New Medications May Offer Hope to Drinkers Battling Alcohol Dependence

Individuals who experience the physical, mental and social symptoms associated with alcohol dependence are offered hope through the results of two recent studies by researchers at the Medical University of South Carolina (MUSC). In separate investigations, researchers found favorable results for a medication to help heavy drinkers who are trying to modify their consumption, as well as a medication to reduce alcohol withdrawal symptoms and prevent relapse.

In a landmark study, MUSC researchers working with investigators at the University of Virginia Health System and elsewhere have found that topiramate, an effective therapeutic medication, not only decreases heavy drinking, but it also lowers all liver enzymes, plasma cholesterol, body mass index (BMI), and systolic and diastolic blood pressure — all of which tend to increase with heavy drinking and pose such serious health risks as heart disease and Cirrhosis. Notably, these combined effects suggest that topiramate may decrease the risk of heart disease in alcohol dependent individuals.

“These findings add growing data indicating that heavy drinkers who modify their drinking with the help of medication and supportive counseling may see an improvement in health and well-being, as well as a potential reduction of risk for the development of heart and liver diseases. This shows that treatment of alcoholism has potential health benefits beyond the immediate behavioral and emotional improvement caused by a reduction in drinking” said Raymond Anton, M.D., distinguished university professor.

By decreasing liver enzymes and cholesterol levels, topiramate also may reduce the risk of fatty liver disease, which leads to Cirrhosis - a common consequence to end-stage liver disease leading to death in some alcoholics.

Additionally, topiramate significantly contributed to a decline in obsessive thoughts and compulsions, components of alcohol craving, and also had a greater improvement in their “overall quality of life,” and specifically an improvement in general and leisure activities and household duties, as well as a reduction in sleep disturbances.

The Food and Drug Administration has approved topiramate for seizures and migraine headaches, but it is not currently approved for treating alcohol dependence. Ortho-McNeil Neurologics, Inc., manufactures topiramate and provided study funding.

Results from the nationwide 14-week trial involving 371 male and female diagnosed alcoholics was published in the June 9 issue of the Archives of Internal Medicine.

In addition, Anton presented initial results from a separate investigation of a 14-week double-blind, placebo-controlled study utilizing the PROMETA ® alcoholism treatment program, developed by Hythiam, inc., at the 2008 Research Society on Alcoholism (RSA) conference in Washington D.C.

Anton suggested that alcohol dependence programs are few in number and not exceptionally effective, which is particularly true for individuals who experience alcohol withdrawal symptoms. PROMETA ®, a combination of generic medications, reduced cravings and alcohol withdrawal symptoms, promoted abstinence, and improved mood and sleep only in those who had symptoms of alcohol withdrawal. Although the PROMETA ® Protocol has been marketed nationally, this was the first scientific study examining its utility in individuals with alcohol dependence.

At the time of the RSA presentation, the data presented covered the initial six-week active treatment phase of the 14-week study. While these are initial findings, additional evaluation of the full 14-week study data is ongoing, and Anton plans to release these specifics in a peer-reviewed publication.

MUSC has an ongoing clinical trial program studying new medications for the treatment of alcohol use disorders. For more information call 843-792-2727.

About MUSC
Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the South. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC educates and trains more than 3,000 students and residents, and has nearly 11,000 employees, including 1,500 faculty members. As the largest non-federal employer in Charleston, the university and its affiliates have collective annual budgets in excess of $1.6 billion. MUSC operates a 750-bed medical center, which includes a nationally recognized Children’s Hospital and a leading Institute of Psychiatry.

About the PROMETA ® Treatment Program
Hythiam’s PROMETA Treatment Program is designed for use by health care providers seeking to treat individuals diagnosed with dependencies to alcohol, cocaine or methamphetamine, as well as combinations of these drugs. The PROMETA Treatment Program includes nutritional supplements, FDA-approved oral and IV medications used off-label and separately administered in a unique dosing algorithm, as well as psychosocial or other recovery-oriented therapy chosen by the patient and his or her treatment provider. As a result, PROMETA represents an innovative approach to managing alcohol, cocaine, or methamphetamine dependence that is designed to address physiological, nutritional, and psychosocial aspects of the disease, and is thereby intended to offer patients an opportunity to achieve sustained recovery.

About Hythiam ®
Hythiam, Inc. provides through its CatasysTM offering, behavioral health management services to health plans, employers and unions through a network of licensed and company managed healthcare providers. Catasys offers integrated substance dependence solutions built around the patented PROMETA Treatment Program for alcoholism and stimulant dependence. The PROMETA Treatment Program, which integrates behavioral, nutritional, and medical components, is also available on a private-pay basis through licensed treatment providers and company managed treatment centers. Hythiam also researches, develops, licenses and commercializes innovative and proprietary physiological, nutritional, and behavioral treatment programs. Hythiam does not practice medicine or manufacture, distribute, or sell any medications and has no relationship with any manufacturers or distributors of medications used in the PROMETA Treatment Program.

Source: Medical University of South Carolina