scholarly journals Plasma and tissue pharmacokinetics of fosfomycin in morbidly obese and non-obese surgical patients: a controlled clinical trial

2019 ◽  
Vol 74 (8) ◽  
pp. 2473-2473 ◽  
Author(s):  
Christoph Dorn ◽  
David Petroff ◽  
Nancy Neumann ◽  
Alexander Kratzer ◽  
Nahed El-Najjar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Surgical Patients ◽  
Controlled Clinical Trial ◽  
Morbidly Obese ◽  
Tissue Pharmacokinetics

Plasma and tissue pharmacokinetics of fosfomycin in morbidly obese and non-obese surgical patients: a controlled clinical trial

2019 ◽  
Vol 74 (8) ◽  
pp. 2335-2340 ◽  
Author(s):  
Christoph Dorn ◽  
David Petroff ◽  
Nancy Neumann ◽  
Alexander Kratzer ◽  
Nahed El-Najjar ◽  
...  
Keyword(s):  
Drug Exposure ◽  
Peak Plasma ◽  
Subcutaneous Tissue ◽  
Plasma Concentrations ◽  
Surgical Patients ◽  
Pharmacokinetic Analysis ◽  
Controlled Clinical Trial ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Tissue Pharmacokinetics

Abstract Objectives To assess the pharmacokinetics and tissue penetration of fosfomycin in obese and non-obese surgical patients. Methods Fifteen obese patients undergoing bariatric surgery and 15 non-obese patients undergoing major intra-abdominal surgery received an intravenous single short infusion of 8 g of fosfomycin. Fosfomycin concentrations were determined by LC-MS/MS in plasma and microdialysate from subcutaneous tissue up to 8 h after dosing. The pharmacokinetic analysis was performed in plasma and interstitial fluid (ISF) by non-compartmental methods. Results Thirteen obese patients (BMI 38–50 kg/m2) and 14 non-obese patients (BMI 0–29 kg/m2) were evaluable. The pharmacokinetics of fosfomycin in obese versus non-obese patients were characterized by lower peak plasma concentrations (468 ± 139 versus 594 ± 149 mg/L, P = 0.040) and higher V (24.4 ± 6.4 versus 19.0 ± 3.1 L, P = 0.010). The differences in AUC∞ were not significant (1275 ± 477 versus 1515 ± 352 mg·h/L, P = 0.16). The peak concentrations in subcutaneous tissue were reached rapidly and declined in parallel with the plasma concentrations. The drug exposure in tissue was nearly halved in obese compared with non-obese patients (AUC∞ 1052 ± 394 versus 1929 ± 725 mg·h/L, P = 0.0010). The tissue/plasma ratio (AUCISF/AUCplasma) was 0.86 ± 0.32 versus 1.27 ± 0.34 (P = 0.0047). Conclusions Whereas the pharmacokinetics of fosfomycin in plasma of surgical patients were only marginally different between obese and non-obese patients, the drug exposure in subcutaneous tissue was significantly lower in the obese patients.

scholarly journals An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Bartolomé Burguera ◽  
Juan Jesús Tur ◽  
Antonio Jorge Escudero ◽  
María Alos ◽  
Alberto Pagán ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Clinical Trial ◽  
Weight Loss ◽  
Lifestyle Intervention ◽  
Behavioral Therapy ◽  
Controlled Clinical Trial ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Weight Changes ◽  
Intensive Lifestyle Intervention

Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients.Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients.Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n=60) or Conventional Obesity Therapy (COT) (n=46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n=37).Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (−11.3% versus −1.6%;p<0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was −29.6% after that same period of time.Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT2009-013737-24.

Multicomponential VR-Enhanced Treatment of Emotional Overeating in Obese Subjects: A Controlled Clinical Trial

2006 ◽  
Author(s):  
Gian Mauro Manzoni ◽  
Gian Luca Cesa ◽  
Daniela Villani ◽  
Gianluca Castelnuovo Enrico Molinari ◽  
Giuseppe Riva
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Obese Subjects
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