RESUMO
Achieving and maintaining optimal glycemic targets is the fundamental goal of the management of diabetes. However, failure of oral antidiabetic drugs (OADs) to sustain the targeted glycemic levels in individuals with progressing disease often requires initiation of insulin therapy. This article consolidates the expert opinions of 377 doctors who participated in 34 advisory board meetings held digitally (n=23) and in person (n=11) across India. The present report underscores the need for readily available alternatives, such as biosimilar insulins, in the Indian healthcare market to make insulin accessible to every patient with diabetes. The introduction of biosimilar insulins in the Indian healthcare market is the key to making insulin accessible to every patient with diabetes. Biosimilars are biologic products that closely resemble reference/originator biologics and demonstrate no clinically meaningful differences in safety and effectiveness. The concept of interchangeability serves as a pivotal differentiator for biosimilars, underlining their reliability and safety, and plays a significant role in their broader acceptance and integration into healthcare systems. The 'interchangeability' designation by the United States Food and Drug Administration (USFDA) elevates the biosimilar concept, promoting faster and broader adoption of insulin biosimilars, especially benefiting patients prone to non-adherence to insulin therapy. Healthcare providers are encouraged to consider the option of initiating or transitioning to biosimilar insulin glargine to address the insulin accessibility challenges.
RESUMO
This is a non-randomized, open-label, prospective single-arm interventional multicentric study conducted between 2021 and 2022 at three different centers situated in Pune, India. It was conducted to evaluate the efficacy and safety of the Sitcom® tablet (Euphorbia prostrata 100 mg) once daily and Sitcom® cream (Euphorbia prostrata 1%w/w) for 14 days in hemorrhoids during pregnancy. The endpoints were to assess hemorrhoidal symptoms relief during the follow-up periods (one, two, four, and eight weeks and 30 days postpartum), relapse of symptoms, improvement in the disease condition at week two and 30 days postpartum, and adverse events. A total of 100 patients (mean age 24.1 years) were included; the majority (71.0%) had mild per-rectal bleeding, 69.0% with mild itching and 46.0% with moderate pain during defecation. The mean score of per-rectal bleeding and pain at defecation showed a significant reduction at each visit (86.6% and 49.3% (two weeks), 95.3% and 59.9% (four weeks), and 100% and 77.6% (eight weeks)). The mean pain score at defecation, itching, exudates, and swelling showed a significant reduction of 77.6%, 96.9%, 100%, and 84.5% at eight weeks (p<0.001). After two weeks and post postpartum follow-up, >90% and 100% good to excellent overall improvement in the disease condition were noted, respectively. No adverse events in the mother or newborn were noted. This pivotal study underscores the potential of a combination therapy with Euphorbia prostrate 100 mg tablet and cream 1% as a potential solution for managing the distressing burden of hemorrhoids in pregnant women. Furthermore, these observations will empower clinicians in the judicious selection of the most suitable course of action for hemorrhoid management during pregnancy.
RESUMO
BACKGROUND: The skin of patients with atopic dermatitis is colonized with Staphylococcus aureus. Reduction of bacterial colonization has been reported to be effective in the treatment of atopic dermatitis. AIM: To assess the efficacy and safety of a combination of fluticasone propionate 0.005% and mupirocin 2.0% ointment twice daily for 2 weeks in patients with atopic dermatitis clinically suspected of secondary bacterial infection. METHODS: An open-label, non-randomized study of 122 patients (64 males and 58 females) from 20 centers was conducted. Atopic dermatitis was diagnosed by clinical assessment and scoring was done on the visual analogue scale (VAS). Clinical evaluation of the lesions was done on day 1 (baseline), day 8 and on day 15 of study visits. RESULTS: At baseline, many patients had moderate itching (41.8%), moderate dryness (41.8%) and mild weeping lesions (49.2%). The baseline proportions of the clinicians' global impressions (CGI) scale for mild, moderate and severe atopic dermatitis lesions were 19.7%, 55.7% and 12.2% respectively. At the end of the treatment period, 67.2% patients had mild disease, whereas only 9% and 0.8% patients had moderate and severe disease respectively. At baseline, only 33.65% patients were comfortable with the existing lesions when assessed on visual analog scale (VAS). However, after the treatment, this proportion increased to 51.77% and 78.60% patients on day 8 and on day 15 respectively. CONCLUSION: Twice daily topical application of a fluticasone propionate 0.005% and mupirocin 2.0% ointment is an effective and safe therapeutic regimen in atopic dermatitis.
