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Scalp psoriasis: topical calcipotriol 50 micrograms/g/ml solution vs. betamethasone valerate 1% lotion.

Forty-two patients aged between 6 and 61 years (mean: 33.5 years) with psoriasis of the scalp were enrolled in this study. Twenty-seven patients (69%) were males and 15 (31%) were females. The aim of our study was to evaluate the efficacy, safety and tolerability of topical calcipotriol 50 micrograms/g/ml solution vs. betamethasone valerate 1% lotion in the treatment of psoriasis of the scalp. The study was randomized with the twice-daily application of either calcipotriol solution or betamethasone valerate lotion for 6 weeks. Treatment evaluation was clinically based on signs of psoriasis (thickness, redness, scaliness) which were scored from 0 = absent to 4 = severest possible involvement and was performed at the start of treatment and at weeks 2 and 6 of treatment. The results showed a marked improvement and clearance at the end of treatment in 15 (72.8%) of the 24 patients in the calcipotriol group and in 13 of the 18 patients (72%) in the betamethasone group. The mean total sign score at baseline was 5.1 in the calcipotriol group and 5.4 in the betamethasone valerate group. At the end of treatment, this score was decreased to 2.1 and 1.49, respectively. No significant adverse effects were reported in either group except in two patients (8.3%) in the calcipotriol group who developed signs of irritation including itching and erythema. In conclusion, both drugs were effective and well tolerated in the treatment of scalp psoriasis but in some patients calcipotriol had to be given for more prolonged courses.

Administration, Topical↗

Controlled, open, randomized multicenter trial comparing the effects of treatment on quality of life, safety and efficacy of budesonide foam and betamethasone enemas in patients with active distal ulcerative colitis.

BACKGROUND/AIMS: There is evidence of a higher quality of life with foams as compared with enemas. The purpose of this study was to assess the effect of treatment with budesonide foam or betamethasone enema on the quality of life and the clinical outcome in patients with distal ulcerative colitis. METHODOLOGY: In an open multicenter trial, patients with active distal ulcerative colitis were randomized to receive 2 mg/50 mL budesonide foam or 5 mg/100 mL betamethasone enema. Primary outcome variable was the change in the mean Life Quality Index. Therapeutic efficacy was determined by clinical activity, endoscopical and histological indices. RESULTS: 38 patients were included in the study. The decrease of the mean Life Quality Index was more pronounced in the budesonide group. No significant difference in the efficacy of treatment was observed for both groups. Betamethasone suppressed the plasma cortisol level in the majority of the patients (87%) compared to only 22% of the patients receiving budesonide. CONCLUSIONS: The quality of life is not significantly different in patients during treatment with budesonide foam or betamethasone enema for active distal ulcerative colitis. However, while having comparable clinical efficacy budesonide foam has less effect on the plasma cortisol level thus potentially minimizing steroid side effects.

Administration, Rectal↗

Comparison of the effects of nebulized terbutaline with or without intravenous betamethasone on exhaled nitric oxide in children with acute asthma attack.

BACKGROUND AND PURPOSE: Exhaled nitric oxide (eNO), a non-invasive marker that reflects the degree of airway inflammation, may be useful for assessing the response to anti-inflammatory treatment of asthma. The purpose of this randomized prospective study was to compare the effect of a nebulized terbutaline plus a single intravenous dose of betamethasone at baseline followed by a second of terbutaline at 6 h with the effect of the same protocol of nebulized terbutaline alone on airway inflammation of acute asthmatic children as demonstrated by eNO levels. METHODS: Children visiting the emergency department due to acute asthma attack were recruited. All enrolled patients had fluorescent assay-proven hypersensitivity to Dermatophagoides pteronyssinus. Patients were randomized to receive either nebulized terbutaline plus intravenous betamethasone (experimental group, n = 11) or nebulized terbutaline alone (control group, n = 11) at baseline followed by a second dose of nebulized terbutaline alone 6 h later. RESULTS: Exhaled NO concentrations were significantly reduced in the experimental group at 7 h (40.25 +/- 12.43 vs 28.88 +/- 18.02 ppb; p = 0.005) and 12 h (40.25 +/- 12.43 vs 30.11 +/- 18.16 ppb; p = 0.007) after treatment. The eNO level in the experimental group was also reduced at 7 h (28.88 +/- 18.02 vs 38.12 +/- 16.50 ppb; p = 0.034) and 12 h (30.11 +/- 18.16 vs 39.36 +/- 17.63 ppb; p = 0.035) compared to the control group. The change of eNO concentration was correlated to the change of peak expiratory flow rate (PEFR) [r = -0.678; p = 0.022] and pulmonary index scores (r = 0.606; p = 0.048) at 7 h after treatment in the betamethasone group. CONCLUSION: Nebulized terbutaline given at baseline and 6 h later was significantly more effective in improving PEFR and asthmatic symptoms (pulmonary index scores) for at least 12 h when the initial dose was administered in combination with intravenous betamethasone.

