An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India.

Background Chemotherapy-induced nausea and vomiting is a common and unpleasant treatment-related side effect reported by cancer patients receiving chemotherapy. Akynzeo® or NEPA (NEtupitant + PAlonosetron) is the first fixed combination of netupitant and palonosetron that targets both critical pathways involved in emesis while providing a convenient, single oral dose therapy. The current study aimed to assess the effectiveness and safety of NEPA in a real-world setting in India. Methodology This was an open-label, multicenter, prospective, single-arm study conducted at six different locations across India. The study included patients of either gender, aged ≥18 years, naive to chemotherapy, scheduled to receive highly or moderately emetogenic chemotherapy (HEC/MEC), and scheduled to receive oral NEPA, as determined by the investigator. Results A total of 360 people were screened and enrolled in the study. HEC was prescribed to 289 (81.64%) patients, while MEC was prescribed to 65 (18.36%) patients. Complete response was achieved in 94.92% of patients during the acute phase, 95.20% during the delayed phase, and 93.22% during the overall phase. During the overall phase, 92.73% and 95.38% of patients on the HEC and MEC regimens, respectively, achieved complete response. Adverse events were reported in 3.88% of patients. Conclusions Oral NEPA was found to be effective in the Indian real-world setting, eliciting a >90% complete response with HEC and MEC regimens across the acute, delayed, and overall phases.

Correction: An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India.

[This corrects the article DOI: 10.7759/cureus.56447.].

ExPert ConsEnsus on the management of Advanced clear-cell RenaL celL carcinoma: INDIAn Perspective (PEARL-INDIA).

In advanced Renal Cell Carcinoma (aRCC), systemic therapy is the mainstay of treatment, with no or little role for surgery in these patients. Tyrosine kinase inhibitors (TKIs) and immune-oncological (IOs) therapies, either alone or in combination, are recommended in these patients depending on patient and tumour factors. The sequencing of therapies is critical in RCC because the choice of subsequent line therapy is heavily dependent on the response and duration of the previous treatment. There are additional barriers to RCC treatment in India. Immunotherapy is the cornerstone of treatment in ccRCC, but it is prohibitively expensive and not always reimbursed, effectively putting it out of reach for the vast majority of eligible patients in India. Furthermore, in advanced RCC (particularly the clear cell variety), Indian oncologists consider the disease burden of the patients, which is particularly dependent on the quantum of the disease load, clinical symptoms, and performance status of the patient, before deciding on treatment. There are no India-specific guidelines for clear cell RCC (ccRCC) treatment or the positioning and sequencing of molecules in the management of advanced ccRCC that take these country-specific issues into account. The current consensus article provides expert recommendations and treatment algorithms based on existing clinical evidence, which will be useful to specialists managing advanced ccRCC.

INDIan Consensus on the mAnagemenT of cOugh at pRimary care setting (INDICATOR).

BACKGROUND: Cough has a prevalence of 9.6% globally and 5-10% in India. Though it is a reflex action, it affects an individual's quality of life (QoL) when uncontrolled. There was a need to create an integrated guidance document on managing cough focused on primary care physicians in the Indian setting. This consensus intends to bridge this gap by providing clinical recommendations to diagnose and manage cough in primary healthcare in India. MATERIALS AND METHODS: The modified Delphi method was used to arrive at a consensus on clinical statements. The panel comprised 10 experts, including pulmonologists, otolaryngologists, a pediatrician, and a general physician. The statements were discussed under the following domains: definition, etiology, diagnosis, and treatment. RESULTS: A total of 109 clinical statements were framed, with 75 reaching consensus, 13 reaching near consensus, and 21 reaching no consensus. The experts recommended empiric use of nonopioid antitussive agents for symptomatic relief of acute dry cough. The use of oral antihistamines, oral decongestants, or mucoactive agents as a part of fixed-dose combinations (FDCs) in cough associated with rhinitis or upper airway cough syndrome (UACS) can be considered for symptomatic relief. Maintaining good hydration is important to manage a productive cough. Codeine-based preparations are to be considered as a last resort in patients with an unexplained chronic cough when other treatments have failed. Additionally, insights were captured on red flag signs, nonpharmacologic therapy, special populations, and referral to higher centers. Experts have also proposed a management algorithm with an integrated care pathway approach for acute, subacute, and chronic coughs. CONCLUSION: The present consensus fills the existing need and may guide the physician to successfully diagnose and manage cough in the primary healthcare setting in India.

