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Monza, Italy

Zanardi M.,Presidio | Quirico E.,Presidio | Benvenuti C.,Rottapharm Madaus | Pezzana A.,Presidio
Minerva Ginecologica | Year: 2012

Aim. The aim of this paper was to determine the activity of a natural nutraceuticals combination (AP=Berberine+Red Yeast Rice) on dyslipidemia which frequently persists after life style changes in patients on hormone-therapy following breast cancer (HT-BC). Methods. Twenty-one HT-BC patients, free of tumor, mean age 59.9 years, BMI 28,9 kg/m2, waist circumference 95.9 cm, with altered lipid profile (total cholesterol 269.0 mg/dL, high-density lipoprotein (HDL) cholesterol 54.9 mg/dL, low-density lipoprotein (LDL) cholesterol 184.0 mg/dL, and triglycerides 263.3 mg/dL) were recruited. They were recommended a 3-month period of diet followed by a 3-month period of treatment with AP 1 tablet/day. AP tablets contain berberine 500 mg, red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, folic acid 0.2 mg, coenzyme Q10 2 mg, and asthaxantin 0.5 mg. Results. The lipid profile was significantly improved by AP vs. diet: 1.8% decrease in total cholesterol on diet and a further 15.3% decrease with AP vs. diet (P<0.001); a 3.1% decrease in LDL cholesterol after diet and an 18.9% decrease after AP treatment vs diet alone (P<0.01); a 2.3% decrease in triglycerides after diet alone and a 36.5% decrease after AP vs. diet (P<0.05). Conclusion. Adequate life style therapy is effective in reducing, but not in normalizing, the lipid profile in patients on hormone-therapy following breast cancer. The use of natural nutraceuticals as AP, combined with diet, leads to a good therapeutic response and optimal acceptance by the patients.

Agosta C.,Casa di Cura San Clemente | Atlante M.,Regina Apostolorum Hospital | Benvenuti C.,Rottapharm Madaus
Minerva Ginecologica | Year: 2011

Aim. The aim of this paper was to evaluate the activity of magnolia bark extract added to isoflavones and lactobacilli in menopausal women with typical menopausal symptoms and concomitant borderline psychoaffective and/or sleep alterations, of severity not requiring a psychopharmacological therapy. Methods. Menopausal women were enrolled in a multicenter, controlled, parallel-group study and randomized to E (isoflavones 60 mg + Lactobacillus sporogenes + calcium and vitamin D3 - Estromineral, Rottapharm Madaus) versus ES (magnolia bark extract + E - Estromineral serena) 1 tablet/night for 12 weeks. Results. In 91 gynecological centers, 634 women were treated (300 with E and 334 with ES), mean age 53.1 years and Body Mass Index (BMI) 25.2 kg/m2; 28% were past hormone replacement therapy HRT users and 3.3% had had a previous breast cancer. Both treatments significantly reduced versus baseline the symptoms tested at 0, 4, 8 and 12 weeks. E and ES showed a similar efficacy on hot flushing, nocturnal sweating with awakenings, palpitations and vaginal dryness. ES was more active on insomnia, irritability, anxiety, depressed mood, asthenia and loss of libido. Woman's well-being and physician's final judgment were positive in >70% in both groups. The rate of adverse events was 1% with E (metrorrhagia, cramps and constipation) and 1.2% with ES (gastralgia, blood loss, constipation and breast tension). Conclusion. Isoflavones are effective in improving the classical menopause symptoms. The clinical activity of magnolia bark extract on the relevant psycho-affective symptoms, particularly anxiety, irritability and insomnia, was evident. ES in the mild psychical alterations that can occur in climacterium avoids to run the known dependence risks linked to psychopharmacological agents withdrawals.

Rovati L.C.,Rottapharm Madaus | Girolami F.,Clinical Research Unit | Persiani S.,Clinical Research Unit
Therapeutic Advances in Musculoskeletal Disease | Year: 2012

