IntroductionClinicians’ skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide®) and the leading innovator brand (Meronem®) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety.MethodsPatients from different high care and intensive care units were recruited for observation when prescribed either of the meropenem brands under investigation. Blood samples were collected over 6 hours after a 30 minute infusion of the different brands. Meropenem concentration curves were established against United States Pharmacopeia standard meropenem (Sigma-Aldrich) by using standard laboratory techniques for culture of Klebsiella pneumoniae. Patients’ plasma samples were tested ex vivo, using a disc diffusion assay, to confirm antimicrobial activity and estimate plasma concentrations of the two brands.ResultsBoth brands of meropenem demonstrated similar curves in donor plasma when concentrations in vials were confirmed. Patient-specific serum concentrations were determined from zones of inhibition against a standard laboratory Klebsiella strain ex vivo, confirming at least similar in vivo concentrations as the concentration curves (90% confidence interval) overlapped; however, the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem.ConclusionThis observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on registration status as well as bioassay results, demonstrating sufficient overlap for clinical comfort. The slightly higher observed comparator meropenem concentration (4%) is still clinically acceptable due to the large therapeutic index and should ally fears of inferiority.

IntroductionAbundant anecdotal evidence for products claiming to reduce veisalgia after alcohol overindulgence are available on the Internet and as many advertisements in journals. None of these claims are, however, substantiated by research. The aim of this research was to ascertain the validity of such claims for the substance Absorbatox™, a potentiated aluminosilicate (cation exchanger able to bind NH4+, histamine, and other positively charged ions) by investigating the signs and symptoms, as well as blood or breath alcohol levels, in healthy volunteers.MethodsBlood or breath alcohol levels were measured in all volunteers in initial controlled experiments, and symptoms were scored on a diary card for gastrointestinal tract symptoms, as well as other symptoms such as headache and light sensitivity. Eighteen volunteers completed the initial blood alcohol study, which investigated the effect of Absorbatox™ on blood alcohol levels after fasting. The follow-up studies researched the effects of the symptoms and signs of alcohol overindulgence. The “night out” study was completed by ten volunteers in a typical controlled environment, which was followed by the real-life four-leg crossover study. In the crossover study, volunteers (number =25 completers) had to fill matching diary cards to containers of two placebo and two active drugs after a night out where they themselves decided on the container (color coded) to be used and the amount of alcohol to be consumed.ResultsAbsorbatox™ had no effect on blood alcohol levels, but it significantly reduced the symptoms and signs of veisalgia by approximately 40%–50%.ConclusionThis research indicates that Absorbatox™ does not have an effect on blood- or breath-alcohol levels. Furthermore, treatment with Absorbatox™ resulted in an overall significant reduction in central nervous system and gastrointestinal tract symptoms associated with veisalgia, warranting further investigation.

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Background: Irritable Bowel Syndrome (IBS) is one of the most common gastrointestinal disorders presenting in clinical practice. IBS is a functional bowel disorder in which abdominal pain or discomfort is associated with a change in bowel habit and with features of disordered defecation. Methods: IBS candidates were enrolled in the study using the Rome III diagnostic criteria. Participants were identified as IBS-D (diarrhoea dominant), IBS-C (constipation dominant) as well as an IBS-M (mixed group). The participants were randomly assigned; for intention to treat with 750 mg potentiated clinoptilolite three times daily or placebo. The primary endpoint was to determine whether or not the patient experienced adequate relief of symptoms. Results: At the end of treatment 67% and 40% of patients were classified as overall responders in the potentiated clinoptilolite and placebo groups respectively (N=50). After week three of treatment the number of weekly responders was significantly higher (p=0.048) in the potentiated clinoptilolite group compared to the Placebo group, and at week four of treatment the number of weekly responders was borderline significant higher in the potentiated clinoptilolite group (P=0.06). Secondary endpoints were measured but the population size proved too small to realistically obtain statistical significance (p > 0.5). Conclusion: Potentiated clinoptilolite shows clinical benefit, and should be tested further in larger clinical trials. In addition, potentiated clinoptilolite also shows reduced symptoms of IBD-D and IBS-M respectively. It is recommended that clinical response to dose variation should also be further investigated in designated populations of IBS-M and IBS-D patients.

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