Fluticasone Furoate/Vilanterol Use Trends and Characteristics in Patients With Obstructive Airway Disease: A Real-World Study of 10,374 Patients From India.

Introduction Obstructive Airway Diseases (OADs) are the leading cause of death among chronic respiratory diseases worldwide, and novel therapies are direly needed. Fluticasone furoate/vilanterol (FF/Vi) (100/25 µg) is the first once-daily ICS/uLABA marketed in India for COPD since 2021. Considering its limited real-world experience in OAD patients in Indian clinical settings, a large drug utilization study (DUS) was planned. Methodology We conducted a cross-sectional, observational DUS at 1900 outpatient clinics in India from October 2021 to March 2022. Prescription data and medical history of patients who were prescribed the FF/Vi combination were collected. Results It was observed that FF/Vi was prescribed in an almost equal number of patients with COPD (44.2%) and asthma (42.9%). The majority of the patients (74%) were switched from previous ICS/LABA to this ICS/uLABA, while 26% of patients were treatment naïve. The average CAT score was 19.5±7.8 (43.2% GOLD Group C and 32.2% GOLD Group B) in COPD patients, while the average ACQ-5 score was 2.6±1.3 (33.1% GINA Step 3, 29.5% GINA Step 2) in asthmatic patients. Most of the patients (63.9%) had raised biomarkers (Blood eosinophil count >300 cells/µl). Prior history of exacerbation was present in 65% of patients with annual exacerbation rates of 1.2 in COPD, 1.1 in asthma, and 1.2 in asthma-COPD overlap syndrome (ACOS). Leukotriene inhibitors (42%) and LAMAs (30.8%) were common add-on medications. Conclusion We observed a trend towards a shift to once-daily ICS/uLABA (FF/Vi) by physicians, especially in symptomatic and exacerbating OAD patients with underlying comorbidities.

ICS/Ultra LABA in the Treatment of Obstructive Airway Diseases: A Consensus of Indian Experts.

Inhaled corticosteroid and ultra-long-acting beta-agonist (ICS/uLABA) combination is a recent advancement in the armamentarium against obstructive airways diseases (OADs). The combination of ICS/uLABA has several advantages, creating a favorable landscape for its utilization. Fluticasone furoate/vilanterol trifenatate (FF/Vi) is one such example of an ICS/uLABA. It offers several benefits from both drugs, such as a convenient once daily dosing schedule; high lipophilicity; high receptor affinity of fluticasone furoate along with high functional selectivity and a quick onset of action of vilanterol. However, the Global Initiative for Asthma (GINA) as well as the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines do not clearly define the positioning of ICS/uLABA compared to conventional ICS/LABAs. There are a few areas of uncertainty especially around the appropriate reliever strategy with ICS/uLABA in Asthma. The current consensus was planned with a group of Indian pulmonology experts to provide more clarity on the potential use of FF/Vi in Asthma and COPD. The clinical statements highlighted in this consensus manuscript address crucial clinical questions revolving around the efficacy and safety of FF/Vi as compared to conventional ICS/LABAs and identify the ideal patient profile for its use. This consensus paper also sheds light upon the appropriate reliever to be used along with FF/Vi in Asthma and the utilization of FF/Vi-based triple therapy in OADs. Expert recommendations mentioned in this paper will serve as guidance to pulmonologists as well as consultant physicians who are involved in providing care to OAD patients and will help them weigh the various factors that need to be taken into account while prescribing ICS/uLABA combination.

The Effectiveness of an Oral Fixed-Dose Combination of Netupitant and Palonosetron (NEPA) in Patients With Multiple Risk Factors for Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Observational Indian Study.

