Betamethasone

Betamethasone is a synthetic corticosteroid and agonist of glucocorticoid receptor [1].

Betamethasone has shown the inflammatory response by the betamethasone-receptor complex modulated the activity of certain genes, altering the production and activity of proteins. These proteins include phospholipase A2, cyclooxygenase-2 and NO-synthase. Betamethasone has been reported to inhibit the expression of these enzymes results in reduced production of such inflammatory mediators as prostaglandins, leukotrienes and nitric oxide. In addition betamethasone has also revealed to inhibit keratinocyte proliferation [1].

References:
[1] Pharmacology Review(s)-FDA.

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021852s000_PharmR.pdf

A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP).[Pubmed:28301043]

Br J Dermatol. 2017 Jul;177(1):197-205.

BACKGROUND: Around two-thirds of patients with psoriasis do not adhere to topical treatment. The Topical Treatment Optimization Programme (TTOP), a five-element tool, includes guidance for the conversation between dermatologists/nurses and patients, patient information material, telephone/e-mail helpdesks and treatment reminders. It has been developed by patients and dermatologists to help increase adherence to treatment in psoriasis. OBJECTIVES: To compare TTOP with standard of care ('non-TTOP') within a large European investigator-initiated study, PSO-TOP (clinicaltrials.gov NCT01587755). METHODS: Patients with mild-to-moderate psoriasis received calcipotriol/Betamethasone dipropionate gel as standardized study medication and were randomized 1 : 1 to either TTOP or non-TTOP management. Study medication was applied once daily for 8 weeks followed by 'as needed' application for an additional 56 weeks. Response was defined as a Physician's Global Assessment (PGA) of 'clear' or 'almost clear'. RESULTS: In 1790 patients (full analysis set), response rates after 8 weeks (primary objective) were significantly higher for TTOP (36.3%) than for non-TTOP (31.3%, P = 0.0267). Better clinical outcome was accompanied by higher rates of patients feeling well informed about their skin condition, treatment and other factors related to adherence, but the Dermatology Life Quality Index was not statistically different. TTOP patients regarded the structured one-to-one conversations with their dermatologist/nurse as the most important element of TTOP. CONCLUSIONS: Patients randomized to the TTOP intervention had a better clinical response than patients receiving standard of care. Improved communication between the healthcare provider and patient might be an important element in increasing adherence to topical therapy in psoriasis.

Impact of a terbinafine-florfenicol-betamethasone acetate otic gel on the quality of life of dogs with acute otitis externa and their owners.[Pubmed:28295766]

Vet Dermatol. 2017 Aug;28(4):386-e90.

BACKGROUND: Treatment of canine otitis externa with owner-administered products can be difficult. OBJECTIVES: To evaluate otic treatment administered by a veterinarian on quality of life (QoL) of dogs with otitis externa and their owners, and on clinical and cytology parameters of otitis; compared to an owner-administered treatment. ANIMALS: Fifty client-owned dogs randomly randomized into two groups and treated for 2 weeks. METHODS: Veterinarians treated Group A dogs with a veterinary licensed otic gel on two occasions at a 1 week interval; owners treated Group B dogs once daily with a veterinary licensed otic drop based product along with twice weekly cleaning. Veterinarians evaluated otitis with the OTI-3 scale and semi-quantitative cytological examination on days 0, 7, 14 and 28. At each visit, owners assessed QoL with a validated questionnaire and pruritus with a Visual Analog Scale. Scores before and after treatment of each group, and differences between groups were analysed statistically. RESULTS: In both groups, all parameters improved significantly. There was a significantly higher improvement of QoL scores, for dogs and owners, in Group A, compared to Group B at all time points (P < 0.05), except for owner QoL on Day 28. There was no difference in improvement of OTI-3 between groups at any time point, whereas Group A cytology scores and pruritus improved significantly more by Day 7 (P = 0.0026 and P = 0.0294, respectively). CONCLUSION: A veterinarian-administered otic gel provided equivalent efficacy and higher QoL to dogs with otitis externa and their owners, compared to an owner-administered topical otic therapy.

Longitudinal progression of fetal short-term variation and average acceleration and deceleration capacity after antenatal maternal betamethasone application.[Pubmed:28342395]

Eur J Obstet Gynecol Reprod Biol. 2017 May;212:85-90.

OBJECTIVE: To analyze the effect of maternal Betamethasone given for fetal lung maturation on fetal short-term variation (STV) and average acceleration and deceleration capacity (AAC/ADC). Both of these factors are calculated by phase-rectified signal averaging (PRSA) and represent new parameters to assess the fetal autonomic nervous system. STUDY DESIGN: A longitudinal prospective study including 26 pregnant women at risk for preterm delivery was performed. Two injections of 12mg Betamethasone were administered intramuscularly at a 24h interval for lung maturation. Cardiotocography recordings were performed at defined time intervals: day 0 (before the first injection) and days 1, 2, 4 after the first corticosteroid administration. AAC/ADC and STV were calculated. RESULTS: An increase of all parameters (STV, AAC and ADC) was documented between day 0 and day 1. Between day 1 and day 2, all three indices were significantly reduced (p<0.05). STV declined by 19.8%, AAC by 10.1% and ADC by 14.8%. A normalization of these values was seen after 96h. CONCLUSION: Similar to STV, AAC/ADC shows significant changes after maternal Betamethasone administration. The corticosteroid-induced transient decrease of the levels needs to be taken into account in the assessment of the fetal status to avoid misinterpretation of these parameters.

Reproductive disorders in female rats after prenatal exposure to betamethasone.[Pubmed:28326570]

J Appl Toxicol. 2017 Sep;37(9):1065-1072.

Betamethasone is the drug of choice for antenatal treatment, promoting fetal lung maturation and decreasing mortality. Previous studies in rats reported male programming and alteration in sperm parameters and sexual behavior following intrauterine Betamethasone exposure. The impact on the female reproductive development is not known. In this study, rat female offspring was assessed for sexual development, morphophysiology of the reproductive tract and fertility after maternal exposure to 0.1 mg kg(-1) of Betamethasone or vehicle on gestational days 12, 13, 18 and 19. The treatment promoted reduction of litter weight on postnatal day 1, morphological masculinization in females, delay in the age of puberty onset, reduction in estrus number, increase in estrous cycle length and increase in luteinizing hormone serum levels and uterus weight. The females from the Betamethasone group showed an increase of myometrial uterine area and decrease in endometrial uterine area. These animals also performed less lordosis during the sexual behavior test and showed impaired reproductive performance. The uterus showed higher contraction in the treated group as shown by a pharmacological assay. In conclusion, prenatal Betamethasone exposure in rats promoted female masculinization, altered sexual development and reproductive parameters. Copyright (c) 2017 John Wiley & Sons, Ltd.