Contrasting clinical characteristics and treatment patterns in women with newly diagnosed advanced-stage epithelial ovarian cancer in Australia, South Korea and Taiwan.

OBJECTIVE: The real-world INFORM study analyzed sociodemographics, treatment patterns and clinical outcomes for patients with newly diagnosed advanced epithelial ovarian cancer (EOC) in Australia, South Korea (S.Korea) and Taiwan preceding incorporation of poly(ADP-ribose) polymerase inhibitors into clinical practice. METHODS: Retrospective data from patients diagnosed with EOC (high-grade serous EOC for Taiwan) between January 2014 and December 2018 with ≥12 months follow-up from diagnosis were analyzed descriptively. Survival was evaluated by Kaplan-Meier with two-sided 95% confidence interval (CI). RESULTS: Of the 987 patients (Australia, 223; S.Korea, 513; Taiwan, 251), 98% received platinum-based chemotherapy (CT). In S.Korea and Taiwan 76.0% and 78.9% respectively underwent primary cytoreductive surgery; in Australia, 56.5% had interval debulking surgery. Bevacizumab was included in primary/maintenance therapy for 22.4%, 14.6% and 6.8% of patients in Australia, S.Korea and Taiwan, respectively. Patients receiving bevacizumab were high-risk (reimbursement policy) and achieved similar real-world progression-free survival (PFS) compared with CT only. Overall, the median real-world PFS (months; 95% CI) was similar across Australia (16.0 [14.63-18.08]), S.Korea (17.7 [16.18-19.27]) and Taiwan (19.1 [17.56-22.29]). CONCLUSION: This study reveals poor prognosis despite differences in demographics and treatment patterns for patients with EOC across Asia-Pacific suggesting the need for biomarker-driven novel therapies to improve outcomes.

Prevalence and risk factors of vascular complications in type 2 diabetes mellitus: Results from discover Middle East and Africa cohort.

Background: We evaluated the prevalence of vascular complications and associated risk factors in individuals with type 2 diabetes mellitus (T2DM) initiating second-line glucose-lowering therapy from the Middle East and Africa (MEA) cohort of the 3-year prospective DISCOVER study involving 15,992 patients in 38 countries. Methods: Baseline cross-sectional data collected from healthcare settings were used to assess micro and macrovascular complications prevalence as crude and age- and sex-standardised. The multi-variable analysis assessed factors associated with these complications. Results: Of 3,525 enrolled patients (mean age: 54.3 ± 10.8 years), >40% had hypertension and hyperlipidaemia. Metformin monotherapy was the first-line therapy in 56.5%, followed by metformin+sulphonylurea (20.3%). Crude and standardised prevalence of microvascular complications were 17.7% and 16.9% (95% confidence interval [CI], 16.77-16.98) and macrovascular complications were 10.7% and 8.7% (95% CI, 8.59-8.76). Factors significantly (p<0.05) associated with micro and macrovascular complications (odds ratios [95% CI]) were age (1.24 [1.12-1.39] and 1.58 [1.35-1.84]), male sex (1.33 [1.04-1.70] and 1.71 [1.22-2.40]), hyperlipidaemia (1.33 [1.07-1.65] and 1.96 [1.46-2.63]) and hypertension (1.75 [1.40-2.19] and 2.84 [2.07-3.92]). Conclusion: A substantial burden of vascular complications with prominent risk factors in the MEA cohort calls for early preventive interventions.

Characteristics and Treatment Patterns of Patients with Type 2 Diabetes Mellitus in the Middle East and Africa Cohort of the DISCOVER Study Program: a Prospective Study.

