scholarly journals Comparative Efficacy and Safety of Low Dose versus High Dose Isotretinoin in Severe Acne Vulgaris Patients

2019 ◽  
Vol 8 (1) ◽  
pp. 18-22
Author(s):  
Maria Syed ◽  
Syed Afaq Ahmed

Background: Oral isotretinoin is the recommended treatment for acne vulgaris, a skin disease especially common in teenagers and adolescents. This study was designed to compare the efficacy and safety of low dose with high dose isotretinoin in severe acne vulgaris patients.Material and Methods: This randomized controlled trial included 110 patients with a clinical diagnosis of acne vulgaris. They were divided into two groups. Both groups were matched for age (mean 18.2±3.7 vs 17.6±3.2 years), weight (mean 58±10.2 vs 60.7±9.3 Kg), gender and disease duration (3±1.1 vs 3±1.0 years). Group A received low dose oral isotretinoin (20 mg/day) while group B received standard high dose regimen (1mg/kg/day). All patients were followed up for 16 weeks to assess efficacy (assessment of complete remission) and safety (mucocutaneous side effects). All calculations were performed using SPSS v. 16 with p value <0.05 considered as statistically significant.Results: There was no statistically significant difference in efficacy. However, significantly fewer mucocutaneous side effects were reported in group A (80%) as compared to group B (100%). This safety profile spectrum was observed across all pre-defined subsets i.e chielitis (78.1% vs 98.2%), dry skin (69.1% vs 92.7%), dry mouth (47.2% vs 72.7%) and facial rash (12.7% vs 30.9%).Conclusion: In patients with severe acne vulgaris, efficacy (complete remission) of low dose oral isotretinoin is almost equal to conventional high dose regimen but it is statistically superior in terms of safety (mucocutaneous side effects).

Author(s):  
Santhosh A. Shetti ◽  
Nagesh H. N. ◽  
Nagabushan Hanumanthaiah

Background: Acne Vulgaris is chronic inflammatory disease of pilosebaceous units. Oral isotretinoin is recommended for moderate to severe acne vulgaris who are not responding satisfactorily to conventional therapies. Recent reports indicate that acne patients have been benefiting from the low dose treatment protocols. However, long term daily use of this drug results in frequent side effects such mucocutaneous and systemic side effects. Our aim was to assess and compare the various side effects and patient satisfaction of oral isotretinoin in low dose continuous and intermittent treatment of moderate to severe acne vulgaris.Methods: This was a prospective randomized open labeled comparative study carried out at outpatient department in the Department of Dermatology in Mandya Institute of Medical sciences, Mandya. Patients with moderate to severe acne were assigned equally (50 subjects each) to one of the two treatment regimens by using block randomization technique, Group A was given low dose continuous regimen-20 mg oral isotretinoin once daily for 4 months and Group B was given low dose intermittent regimen-20 mg oral isotretinoin once daily for 1 week out of every 4 weeks. The patients were followed up every 4th week during the treatment period. The patients were examined and side effects were noted in each visit. A six month follow-up evaluation was done to analyze patient satisfaction.Results: Muco-cutaneous dryness was most common adverse effect noted in both the groups A and B. Itching (42%), Alopecia (44%), Myalgia (36%) were seen most commonly in group A and Acne flaring (47%) was most common with group B. With regard to patient satisfaction, in group A 42% were satisfied and 20% were very satisfied, in group B 36% were satisfied and 14% were very satisfied.Conclusions: Study suggests that, Muco-cutaneous dryness was most common side effect in both treatment regimens. Side effects were more frequent with low dose continuous than low dose intermittent isotretinoin regimen. Patient satisfaction was better in continuous regimen.


1996 ◽  
Vol 14 (8) ◽  
pp. 2274-2279 ◽  
Author(s):  
E Jäger ◽  
M Heike ◽  
H Bernhard ◽  
O Klein ◽  
G Bernhard ◽  
...  