Background Female gender, young age, first chemotherapy cycle, and low alcohol intake have all been linked to an increased risk of nausea and vomiting from chemotherapy. We intended to see if netupitant and palonosetron (NEPA) could prevent chemotherapy-induced nausea and vomiting (CINV) in patients with risk factors such as age, gender, chemotherapy cycle number, and alcohol consumption history. Methods In this retrospective study, chemotherapy-naïve patients who were prescribed netupitant (300 mg) and palonosetron (0.50 mg) (NEPA) before the first cycle of chemotherapy were analyzed for overall, acute, and delayed phases of complete response (CR), complete protection (CP), and control. Results In the acute phase (AP), delayed phase (DP), and overall phase (OP), complete response was 88.23%, 86.27%, and 86.27%, respectively; complete protection was 80.39%, 78.43%, and 76.47%, respectively; and complete control was 76.47%, 72.54%, and 70.58%, respectively, in the whole population (i.e., 51 patients). Complete response, protection, and control in the overall phase were achieved by 86.27%, 72.72%, and 68.18% of patients who received the highly emetogenic chemotherapy (HEC) regimen (i.e., 44 patients), respectively. Conclusion NEPA provided a consistent magnitude of benefit for patients who are at high risk, receiving HEC and moderately emetogenic chemotherapy (MEC), and having good control in the acute, delayed, and overall phases of CINV.

Real-World Experience with Favipiravir for the Treatment of Mild-to-Moderate COVID-19 in India.

Background: Favipiravir, an RNA-dependent RNA polymerase inhibitor (RdRp), is a broad-spectrum oral antiviral agent approved in India under emergency use authorization, for the treatment of mild-to-moderate coronavirus disease (COVID-19). The present study was planned to evaluate the effectiveness and safety of favipiravir in real-world clinical practice. Materials and Methods: This was a multicentric, retrospective, single-arm study conducted across four centres in India, after obtaining permission from the independent ethics committee. Medical records were analysed to evaluate effectiveness and safety of patients who were prescribed favipiravir. Results: The medical records of a total of 360 patients met the inclusion criteria, with 358 of them available for the final analysis. Males made up 58.46% of the study population. The average age of enrolled patients was 51.80 ± 16.45 years. The most common symptoms were fever, cough, and myalgia-fatigue. The median time to clinical cure and fever relief was five and four days, respectively. The average length of stay in the hospital was six days. In total, 8% of the patients experienced adverse events. Hepatic enzyme elevation, diarrhoea, decreased appetite, headache, fatigue, and giddiness were the common symptoms. Conclusion: In our real-world study, favipiravir was found to have a clinical cure rate of more than 90% in mild-to-moderate COVID-19 patients. This supports the use of favipiravir in the treatment of COVID-19. Favipiravir was well tolerated, with only minimal side effects, which were transient in nature.

Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting.

Purpose: To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India. Patients and Methods: This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India. Patients with mild-to-moderate COVID-19 received favipiravir (3600 mg [1800 mg orally twice daily] on the first day, followed by 800 mg orally twice daily, up to a maximum of 14 days) as a part of their treatment. The primary endpoints were to evaluate the safety of favipiravir by assessing the number of adverse events (AEs) and treatment-related AEs. The secondary endpoints were to evaluate the efficacy of favipiravir by assessing time to clinical cure, rate of clinical cure, time to pyrexia resolution, rate of oxygen requirement, and all-cause mortality. Results: A total of 1083 patients were enrolled in this study from December 2020 to June 2021. Adverse events were reported in 129 patients (11.9%), 116 (10.7%) of whom had mild AEs. Dose modification or withdrawal of favipiravir treatment was reported in four patients (0.37%). The median time to clinical cure and pyrexia resolution was 7 and 4 days, respectively. A total of 1036 patients (95.8%) exhibited clinical cure by day 14. Oxygen support was required by 15 patients (1.4%). One death was reported, which was unrelated to favipiravir. Conclusion: In the real-world setting, favipiravir was well-tolerated, and no new safety signals were detected.

Use of single-inhaler triple therapy in the management of obstructive airway disease: Indian medical experts' review.

