0.4% glyceryl trinitrate ointment: new drug. Not useful for anal fissures

Prescrire Int. 2008 Apr;17(94):52-3.

Abstract

(1) Anal fissures are very painful but often heal spontaneously. After eliminating other diagnoses, various treatments can be tried while waiting for fissures to heal: warm seat baths, local anaesthetics, and adequate fibre and fluid intake. (2) Clinical evaluation of glyceryl trinitrate 0.4% ointment, a nitrate derivative, is mainly based on a double-blind trial versus excipient in 193 adults with "chronic" fissures. This trial failed to show a clinically relevant analgesic effect of glyceryl trinitrate 0.4%, with only a 3-mm difference versus the excipient on a 100-mm pain rating scale. In another trial including 229 patients, neither 0.2% nor 0.4% glyceryl trinitrate was more effective on pain than placebo. (3) Another placebo-controlled trial including 304 adults treated for 8 weeks showed no efficacy of various doses of glyceryl trinitrate, versus the excipient, on the healing of anal fissures. (4) The most frequent adverse effect, as expected with a nitrate derivative, is headache, which affects about two-thirds of patients and is severe in 20% of cases. Abrupt-onset hypotension is a risk during concomitant use of other vasodilatory drugs. (5) There are no data on pregnant women exposed to glyceryl trinitrate. (6) In summary, glyceryl trinitrate 0.4% ointment does not reduce the pain linked to chronic anal fissures, but it does carry a risk of sometimes severe headache. It is best to continue using simple, non-aggressive treatments.

MeSH terms

  • Adult
  • Chronic Disease
  • Clinical Trials as Topic
  • Fissure in Ano / drug therapy*
  • France
  • Humans
  • Nitroglycerin / administration & dosage
  • Nitroglycerin / adverse effects
  • Nitroglycerin / therapeutic use*
  • Ointments / administration & dosage
  • Ointments / adverse effects
  • Ointments / therapeutic use
  • Pain / drug therapy
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / adverse effects
  • Vasodilator Agents / therapeutic use*
  • Wound Healing / drug effects

Substances

  • Ointments
  • Vasodilator Agents
  • Nitroglycerin