Key points from the evidence

Key points from the evidence

The content of this evidence summary was up-to-date in July 2013. See summaries of product characteristics (SPCs), British national formulary (BNF), BNF for children (BNFc) or the MHRA or NICE websites for up-to-date information.

Summary

There is weak evidence from case series that oral glycopyrronium bromide tablets reduce sweating in people with hyperhidrosis. The most commonly reported adverse effects are antimuscarinic, particularly dry mouth. There is no randomised controlled trial evidence of the use of oral glycopyrronium bromide for hyperhidrosis.

Regulatory status: unlicensed

Effectiveness

  • No randomised controlled trials were identified.

  • Across a number of case series, involving around 150 adults, children and young people, hyperhidrosis 'responded' to oral glycopyrronium bromide tablets in 67–90% of participants.

Safety

  • Contraindicated in medical conditions that preclude antimuscarinic therapy.

  • Specific warnings about:

    • fever and heat stroke as a result of decreased sweating in high environmental temperatures,

    • diarrhoea, which may be an early symptom of incomplete intestinal obstruction.

Patient factors

  • Glycopyrronium bromide tablets and oral solution or suspension are imported or prepared by 'specials' manufacturers.

  • Dosage varies, ranging from 1 mg to a maximum 8 mg (in divided doses) daily in case series.

  • Across case series 29–79% of participants experienced adverse effects, most frequently dry mouth (affecting 16–63%).

  • In 3 case series, 26%, 20% and 3% of participants withdrew because of adverse effects.

  • In 2 case series, no withdrawals because of adverse effects were reported.

Resource implications

  • The cost of glycopyrronium bromide tablets varies depending on the source and the dosage used.

  • In 2012 in England there were 21,600 items dispensed for oral glycopyrronium bromide at a net cost of £5,732,400 (indications not known).

  • Cost per item for tablets between £268.57 and £712.34 (number of tablets per item not known).

Key points

Glycopyrronium bromide is an antimuscarinic drug that prevents the stimulation of sweat glands. This evidence summary reviews the use of oral glycopyrronium bromide for treating hyperhidrosis, or excessive sweating.

Oral preparations of glycopyrronium bromide (tablets and solution or suspension) are not licensed or available in the UK for treating hyperhidrosis. Such preparations must be either imported or prepared by 'specials' manufacturers. Use for this indication would be unlicensed.

Glycopyrronium bromide powder for solution (Robinul powder) is currently licensed for the iontophoretic treatment (electromotive drug administration) of primary (idiopathic) hyperhidrosis of the palms of hands and soles of feet in children and adults.

No randomised controlled trials were identified. Five case series reported the use of oral glycopyrronium bromide tablets in people with hyperhidrosis: 3 in a total 100 adults with focal or generalised primary hyperhidrosis (Bajaj and Langtry 2007; Lee et al. 2012; Walling 2012); 1 case series in 31 children or young people with focal primary hyperhidrosis (Paller et al. 2012); and 1 case series in 19 adults or young people with compensatory hyperhidrosis following sympathectomy for focal primary hyperhidrosis (Gong and Kim 2013).

Dosages of oral glycopyrronium bromide in these case series ranged from 1 mg to a maximum 8 mg (in divided doses) daily, and treatment duration was variable or unreported. In all but 1 study, participants had tried previous treatments and either the condition had not responded, or they had been intolerant to the treatment.

Across these case series, hyperhidrosis responded to treatment in 67 to 90% of participants. These response rates were based on absolute responses to therapy as recorded in patient records, or on patient questionnaires, which could be subjective and do not appear to be validated.

Adverse effects affected between 29 and 79% of participants, the most frequent being dry mouth (affecting 16–63%). Two studies (Bajaj and Langtry 2007; Walling 2012) reported that, respectively, 26% and 20% of participants stopped treatment because of adverse effects. Paller et al. (2012) reported that 1 child (3%) stopped because of palpitations. The other 2 studies reported no withdrawals because of adverse effects.

Additional safety information is included in the labelling of the oral glycopyrronium bromide products available in the USA but not licensed for hyperhidrosis (glycopyrrolate tablets, USP, Robinul and Robinul Forte; glycopyrrolate oral solution, Cuvposa). The tablets are contraindicated in medical conditions that preclude antimuscarinic therapy. There are also warnings about fever and heat stroke as a result of decreased sweating in high environmental temperatures, and diarrhoea, which may be an early symptom of incomplete intestinal obstruction. Listed adverse effects include dry mouth, urinary retention, blurred vision, palpitations, drowsiness, vomiting and constipation.

Overall, the 5 case series provide weak evidence of the efficacy and safety of oral glycopyrronium bromide for treating hyperhidrosis.

About this evidence summary

'Evidence summaries: unlicensed or off-label medicines' summarise the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, where there are no clinically appropriate licensed alternatives. The summaries provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies.

The summaries support decision-making on the use of an unlicensed or off-label medicine for an individual patient, where there are good clinical reasons for its use, usually when there is no licensed medicine for the condition requiring treatment, or the licensed medicine is not appropriate for that individual.

The strengths and weaknesses of the relevant evidence are critically reviewed within this summary, but this summary is not NICE guidance.