Advancing understanding of treatment through clinical trials

November 03, 2012

Three late-breaking studies presented during the American Society of Nephrology's Annual Kidney Week provide new information on drugs being tested in patients with diabetes or kidney disease.

Hans-Henrik Parving, MD (University of Copenhagen, in Denmark) and his colleagues investigated whether the drug aliskiren might improve the prognosis of patients with type 2 diabetes who are at high risk for developing heart and kidney problems. The randomized double-blind ALTITUDE trial included 8561 individuals who received aliskiren (300 mg once daily) or placebo on top of a drug that blocks the renin-angiotensin-aldosterone system (RAAS), a complex hormone system that regulates blood pressure and fluid balance. (Drugs that target the RAAS have limited effectiveness in part due to feedback responses, such as compensatory increases in an enzyme called renin. Aliskiren is a direct renin inhibitor and may help overcome these shortcomings because it suppresses the reactive rise in renin activity stimulated by other RAAS blockers.) After an average follow-up of 32.9 months: "The trial does not support administration of aliskiren on top of standard therapy with RAAS blockade in type 2 diabetic patients at high risk for cardiovascular and renal events, and may even be harmful," the authors concluded.

Another team led by Vicente Torres, MD, PhD (Mayo Clinic) tested the potential of a vasopressin V2 receptor antagonist (tolvaptan) to inhibit cyst growth and slow kidney function decline in patients with autosomal dominant polycystic kidney disease (ADPKD). This condition causes kidney cysts often associated with pain, hypertension, and kidney failure. The phase 3, multi-center, double-blind, placebo-controlled, 3-year trial included 1445 ADPKD patients who were randomized 2:1 to split dose tolvaptan (45/15, 60/30 or 90/30 mg daily as tolerated) or placebo. "Tolvaptan demonstrated clinically meaningful disease-specific benefits for ADPKD patients which may be clinically meaningful," said Dr. Torres. While the trial findings are encouraging, tolvaptan has not yet been approved for this indication.

A third trial, called EVOLVE, was designed to test the hypothesis that treatment with cinacalcet compared with placebo reduces the risk of premature death or non-fatal heart-related events among dialysis patients with secondary hyperparathyroidism. (Secondary hyperparathyroidism, when the parathyroid gland produces excess amounts of parathyroid hormone, arises in most patients with chronic kidney disease as their disease progresses. It can lead to a number of complications, including cardiovascular problems.) Results from analyses using multivariable adjustment and censoring data 6 months after patients stopped taking the drug will be presented, along with safety data, by Glenn Chertow, MD (Stanford University School of Medicine).
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Study co-authors for "The Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)" (abstract 6313) include Barry M. Brenner, MD, John Mcmurray, Dick de Zeeuw, MD, PhD, Steven Mark Haffner, MD, Scott D. Solomon, MD, Nish Chaturvedi, Frederik I. Persson, MD, Akshay Suvas Desai, Maria Nicolaides, and Marc A. Pfeffer, MD, PhD.

Study co-authors for "Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease: The TEMPO 3:4 Trial" (abstract 6357) include Arlene B. Chapman, MD, Olivier Devuyst, MD, PhD, Ron T. Gansevoort, MD, PhD, Jared J. Grantham, MD, Eiji Higashihara, MD, Ronald D. Perrone, MD, Holly B. Krasa, John Ouyang, PhD, Osamu Sato, and Frank S. Czerwiec, MD, PhD.

Study co-authors for "Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE) trial" (abstract 6450) include Geoffrey A. Block, MD, Ricardo Correa-Rotter, MD, Tilman B. Drueke, MD, Jurgen Floege, MD, William G. Goodman, MD, Christian Mix, MD, Marie-Louise Trotman, Yumi Kubo, Charles A. Herzog, MD, Gerard M. London, MD, Kenneth Mahaffey, MD, Sharon M. Moe, MD, David C. Wheeler, MD, and Patrick S. Parfrey, MD.

ASN Kidney Week 2012, the largest nephrology meeting of its kind, will provide a forum for 13,000 professionals to discuss the latest findings in renal research and engage in educational sessions related to advances in the care of patients with kidney and related disorders. Kidney Week 2012 will take place October 30 - November 4 at the San Diego Convention Center.

The content of these studies does not reflect the views or opinions of The American Society of Nephrology (ASN). Responsibility for the information and views expressed therein lies entirely with the author(s). ASN does not offer medical advice. All content in ASN publications is for informational purposes only, and is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This content should not be used during a medical emergency or for the diagnosis or treatment of any medical condition. Please consult your doctor or other qualified health care provider if you have any questions about a medical condition, or before taking any drug, changing your diet or commencing or discontinuing any course of treatment. Do not ignore or delay obtaining professional medical advice because of information accessed through ASN. Call 911 or your doctor for all medical emergencies.

Founded in 1966, and with more than 13,500 members, the American Society of Nephrology (ASN) leads the fight against kidney disease by educating health professionals, sharing new knowledge, advancing research, and advocating the highest quality care for patients.

American Society of Nephrology

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