INTRODUCTION: Despite the high prevalence of type 2 diabetes (T2D) and suboptimal glycemic control in the Middle East and Africa, comprehensive data on the management of T2D remain scarce. The main aim of this study is to describe the characteristics and treatment of patients with T2D initiating second-line glucose-lowering therapy in these regions. METHODS: DISCOVER is a global, 3-year, prospective observational study of patients with T2D enrolled at initiation of second-line glucose-lowering therapy. Baseline characteristics and treatments are presented for patients from 12 countries divided into three regions: Mediterranean, Gulf Cooperation Council, and South Africa. RESULTS: Among 3525 patients (52.5% male, mean age 54.3 years), mean time since T2D diagnosis was 6.2 years [across-region range (ARR) 5.8-7.5 years] and mean glycated hemoglobin levels were 8.7% (72.0 mmol/mol) [ARR 8.6-9.0% (68-75 mmol/mol)]. At first line, metformin was prescribed for 88.1% (ARR 85.4-90.3%) of patients and a sulfonylurea for 34.4% (ARR 12.7-45.4%). Sulfonylureas and dipeptidyl peptidase-4 inhibitors were prescribed at second line for 55.5% (ARR 48.6-82.5%) and 49.0% (ARR 3.7-73.8%) of patients, respectively. Main reasons for choice of second-line therapy were efficacy (73.2%; ARR 60.1-77.7%) and tolerability (26.8%; ARR 3.7-31.2%). CONCLUSIONS: We demonstrate considerable inter-region variations in the management of T2D, likely affected by multiple factors (health system, physician behavior, and patient compliance), all of which should be addressed to optimize outcomes.

The 7+ Habits of Highly Effective Medical Directors.

Medical Directors in the pharmaceutical industry are responsible for fulfilling multiple roles, including scientific expert, conscience keeper and people leader, as well as being the external face of the organisation. The capabilities described in the book The 7 Habits of Highly Effective People® are not just the integral qualities of a successful leader, they are important capabilities that are critical to becoming an impactful medical leader too. As scientific, functional and enterprise leaders, country and cluster Medical Directors must possess these seven qualities. Each of the seven habits can be adapted and utilised to shape the specific areas that Medical Directors are responsible for: intuitive creativity, patient centricity, prioritisation, enterprise leadership, communication and behavioural change, building a team, partnering and scientific and technological leadership. To excel in their function, current and future Medical Directors need to sharpen their existing skills and build specific capabilities. Energy management in physical, mental, emotional and spiritual domains is the way forward.

Medical affairs post-COVID 19: Are we ready to take the baton?

The spread of coronavirus epidemic has resulted in a change in the work schedule for Medical affairs professionals in the pharmaceutical industry. There has been an increase in virtual scientific interactions and prioritization of scientific communication. In the long term, this is likely to affect the structure and responsibilities of Medical affairs teams. New areas such as interactions with patients' groups, leading treatment access in specific channels of health-care delivery and role in specialty care are likely to be an integral part of the Medical Affairs function. Along with that, Medical Affairs teams would take a proactive role in developing platforms for real-world evidence programs and forging cross-industry partnerships. To make this successful, Medical affairs teams will have to build specialized skills such as expertise in healthcare, use of digital technology, patient engagement, and soft skills such as agility and ability to influence. The future of medical affairs is set for a major change.

Developing Medical Affairs Leaders Who Create the Future.

Medical affairs has evolved over recent years from a support, to a partner, to a strategic leadership function. In the future, there will be significant changes in healthcare and pharmaceutical industries, and many of these will be due to technological advances and digitalisation. Medical affairs will be largely influenced by these developments in terms of partnerships with key stakeholders, embracing innovation and patient-centric healthcare, and demonstrating value for novel treatment options. In order to secure future success within their roles, medical affairs professionals will have to demonstrate specific capabilities founded on communications and behavioural change, business leadership acumen, knowledge acquisition and self-development, and the ability to generate real-world evidence from insights and expertise within data science and analytics. It will be our responsibility as medical affairs leaders to create this foundation for the leaders of tomorrow.

Place of sodium-glucose cotransporter-2 inhibitors in East Asian subjects with type 2 diabetes mellitus: Insights into the management of Asian phenotype.

The burden of type 2 diabetes (T2DM) in East Asia is alarming. Rapid modernization and urbanization have led to major lifestyle changes and a tremendous increase in the prevalence of obesity, metabolic syndrome, and diabetes mellitus. The development of T2DM at a younger age, with lower body mass index, higher visceral adiposity, and more significant pancreatic beta-cell dysfunction compared to Caucasians are factors responsible for the increased prevalence of T2DM in East Asians. Sodium-glucose Cotransporter-2 (SGLT2) inhibitors (canagliflozin, dapaglifozin, empagliflozin, etc.) reduce renal glucose reabsorption, leading to favorable effects on glycemic, blood pressure, and weight control. The insulin-independent mechanism enables their use as monotherapy or combination therapy with insulin and other oral antidiabetic agents. The role of SGLT2 inhibitors in the management of T2DM among East Asians is an interesting area of research, given that East Asians have been proven to be uniquely different from Caucasians. This review provides comprehensive coverage of the available literature not only on the efficacy and safety, but also on the recent cardiovascular and renal outcomes of SGLT2 inhibitors, focusing among East Asians.

