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Subsequent RCTs verified the dose—response relationship between orlistat and weight loss in obese patients who were consuming a reduced energy diet [ Hauptman et al. A meta-analysis of 29 studies of orlistat revealed a mean additional weight loss of 2.

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Secondary benefits of orlistat-induced weight loss have also been evaluated. Benefits such as lower plasma total and low-density lipoprotein LDL cholesterol concentrations, smaller waist circumference, lower fasting plasma glucose concentrations, and reductions in systolic and diastolic blood lose weight tablets australia have been found among patients treated with orlistat [ Hill et al.

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More severe adverse drug events have also been described with orlistat use, including liver injury and AKI. Although data are limited to case reports, between and the American Food and Drug Administration received 32 reports of serious liver injury in patients using orlistat [ DeLancey, ].

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In a patient with underlying stage III chronic kidney disease CKD; among other lose weight tablets australiainitiation of orlistat treatment coincided with an increase in serum creatinine concentration, an increase in urine oxalate concentration and the presence of calcium oxalate crystals in the lumen of the renal tubules. These findings resolved 1 month after discontinuation of orlistat.

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Courtney and colleagues reported similar findings in a year old lose weight tablets australia with diabetic nephropathy [ Courtney et al.

Following these case reports, a retrospective review of renal biopsies by Karamadoukis and colleagues identified two cases of calcium oxalate crystals in patients with unexplained acute tubular necrosis; both of these patients were taking orlistat at the time of biopsy [ Karamadoukis et al. These same investigators later identified a year-old man with a history of type 2 diabetes who had been taking orlistat for 3 months.

Following hospital admission for AKI, the patient suffered a progressive decline in renal function that eventually necessitated hemodialysis [ Karamadoukis et al. Most recently, we published a pre—post study using the health administrative databases of Ontario, Canada.

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We studied patients using orlistat and compared their risk of AKI in the 12 months preceding orlistat initiation to their risk of AKI in the following 12 months [ Weir et al.

Orlistat is thought to cause AKI through enteric hyperoxaluria, which can also be seen lose weight tablets australia patients with fat-malabsorption syndromes.

In this lose weight tablets australia, unabsorbed fat in the small bowel resulting from orlistat use produces calcium soaps, which reduce the availability of free enteric calcium [ Ahmed, ].

As a result, calcium can no longer bind and sequester oxalate inside the gut and this allows increased intestinal oxalate absorption. This leads to increased renal oxalate excretion.

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Supersaturation of oxalate in renal tubules is a risk factor for calcium oxalate precipitation, which can lose weight tablets australia in AKI [ Williams and Wandzilak, ; Holmes et al. This mechanism is supported by the human reports of orlistat-associated AKI and also by the work of Ferraz and colleagues who observed increases in urinary oxalate excretion in rats with orlistat-induced fat malabsorption [ Ferraz et al.

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Although the current literature draws associations between orlistat and AKI, it provides little insight into the frequency with which AKI occurs or the factors that may predict it.

In our population-based study of patients, we identified 18 individuals 1. When we consider that 5 individuals 0. Even less information lose weight tablets australia available to identify risk factors for orlistat-associated AKI.

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Compared with those who did not experience a hospitalization for AKI, patients who did have AKI were slightly older mean age 60 versus 58 yearssource generally in poorer health mean Charlson comorbidity index 2.

Although this provides an lose weight tablets australia of some potentially important risk factors, it is important to note that we assessed a relatively small number of AKI events.

Despite the associations between orlistat and AKI, establishing causality between drug lose weight tablets australia and adverse outcome is challenging [ Macedo et al. Although innumerable algorithms and probabilistic models have been developed to improve upon the common practice of assigning causality based on expert opinion, no gold standard exists [ Agbabiaka et al.

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Therefore, when assessing the relationship between orlistat exposure and AKI, in the absence of a gold-standard methodology, we are left to consider the elements of causal relationships commonly identified in the literature.

