Objective. To generate data on the drug utilization pattern and cost of drug treatment and to determine the rationality of prescriptions. Methods. A retrospective cross-sectional drug utilization study was conducted in the medical emergency unit of our hospital. Patient case records were reviewed to extract data on the pattern of drug use. Cost of drug treatment for the emergency visit was calculated by referring to the cost mentioned in Monthly Index of Medical Specialties and the rationality of prescriptions was evaluated using WHO core indicators of drug utilization. Results. 1100 case records were reviewed. Majority of patients received proton pump inhibitors followed by multivitamins. The median cost per prescription was 119.23$ (7.32$–7663.46$). Majority (49.9%) of drug cost was driven by antibiotics alone. An average of 4.9 drugs was prescribed per prescription. There were 14.89% encounters with antibiotics. 75.17% of the drugs were given as injectables and only 29.27% of the drugs were prescribed as generics. Conclusion. There is need to rationalize the drug therapy in terms of increasing prescribing of drugs by generic name and to avoid overuse of PPIs and multivitamins in emergency unit. Also the hospital pharmacy should be encouraged to procure more cost effective alternative antibiotics in future.
Diabetes, a silent killer, is a leading cause of neuropathy. Around 50% of diabetic patients develop peripheral neuropathy in 25 years. Painful diabetic neuropathy manifests as burning, excruciating, stabbing or intractable type of pain or presents with tingling or numbness. The pathophysiology of this condition is due to primarily metabolic and vascular factors. There is increase in sorbitol and fructose, glycated endproducts, reactive oxygen species and activation of protein kinase C in the diabetic state. All these factors lead to direct damage to the nerves. The first step in the management of painful diabetic neuropathy is a tight glycaemic control. Currently there is no drug which can halt or reverse the progression of the disease. Most of the therapies prevalent aim at providing symptomatic relief. Antidepressants like tricyclic antidepressants (TCAs) and selective norepinephrine reuptake inhibitors (SNRIs) have good efficacy in controlling the symptoms. Selective serotonin reuptake inhibitors have not shown the same consistent results. Anticonvulsants including pregabalin, gabapentin and lamotrigine have shown good results in the control of symptoms whereas same was not found with carbamazepine, oxcarbazepine and topiramate. Topical agents (capsaicin, topical nitrates and topical TCAs) and local anaesthetics have also been used with good results. Use of opioids and non steroidal anti-inflammatory drugs although common but is not preferable. The newer therapies under studies are NMDA antagonists, aldose reductase inhibitors, neurotropic factors, vascular endothelial growth factor, Gamma linolenic acid, protein kinase C beta inhibitors, immune therapy, hyperbaric oxygen and alpha lipoic acid.
Background: MONALEESA-7 (NCT02278120), the first large randomized phase III clinical trial dedicated to investigating a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) plus ET vs ET + placebo (PBO) in pre- or perimenopausal patients with HR+/HER2− ABC, previously demonstrated a statistically significant improvement in OS with the addition of ribociclib (RIB) to ET vs PBO + ET (median, not reached vs 40.9 months; HR, 0.71 [95% CI, 0.54-0.95]; P = .00973; Im SA, et al. N Engl J Med. 2019). This concluded the protocol-defined final analysis of OS and the patients and investigators were unblinded to their treatment assignment allowing patients on the PBO arm to cross-over to RIB treatment. Longer follow-up allows for more events to further characterize the long-term survival benefits. Here we report an exploratory update of OS after a minimum of ~ four years of follow-up, an additional 20 months since the last report. Methods: Pre- or perimenopausal patients with HR+/HER2− ABC were randomized 1:1 to receive RIB or PBO plus goserelin with either a nonsteroidal aromatase inhibitor (NSAI; letrozole or anastrozole) or tamoxifen. RIB is approved in combination with an NSAI in pre- or perimenopausal patients. Patients who had received a prior CDK4/6i or ET in the advanced