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PubMed1974

Steroid aerosols in asthma: an assessment of betamethasone valerate and a 12-month study of patients on maintenance treatment.

Betamethasone valerate aerosol is a new compound for the treatment of asthma. Its clinical effectiveness was established in a double-blind cross-over trial in non-steroid-dependent asthmatic patients. At a dosage of 400 to 800 mug/day for three months there was no evidence of suppression of hypothalamic-pituitary-adrenal function, as assessed by tetracosactrin and insulin stress tests.A 12-month follow-up study of 120 patients using steroid aerosols (betamethasone valerate or beclomethasone dipropionate) indicated that tolerance does not develop and that a daily maintenance dose of 200 mug/day was adequate in most patients. Temporary lack of response was observed during episodes of sputum production or of heavy exposure to antigen.There were no observed side effects other than fungal infections of the respiratory tract. However, the incidence of candidiasis of the pharynx (13%) and particularly of the larynx (5%) in apparently immunologically normal patients was disturbing. These infections were not seen in patients taking 200 mug/day. Though there is yet no evidence that fungal infections associated with steroid aerosols may penetrate the trachea and bronchi the possibility of this indicates that caution should be exercised in their use, particularly in long-term high dosage.

Adolescent↗

PubMed2005

Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial.

OBJECTIVE: To test whether steroids reduce respiratory distress in babies born by elective caesarean section at term. DESIGN: Multicentre pragmatic randomised trial. SETTING: 10 maternity units. PARTICIPANTS: 998 consenting women randomised at decision to deliver by elective caesarean section; 503 randomised to treatment group. INTERVENTIONS: The treatment group received two intramuscular doses of 12 mg betamethasone in the 48 hours before delivery. The control group received treatment as usual. OUTCOME MEASURES: The primary outcome was admission to special care baby unit with respiratory distress. Secondary outcomes were severity of respiratory distress and level of care in response. RESULTS: Sex, birth weight, and gestation were not different between the two groups. Of the 35 babies admitted to special baby units with respiratory distress, 24 were in the control group and 11 in the intervention group (P = 0.02). The incidence of admission with respiratory distress was 0.051 in the control group and 0.024 in the treatment group (relative risk 0.46, 95% confidence interval 0.23 to 0.93). The incidence of transient tachypnoea of the newborn was 0.040 in the control group and 0.021 in the treatment group (0.54, 0.26 to 1.12). The incidence of respiratory distress syndrome was 0.011 in the control group and 0.002 in the treatment group (0.21, 0.03 to 1.32). CONCLUSIONS: Antenatal betamethasone and delaying delivery until 39 weeks both reduce admissions to special care baby units with respiratory distress after elective caesarean section at term.

Betamethasone↗

PubMed1997

Preterm newborn lamb renal and cardiovascular responses after fetal or maternal antenatal betamethasone.

The optimal dose, route of administration, and treatment-to-delivery interval necessary to induce beneficial extrapulmonary effects of glucocorticoids are not known. Pregnant ewes (127 days gestation) were randomized to receive maternal or fetal intramuscular injections of betamethasone (0.2 or 0.5 mg/kg body wt) or saline 24 h before cesarean delivery of their lambs. Three hours after delivery, low-dose maternal vs. control lamb mean arterial pressure [64 +/- 4 vs. 47 +/- 2 (SE) mmHg], glomerular filtration rate (1.7 +/- 0.2 vs. 0.7 +/- 0.1 ml.min-1.kg-1), and total renal sodium reabsorption (219 +/- 31 vs. 85 +/- 12 mueq.min-1.kg-1) were increased. Comparable increases were observed in the high-dose maternal and fetal groups without effects in the low-dose fetal group. This study provides the first quantitative data demonstrating that even short-term (24-h) antenatal betamethasone exposure alters preterm newborn cardiovascular and renal functions. These responses are route and dose dependent and are comparable to glucocorticoid-induced maturational effects after longer-term antenatal exposure.

Administration, Topical↗

PubMedDate not supplied

Differential modulation of transforming growth factor-beta by betamethasone-17- valerate and isotretinoin: corticosteroid decreases and isotretinoin increases the level of transforming growth factor-beta in suction blister fluid.

