Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome

Background: In adults with primary focal segmental glomerulosclerosis (FSGS), daily prednisone may induce complete remissions (CR) and partial remissions (PR), but relapses are frequent and adverse events are common. Methods: We carried out 2 open-label, uncontrolled trials to explore the efficacy and tolerability of pulse oral dexamethasone as an alternative to daily prednisone. We enrolled adult patients with proteinuria > 3.5 g/day despite the use of renin-angiotensin-aldosterone blockade. In the first trial, we enrolled 14 subjects with FSGS and administered 4 dexamethasone doses (25 mg/m2) daily for 4 days, repeated every 28 days over 32 weeks. The second trial involved a more intensive regimen. Eight subjects received 4 dexamethasone doses of 50 mg/m2 every 4 weeks for 12 weeks, followed by 4 doses of 25 mg/m2 every 4 weeks for 36 weeks; subjects were randomized to 2 doses every 2 weeks or 4 doses every 4 weeks. Results: In the first trial, we enrolled 13 subjects with FSGS and 1 with minimal change disease and found a combined CR and PR rate of 36%. In the second trial, we enrolled 8 subjects. The combined CR and PR rate was 29%. Analysis combining both trials showed a combined CR and PR rate of 33%. Adverse events were observed in 32% of subjects, with mood symptoms being most common. There were no serious adverse events related to the study. Conclusion: We conclude that high dose oral dexamethasone is well tolerated by adults with idiopathic nephrotic syndrome and may have some efficacy.

Comparative Efficacy of Low-Dose Oral Corticosteroids and Oral Mini Pulse Dexamethasone in Patients of Vitiligo

Introduction: Vitiligo is a common, acquired, discoloration of the skin with unknown etiology. There are numerous treatment options available for vitiligo, but none is universally effective. Systemic corticosteroids suppress immunity and lead to repigmentation but produce unacceptable side effects. Oral corticosteroid low dose treatment may be associated with fewer side effects than usual dose-treatment. Several data also showed that oral dexamethasone pulse treatment was effective in arresting progression of vitiligo yet fails to induce satisfactory repigmentation in the great majority of their patients.Objectives: A clinical trial was carried out to compare the efficacy of low-dose oral corticosteroids and oral mini pulse dexamethasone in patients of vitiligo.Materials and Methods: The study was conducted in the Department of Dermatology and Venereology, Combined Military Hospital (CMH), Dhaka, Bangladesh during January 2013 to December 2013. Total sixty patients of vitiligo were enrolled and divided into group A and group B. Thirty of group A patients were treated with oral prednisolone daily and thirty of group B patients were treated with oral dexamethasone pulse therapy weekly.Results: Out of sixty patients of vitiligo, maximum patients of both groups had progressive type of vitiligo. In Group-A, the duration of illness was an average of 10 months and in group-B, it was an average of 8.20 months. Single lesion was 15 (50%) for Group-A and 14 (46.7%) for Group-B. Multiple lesions were 15 (50%) & 16 (53.6%) for Group-A and Group-B respectively. The study showed that improvement rate was highest for the lesions on the extremities, which was 18 (34.6%) and lowest for back 03 (5.8%). Out of all patients from Group-A, the mean size of the lesions were 8.17cm, 5.90 cm, 4.32 cm and 3.57 cm at 1st visit, 2nd visit, 3rd visit and 4th visit respectively. In Group-B, the mean sizes of the lesions were 7.50 cm, 4.92 cm, 3.00 cm, and 4.75 cm at 1st visit, 2nd visit, 3rd visit and 4th visit respectively. Among the patients 27 (90%) of group-A and 25 (83.3%) of group B were improved after 16th week of treatment, slight response 4(13.3%) and 6(20%), moderate response 22(63.2%) and 18(59.4%) and marked response was 1(3.3%) and 1(3.3%) in group A and group B respectively.Conclusion: The study concluded that both the drugs, oral prednisolone and dexamethasone when used individually, were found to be equally effective in the treatment of vitiligo.Journal of Armed Forces Medical College Bangladesh Vol.11(1) 2015: 54-58

Low-Dose Oral Mini-Pulse Dexamethasone Therapy in Progressive Unstable Vitiligo

Background: The course of vitiligo is unpredictable. If the disease is spreading rapidly, the progression can be controlled with the use of systemic steroids daily or in pulsed form. The present study was planned to assess the efficacy of low-dose dexamethasone oral mini-pulse therapy in progressive unstable vitiligo. Materials and Methods: In this retrospective study, the case records of patients with vitiligo during the period from January 2006 to December 2010 were studied. Patients who had progressive unstable disease were included. These patients were administered oral dexamethasone 2.5 mg per day on 2 consecutive days after breakfast in a week. The patients were asked to come for regular follow-up to assess the arrest of disease activity, relapse of disease activity, and adverse effects. Results: A total of 444 patients were analyzed. In 408 (91.8%) patients, arrest of disease activity was achieved at a mean duration of 13.2 ± 3.1 weeks. In addition, some repigmentation of the lesions was seen in all patients after a mean of 16.1 ± 5.9 weeks. During the follow-up, 50 of 408 (12.25%) patients experienced one or two episodes of relapse in disease activity, which were treated with reinstitution of low-dose dexamethasone oral mini-pulse therapy. The mean disease-free survival (DFS) until the first relapse was 55.7 ± 26.7 weeks, and the mean DFS until the second relapse was 43.8 ± 7.2 weeks. Adverse reactions such as weight gain, lethargy, and acneiform eruptions were observed in 41 (9.2%) patients. Conclusion: Low-dose oral mini-pulse dexamethasone therapy is a good option for arresting progressive unstable vitiligo with minimal adverse effects.