These click include an appropriate temporal sequence, a biologically plausible mechanism, the effects of drug challenge, dechallenge and rechallenge, the existence of confirmatory laboratory or pathological data, a consideration lose weight tablets australia alterative aetiologies lose weight tablets australia the demonstration of a dose—response relationship [ Miremont et al.

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In the case of orlistat and AKI, the literature fulfills some but not all of these requirements. Aside from the cross-sectional biopsy study, all studies describe an appropriate temporal relationship between orlistat exposure and AKI outcome.

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The putative mechanism underlying this relationship is plausible and supported by both animal data and histologic findings in humans. Although there is no documentation of patients being rechallenged with orlistat, the dechallenges reported by the groups of Singh and Courtney showed reversal lose weight tablets australia the kidney injury.

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These case reports also provide pathological confirmation of oxalate nephropathy, which is congruent with the proposed pathophysiology. Although there appears to be strong support for a causal relationship between orlistat and AKI, the body of evidence has some important weaknesses.

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Case reports offer interesting observations, such as the presence of calcium oxalate crystals on biopsy or the resolution of AKI upon withdrawal of orlistat, but they cannot establish causality nor estimate risk. Observational studies are lose weight tablets australia in their ability to establish causality by the influence of bias and confounding variables.

Confounding variables can also threaten the validity of observational studies, and when these variables are unknown, unmeasured or inaccurately measured, statistical adjustment cannot adequately mitigate their effects.

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Because these limitations leave the door open for alternative aetiologies of AKI, causality is difficult to establish outside the setting of randomized trials.

Lose weight tablets australia, trials designed to establish efficacy are not lose weight tablets australia powered to detect rare outcomes such as AKI [ Tsang et al. Furthermore, patients with pre-existing CKD, who would likely be at the highest risk for developing AKI, are often excluded from randomized trials [ Coca et al.

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The existing trials of orlistat do not provide information on the risk of AKI and given its flagging market share, we are unlikely to see future large-scale trials involving this drug. Establishing unequivocal causality lose weight tablets australia the setting of adverse drug reactions is very difficult.

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Without evidence from randomized trials or multiple observational studies, we cannot confidently label orlistat a cause of AKI. However, we believe there is sufficient evidence to consider exposure to orlistat a potential cause of AKI. In patients with otherwise unexplained Lose weight tablets australia, discontinuation of orlistat would be a reasonable course of action and in patients at risk of AKI, such as those with multiple comorbidities or pre-existing CKD, orlistat should be prescribed with caution and close observation.

Authors acknowledge Brogan Inc.

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The opinions, results and conclusions are those of the authors and are independent from the funding sources. The authors declare that there are no conflicts of interest.

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Michael M. BeyeaAmit X. Gargand Matthew A. Author information Copyright and License information Disclaimer.

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Corresponding author. Matthew A.

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Abstract Orlistat is an inhibitor of gastric and pancreatic lipase with proven efficacy in the augmentation and maintenance of weight loss. Keywords: acute kidney injury, orlistat. Introduction Obesity is fast becoming a worldwide epidemic.

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Orlistat efficacy Orlistat, also known as tetrahydrolipstatin is a potent, selective and reversible inhibitor of gastric and pancreatic lipases [ Guerciolini, ]. Proposed mechanism of orlistat-associated Lose weight tablets australia Orlistat is thought to cause AKI through enteric hyperoxaluria, which can also be seen in patients with fat-malabsorption syndromes.

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Epidemiology of orlistat-associated AKI Although the current literature draws associations between orlistat and AKI, it provides little insight into the frequency with which AKI occurs or the factors that may predict it.

Causality Despite the associations between orlistat and AKI, establishing causality between drug exposure and adverse outcome is challenging [ Macedo et al. Conclusion Establishing unequivocal causality in lose weight tablets australia setting of adverse drug reactions is very difficult. Acknowledgments Authors acknowledge Brogan Inc. References Agbabiaka Lose weight tablets australia.

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Actualization of the method used in France. An original model for validation of drug causality assessment methods: case reports with positive rechallenge.

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