Acute Disease↗

Neonatal outcomes with different betamethasone dosing regimens: a comparison.

OBJECTIVE: To determine any differences in neonatal outcomes when dosing betamethasone every 12 hours vs. 24 hoursfor anticipated preterm delivery. STUDY DESIGN: A retrospective review of births at <36 weeks' gestation from January 1, 1996, to July 1, January 1, 1996, to July 1, 2000. Maternal and neonatal charts were reviewed. The deliveries were separated into 3 groups: those not receiving antenatal corticosteroids, those who received betamethasone 12 hours apart and those who received 24-hour dosing. Demographic, obstetric and neonatal variables were compared between the groups. RESULTS: There were 909 deliveries analyzed. With the 2 betamethasone groups, a significant difference was found for more maternal antibiotic use (90.4% vs. 83.6%, p=0.03), venous cord blood gas pH (7.31 vs. 7.32, p=0.04) and neonatal surfactant use (39.8% vs. 25.5%, p = 0.001) in the 12-hour group as compared to the 24-hour group. For all other outcomes there was no difference. CONCLUSION: Outcomes using a 12-hour dosing schedule of betamethasone were similar to those using a 24-hour regimen in this retrospective review. Twelvehour dosing could be considered an alternative way to deliver antenatal corticosteroids.

Adult↗

[A case of asthma exacerbated by sulfite contained in betamethasone].

Adverse reactions to preservatives contained in food and medications have been recognized with increasing frequency. We have recently seen an asthmatic patient in whom wheezing and dyspnea increased after injection of betamethasone. The patient was a 26-year-old woman who had had bronchial asthma since 1980. She was treated at another hospital for moderate wheezing and betamethasone injections were given in May 1988. After this treatment her condition deteriorated acutely and she was transferred to our hospital. To confirm the possible relationship between betamethasone (sulfite) and asthmatic attack, provocation challenge tests were conducted. Intradermal skin test revealed an immediate positive reaction to sodium bisulfite at a concentration of 100 mg/L. Challenge test with increasing amounts of sodium bisulfite showed a 52% decrease in FEV1, 50 min after inhalation of 5 mg/ml solution. In addition, another inhalation challenge was conducted by use of an Astograph. Rrs immediately increased during inhalation of 10 mg/ml solution. These results suggested that sulfite contained in betamethasone preparation provoked exaggerated bronchospasm in this patient.

Adult↗

[Ambroxol versus betamethasone for the promotion of antepartum lung maturity in pathological pregnancies].

Although glucocorticoids have been universally implemented to stimulate fetal lung maturity, their effectiveness and side effects are still widely contested. In search of alternative drugs a double-blind study was conducted between June 1981 and June 1984 comparing betamethasone, a conventional corticoid, and ambroxol, a bromhexine metabolite for efficacy and tolerance in prenatal prevention of the respiratory distress syndrome (RDS) in premature infants and full-term neonates. The therapeutic efficacies of betamethasone and ambroxol for this indication proved to be comparable. Since the possible risks of corticoid therapy in abnormal pregnancies are repeatedly discussed in the literature and in daily clinical practice. 137 patients with EPH gestosis, placental insufficiency, diabetes mellitus, and premature rupture of the membranes were selected from the original group of 308 patients. Only minor side effects (e.g. nausea) were present in a few of the 137 cases undergoing treatment with the 2 test substances. No side effects were observed in the neonates. The incidence of fetal RDS was comparable in both groups (2.9% with ambroxol, 2.2% with betamethasone). Transient and mild RDS cases were slightly more frequent in the ambroxol group than in the betamethasone group. To date, contraindications to ambroxol treatment in abnormal pregnancies are unknown and since generally the rate of potential side effects is considered to be lower in comparison with corticoid treatment, the use of ambroxol especially in abnormal pregnancies corresponding indication can be recommended.