Glucosamine is an amino monosaccharide and a natural constituent of glycosaminoglycans in articular cartilage. When administered exogenously, it is used for the treatment of osteoarthritis as a prescription drug or a dietary supplement. The latter use is mainly supported by its perception as a cartilage building block, but it actually exerts specific pharmacologic effects, mainly decreasing interleukin 1-induced gene expression by inhibiting the cytokine intracellular signaling cascade in general and nuclear factor-kappa B (NF-kB) activation in particular. As a whole, the use of glucosamine in the management of osteoarthritis is supported by the clinical trials performed with the original prescription product, that is, crystalline glucosamine sulfate. This is the stabilized form of glucosamine sulfate, while other formulations or different glucosamine salts (e.g. hydrochloride) have never been shown to be effective. In particular, long-term pivotal trials of crystalline glucosamine sulfate 1500 mg once daily have shown significant and clinically relevant improvement of pain and function limitation (symptom-modifying effect) in knee osteoarthritis. Continuous administration for up to 3 years resulted in significant reduction in the progression of joint structure changes compared with placebo as assessed by measuring radiologic joint space narrowing (structure-modifying effect). The two effects combined may suggest a disease-modifying effect that was postulated based on an observed decrease in the risk of undergoing total joint replacement in the follow up of patients receiving the product for at least 12 months in the pivotal trials. The safety of the drug was good in clinical trials and in the postmarketing surveillance. Crystalline glucosamine sulfate 1500 mg once daily is therefore recommended in the majority of clinical practice guidelines and was found to be cost effective in pharmacoeconomic analyses. Compared with other glucosamine formulations, salts, or dosage forms, the prescription product achieves higher plasma and synovial fluid concentrations that are above the threshold for a pharmacologically relevant effect, and may therefore justify its distinct therapeutic characteristics. © The Author(s), 2012.

Benvenuti C.,Rottapharm Madaus | Setnikar I.,Nutraceutical R and D
Arzneimittel-Forschung/Drug Research | Year: 2011

Purpose of the study: To verify the single dose bioavailability of two oral formulations of soy isoflavones, with and without lactobacilli, in menopausal women in antibiotic therapy. Methods: Twelve menopause women (mean age 54.3 years, BMI 25.0 kg/m 2) participated in a controlled cross-over study. Reference and test treatments were: R = tablets containing soy isoflavones 60 mg (genistin 30 mg + daidzin 30 mg) + calciumand vitamin D 3; E = R + 500 million vital spores of Lactobacillus sporogenes (E is Estromineral®, a food supplement containing soy isoflavones 60 mg, calcium 141 mg and vitamin D 3 5 μg). The design included 2 periods of 5 days of amoxicillin + clavulanate treatment with a 2-week wash-out. After each period alternatively a single dose of each formulation was given in randomised sequence. Genistein and daidzein were determined in plasma by HPLC, sampled 10 times within 24 h after dosing. Results: Genistein pharmacokinetics parameters were higher after E than after R administration: peak plasma concentration (C max) +24.3%, area under the concentration curve (AUC 0-24) +24.4% and mean residence time +11.0%. Daidzein C max and AUC showed a larger variability on R, evidenced by higher scatter from the mean on the formulation without lactobacilli. Conclusion: A trend is shown for a greater absorption of genistein from a formulation containing lactobacilli. © ECV • Editio Cantor Verlag.

Trimarco B.,University of Naples Federico II | Benvenuti C.,Rottapharm Madaus | Rozza F.,University of Naples Federico II | Cimmino C.S.,University of Naples Federico II | And 2 more authors.
Mediterranean Journal of Nutrition and Metabolism | Year: 2011

Efficacy of a new patented proprietary combination of natural nutraceuticals (PN) containing natural hypolipidemic as red yeast, policosanol and berberine was tested in a large study on dyslipidemic patients in clinical practice. A parallel, controlled, randomized, multicenter study was designed. After 2 weeks on a stable dietary regimen, the patients were randomized to PN 1 tablet/day associated with diet (PN + D) or diet alone (D) for 16 weeks. Entry criteria were: Tot-Chol >200 mg/dL or LDL-Chol >150 mg/dL without a clear indication for statins, or plasma triglycerides>150 mg/dL. Lipid pattern and CV parameters were evaluated at baseline and monthly. 1,751 patients were enrolled in 248 Italian units, 933 patients on PN + D and 818 on D. The baseline lipid values were: Tot-Chol 255.4 versus 243.1 mg/dL, LDLChol 170.1 versus 162.2 mg/dL, HDL-Chol 50.0 versus 48.8 mg/dL, and TG 190.5 versus 184.4 mg/dL. PN constantly and significantly improved lipid parameters versus D group: at 16 weeks-19.1 versus-9.4% for Tot-Chol (p<0.001),-23.5 versus-10.8% for LDLChol (p<0.001), +11.6 versus +4.0% for HDL-Chol (p<0.001),-17.9 versus-11.3% for TG (p<0.001). In conclusions, PN plus diet allows an effective improvement of blood lipids with a significant reduction of global CV risk, suggesting a role for PN in CHD prevention. © 2011 Springer-Verlag.

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