PURPOSE To determine the most effective dose of leucovorin (folinic acid [FA]) within a weekly bolus fluorouracil (FU) schedule, we conducted a randomized multicenter trial to compare therapeutic effects and toxicity of high-dose FA versus low-dose FA combined with FU at equal doses in both treatment groups. PATIENTS AND METHODS Patients with measurable inoperable or metastatic colorectal cancer were randomized to receive weekly FU 500 mg/m2 by intravenous (IV) bolus combined with high-dose FA 500 mg/m2 (group A) or low-dose FA 20 mg/m2 (group B) by 2-hour infusion. RESULTS Of 291 assessable patients (group A, n = 148; group B, n = 143), we observed, in group A, complete response (CR)/partial response (PR) in 32 (21.6%), no change (NC) in 64 (43.2%), and progressive disease (PD) in 52 (35.1%); and in group B, CR/PR in 25 (17.5%), NC in 63 (44.1%), and PD in 55 (38.5%). The median response duration was 24.8 weeks in group A and 23.1 weeks in group B. Median progression-free intervals were 29.3 weeks (group A) and 30 weeks (group B). The median survival time was 55.1 weeks in group A and 54.1 weeks in group B. Overall toxicity was moderate. Mild nausea and vomiting, and stomatitis were common side effects in both groups. The incidence of World Health Organization (WHO) grade III/IV diarrhea was significantly higher in group A (40 v 23 patients). Severe side effects were observed only in a minority of patients in both arms. WHO grade IV diarrhea was observed in seven patients: four in group A and three in group B. The rate of toxicity-related adjustments of dose and schedule was comparable in both groups. CONCLUSION High-dose FA/FU is not superior to low-dose FA/FU within a weekly treatment schedule. Response rates and survival were comparable in both treatment arms. Treatment-related toxicity was higher in group A (high-dose FA). Therefore, low-dose FA combined with weekly FU may be considered the preferred treatment for metastatic colorectal cancer.


2016 ◽  
Vol 7 (5) ◽  
pp. 378 ◽  
Author(s):  
DaulatRam Dhaked ◽  
RamSingh Meena ◽  
Anshul Maheshwari ◽  
UmaShankar Agarwal ◽  
Saroj Purohit

2016 ◽  
Vol 11 (1) ◽  
pp. 54-58
Author(s):  
Md Shirajul Islam Khan

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


2018 ◽  
Vol 31 (6) ◽  
pp. e12715 ◽  
Author(s):  
Magdy Abd El Aziz Ragab ◽  
Salma Samir Omar ◽  
Andrew Collier ◽  
Reham Abdel Haleem Abo El-Wafa ◽  
Neveen Gomaa

2016 ◽  
Vol 39 (6) ◽  
pp. 52 ◽  
Author(s):  
Tolga Yakar ◽  
Mehmet Demir ◽  
Ozlem Dogan ◽  
Alper Parlakgumus ◽  
Birol Ozer ◽  
...  

Purpose: We aimed to evaluate and compare the efficacy and safety of high-dose furosemide+salt orally by comparing HSS+ furosemide (i.v.) and repeated paracentesis in patients with RA. Methods: This was a prospective study of 78 cirrhotic patients with RA, randomized into three groups: Group A (n= 25) i.v. furosemide (200-300 mg bid) and 3% hypotonic saline solution (HSS) (once or twice a day); Group B (n= 26) oral furosemide tablets (360-520 mg bid) and salt (2.5 g bid); and, Group C (n= 27) repeated large-volume-paracentesis (RLVP) with albumin infusion. Patients without hyperkalemia were administrated 100 mg of spironolactone/day. During the follow-up; INR, creatinine, and total bilirubin levels were measured to determine the change in MELD (model of end stage liver disease) score. Results: Hepatic encephalopathy (HE), severe episodes of spontaneous bacterial peritonitis (SBP) and pleural effusions (PE) occurred more frequently in Group C. Improvement in Child-Pugh and MELD score was better in Group A and B than Group C. In Group B, improvements were seen in the Child-Pugh and MELD score, reduction in body weight, duration and number of hospitalization. In Groups A and B, remarkable increases in diuresis were observed (706±116 to 2425±633 mL and 691±111 to 2405±772 mL) and serum sodium levels also improved. HE and SBP were occurred more often in group C (p


Author(s):  
Niloofar Afshari ◽  
Mehdi Amirnia ◽  
Davod Ahmadi ◽  
Saeed Kashefi ◽  
Vahideh Aghamohammadi

Background: Rising follicular keratin secretion, increasing sebum production, and Propionibacterium acnes are among the main etiology of acne vulgaris formation. Antibiotics are the predominant conventional treatment of acne. Antibiotic resistance is the main problem in the ordinary treatments of acne. Therefore, newer treatments are necessary. Intense pulsed light (IPL) is a novel therapeutic option with rapid application in this field. Methods: Patients referred to us were randomized into two groups: group A (cases) and group B (controls). In addition to conventional antibiotic therapy, IPL was prescribed to group A while azithromycin alone was prescribed to group B. IPL treatment was performed weekly for five weeks and the patients were followed for three months. Declining inflammatory lesions count after the intervention was considered the remission scale. Results: In group A, moderate, partial, and complete remission occurred in 4, 9, and 7 patients, respectively. In group B, moderate, partial, and complete remission occurred in 10, 7, and 3 patients, respectively. Statistically, the remission difference was meaningful between the two groups. Conclusion: IPL with conventional antibiotics is an effective treatment choice in moderate to severe acne vulgaris but also is a more accelerating agent in treatment versus antibiotics alone.