Intravenous anidulafungin followed optionally by oral voriconazole for the treatment of candidemia in Asian patients: results from an open-label Phase III trial.

BACKGROUND: Candidemia is a significant cause of morbidity and mortality in hospitalized patients, particularly in Asia. Anidulafungin has been reported to be an effective treatment for candidemia in Western populations, but little is known about its efficacy in Asian patients, where the clinical presentation and epidemiology may be different. METHODS: An open-label study of anidulafungin for the treatment of candidemia was recently conducted in several Asian countries. Treatment was initiated with intravenous anidulafungin, given for at least 5 days, with the option to complete treatment with oral voriconazole. The primary endpoint was global (clinical and microbiological) response, and the primary analysis was the proportion of patients in the modified intent-to-treat population with successful global response at the end of therapy. Secondary analyses included proportion with successful global response in clinically relevant patient subgroups. The safety and tolerability profile of anidulafungin and voriconazole in this population was also investigated. RESULTS: Forty-three patients were studied, including 42 in the modified intent-to-treat population. Eighteen patients were > 65 years, the largest age subgroup, and 21 had central venous catheters. The most common Candida species causing infection were C. tropicalis (n = 18) and C. albicans (n = 10). In the primary analysis, 73.8% had a successful global response at end of therapy. Success rates in subgroups were: 72.2% for C. tropicalis and 71.4% for C. albicans infection, 58.8% for patients > 65 years, and 81.0% for patients with central venous catheters. Safety and tolerability were comparable with the known profiles for anidulafungin (and voriconazole). CONCLUSIONS: Although the epidemiology of Candida infections was different in this open-label study, the efficacy of anidulafungin in Asian patients with documented candidemia was consistent with previous studies in Western populations. No new safety concerns were identified. TRIAL REGISTRATION: http://www.clinicaltrials.gov identifier NCT00537329.

Evolving role of pharmaceutical physicians in the industry: Indian perspective.

The Indian pharmaceutical industry, like any other industry, has undergone significant change in the last decade. The role of a Medical advisor has always been of paramount importance in the pharmaceutical companies in India. On account of the evolving medical science and the competitive environment, the medical advisor's role is also increasingly becoming critical. In India, with changes in regulatory rules, safety surveillance, and concept of medical liaisons, the role of the medical advisor is evolving continuously and is further likely to evolve in the coming years in important areas like health economics, public private partnerships, and strategic planning.

Conducting feasibilities in clinical trials: an investment to ensure a good study.

Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan in comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension.

AIM: To compare the efficacy and tolerability of Xalatan with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). MATERIALS AND METHODS: This was a single-center, randomized, open label, crossover, two period comparative study. At the baseline visit, subjects were randomized to two groups. Group A received Xalatan for weeks 1-12 followed by Latoprost for weeks 13-24. Group B received Latoprost for weeks 1-12 followed by Xalatan for weeks 13-24. RESULTS: 30 subjects were recruited, 12 in Group A and 18 in Group B. In subjects administered Xalatan, intraocular pressure (IOP) showed a greater decrease (P < 0.001) from 23.64 +/- 3.13 mmHg at baseline to 14.29 +/- 1.61 mmHg at week 12 (fall of 9.35 +/- 3.55 mmHg, 38.66% +/- 10.29) than that seen in the Latoprost group (22.74 +/- 2.47 mmHg to 16.98 +/- 2.49 mmHg, fall of 5.76 +/- 1.41 mmHg; 25.42% +/- 5.98). In period 2 when subjects were crossed over to Xalatan from Latoprost, there was a further fall from 16.98 +/- 2.49 mmHg to 16.09 +/- 1.49 at week 24 (fall of 0.89 +/- 1.59 mmHg; 4.3% +/- 8.76). However, when subjects were crossed over to Latoprost from Xalatan, the IOP rose from 14.29 +/- 1.61 mmHg to 15.36 +/- 1.71 mmHg at week 24 (8.86% +/- 17.76). There was no significant difference in incidence of conjunctival hyperemia or any other adverse events in both the groups. CONCLUSION: The magnitude of IOP lowering in patients with POAG and OH with Xalatan and Latoprost is different. In our study, the IOP lowering with Xalatan was higher than that with Latoprost.