Ambroxol↗

Glucose intolerance after short-term administration of corticosteroids in healthy subjects. Prednisone, deflazacort, and betamethasone.

Glucocorticoid-induced glucose intolerance has been related to the dose, duration of treatment, and steroid compound. However, a clear demonstration of this phenomenon is still lacking for fluorinated corticosteroids. We performed an oral glucose tolerance test in six healthy volunteers after the short-term administration of deflazacort (18 + 18 mg), prednisone (15 + 15 mg), and betamethasone disodium phosphate (1.5 + 1.5 mg) at equivalent anti-inflammatory doses, in random sequence, and in a triple crossover design. Fasting plasma glucose levels were not modified by deflazacort, whereas fasting plasma glucose levels together with insulin and C-peptide values were progressively and significantly increased by prednisone and betamethasone. During oral glucose tolerance testing a significant increase in the plasma glucose and insulin peaks was recorded after betamethasone and, to a lesser extent, after prednisone and deflazacort. These results suggest that betamethasone induces greater glucose intolerance and insulin resistance than prednisone and deflazacort.

Adult↗

[Comparison of the effect of Lasolvan and betamethasone on lung maturity of fetal rabbits].

8 rabbits received Lasolvan i.v. on day 25, 26 and 27 of pregnancy. 8 rabbits received betamethasone i.m. on 26th and 27th day of pregnancy. The control group received 0.9% NaCl. On day 28 of pregnancy the caesarean section was carried out, the newborn rabbits killed after 45 minutes. In their lungs the lecithin contents was significantly higher in the Lasolvan group than in the betamethasone group and control group, but in the betamethasone group not significantly higher than in the control group. Betamethasone caused in the fetuses the lowering of the body weight, of the wet weight of lungs, of the dry weight lungs and the increase of the pulmonary fluid contents. Lasolvan had no such undiserable effect.

Ambroxol↗

[Influence of betamethasone on the vascular resistance in human placenta perfused in vitro].

The study was carried out on 48 human placentas perfused in vitro. Betamethasone was administered into the arterial system in the following single doses: 0.4 mg, 2 mg, 10 mg. It was found that betamethasone decreases the pressure of perfusion in different ways depending on the dose. A statistically significant decrease in perfusion pressure was observed in 30th minute of the experiment after administering 2 mg while a dose of 10 mg induced a significant perfusion pressure in 30th and 60th minute of the experiment. The relaxation of the blood vessels of the placenta under the influence of betamethasone was attributed to the action of dopamine on the dopaminergic receptors of the vessels and glucocorticoids modifying this action. The results of the experiments point to a positive action of betamethasone on the blood vessels of human placenta.

Betamethasone↗

Delayed-type hypersensitivity responses in mice treated with pertussis toxin and betamethasone.

Effects of pertussis toxin (PT) and betamethasone on delayed-type hypersensitivity (DTH) in mice were studied. When mice received PT (1 microgram/mouse) at the time of immunization or elicitation, a depression of DTH responses was observed. In addition, when mice received PT five days before and at the time of immunization, the DTH responses were suppressed. The administration of betamethasone along with PT at the time of immunization and elicitation caused an inhibition of DTH responses. These results suggest that PT depressed the DTH responses and that betamethasone suppressed such responses. Based on these findings, possible mechanisms by which PT and betamethasone affect DTH are discussed.

Animals↗

[Ambroxol versus betamethasone for stimulating antepartal lung maturity--a multicenter study].