setting were excluded. Patients who received ET in the (neo)adjuvant setting or ≤ 1 prior line of chemotherapy for advanced disease were eligible to enroll. Updated OS were evaluated by Cox proportional hazards model and summarized using Kaplan-Meier methods. Additional post-progression endpoints such as progression-free survival 2 (PFS2), time to chemotherapy (CT) and CT-free survival were also evaluated and summarized. Results: The data cutoff for this updated OS analysis was 29 June 2020, and the median follow-up was 53.5 mo (min, 46.9 mo). These updated results with extended follow-up demonstrated an OS benefit with RIB + ET vs PBO + ET (median, 58.7 vs 48.0 mo; HR, 0.76 [95% CI, 0.61-0.96]). In patients receiving an NSAI, a similar OS benefit was observed with RIB + NSAI vs PBO + NSAI (median, 58.7 vs 47.7 mo; HR, 0.80 [95% CI, 0.62-1.04]). The survival benefit shown in subgroup analyses was consistent with the intent-to-treat (ITT) population. PFS2, time to chemotherapy (CT), and CT-free survival for the ITT and NSAI populations are in the Table. Among the patients who discontinued study treatment, 77.3% and 78.1% in the RIB + ET vs PBO + ET arms received a subsequent antineoplastic therapy, respectively, and 12.9% and 26.1% received a subsequent line of CDK4/6i. Additionally there were 15 patients in the PBO arm that crossed over to the RIB arm following unblinding and prior to disease progression. Conclusions: With an extended follow-up of more than 4 years, RIB + ET continued to demonstrate a clinically relevant OS benefit compared with ET alone in pre- or perimenopausal patients with a median OS ~5 years with RIB +ET in HR+/HER2− ABC. A similar benefit with RIB was observed for PFS2, time to CT, and CT-free survival. ITTNSAI cohortRIB + ETn=335PBO + ETn=337RIB + NSAIn=248PBO + NSAIn=247PFS2Events, n (%)177 (52.8)221 (65.6)131 (52.8)159 (64.4)Median, mo44.231.043.630.4HR (95% CI)0.68 (0.56-0.83)0.69 (0.55-0.87)Time to first CTEvents, n (%)144 (43.0)173 (51.3)107 (43.1)129 (52.2)Median, mo50.936.850.936.0ITT HR(95% CI)0.69 (0.56-0.87)0.66 (0.51-0.85)CT-free survivalEvents, n (%)190 (56.7)236 (70.0)139 (56.0)169 (68.4)Median, mo42.426.442.525.9HR (95% CI)0.67 (0.55-0.81)0.64 (0.51-0.81) Citation Format: Debu Tripathy, Seock-Ah Im, Marco Colleoni, Fabio Franke, Aditya Bardia, Nadia Harbeck, Sara Hurvitz, Louis Chow, Joohyuk Sohn, Keun Seok Lee, Saul Campos-Gomez, Rafael Villanueva Vazquez, Kyung Hae Jung, K Govind Babu, Paul Wheatley-Price, Michelino De Laurentiis, Young-Hyuck Im, Sherko Kümmel, Nagi El-Saghir, Mei-Ching Liu, Sharonjeet Kaur, Claudia Gasch, Craig Wang, Yongyu Wang, Arunava Chakravartty, Yen-Shen Lu. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD2-04.
Polycystic ovary syndrome (PCOS) is a persisting challenge to clinical and basic research scientists as none of the presently available medications have been fully able to combat these consequences. The aim of the present review is to summarize the different lines of treatment available for the different symptomologies that women with PCOS presents. In this comprehensive review, search was made for various treatment options available for PCOS by using Cochrane library, Pubmed, Medline, in addition to the relevant printed medical journals and periodicals. The search results revealed that oral contraceptives containing oestrogen and progesterone regularize the menstruation, antiandrogens like spironolactone and drosperinone have proven to be effective in hirsutism and acne, clomiphene is the gold standard for ovulation induction, but multiple pregnancies and clomiphene failure add to its limitation. Hence, aromatase inhibitors like letrozole, low-dose gondotropins, and ovarian drilling procedure have shown to be beneficial effect in clomiphene-resistant cases. Insulin sensitizers such as metformin, thiazolidinediones, and d-chiro-inositol increase insulin sensitivity and improve ovulation rate. Recently, melatonin, N-acetyl cysteine, acarbose, and statins have shown positive results in different symptomologies of PCOS. The results show that PCOS treatment constitutes varied line of treatment depending upon the clinical features with which a woman is presenting. Still, unfortunately, none of the treatments are fully able to combat the PCOS.
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