Retinoids and glucocorticoids are known to have a potential to modulate the expression of transforming growth factor-beta (TGF-beta). We investigated the effect of oral isotretinoin (13-cis-retinoic acid) on the expression of two distinct isoforms of TGF-beta, TGF-beta1 and TGF-beta2, in suction blister fluid and serum in acne patients. We also investigated the effect of topical glucocorticoid (betamethasone-17-valerate) and age on suction blister fluid TGF-beta1 in healthy volunteers. Six weeks of isotretinoin treatment caused a statistically significant 19% increase in suction blister fluid TGF-beta1. The suction blister fluid TGF-beta2 level remained below the sensitivity level of the immunoassay in many cases. Isotretinoin did not affect the serum TGF-beta1 or TGF-beta2 level. Betamethasone-17-valerate pretreatment for 3 days twice a day caused a statistically significant 17% decrease in suction blister fluid TGF-beta1. The active form of TGF-beta1 represented 5% of the total TGF-beta1 in suction blister fluid. Our diffusion calculations suggest that all TGF-beta1 and TGF-beta2 detected in suction blister fluid have diffused from systemic circulation. The increase in suction blister fluid TGF-beta1 after isotretinoin treatment seems to be of local origin, while the decrease in suction blister fluid TGF-beta1 after glucocorticoid pretreatment seems to be due to glucocorticoid-induced vasoconstriction resulting in decreased diffusion of TGF-beta1 from the circulation. Modulation of local interstitial fluid TGF-beta1 concentration may be one mechanism by which isotretinoin and glucocorticoids mediate their effects in skin.

Acne Vulgaris↗

PubMed2001

Effect of betamethasone on computerized cardiotocographic parameters in preterm growth-restricted fetuses with and without cerebral vasodilation.

OBJECTIVE: To verify the effects of maternal corticosteroid administration on fetal behavior and heart rate variation using computerized cardiotocography (cCTG) in a selected group of growth retarded fetuses. STUDY DESIGN: Fifty singleton pregnancies complicated by fetal growth restriction were enrolled in the study before 34 weeks of gestation. All of them received two intramuscular injections of 12 mg of betamethasone 24 h apart. Fetal heart rate was recorded by cCTG before the first injection, and every 24 h for the 3 days following the end of the treatment. After Doppler evaluation of cerebral circulation, fetuses were divided into a group with and a group without signs of cerebral vasodilation. Basal heart rate, short- and long-term variation, percentage of time spent in high variability, fetal movements and percentage of small accelerations were evaluated. RESULTS: Basal fetal heart rate did not show significant changes. Short-term variation and percentage of time spent in high variability significantly decreased in fetuses with but not in fetuses without vasodilation. Long-term variation and fetal movements significantly decreased in both groups. CONCLUSIONS: Maternal administration of betamethasone in growth-retarded fetuses with cerebral vasodilation is associated with significant but transitory modifications of fetal heart rate variation.

Betamethasone↗

PubMed2002

A case of cutaneous delayed-type allergy to oral dexamethasone and to betamethasone.

Corticosteroids are drugs that may cause allergic contact dermatitis, but systemic allergic reactions to these drugs are rare. A 29-year-old man developed a maculopapular rash during an oral therapy with betamethasone. Patch tests demonstrated a delayed-type allergy to dexamethasone, betamethasone and fluocortolone. Oral, intramuscular or topical provocation tests with other corticosteroids - deflazacort, hydrocortisone, methylprednisolone, fluticasone dipropionate, triamcinolone and prednisone - were all negative. This demonstrates that a patient with a systemic allergy to a group of corticosteroids can tolerate those of other groups.

Administration, Oral↗

PubMed2003

The atrophogenic potential and dermal tolerance of calcipotriol/betamethasone dipropionate ointment compared with betamethasone dipropionate ointment.

