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Product News June 2004

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Details below of:
Chromium picolinate - antidepressant
Abilify (aripiprazole) - antipsychotic
Tracleer (bosentan) - pulmonary hypertyension

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New Data Show Chromium Picolinate Exerts a Selective Anti-Depressant Effect in People with Atypical Depression

Clinical Trial Linking Anti-Depressant Response To Carbohydrate Cravings Reported to International Experts at CINP Congress

  A new double-blind, placebo-controlled clinical trial in 113 patients diagnosed with atypical depression found that daily supplementation with chromium picolinate had significant anti-depressant effects in a patient sub-group with high levels of carbohydrate cravings. Subjects with the highest levels of carbohydrate cravings at baseline experienced the most significant clinical response to the chromium picolinate. The results of the 8-week, multi-center study were presented at the 24th International Neuropsycho-pharmacology Congress (CINP) in Paris (www.cinp2004.com).

Carbohydrate cravings, weight gain and unexplained fatigue are hallmark symptoms of atypical depression, a common, but frequently undiagnosed, depressive disorder estimated to affect as many as one-third of depressed patients. According to a 1990 World Health Organization study, depression is ranked as the fourth most deadly disease worldwide and is expected to be second only to heart disease by 2020.

The new study also found that nutritional supplementation with chromium in the form of chromium picolinate significantly improved carbohydrate cravings, in addition to other distinct symptoms of atypical depression. There is currently no recognised treatment for carbohydrate cravings.

Commercially available Chromax(r) Chromium Picolinate, which has been affirmed as safe for use in foods in the US (GRAS), was used in the study.   The safety of Chromax Chromium Picolinate was further confirmed in a recent review published in the June 2004 issue of Food and Chemical Toxicology.

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 ABILIFY (aripiprazole) Antipsychotic

  Two in every three patients rated ABILIFY as much better eight weeks after switching from a previous antipsychotic treatment, according to results of BETA (Broad Effectiveness Trial with Aripiprazole), a naturalistic study involving 1,500 patients.

BETA was conducted in a 'real world' setting, where physicians prescribed ABILIFY or another antipsychotic (in a four to one ratio) to patients who needed to switch treatment because of lack of effect or intolerable side effects.

ABILIFY delivers short and long-term efficacy, controls the symptoms of schizophrenia, and is enhanced by a comprehensive safety and tolerability profile. ABILIFY is the first dopamine system stabiliser used to treat schizophrenia and it is suggested that it works in a different way to all other antipsychotics. Due to its unique mechanism of action, ABILIFY works by decreasing dopamine activity where D2 receptors are over stimulated and increasing dopamine activity where they are under stimulated, thus creating dopamine stabilisation in certain areas of the brain.[2]

 ABIILFY has also been shown to be less likely to cause metabolic syndrome, which may put patients with schizophrenia at risk for heart attack and diabetes. Metabolic syndrome occurred half as often in patients taking ABILIFY compared with patients taking olanzapine,[4] according to a new study presented at CINP. Metabolic syndrome, defined as >5 percent increase in weight, worsening of lipid levels, hypertension and increased glucose, occurred in 10 percent of patients taking ABIILFY, compared with 20 percent of patients taking olanzapine during the one-year study (relative risk=2.1; 95% CI: 1.3-3.1; p=0.0016).

ABILIFY is now available to patients in the EU and many other European countries. In Europe , ABILIFY is manufactured in 5 mg, 10 mg, 15 mg and 30 mg tablets. The recommended starting dose is 15 mg. It is taken once-daily with or without food, with no need for titration.

  In a 26-week, placebo-controlled trial in stabilised patients with chronic schizophrenia, ABILIFY had significantly greater reduction in relapse rate, 34% in the ABILIFY treatment group and 57% in the placebo group.

Uncommon cases of seizures were reported during treatment with aripiprazole. Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.

References

[1] Jody D, Tandon R, Stock E et al. A naturalistic study of aripiprazole treatment in a general psychiatric setting. Poster presented at CINP (Paris, June 2004)

[2] Jordan S, Chen R, Johnson J. Guanosine'-O-(3-[35S]THIO)-triphosphate binding assays can be insensitive in detecting D2 partial agonist drug activity. Poster presented at CINP (Paris, June 2004)

[3] Baca E , Roca M, Varela C, on behalf of the ACE Study Investigators group. Most frequent adverse events among schizophrenic outpatients in Spain . Poster presented at CINP (Paris, June 2004)

[4] Casey D, L'Italien GJ, Cislo P. Incidence of metabolic syndrome in olanzapine and aripiprazole patients. Poster presented at APA (Baltimore, Maryland , USA in February 2004)

 

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New Guidelines Include Tracleer (bosentan) as a Recommended Treatment of Pulmonary Arterial Hypertension (PAH)

The Taskforce of the 3rd World Symposium on Pulmonary Arterial Hypertension today published new evidence-based guidance for the classification, diagnosis and treatment of patients with Pulmonary Arterial Hypertension (PAH). The guidelines, published in the Journal of the American College of Cardiology (1), graded Tracleer(R) (bosentan), the first oral dual ERA, with the highest "level of evidence", (grade A; see editors notes), for the treatment of patients with IPAH (idiopathic pulmonary arterial hypertension) class III and PAH related to connective tissue disease.

Around 100,000 people in Europe and the US currently suffer from pulmonary arterial hypertension, which includes IPAH and PAH related to other diseases such as scleroderma(2). Early detection and diagnosis is extremely important in order to provide appropriate treatment that may significantly improve patients' lives. Unfortunately, diagnosis can often be delayed because initial symptoms are unspecific (i.e. breathlessness) and therefore go undetected or are attributed to other diseases.

About Tracleer(R)

Tracleer(R), the first oral dual endothelin receptor antagonist, has demonstrated its efficacy in two pivotal, placebo-controlled studies(3,4). Tracleer(R) has shown statistically significant improvements in the primary efficacy endpoint of exercise capacity with patients achieving a significantly greater, and clinically meaningful increase in walking distance compared to placebo.

Clinical trials have also demonstrated Tracleer(R)'s efficacy in significantly decreasing dyspnea (shortness of breath), one of the most debilitating symptoms for people with PAH. Additionally, treatment with Tracleer(R) is also associated with a significant delay in disease progression (the time to clinical worsening)(4). Clinical worsening is defined as combined endpoint of death, hospitalization or discontinuation due to worsening PAH.

References:

(1). Galiè N and Rubin L. Pulmonary Arterial Hypertension Epidemiology, Pathobiology, Assessment and Therapy. JACC 2004;43:12(supplement S)

(2). Zaret BL et al. Yale University School of Medicine Heart Book. New York : Hearst Books, 1992. p.178.

  (3). Channick R et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo controlled study. Lancet 2001; 358:1119-23

(4). 5 Rubin LJ, Badesch DB, Barst RJ, Galie N, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002:346:896-903

 

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