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| |  FDA Approves Renagel Capsules For Patients With End Stage Renal Disease WALTHAM, MA and CAMBRIDGE, MA -- Nov. 2, 1998 -- The United States Food and Drug Administration has approved GelTex Pharmaceuticals, Inc.’s and Genzyme General’s Renagel(R) Capsules (sevelamer hydrochloride) for the reduction of serum phosphorus in patients with end stage renal disease (ESRD). The safety and efficacy of Renagel Capsules in ESRD patients who are not on hemodialysis have not been studied. Control of blood phosphorus is an integral part of managing the care of ESRD patients. There are an estimated 220,000 ESRD patients on dialysis in the U.S. "Hyperphosphatemia is a major complication faced by end stage renal disease patients, a population that is increasing by six to eight percent per year," said Eduardo Slatopolsky, M.D., professor of renal diseases in medicine at the Washington University School of Medicine in St. Louis, MO., and a leading expert in the treatment of hyperphosphatemia. "Current therapies include calcium- and aluminium-based agents. Clinical studies in hemodialysis patients have shown that Renagel can safely and effectively treat hyperphosphatemia without the use of calcium, allowing aggressive management of this condition while limiting the risks of hypercalcemia. "Renagel is also free of aluminium, which is used to treat hyperphosphatemia. Aluminium can cause aluminium intoxication." Renagel is designed to bind and remove dietary phosphorus in the gastrointestinal tract and eliminate phosphorus through normal digestive processes. Renagel does not contain aluminium or calcium. In hemodialysis patients, Renagel decreases the incidence of hypercalcemic episodes relative to patients on calcium acetate treatment. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. In a placebo-controlled study, there were no differences between Renagel Capsules and placebo for any adverse event. In a crossover study comparing Renagel with calcium acetate, the adverse events reported for Renagel Capsules were similar to those reported for calcium acetate. In a 44-week, open-label extension study, adverse events possibly related to Renagel Capsules, which were not dose-related, included nausea (seven percent), constipation (two percent), diarrhea (four percent), flatulence (four percent) and dyspepsia (five percent). No drug-drug interaction studies were performed in humans. ESRD patients retain excess phosphorus, which is normally excreted through the kidneys in urine. If left untreated, elevated blood phosphorus levels can lead to a number of serious conditions, including renal bone disease and soft tissue and vascular calcifications. The ability of Renagel Capsules to lower serum phosphorus in ESRD patients on hemodialysis was demonstrated in approximately 400 patients in three Phase II studies with treatment duration ranging from two to 12 weeks and two Phase III studies with treatment duration of eight weeks. Four of the five studies were open-label dose-titration studies. One of the Phase II studies was a placebo-controlled study. In a Phase III crossover study, 84 ESRD patients on hemodialysis who were hyperphosphatemic (serum phosphorus greater than 6.0 mg/dL) following a two-week phosphate binder washout period were randomised to receive either Renagel Capsules for eight weeks followed by calcium acetate for eight weeks or calcium acetate for eight weeks followed by Renagel Capsules for eight weeks. Treatment periods were separated by a two-week phosphate binder washout period. Patients started on Renagel Capsules or calcium acetate tablets three times per day with meals. Over each eight-week treatment period, at three separate time points the dose of either agent could be titrated up one capsule or tablet per meal (three per day) to control serum phosphorus. Renagel Capsules significantly decreased mean serum phosphorus by about 2 mg/dL. In addition, 192 patients were treated for an additional 44 weeks in a long-term extension study. In all of the clinical studies, including a Phase III, open-label, dose titration trial of 172 patients, Renagel significantly lowered serum phosphorus levels. In addition to phosphorus reductions, in the two pivotal Phase III clinical studies and the long-term extension study, there was a statistically significant decrease in total and LDL cholesterol.
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