2015 ◽  
Vol 3 (1) ◽  
Author(s):  
Pamela K. Sari ◽  
Poppy M. Lintong ◽  
Lily L. Loho

Abstract: Androgenic-anabolic steroids (AAS) are synthetic derivatives of the male hormone endogenous testosterone that stimulates anabolic (protein synthesis) and androgenic effects (masculinization). Long-term usage of AAS can result in liver damage. However, physiological concentrations of testosterone can stimulate protein synthesis which lead to an increase in muscle size, body mass, and endurance. This study aimed to determine the histopathology of liver and skeletal muscles of wistar rats that were given low dose and high dose injection of AAS. Subjects were 21 wistar rats divided into 7 groups. Group A was given standard pellets for 56 days (negative control), terminated on days 29,43, and 57. Group B was treated with low-dose AAS injection and standard pellets for 28 days, terminated on day 29. Group C was treated with low-dose AAS injection and standard pellets for 42 days, terminated on day 43. Group D was treated with low-dose AAS injection and standard pellets for 56 days, terminated on day 57. Group E was treated with high-dose AAS injection and standard pellets for 28 days, terminated on day 29. Group F was treated with high-dose AAS injection and standard pellets for 42 days, terminated on day 43. Group G was treated with high-dose AAS injection and standard pellets for 56 days, terminated on day 57. The results showed that the histopathology of liver and muscles in group A was still normal. In group B, the architecture of liver was still normal with a few inflammatory cells around the Kiernan triangle while in muscle the ratio of myofibril diameter was 1.28:1. In group C and group D, there were widening of the hepatic artery, bile duct, and portal vein containing blood fibrin, and inflammatory cells around the Kiernan triangle. The ratio of myofibril diameter was 1.43:1 in group C and 2.14:1 in group D. In group E, F and G, there were micro-vesicular fatty cells in the peripheral part of the liver meanwhile the myofibril diameter ratio of the muscles in group E was 1.43:1, group F 2.1:1, and group G 2.28:1. Conclusion: Administration of AAS injection of low dose and high dose for less than 4 weeks could result in inflammation, dilation of the portal vein, hepatic artery and bile duct meanwhile administration of AAS for over 4 weeks could ressult in focal fatty liver (steatosis). The administration of AAS injection of low dose and high dose for 4,6 and 8 weeks reslutid in enlargement of skeletal muscle (muscle hypertrophy).Keywords: androgenic-anabolic steroids, liver, skeletal muscleAbstrak: Anabolik Androgenik Steroid (AAS) adalah derivat sintetis dari hormon sex testosteron endogen pria, yang merangsang efek anabolik (sintesis protein) dan androgenik (maskulinisasi). Penggunaan AAS jangka panjang dapat mengakibatkan terjadinya kerusakan hati namun secara fisiologi testosteron dapat menstimulasi sintesis protein sehinggaberdampak pada peningkatan ukuran otot, massa tubuh dan ketahanan tubuh. Penelitian ini bertujuan untuk mengetahui gambaran histopatologi hati dan otot rangka wistar yang diberikan AAS injeksi dosis rendah dan dosis tinggi. Subjek penelitian 21 ekor wistar yang dibagi menjadi 7 kelompok. Kelompok A diberi pelet standar selama 56 hari (kontrol negatif), terminasi pada hari ke-29, 43, dan 57. Kelompok B diberi perlakuan AAS injeksi dosis rendah dan pelet standar selama 28 hari, terminasi hari ke-29. Kelompok C diberi AAS injeksi dosis rendah dan pelet standar selama 42 hari, terminasi hari ke-43. Kelompok D diberi AAS injeksi dosis rendah dan pelet standar selama 56 hari, terminasi hari ke-57. Kelompok E diberi perlakuan AAS injeksi dosis tinggi dan diberi pelet standar selama 28 hari, terminasi hari ke-29. Kelompok F diberi perlakuan AAS injeksi dosis tinggi dan diberi pelet standar selama 42 hari, terminasi hari ke-43. Kelompok G diberi perlakuan AAS injeksi dosis tinggi dan diberi pelet standar selama 56 hari, terminasi hari ke-57. Hasil penelitian menunjukkan pada kelompok A didapatkan gambaran histopatologi hati normal sedangkan pada otot tidak terdapat perubahan. Pada kelompok B didapatkan arsitektur hati masih normal dengan sedikit sel radang disekitar segitiga Kiernan sedangkan pada otot terlihat diameter miofibril ratio 1,28:1. Pada kelompok C dan D terlihat pelebaran arteri hepatika, duktus biliaris, dan vena porta yang berisi fibrin darah, serta sel-sel radang di sekitar segitiga Kiernan. Pada kelompok C diameter miofibril ratio 1,43;1 dan pada kelompok D 2,14:1. Pada kelompok E, F dan G terdapat sel-sel perlemakan mikrovesikuler di perifer sedangkan pada otot diameter miofibril ratio kelompok E 1,43:1, kelompok F 2,1:1, dan kelompok G 2,28:1. Simpulan: Pada pemberian AAS injeksi dosis rendah dan dosis tinggi kurang dari 4 minggu terjadi peradangan hati, pelebaran vena porta, arteri hepatika dan duktus biliaris sedangkan lebih dari 4 minggu terdapat perlemakan (steatosis) fokal hati. Pemberian AAS injeksi dosis rendah dan tinggi dalam waktu 4,6 dan 8 minggu menunjukkan pembesaran otot rangka (hipertrofi otot).Kata kunci: AAS, hati, otot rangka


