Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen® and Smart B® in Women with Climacteric Syndrome in Perimenopause

Article

Author: Kachko, Vera A ; Shulman, Lee P ; Burchakov, Denis I ; Kuznetsova, Irina V ; Uspenskaya, Yulia B

INTRODUCTIONPerimenopause is a time of transition in a woman's life that links her reproductive years to the cessation of ovulation, or menopause. For many women, this time is characterized by a variety of physiological and lifestyle changes, including increasing irregularity in menstrual bleeding, frequency and severity of vasomotor symptoms, etc. Therapies evaluated specifically for the perimenopausal women are very limited. This study aimed to evaluate the effectiveness and safety of Amberen^® (a succinate-based non-hormonal supplement) combined with a Smart B^® (vitamin B) complex in women with typical (without complications) mild to moderate climacteric syndrome during perimenopause.METHODSWomen up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.RESULTSA total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.CONCLUSIONThe use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life.CLINICALTRIALSGOV IDENTIFIERNCT03897738.

03 Apr 2023·Journal of Asthma

Comparison of three alternatives for the management of moderate asthma in children aged 6–11 years: a cost-utility analysis

Article

Author: Antonio Buendía, Jefferson ; Patiño, Diana Guerrero ; Lindarte, Erika Fernanda

BACKGROUNDRecent asthma guidelines for children 6-11 years with persistent asthma advocate three alternatives: SMART (budesonide/formoterol 80/4.5 mcg qd plus additional doses as needed), fixed combination of budesonide/formoterol, and fixed-dose budesonide. Concerns have arisen as to which of the proposed alternatives has the best possible cost-effectiveness profile. This study aimed to assess the health and economic consequences of SMART, fixed combination, and fixed-dose budesonide therapy in children 6-11 years old with persistent asthma.METHODSA probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with persistent asthma. Total costs and QALYs of SMART, fixed combination, and fixed-dose budesonide therapy were calculated over a time horizon of 6 years. Multiple sensitivity analyses were conducted.RESULTSThe mean QALY per patient was 0.57 and 0.56 QALYs per patient per year of SMART and fixed combination and 0,52 with fixed-dose budesonide. The total mean of discounted costs per patient per cycle were US$111 for SMART, US$133 for fixed combination, and US$67 for fixed-dose budesonide. The net monetary benefit of SMART was US$12,549, US$12278 for fixed combination, and US$11,380 for fixed-dose budesonide.CONCLUSIONOur study showed that SMART was more cost-effective than fixed combination and fixed-dose budesonide. These findings complement and support the GINA 2021 and National Asthma Education and Prevention Program asthma guideline recommendations for use of inhaled corticosteroids-formoterol in children 6-11 years old with persistent asthma.

02 Dec 2022·Journal of AsthmaQ4 · MEDICINE

SMART therapy in adolescent and adults patients with moderate persistent asthma: a cost-utility analysis

Q4 · MEDICINE

Article

Author: Patiño,, Diana Guerrero ; Buendía,, Jefferson Antonio

BACKGROUNDRecent asthma guidelines, recommends for persistent asthma as first alternative low dose inhaled budesonide-formoterol maintenance and reliever over fixed combination of low doses inhaled corticosteroids - long-acting beta-agonist, or fixed-dose inhaled corticosteroids. Concerns arise as to which of the proposed alternatives has the best possible cost-effectiveness profile. This study aimed to assess the health and economic consequences of SMART, fixed combination, and fixed-dose inhaled corticosteroids in patients with moderate-severe persistent asthma.METHODSA probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with persistent asthma. Total costs and QALYs of SMART, fixed combination, and fixed-dose inhaled corticosteroids were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000.RESULTSThe model suggests a potential gain of 1.27 and 1.34 QALYs per patient per year on SMART respect to fixed combination and fixed-dose ICS respectively. We observed a reduction of US$4 in total discounted cost per person-year on SMART with respect to fixed combination and US$0.1 respect to fixed-dose ICS. In the deterministic and probabilistic sensitivity analyses, our base-case results were robust to variations of all assumptions and parameters.CONCLUSIONSMART therapy was found to be cost-effective regarding fixed combination and fixed-dose inhaled corticosteroids. This evidence supports the use of SMART therapy in Colombia and must to be replicated in others middle-income countries.

100 Deals associated with ICT-2588

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 1	GB	Ellipses Pharma Ltd.	-
Breast Cancer	Preclinical	GB	Incanthera Research & Development Ltd.	-
Lung Cancer	Preclinical	GB	Incanthera Research & Development Ltd.	-
Ovarian Cancer	Preclinical	GB	Incanthera Research & Development Ltd.	-
Prostatic Cancer	Preclinical	GB	Incanthera Research & Development Ltd.	-

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