BACKGROUND: Recently, a combination product (Daivobet) ointment: calcipotriol 50 micro g/g, betamethasone dipropionate 0.5 mg/g) has been developed for the treatment of psoriasis. OBJECTIVE: This study aimed to demonstrate that the atrophogenic potential of Daivobet is less or equal to the skin thinning produced by Diprosone (betamethasone dipropionate 0.05 mg/g). METHODS: The forearms of 45 subjects were treated with Daivobet and Diprosone or Daivobet and its vehicle twice daily over a 4-week period. Sonographic measurements for full skin thickness, clinical assessments and biopsies were carried out. RESULTS: A confidence interval approach was used to establish that skin thinning following treatment with Daivobet was equal to or less than thinning with Diprosone. Histological results did not suggest differences between Daivobet and Diprosone. Clinical signs of atrophy or irritation were not observed. CONCLUSIONS: The atrophogenic potential of Daivobet and Diprosone was similar following twice daily application over a 4-week treatment period. Skin irritation was not observed.

Adult↗

PubMedDate not supplied

Effect of betamethasone administration on fetal heart rate tracing: a blinded longitudinal study.

OBJECTIVE: Computerized fetal heart rate (FHR) analysis revealed that antenatal corticosteroids transiently suppress multiple parameters of fetal well-being, potentially leading to the erroneous diagnosis of fetal distress and to unnecessary iatrogenic delivery of premature infants. Our aim was to determine whether clinicians who visually analyze FHR tracings detect these suppressive effects, thereby potentially affecting their clinical management decisions. METHODS: Singleton pregnancies admitted for preterm labor between 26 and 34 weeks' gestation received two doses of betamethasone, 24 h apart, and were monitored daily between 16:00 and 19:00 h for 5 days. FHR tracings were randomly coded and presented in a non-consecutive order to four clinicians, who were unaware of the time of steroid administration. FHR baseline, FHR variability, number of accelerations and amplitude of maximal FHR acceleration were determined. Variability was scored semiquantitatively based on a modified Hon score. Analysis of variance (ANOVA) with repeated measures was used for primary analysis and followed up with the Wald test of significance. Corrections for multiple comparisons were made and only p < 0.005 considered significant. ANOVA was also used to assess the uniformity of trend in the interpretation by the four examiners for each given day. RESULTS: Baseline FHR was elevated, FHR variability was decreased, and the number of accelerations decreased on day 1 (p < 0.0001; p < 0.0001; p < 0.0001) and day 2 (p > 0.0001; p < 0.0001; p < 0.0001) in comparison to day 0. On day 3, the FHR baseline, variability and number of accelerations returned to pre-exposure values (p = NS). The maximal amplitude of FHR accelerations showed a trend towards reduction (p = 0.08). Subgroup analysis by gestational age (group I = 26-30 weeks and group II = 30-34 weeks) showed the same response patterns and significance levels for both groups. CONCLUSIONS: Betamethasone causes profound, but transient, suppression of FHR parameters, which can mimic fetal distress. This effect is clinically recognized by visual FHR analysis. Clinicians need to be aware of this phenomenon, in order to avoid unwarranted iatrogenic delivery.

Anti-Inflammatory Agents↗

PubMed1976

An evaluation of betamethasone dipropionate (Diprosone) versus Locacorten 0.02% cream.

A double-blind randomized evaluation of betamethasone dipropionate cream (Diprosone) compared with Locacorten 0.02% cream flumethason privalate in 60 patients over 3 consecutive weeks showed the betamethasone dipropionate cream to be significantly more effective in the treatment of psoriasis and other steroid-responsive dermatoses.

Administration, Topical↗

PubMedDate not supplied

Cardiovascular and pulmonary effects of betamethasone during midtrimester on fetal rats.

In order to elucidate the effects of corticosteroids on fetal hearts during midtrimester, pregnant rats were injected with a daily dose of betamethasone (1 mg/kg) from the 12th day through the 17th day of pregnancy. The fetal cardiovascular and pulmonary systems were studied on the 21st day of pregnancy (term). The treated fetuses showed the following signs of hydrops fetalis: retarded growth, pale, edematous skin, and decreased movement. The thymus and lung displayed prominent hypoplasia. The morphometry of the treated fetuses revealed: decreased right ventricle mass by 37% and decreased left ventricle mass by 29%. We concluded betamethasone had a significant effect on the developing fetal cardiovascular system, inducing hydrops fetalis. Additionally, beta-methasone caused hypoplasia of the thymus and lung.

