New drug therapy to aid specialists and GPs in the treatment of Alcohol Dependence.

4 February 1999

The treatment of patients with alcohol dependency is set to enter a new era in Australia with the recent approval of REVIA (naltrexone) an opioid antagonist - the first drug treatment for alcohol dependency for 50 years according to Professor Bruce Rounsaville, Professor of Psychiatry at Yale University School of Medicine, USA.

"Despite the fact that alcohol dependence is one of the most prevalent public health issues in modern society, there have been no clearly effective pharmacotherapies available for relapse prevention until now," said Professor Whelan, Professor of Drug and Alcohol Studies at St Vincent's Hospital and REVIA clinical trialist.

"REVIA, in combination with counselling, offers doctors a new and extremely effective way to manage the up to 800,000 Australians with alcohol dependency," he added.

Professor Rounsaville said: "In our experience in the US we have found that GPs are well positioned to manage patient's alcohol dependency treatment with a combination of strong counselling techniques and this new therapeutic option."

Dr Benny Monheit, a general practitioner and head of the RACGPs drug and alcohol addiction course said "Many GPs have been disappointed with alcohol treatment in the past - counseling or support groups on their own have very limited success.

"With the introduction of REVIA, treatment success can be doubled - which is a huge stride forward. If the GP is empathic, uses the family for support and is prepared to give the alcohol dependent patient a go on REVIA it can be a very powerful treatment option."

Whilst specialists will continue to manage the difficult or complicated cases - such as those with comorbid conditions - Dr Monheit believes REVIA's availability in Australia will see an exciting role for GPs in alcohol dependency treatment in this country.

Although not immediately, it is likely that the introduction of REVIA will mean that GPs will play a major role in the management of alcohol dependency in the future; as our levels of knowledge and experience increase." said Dr Monheit.

REVIA's exact mechanism of action in alcoholism is unknown, however data suggests that the body's opioid system may be involved. The body's own opioids are released in the brain when alcohol is consumed. REVIA is thought to reduce an individuals craving for alcohol by acting on the neurochemical pathways in the brain and blocking these opioids.

In combination with the standard psychosocial therapy REVIA has been shown to be significantly superior to placebo in measures of drinking and alcohol related problems, including abstention rates, number of drinking days, relapse and severity of alcohol related problems.¹

In a combined analysis of two 12-week clinical trials, evaluating the effectiveness of REVIA, patients who received REVIA were nearly twice as successful in avoiding relapse and significantly more successful in remaining abstinent than patients who received placebo².

"Our research clearly confirms the role and significance of REVIA in the treatment of alcohol dependency. Although it is not a cure, as an adjunct to psychosocial therapy, REVIA is an important new therapeutic option which can help patients control their dependency," said Professor Rounsaville.

Recent clinical studies conducted in Australia support these results. In one trial, involving 111 individuals at the Austin & Repatriation Medical Centre, the researchers concluded that at a dose of 50mg per day, REVIA was superior to placebo, when combined with a standard alcohol relapse-prevention program in reducing relapse to problematic drinking in alcohol dependent individuals³.

REVIA is taken as a 50mg tablet once daily. Shortly after the first dose, REVIA's effects on blocking the craving for alcohol occur. If REVIA is tolerated and the patient is successful in reducing or stopping drinking, the recommended course of treatment is for 3 months.

In a clinical safety study of REVIA, with approximately 570 individuals, the following side effects occurred in two per cent or more of those treated: nausea (10%), headache (7%), dizziness (4%), nervousness (4%), fatigue (4%), insomnia (3%), anxiety (2%), and sleepiness (2%).⁴ Except for the side effects, which are usually short lived and mild, patients report that they are largely unaware of being on medication.

Professor Rounsaville will be in Australia from 1 - 5 March 1999 to share with specialists and GPs his practical experience regarding REVIA's role in the treatment of alcohol dependency.

REVIA is distributed by Orphan Australia under licence from DuPont Pharmaceuticals Company. Orphan Australia is a small pharmaceutical company that supplies pharmaceutical products typically used by specialists to treat serious disorders that affect relatively small populations. Orphan Australia have developed a range of educational materials, designed to provide information and resources on the use of REVIA.

References:

1. O'Malley SS, Jaffe AJ, Chang G, Schottenfeld RS, Meyer RE, Rounsaville B. Naltrexone and coping skills therapy for alcohol dependence. Arch Gen Psychiatry. 1992; 49: 881-887.
2. O'Malley SS, Croop RS, Wroblewski JM, Labriola DF, Volpicelli JR. Naltrexone in the Treatment of Alcohol Dependence: A Combined Analysis of Two Trials. Psychiatric Annals 25: 11 November 1995.
3. Preliminary report by Professor Philip Morris, Dr Mal Hopwood and Professor Greg Whelan. Austin & Repatriation Medical Centre and St Vincent's study into the treatment of alcohol dependency with naltrexone.
4. Croop RS, Faulkner EB, Labriola DF. The safety profile of naltrexone in the treatment of alcoholism: Results from a multicentre usage study. Archives of General Psychiatry. 1997; 54: 1130-35.

For further information contact:

Helen Mills or Caroline Duell
Hill and Knowlton
(03) 9820 8999

Notes to Editors:

• The RACGP is currently looking into the provision of training courses to help equip GPs with the counseling skills needed to assist individuals with alcohol dependency.
• In Australia, alcohol dependency costs over $6 billion annually. According to new statistics from a World Health Authority (WHO) Collaborative study coordinated by the University of Sydney, alcohol dependency is one of the most important public health and social problems affecting the developed world.