ABSTRACT
Everolimus allows calcineurin-inhibitor reduction without loss of efficacy and may improve renal-transplant outcomes. In a 24-month, open-label study, 833 de novo renal-transplant recipients were randomized to everolimus 1.5 or 3.0 mg/day (target troughs 3-8 and 6-12 ng/mL, respectively) with reduced-exposure CsA, or mycophenolic acid (MPA) 1.44 g/day plus standard-exposure CsA. Patients received basiliximab +/- corticosteroids. The primary endpoint was composite efficacy failure (treated biopsy-proven acute rejection, graft loss, death or loss to follow-up) and the main safety endpoint was renal function (estimated glomerular filtration rate [eGFR], by Modification of Diet in Renal Disease [MDRD]) at Month 12 (last-observation-carried-forward analyses). Month 12 efficacy failure rates were noninferior in the everolimus 1.5 mg (25.3%) and 3.0 mg (21.9%) versus MPA (24.2%) groups. Mean eGFR at Month 12 was noninferior in the everolimus groups versus the MPA group (54.6 and 51.3 vs 52.2 mL/min/1.73 m(2) in the everolimus 1.5 mg, 3.0 mg and MPA groups, respectively; 95% confidence intervals for everolimus 1.5 mg and 3.0 mg vs MPA: -1.7, 6.4 and -5.0, 3.2, respectively). The overall incidence of adverse events was comparable between groups. The use of everolimus with progressive reduction in CsA exposure, up to 60% at 1 year, resulted in similar efficacy and renal function compared with standard-exposure CsA plus MPA.
Subject(s)
Kidney Transplantation/methods , Mycophenolic Acid/administration & dosage , Adrenal Cortex Hormones , Adult , Antibodies, Monoclonal , Basiliximab , Biopsy , Enzyme Inhibitors , Everolimus , Female , Humans , Immunosuppressive Agents/pharmacology , Kidney/drug effects , Kidney/pathology , Kidney/physiopathology , Kidney Function Tests , Kidney Transplantation/adverse effects , Male , Middle Aged , Mycophenolic Acid/therapeutic use , Recombinant Fusion Proteins , Safety , Sirolimus/adverse effects , Sirolimus/analogs & derivatives , Treatment OutcomeABSTRACT
A case suggesting the occurrence of onchocerciasis in Ecuador was first reported in 1952. The appearance of another case in 1977 provided the stimulus to do an epidemiologic survey on an isolated 20-km section of the Cayapa River in Esmeraldas Province. The Mazzotti test, skin biopsy, and nodulectomy were performed on 300 inhabitants of the area. Of the 300 who were tested, 210 (70%) reacted positively to the Mazzotti test, only 20 of whom had a negative skin biopsy. An additional 10 patients with a negative Mazzotti test had a positive skin biopsy. Combining the results of the Mazzotti test and skin biopsy show a 73% prevalence of onchocerciasis. Sixty-four patients (21%) had nodules, and evidence suggests that ocular pathology may be present.
Subject(s)
Onchocerciasis/epidemiology , Adult , Asian People , Biopsy , Black People , Child , Diethylcarbamazine/pharmacology , Ecuador , Female , Humans , Indians, South American , Male , Onchocerciasis/pathology , Skin/pathologyABSTRACT
Part of the drug budget in Ecuador goes on expensive, non-essential, or unsafe proprietary medicines, while many drugs considered necessary in developed countries are unavailable. The promotional activities of pharmaceutical companies are unchecked and objective drug information in scarce.