Animals↗

PubMedDate not supplied

Combined effect of terbutaline and betamethasone on glucose homeostasis in preterm labor.

The short- and long-term effects of simultaneous administration of terbutaline and betamethasone were investigated in 8 gravidas treated for preterm labor. Their plasma concentrations of glucose, insulin, glucagon, C-peptide, lactate and potassium were compared to a control group receiving intravenous magnesium sulfate and betamethasone. The patients on terbutaline therapy had a marked hyperglycemia at 11 h which remained elevated for 48 h. There was a simultaneous rise in plasma insulin and C-peptide, and a fall in plasma glucagon. Lactate levels were markedly elevated. Only 1 of the 8 patients had an abnormal glucose tolerance test at 1 week of therapy. The metabolic changes of control patients were minimal in comparison and there was no lacticacidemia. This suggests that glucocorticoids potentiate the hyperglycemic response of terbutaline.

Adult↗

PubMed1994

Betamethasone and intrauterine fetal death.

Three cases of intrauterine fetal death occurring shortly (within 24 h) after betamethasone administration are described. Two of the women were diabetic, and the third had secondary infertility due to hyperprolactinemia. None of the stillborns had evidence of gross malformations. In view of the fact that infants born prematurely now have a better chance of survival in intensive-care units than in previous years, we believe that for certain high-risk mothers, the policy of betamethasone administration for preventing respiratory distress syndrome in premature babies must be revised.

Adult↗

PubMed1992

Betamethasone-induced lecithin release in vitro from the fetal membranes.

Lecithin release from fetal membranes and placental tissue was assayed in basal conditions as well as under betamethasone administration. In the absence of the steroid, amnion and chorion released lecithin as a function of incubation time. Both tissues responded to betamethasone by increasing the lecithin release, the amnion exhibited a higher basal level and a greater responsiveness to the hormone than the chorion. Basal lecithin release from placental tissue was unaffected by any steroid concentration.

Amnion↗

PubMed2000

Pulmonary interstitial emphysema 24 hours after antenatal betamethasone treatment in preterm sheep.

During a series of studies investigating the maturational response to antenatal glucocorticoids, we observed that 70% of lambs delivered at 128 d gestation (term = 150 d), 24 h after a single injection of 0.5 mg/kg betamethasone or betamethasone + L-thyroxine (15 microgram/kg), developed pulmonary interstitial emphysema (PIE), compared with less than 5% of control animals or animals delivered 48 h or 7 d after hormone treatment. This study examined whether the lungs of animals that developed PIE were functionally or structurally different from those that did not. Lambs were mechanically ventilated for 40 min after cesarean section delivery. Hormone-treated animals with PIE were ventilated at similar peak inspiratory pressure (PIP) to control animals, whereas those without PIE were able to be ventilated at significantly lower PIP. Volume-dependent elastance (E2V), which provides an index of overdistension during mechanical ventilation, was lowest in PIE animals. Alveolar architecture was distorted in almost all ventilated animals, the most severe distortion occurring in PIE animals. There was no evidence of excessive alveolar wall thinning in PIE animals, although parenchymal collagen was 30% lower, and elastin 120% higher than in control animals. PIE was associated with structural differences, but not with overventilation.

Animals↗

PubMed1990

Anaphylactic challenge causes eosinophil accumulation in bronchoalveolar lavage fluid of guinea pigs. Modulation by betamethasone, phenidone, indomethacin, WEB 2086, and a novel antiallergy agent, SCH 37224.

