Review and analysis of differing regulatory indications and expert panel guidelines for the treatment of hyponatremia

Abstract

Introduction and objective: As evidence grows about the management of hyponatremia, a number of different international and national recommendations/guidelines from professional organizations have recently been published that offer guidance on decision-making. However, they include several important differences that could confuse practising physicians. This article summarizes the key differences in guideline recommendations by various independent groups, taking the marketing authorizations granted by different regulatory agencies into account. It proposes a synthesis of implications for practising physicians as a practical method for resolving these differences as they relate to everyday clinical practice.

Methods: The authors reviewed all recent guidelines and consensus documents worldwide to assess differences and similarities. They also reviewed licensed indications for therapeutic agents in hyponatremia.

Results: The actual indications for the only pharmacological therapy approved across three continents for the treatment of hyponatremia--the vaptans--differ substantially around the world. The numerous treatment guidelines published to date also fail to achieve agreement on hyponatremia management. The possible reasons for these differences are explored in this paper. The authors emphasize the crucial role that clinical judgment must continue to play in decision-making about the management of hyponatremia in individual patients. Such judgments should take into account appropriate appraisals of evidence by authoritative experts in the field, as well as the decisions of regulatory agencies that have based their approvals on a critical review of the efficacy and safety data for approved treatments for hyponatremia.

Conclusion: It is clinical judgment rather than guidelines that should dictate the ultimate choices physicians make for their patients, not only in hyponatremia, but in all aspects of medicine.

Keywords: Conivaptan; Guidelines; Hyponatremia; Mozavaptan; Sodium; Syndrome of inappropriate anti-diuretic hormone secretion (SIADH); Tolvaptan.