Obstructive airway disease (OAD), which includes COPD and asthma, is the leading cause of morbidity and mortality in India. Long-acting bronchodilators (long-acting ß2 agonists (LABAs) and/or long-acting muscarinic antagonists (LAMAs)) and inhaled corticosteroids (ICS) have a vital role in the management of patients with OAD. While symptom burden and exacerbations are common amongst treated patients, poor adherence to inhaler therapy is a frequent challenge. Better treatment options that optimise symptom control, improve quality of life, reduce exacerbation risk and improve adherence are desired. Triple therapy (ICS/LABA/LAMA) is recommended in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021 guidelines for symptomatic COPD patients on ICS/LABA or LABA/LAMA, and who are at increased risk for frequent or severe exacerbations. Similarly, add-on LAMA is recommended in uncontrolled asthma patients on medium- to high-dose ICS/LABA by the Global Initiative for Asthma (GINA) 2021 guideline. In the real world, high-risk and overlapping phenotypes exist, which necessitate early initiation of triple therapy. We aim to provide an expert review on the use of single-inhaler triple therapy (SITT) for OAD management in global and Indian settings, knowledge from which can be extrapolated for appropriate treatment of Indian patients. The OAD population in India may benefit from early optimisation to SITT characterised by a high burden of exacerbating OAD, nonsmoker COPD and asthma-COPD overlap.

Real-world Experience with Favipiravir for Treatment of COVID-19 among Indian Healthcare Professionals.

INTRODUCTION: Favipiravir has shown promising results for COVID-19 globally. Though many Indian patients have received favipiravir, there is a lack of realworld data for its clinical use by the practicing physicians. Hence, a qualitative survey was conducted to understand real-world use of favipiravir in management of COVID-19. METHODS: A cross-sectional, web-based, qualitative survey was conducted between September 2020 to October 2020, among Indian physicians from various specialties involved in COVID-19 care and using favipiravir in their practice. Physicians were provided survey link having a structured questionnaire with 32 questions. They were enquired on- 1) demographics,practice information, 2) place of favipiravir in clinical practice, 3) treatment protocol for mild to moderate COVID-19, 4) dosage and duration of favipiravir, 5) effectiveness of favipiravir, 6) tolerability of favipiravir 7) global efficacy and safety assessment of favipiravir. RESULTS: A total of 500 physicians were contacted, of which 50 physicians completed the questionnaire. 25(50.0%) were from south zone followed by 12(24.0%) from west. . Majority physicians (47, 97.9%) stated that favipiravir was used for COVID-19 in outpatient setting. Favipiravir was considered as the current drug of choice for ' mild COVID-19 with fever(86.6%). All physicians agreed that favipiravir was being used as per the recommended dose.. A total of 75% & 62.5% physicians agreed to observed clinical improvement by around 3-5 days & 5-7 days in symptomatic mild & moderate COVID-19 respectively. CONCLUSION: Majority of the physicians considered favipiravir to be safe and effective in treatment of mild to moderate COVID-19.

Sequencing of Systemic Therapies in the Management of Advanced Prostate Cancer in India: a Delphi-Based Consensus.

INTRODUCTION: With the availability of an increasing number of therapeutic options for advanced prostate cancer (APC), optimal sequencing and combination of therapies have emerged to be the areas of challenges. In the Indian context, there is a dearth of consensus recommendations to guide clinicians regarding optimal sequencing of therapy in APC management. A Delphi-based consensus regarding optimal therapy sequencing in APC management was developed by an expert panel of medical oncologists from across India. METHODS: An expert scientific committee of 11 medical oncologists and an expert panel of 53 medical oncologists from India constituted the panel for the Delphi consensus. In the first phase, a questionnaire with 41 clinical statements was developed in several critical controversial areas in APC treatment. In the second phase, 29 clinical statements were reworked and sent to eight experts to obtain their opinions on best practices. The consensus ratings were based on a 9-point Likert scale. Based on the overall response, statements with a mean score of ≥ 7 with 1 outlier were considered as "consensus." RESULTS: Degarelix was the preferred androgen deprivation therapy (ADT). While ADT plus docetaxel was the preferred option for metastatic castrate-sensitive/naïve prostate cancer patients with high-volume disease, ADT with abiraterone was the preferred choice for low-volume disease. Docetaxel was the preferred first-line treatment option in men who received ADT alone in the castrate-sensitive/naïve setting. For patients progressing on or after docetaxel for metastatic castrate-resistant prostate cancer (without prior abiraterone or enzalutamide), the experts reached a consensus on the use of enzalutamide as the preferred second-line treatment option. No consensus was reached for the third-line treatment options. CONCLUSION: This article is intended to serve as a guide to help clinicians discuss with their patients as part of the shared and multidisciplinary decision-making for improved APC management in India.

