are promising, but a further evaluation needs to be conducted in a larger study cohort.
With the initial improvement seen in A1C, this study also presents an interesting study topic moving forward. Though the results were not maintained throughout the study and were deemed to not be statistically significant, the authors concluded that the improvement in glycemia need to be evaluated further in a larger cohort and for a longer period of time.