ABSTRACT
BACKGROUND: In animal studies and a pilot trial in patients with congestive heart failure, the thyroid hormone analog 3,5 diiodothyropropionic acid (DITPA) had beneficial hemodynamic effects. METHODS AND RESULTS: This was a phase II multicenter, randomized, placebo-controlled, double-blind trial of New York Heart Association class II to IV congestive heart failure patients randomized (2:1) to DITPA or placebo and treated for 6 months. The study enrolled 86 patients (n=57 to DITPA, n=29 to placebo). The primary objective was to assess the effect of DITPA on a composite congestive heart failure end point that classifies patients as improved, worsened, or unchanged based on symptom changes and morbidity/mortality. DITPA was poorly tolerated, which obscured the interpretation of congestive heart failure-specific effects. Fatigue and gastrointestinal complaints, in particular, were more frequent in the DITPA group. DITPA increased cardiac index (by 18%) and decreased systemic vascular resistance (by 11%), serum cholesterol (-20%), low-density lipoprotein cholesterol (-30%), and body weight (-11 lb). Thyroid-stimulating hormone was suppressed in patients given DITPA, which reflects its thyromimetic effect; however, no symptoms or signs of potential hypothyroidism or thyrotoxicosis were seen. CONCLUSIONS: DITPA improved some hemodynamic and metabolic parameters, but there was no evidence for symptomatic benefit in congestive heart failure.
Subject(s)
Diiodothyronines/administration & dosage , Diiodothyronines/adverse effects , Heart Failure/drug therapy , Propionates/administration & dosage , Propionates/adverse effects , Adolescent , Adult , Aged , Body Weight , Cholesterol/blood , Double-Blind Method , Fatigue/blood , Fatigue/chemically induced , Female , Gastrointestinal Diseases/blood , Gastrointestinal Diseases/chemically induced , Heart Failure/blood , Humans , Lipoproteins, LDL/blood , Male , Middle Aged , Thyroid Hormones , United States , United States Department of Veterans Affairs , Vascular Resistance/drug effectsSubject(s)
Benzofurans , Benzopyrans/adverse effects , Caffeine/adverse effects , Dietary Supplements/adverse effects , Diiodothyronines/adverse effects , Phenylpropanolamine/adverse effects , Yohimbine/adverse effects , Benzopyrans/chemistry , Caffeine/chemistry , Diiodothyronines/chemistry , Drug Combinations , Phenylpropanolamine/chemistry , Product Surveillance, Postmarketing , Yohimbine/chemistryABSTRACT
BACKGROUND: LipoKinetix (Syntrax, Cape Girardeau, Missouri) is a dietary supplement marketed for weight loss. OBJECTIVE: To describe a possible causal association between LipoKinetix and hepatotoxicity. DESIGN: Case series. SETTING: Outpatient clinic, tertiary care hospital, and U.S. Food and Drug Administration databases. INTERVENTION: Routine medical and supportive care. MEASUREMENTS: Clinical and laboratory evaluation. RESULTS: All patients developed acute hepatotoxicity within 3 months of starting LipoKinetix. At presentation, symptoms and results of laboratory tests were characteristic of acute hepatitis. All patients recovered spontaneously after LipoKinetix use was discontinued. Three of the seven patients, including one who developed fulminant hepatic failure complicated by cerebral edema, were taking LipoKinetix alone at the time of presentation. Of the four patients who were taking multiple supplements, two resumed taking supplements other than LipoKinetix without incident. CONCLUSIONS: The use of LipoKinetix may be associated with hepatotoxicity. Despite extensive evaluations, no other cause for hepatotoxicity could be identified in the seven patients studied.