Comparative efficacy and safety of glycopyrronium/formoterol fixed-dose combination versus glycopyrronium monotherapy in patients with moderate-to-severe COPD.

Background: The safety and efficacy of fixed-dose combination (FDC) of glycopyrronium bromide 12.5 µg/formoterol fumarate 12 µg (GB/FF) twice daily as dry powder inhalers (DPIs) compared to glycopyrronium 50 µg monotherapy (GLY) once daily as DPI in subjects with moderate-to-severe chronic obstructive pulmonary disease (COPD) were evaluated. Methods: This was a phase-3, randomized, double-blind, active-controlled, parallel-group, superiority study conducted in India. COPD patients aged ≥40 to ≤65 years, current or ex-smokers with FEV1/FVC <0.70, using ICS, LAMA, or LABA for ≥1 month were included. Subjects were randomized (1:1) to GB/FF or GLY for 12 weeks. The primary efficacy endpoint was the change from baseline in peak FEV1 at the end of 12 weeks. The study is registered with the Clinical Trials Registry of India (CTRI/2017/02/007814). Results: Between March 2017 and July 2018, 331 patients were enrolled and randomized into GB/FF FDC (165 patients) and GLY monotherapy (166 patients) groups. At week 12, the difference in change from baseline in the peak FEV1 for GB/FF DPI versus GLY was 0.115 L (SE = 0.02; 95% CI = 0.061, 0.170; P < 0.0001). Trough FEV1 increased significantly in the GB/FF group compared to the GLY group with a treatment difference of 0.078 L (SE = 0.02; 95% CI = 0.015, 0.14; P = 0.01). There were no significant differences in adverse events between the groups. Conclusion: FDC of GB/FF (12.5/12 µg twice daily) as a DPI provides superior bronchodilation and lung function improvement over GLY (50 µg once daily) monotherapy. It is safe and well tolerated in symptomatic COPD patients.

A Real-world Study on Prescription Pattern of Fosfomycin in Critical Care Patients.

BACKGROUND: This study presents a real-world scenario for prescription pattern, efficacy, and safety data on the current clinical use of intravenous fosfomycin in critically ill patients in Indian settings. PATIENTS AND METHODS: This was a retrospective cohort study conducted for a period of 10 months among critically ill patients admitted to hospital's critical care unit. The primary objective of the study was to analyze the prescription pattern of intravenous fosfomycin, and the secondary objective was to evaluate the safety profile and patient outcomes. RESULTS: A total of 309 patients were enrolled, and they were diagnosed with bacteremia (45.3%), pneumonia (15.85%), septic shock (14.24%), and urinary tract infections (UTI) (13.91%). The average dose of fosfomycin given was 11.7 ± 4.06 gm/day. The average duration of the therapy was 4.85 ± 3.59 days with a median duration of 4 days. Fosfomycin was given at 8 hourly dosing frequency to maximum (45.6%) cases. Hypokalemia was the most observed adverse event. The overall survival was seen in 55% of patients. CONCLUSION: Our data suggest that UTI, infection caused by Escherichia coli, and a daily dose of >12 g were associated with better clinical outcomes. The overall survival of critically ill patients receiving fosfomycin was 55%. HOW TO CITE THIS ARTICLE: Zirpe KG, Mehta Y, Pandit R, Pande R, Deshmukh AM, Patil S, et al. A Real-world Study on Prescription Pattern of Fosfomycin in Critical Care Patients. Indian J Crit Care Med 2021;25(9):1055-1058.

The effectiveness of NEPA in the prevention of chemotherapy-induced nausea vomiting among chemo naive patients in an Indian setting.