Author(s):  
Rashmi Jindal ◽  
Samarjit Roy ◽  
Akanksha Jain

<p class="abstract"><strong>Background:</strong> Oral isotretinoin and azithromycin are two important drugs used in management of acne. Their mode of action is different and thus theoretically the combination of these two should have a synergistic effect.</p><p class="abstract"><strong>Methods:</strong> In this randomized comparative trial 100 patients were randomized into two groups. One received oral isotretinoin (0.3 mg/kg/day) alone and the other group received pulsed azithromycin (500 mg/day for three days in a week for 8 weeks) in addition to oral isotretinoin. Improvement in acne was noted as percentage improvement in mean acne score.<strong></strong></p><p class="abstract"><strong>Results:</strong> No statistically significant difference was noted in the improvement in mean acne score of both the groups.</p><p><strong>Conclusions:</strong> Addition of pulsed azithromycin to low dose oral isotretinoin does not offer a better treatment outcome in patients of moderate to severe acne. </p>


2019 ◽  
Vol 120 (01) ◽  
pp. 083-093 ◽  
Author(s):  
Francesco Franchi ◽  
Fabiana Rollini ◽  
Emilio Garcia ◽  
Jose Rivas Rios ◽  
Andrea Rivas ◽  
...  

AbstractIn patients requiring dual antiplatelet therapy (DAPT) who also have an indication to be treated with oral anticoagulant (OAC) drugs, aspirin withdrawal reduces the risk of bleeding. There is limited data on the pharmacodynamic effects associated with adding a nonvitamin K antagonist OAC on a background of aspirin and a P2Y12 inhibitor as well as dropping aspirin. Seventy-five patients on DAPT (aspirin plus clopidogrel) were randomized to DAPT plus high-dose edoxaban (60 mg once daily, Group A), DAPT plus low-dose edoxaban (30 mg once daily, Group B), or DAPT only (Group C) for 10 ± 2 days (Phase I). Afterwards, Groups A and B interrupted aspirin and maintained clopidogrel plus edoxaban for 10 ± 2 days, while patients in Group C maintained DAPT (Phase II). Platelet aggregation and clot kinetics were assessed at baseline, end of Phase I, and end of Phase II using thrombelastography (TEG), light transmittance aggregometry (LTA), VerifyNow P2Y12, and serum thromboxane-B2. The primary endpoint was the comparison of maximum amplitude (MA) measured by TEG, a measure of clot strength, between patients on DAPT plus high-dose edoxaban and patients on DAPT only. Edoxaban prolonged in a dose-dependent manner speed of thrombin generation (TEG R; Group A: 7.7 [6.8–8.7] vs. Group B: 7.4 [6.4–8.5] vs. Group C: 6.3 [5.7–7.0]; p = 0.05) but did not affect other markers of clot kinetics, including TEG MA (Group A: 63 [61–64] vs. Group B: 65 [63–67] vs. Group C: 64 [63–65]; p = 0.10). After aspirin discontinuation, platelet reactivity assessed by LTA using thrombin receptor activating peptide as agonist increased to a greater extent with low-dose edoxaban. Stopping aspirin did not affect markers of P2Y12 reactivity and had no or marginal effects on clot kinetics, but increased markers sensitive to cyclooxygenase-1 blockade.


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