In a multicenter, randomized double-blind study, the effect of Betamethasone and Ambroxol, both used for prenatal prevention of RDS in premature and newborn infants, is compared in a total of 185 patients with premature labour or an induced termination of pregnancy between the 28 and 36th week of gestation. The Ambroxol group of 93 patients is reduced to 77 due to a break up of therapy in 16 patients. The Betamethasone group is likewise reduced from 92 to 85 due to a break up of therapy in 7 patients. The main reason for breaking up therapy in these patients is the impossibility of stopping labour and delivery within 72 hours after admission to the hospital. Both treatment groups show no significant differences with regard to age, weight, history, rate of premature rupture of membranes, gestational age at beginning of therapy and at time of delivery, mode of delivery, rate of tocolytic therapy and prematurity. RDS morbidity, established by a standardized evaluation of the infants considering X-ray, clinical and blood-gas analyses findings, is 9% (7 out of 79 infants) in the Ambroxol group, and 6% (5 out of 86 infants) in the Betamethasone group. Statistically seen, the difference between the two groups is insignificant. Amniotic fluid analyses carried out in a total of 46 patients of both groups show increased surfactant parameters after therapy as compared to initial values before therapy. A significant difference between the two groups is not manifest. The objections against corticosteroids regarding there indications and side effects are generally known. The results of this study indicate that Ambroxol compared to Betamethasone can be considered as an effective drug for prevention of neonatal respiratory distress syndrome.

Ambroxol↗

Stability of betamethasone sodium phosphate, hydrocortisone sodium phosphate, and prednisolone sodium phosphate injections submitted by U.S. hospitals.

The stability of betamethasone sodium phosphate, hydrocortisone sodium phosphate, and prednisolone sodium phosphate, injections stored in hospital pharmacies across the United States was studied. Through a voluntary drug stability program, FDA selected 58 samples (representing two manufacturers) from pharmacies representing a cross section of the country. The samples were analyzed for strength, identification, pH, and related impurities. All of the hydrocortisone sodium phosphate and prednisolone sodium phosphate samples met USP requirements for strength and pH. Assays of the betamethasone sodium phosphate injection samples yielded results that were in compliance with the manufacturer's strength and pH limits; there are no USP requirements for betamethasone sodium phosphate injection. All samples were within USP limits for related free steroids. Betamethasone sodium phosphate, hydrocortisone sodium phosphate, and prednisolone sodium phosphate injections obtained from hospital pharmacies appear to be stable after storage under actual marketplace conditions.

Betamethasone↗

Polymorphonuclear leucocytes functions from premature infants after prevention of respiratory distress syndrome with betamethasone and ambroxol.

An increase in the infection rate both in mother and newborn after antenatal administration of corticosteroids for prevention of RDS has been shown. The aim of this study was to compare PMN functions in two groups of premature infants whose mothers had received betamethasone or ambroxol for prevention of RDS. Blood samples were collected within the first four days of life from 40 newborns. Thirteen infants received antenatal administration of 6 mg of betamethasone acetate and 6 mg sodium phosphate i.m., which was repeated 24 hours later. Twelve received antenatal administration of ambroxol, 1 g i.v. every day for 5 days. Fifteen did not receive any antenatal treatment. Mean gestational age and mean birth weight was not significantly different between the betamethasone group (33 +/- 3.1 weeks and 2080 +/- 567 g) and the ambroxol group (32.9 +/- 3.4 weeks and 2164 +/- 793 g). Phagocytosis and killing ability was significantly lower in the betamethasone group in comparison to the ambroxol group (21.3% +/- 2.2 rather than 48.4% +/- 15; p 0.01 and 11.4% +/- 1.7 rather than 20.5% +/- 6.1; p 0.01 respectively). Immunoglobulin or complement levels were not significantly different in the three groups.

Ambroxol↗

Prenatal starvation, betamethasone and lung development in newborn rats.

This study examined the potential benefit of simultaneous transplacental betamethasone, which accelerates fetal lung maturation. Pregnant rats were placed in one of 4 groups: Control (C), fed ad libitum until term and given daily physiological saline injections from day 15 of gestation until term; Betamethasone (B), fed as group C but given daily physiological saline injections of 2.0 mg betamethasone/kg body weight from day 15 until term; Starved (S), given 50% rations from day 15 until term and injected as group C; Starved+Betamethasone (SB), fed as group S and injected as group B. Controls and group B did not differ in body or lung weight, protein or DNA, but group B lungs contained more lavageable and tissue surfactant. The S neonates weighed about 40% less than controls, with a proportional reduction in lung weight, DNA, protein or lavage and tissue phospholipids. Betamethasone may alleviate the impact of starvation on the developing lung by accelerating the process of alveolarization which was solved by caloric deprivation.

