Atorvastatin for the prevention of cholelithiasis following bariatric surgery: an investigator-blinded, randomized controlled trial

The primary objective is to evaluate the efficacy of 40 mg of atorvastatin in preventing the formation of gallstones following bariatric surgery compared to standard care. This intervention is initiated two weeks prior to the procedure and continued for six months postoperatively. Secondary objectives include:

• Reduction of LDL cholesterol levels six months after surgery.
• Assessment of the impact on bile acid composition in stool and plasma.
• Evaluation of the safety profile and side effects in this patient population.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients scheduled to undergo laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. Participants include both males and females within the age range defined by code 3. Inclusion requires an intact gallbladder without existing cholelithiasis, as confirmed via preoperative ultrasound, and a preoperative low-density lipoprotein cholesterol level of 2.0 mmol/L or higher.

This investigator-blinded, randomized controlled trial evaluates the efficacy of atorvastatin 40 mg once daily in preventing the formation of gallstones following bariatric surgery. The study methodology involves comparing the administration of the test product, initiated two weeks prior to surgery and continued for six months postoperatively, against standard care. Participants undergo a screening visit to confirm eligibility based on scheduled laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy, an intact gallbladder confirmed via ultrasound, and preoperative LDL cholesterol levels $\ge$ 2.0 mmol/L. The primary endpoint is the incidence of gallstone formation six months after surgery, determined by ultrasound examination. Secondary endpoints include changes in plasma bile acid profiles, fecal bile acid profiles, and plasma LDL-cholesterol levels from baseline to six months post-surgery, as well as the incidence and severity of adverse events. The study duration for individual involvement extends from the preoperative period through six months of follow-up post-surgery.

The experimental treatment consists of atorvastatin administered in an oral route. The dosage is 40 mg, provided once daily. This administration regimen is initiated two weeks prior to bariatric surgery and is continued for a duration of six months following the procedure.

The control group receives standard care as the comparator treatment for the prevention of gallstones.

The primary efficacy endpoint is the incidence of gallstone formation, which is to be assessed six months after bariatric surgery via ultrasound examination. Secondary efficacy parameters include the change in plasma LDL-cholesterol levels and the modification of fecal and plasma bile acid profiles, both of which are measured from baseline to the six-month post-surgical timepoint.