Eosinophil infiltration into bronchoalveolar areas of the lung has been assessed in guinea pigs sensitized to ovalbumin (OA) and then challenged with the aerosolized antigen. Cell content, histamine, and guinea pig albumin (GPA) have been measured in bronchoalveolar lavage (BAL) fluid from these animals. Extensive eosinophil accumulation resulted from sensitization followed by OA challenge; monocytes that initially accounted for greater than 80% of the BAL cells remained essentially constant, and neutrophils comprised less than 3% of the population throughout. Eosinophils were elevated at 3 h, peaked with a fivefold increase at 24 h, and remained elevated for at least 7 days. Histopathologic changes observed in lungs taken from sensitized guinea pigs 24 h after OA challenge confirm this eosinophilia. Increased histamine and GPA were detected only at 5 min. Oral treatment with betamethasone (ED50 = 0.4 mg/kg), phenidone (ED50 = 15 mg/kg), Sch 37224 (ED50 = 0.5 mg/kg), and WEB 2086 (ED50 = 4 mg/kg) decreased eosinophil accumulation in the BAL fluid, indicating roles for 5-lipoxygenase products and PAF in this multimediator-dependent model of allergic inflammation. On the other hand, 4 mg/kg of indomethacin increased total cells with no effect on eosinophils, precluding a major role for cyclooxygenase products. Sch 37224, an antileukotriene agent and an orally active novel antiallergy agent in sheep, guinea pigs, and humans, is as potent as betamethasone at blocking eosinophil infiltration, suggesting that it may also suppress human pulmonary inflammation.

Albumins↗

PubMed1982

Influence of betamethasone on the development of mechanical properties in the fetal rhesus monkey lung.

Previous investigations of the effect of glucocorticoids on fetal lung development have suggested that changes in lung structural properties may be of greater functional significance than changes in lung surfactant. In this study we examined the mechanism of the glucocorticoid-induced change in lung structure and compared it with the changes that occur during normal development. Rhesus monkeys (Macaca Mulatta) were treated with betamethasone prior to 133 days gestational age and then delivered by cesarian section either at 133 days or near term at 160 days. Our results show that normal fetal lung development over the last month of gestation occurs with a 45% increase in lung dry weight and a 56% increase in the maximal air volume per gram lung (Vmax/g). The immediate effect of the steroid was to cause a similar percentage increase in Vmax/g but no increase in lung weight. In fact, there were significant decreases in lung weight at both 133 and 160 days in the treated animals. In addition, we found no significant changes in the mean alveolar size either with normal development or with the steroid treatment. We thus conclude that in the rhesus monkey, the lung maturation process involves both an increase in lung mass and an increase in the number of alveoli per gram of that mass. The betamethasone treatment results in accelerated recruitment of alveoli coupled with impaired growth of lung tissue.

Animals↗

PubMed2003

Biodegradable intrascleral implant for sustained intraocular delivery of betamethasone phosphate.

PURPOSE: To evaluate the feasibility of using a biodegradable intrascleral implant for intraocular sustained delivery of betamethasone phosphate (BP). METHODS: The intrascleral implant (0.5 mm thick and 4 mm in diameter) was made of poly(DL-lactide) containing 25% betamethasone phosphate. The in vitro release of BP from the implant was evaluated by high-performance liquid chromatography (HPLC). The implants were placed into a scleral pocket in the rabbit's eye. The concentrations of BP in the aqueous humor, vitreous, and retina-choroid were measured by HPLC. The toxicity and biocompatibility of the implant were evaluated by slit lamp examination, electroretinography, and light microscopy. RESULTS: In vitro studies demonstrated that the implants released BP in a biphasic pattern for at least 8 weeks. The BP concentrations in the vitreous and the retina-choroid remained within the concentration range capable of suppressing inflammatory responses for more than 8 weeks. The BP concentration was greater in the retina-choroid than in the vitreous. In the aqueous humor, BP was below the detection limit during the observation period. No significant toxicity to the retina was observed. Also, the implant showed good biocompatibility in the eye. CONCLUSIONS: These results suggest that the intrascleral implant would be a promising system for delivery of steroid to the posterior segment of the eye.

Absorbable Implants↗

PubMed1979

A double-blind controlled trial of betamethasone dipropionate 0.05% (Diproderm) in comparison with fluocinolone acetonide 0.025% (Synalar) in psoriasis and other steroid-responsive dermatoses.

In a double-blind randomized study, sixty-two patients suffering from psoriasis or eczema were treated, twice daily for three weeks, either with 0.05% betamethasone 17, 21-dipropionate cream or with 0.025% fluocinolone acetonide cream. The results showed that both topical corticosteroid preparations were effective, well tolerated and cosmetically acceptable. Fifty-seven per cent of the patients treated with betamethasone dipropionate were rated as being 'much better' in the overall assessment of response at the end of the trial period compared to only 25% of those in the fluocinolone acetonide group.

Adolescent↗