Animals↗

Neonatal cushingoid syndrome resulting from serial courses of antenatal betamethasone.

BACKGROUND: Antenatal steroid therapy has been shown to induce accelerated pulmonary maturation in preterm fetuses when delivery is imminent. Although this form of therapy has been used for 20 years, few studies or case reports have discussed the indications for or complications of retreatment, especially when more than two courses of steroids have already been given. We report a case of neonatal cushingoid syndrome with hypothalamic-pituitary-adrenal axis suppression following maternal treatment with seven courses of betamethasone. CASE: A 31-year-old white woman, gravida 3, para 1, spontaneous abortion 1, presented with a single intrauterine pregnancy at 24 weeks' gestation, a bulging amniotic sac, and repeated cerclage failure. Antenatal betamethasone therapy was begun at 12.5 mg intramuscularly every 12 hours for two doses. Because of cervical dilatation, bulging membranes, and intermittent contractions, the expectation of imminent premature delivery did not diminish over the next 42 days. As the effect of antenatal steroids wanes after 7 days, a course of therapy was administered each week for as long as the threat of preterm delivery remained. Seven courses of betamethasone were given before delivery at 34.5 weeks post-conception age. The 2625-g male neonate appeared cushingoid on physical examination, with basal serum cortisol levels less than 3.3 micrograms/dL. CONCLUSION: Physical findings of the neonate and laboratory investigation of both infant and mother suggested combined hypothalamic-pituitary-adrenal axis suppression. The cushingoid features of the infant demonstrate an undesired and previously unreported complication of an effective antenatal therapy. The unusual variant in this case was that the initial indication for steroid therapy (risk of premature delivery) persisted for 8 weeks after the first dose of betamethasone. It remains unknown how many weekly antenatal steroid courses can be administered before marked fetal adrenal suppression becomes evident. Risk-benefit ratios should be carefully considered before each retreatment.

Adult↗

[Clinical and pharmacologic aspects of various betamethasone crystalline suspensions].

The commercially available betamethasone suspensions for injection used in this study have clearly shown quantitative differences in the combination of their easily hydrosoluble betamethasone esters and those difficult to dissolve in water, as well as in the shapes and sizes of their crystals. With regard to their influence on the endogenous cortisol production the two preparations have shown a highly deviating pharmaco-dynamic duration of action-corresponding to their different galenic composition (betamethasone phosphate/acetate approx. 7-8 days; betamethasone phosphate/dipropionate approx. 16-18 days). During the phase of suppression the reduced endogenous cortisol is largely compensated by the pharmaco-dynamic activity of the exogenous steroid.

Adolescent↗

Betamethasone valerate ointment compared with fluocinonide FAPG.

Betamethasone 0.1% as valerate in an ointment base and fluocinonide 0.05% in a fatty alcohol propylene glycol (FAPG) base have been compared in a double-blind trial of 76 patients with either eczema or psoriasis. The results show betamethasone valerate ointment to be significantly (P less than.05) superior to fluocinonide FAPG in the treatment of both these skin conditions. In the light of publications from other studies on betamethasone valerate cream this trial indicates that the ointment base considerably increases the efficacy of betamethasone valerate.

Betamethasone↗

[Betamethasone valerate reference standard (Control 941) of the National Institute of Health Sciences].

The raw material for betamethasone valerate was tested for preparation of the "Betamethasone Valerate Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 194.3 degrees C (decomposition); UV and infrared spectra, the same as those for JP Betamethasone Valerate Reference Standard (Control 844); optical rotation, [alpha]20D = +79.4 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected; assay, 100.0% by HPLC. Based on the above results, the candidate material was authorized as the JP Betamethasone Valerate Reference Standard (Control 941).

Betamethasone Valerate↗