BACKGROUND: Chemotherapy induced nausea- vomiting (CINV) is considered as the most common, feared and most troublesome side effect of chemotherapy. NEPA (NEtupitant 300 mg + PAlonosetron 0.50 mg) is the first commercially available oral fixed-dose combination (FDC) of two active antiemetic agents in India. The present study was planned to evaluate the effectiveness of NEPA in the real world setting of India. METHODS: This was a multicentric retrospective study conducted in two centers in India. The data of all chemonaive patients, who were prescribed NEPA was analyzed. Effectiveness i.e. complete response and complete protection in controlling overall, acute and delayed phase was analyzed. RESULTS: A total of 329 patients were enrolled in the study. 260 received highly emetogenic chemotherapy (HEC) regimen and 69 received moderately emetogenic chemotherapy (MEC) regimen. Among all the enrolled patients, complete response in acute, delayed and overall phase was 93, 85.71 and 85.41% respectively; and completed protection was 88.44, 81.76 and 80.54% respectively. Those who received HEC regimen, the completed response and complete protection in overall phase was 84.61 and 79.61% respectively and those who received MEC regimen the completed response and complete control in overall phase was 84.05 and 84.05% respectively. CONCLUSION: A single oral dose of NEPA targeting dual pathways showed effective control of nausea-vomiting in patients on the HEC and MEC regimens and had good control over nausea-vomiting in acute, delayed and overall phase of nausea-vomiting.

Effectiveness of a novel, fixed dose combination of netupitant and palonosetron in prevention of chemotherapy induced nausea and vomiting: A real-life study from India.

BACKGROUND: A new, oral fixed dose combination of highly selective neurokinin-1 receptor antagonist, netupitant with 5HT3 receptor antagonist, netupitant and palonosetron (NEPA) was approved in India for prevention of chemotherapy induced nausea and vomiting (CINV). AIM: To assess effectiveness of NEPA in real-world scenario. METHODS: We retrospectively assessed the medical records and patient dairies of adult patients who received highly emetogenic or moderately emetogenic chemotherapy (HEC/MEC) and treated with NEPA (Netupitant 300 mg + Palanosetron 0.50 mg) for prevention of CINV. Complete response (CR) was defined as no emesis or no requirement of rescue medication in overall phase (0 to 5 d), acute phase (0-24 h) and delayed phase (2 to 5 d). RESULTS: In 403 patients included in the analysis, mean age was 56.24 ± 11.11 years and 55.09% were females. Breast cancer (25.06%) was most common malignancy encountered. HEC and MEC were administered in 54.6% and 45.4% patients respectively. CR in overall phase was 93.79% whereas it was 98.01% in acute CINV and 93.79% in delayed CINV. Overall CR in HEC and MEC groups was 93.63% and 93.98% respectively. CR was more than 90% in different chemotherapy cycles except in group of patients of cycle 4 where CR was 88.88%. CONCLUSION: NEPA is a novel combination that is effective in preventing CINV in up to 93% cases treated with highly emetogenic or moderately emetogenic chemotherapy. This study brings the first real-life evidence of its effectiveness in India population.

Expert Consensus on Effective Management of Chemotherapy-Induced Nausea and Vomiting: An Indian Perspective.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and feared side effects in cancer patients undergoing chemotherapy. Scientific evidence proves its detrimental impact on a patient's quality of life (QoL), treatment compliance, and overall healthcare cost. Despite the CINV-management landscape witnessing a radical shift with the introduction of novel, receptor-targeting antiemetic agents, this side effect remains a chink in the armor of a treating oncologist. Though global guidelines acknowledge patient-specific risk factors and chemotherapeutic agent emetogenic potential in CINV control, a "one-fit-for-all" approach cannot be followed across all geographies. Hence, in a pioneering attempt, India-based oncologists conveyed easily implementable, region-specific, consensus-based statements on CINV prevention and management. These statements resulted from integrating the analysis of scientific evidence and guidelines on CINV by the experts, with their clinical experience. The statements will strengthen decision-making abilities of Indian oncologists/clinicians and help in achieving consistency in CINV prevention and management in the country. Furthermore, this document shall lay the foundation for developing robust Indian guidelines for CINV prevention and control.

