%0 Journal Article
%A Portolés Pérez, Antonio
%A Rivas Paterna, Ana Belén
%A Sánchez Pernaute, Andrés
%A Torres García, Antonio José
%A Moreno Lopera, Carmen
%A Chicharro, Luis M.
%A Bandrés Moya, Fernando
%A López Picado, Amanda
%A Rubio, Miguel A.
%A Vargas Castrillón, Emilio
%T Effect of Obesity and Roux-En-Y Gastric Surgery on Omeprazole Pharmacokinetics
%D 2022
%@ 1662-4025
%U https://hdl.handle.net/20.500.14352/123509
%X Introduction: The prevalence of obesity is increasing globally. The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability and pharmacokinetic (PK) parameters of omeprazole. Methods: Controlled, open-label, bioavailability clinical trial in patients undergoing Roux-en-Y gastric bypass (RYGB). Healthy patients with obesity (body mass index >35) were included and assessed for omeprazole PKs before and after RYGB (1 and 6 months). PK sampling was done at baseline and several times up to 12 h after drug dosing. Pre- and post-surgery parameters were compared using paired ANOVA or Wilcoxon tests, and control versus cases using ANOVA or Mann-Whitney tests. Given the post-surgery change in body weight, parameters were corrected by dose/body weight. Results: Fourteen case and 24 control subjects were recruited; 92% were women (N = 35/38). In patients who underwent RYGB, maximum plasma concentration (Cmax) was significantly reduced at 1 and 6 months after surgery compared with presurgery values (p = 0.001). Regarding the AUC, the values are lower at 1 and 6 months after surgery than at baseline (p < 0.001). The drug clearance was also increased in the first month after surgery. No differences were found between patients 6 months after surgery and controls. Cmax and AUC corrected by dose/body weight were significantly different between the baseline surgery subjects and controls. Discusion/Conclusions: Omeprazole bioavailability is reduced in patients with obesity at 1 and 6 months after RYGB. However, omeprazole PK parameters 6 months after RYGB are similar to control subjects, and thus no dose correction is required after RYGB for a given indication.
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