An Observational Study to Evaluate the Prevalence of Erectile Dysfunction (ED) and Prescribing Pattern of Drugs in Patients with ED Visiting an Andrology Specialty Clinic, Mumbai: 2012-14.

INTRODUCTION: Erectile dysfunction (ED) is a common occurrence and its incidence is expected to increase significantly along with the increase in various lifestyle diseases. The drug utilization for ED is very low. Also, studies describing the prescription pattern in ED are lacking. MATERIALS AND METHODS: We conducted a retrospective cross-sectional observational study, including a drug utilization analysis, of 606 prescriptions as per the standard guidelines (WHO and STROBE). RESULTS: Out of 606, 249 (41%) were from the age group of 30-39 years. Addictions were present in 388 (64%). Out of 606, 186 had urological, 154 had cardiovascular and 102 had psychological co-morbid disorders. Out of 348, 201 were prescribed Tadalafil (low dose) on a once daily basis. Out of 172, 121 were prescribed Sildenafil (high dose) on an 'as and when required' basis. Nutritional/ herbal supplements were prescribed in 126/606. The ratio of 'Prescribed Daily Dose' to 'Defined Daily Dose' of Tadalafil, Sildenafil, and Dapoxetine were 1.1, 1.3 and 1.5 respectively. CONCLUSION: Measures for de-addiction play an important role in the overall management of ED. The most common co-morbid disorders were urological, like BPH, LUTS, etc, followed by cardiovascular, psychological and diabetes. Overall, rational pharmacotherapy was observed. Tadalafil was the most commonly prescribed drug for ED. The main factor in the selection of a particular PDE5 inhibitor was its pharmacokinetics and cost. Udenafil, being the costliest, was the least prescribed. Dapoxetine was used in a significant number of individuals primarily for PE with ED. The combination of Papaverine, Chlorpromazine ± Alprostadil was used as intracavernosal injection in patients not responding to oral drugs.

A Knowledge, Attitudes and Practices Survey regarding Sex, Contraception and Sexually Transmitted Diseases among Commerce College Students in Mumbai.

INTRODUCTION: One in four Indians is a juvenile. Sexual crimes, pre marital sex, sexually transmitted diseases and unwanted pregnancies are on the rise. It has been shown that lack of sexuality education can significantly contribute to the above. AIM: We conducted this study to determine the knowledge and awareness of college students regarding sex and related matters and the factors affecting the prevalent outlook and practices of youth towards the same. METHODOLOGY: A prospective cross-sectional survey was conducted amongst 500 students of the K.P.B. Hinduja College of Commerce from December 2012 to March 2013 as per the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. MAIN OUTCOME MEASURES: 1. Sex knowledge scores of males and females regarding contraception, sexually transmitted diseases and HIV/AIDS. 2. Percentage response of males and females to questions depicting attitudes and perceptions regarding premarital sex and promiscuity, sexual fantasy and masturbation, unwanted pregnancies and contraception. 3. Responses depicting participant's premarital and high risk sexual activities. RESULTS: The mean age was 18.6 ±1.6 years, 46% of participants were female. The total sex related knowledge scores of males and females were 8.2±1.2 and 6.2±2.4 (p<0.0001), respectively. 84% males and 72% females disagree that virginity should be preserved till marriage. Premarital sex was reported by 48% males and 18% females. Out of those who had premarital sex, 68% males and none of the females had more than one sex partner and 21% males and 12% females had used a contraceptive during their sexual encounter. 87% males and 82% females disagree that sex education in secondary schools will cause a rise in premarital intercourse. 40% males and 13% females are of the view that birth control is primarily a female's responsibility. 14% of males and 21% of females (p = 0.2) reported being forced to have sex. CONCLUSION: Participants, especially females, lacked basic information about sexuality and related concepts. Male participants had a very casual attitude towards having sex with multiple partners. Premarital sex is more common than once believed. In the light of our finds and the current scenario, sexuality education is indispensable in order to guide the youth to develop and adopt healthy and appropriate sexual practices.