Case Studies

DATA ABSTRACTION

Gastric cancer is the third most common cause of cancer-related death across the world. Treatment of gastric cancer generally involves surgery followed by chemoradiation therapy or chemotherapy. Our client wanted to evaluate the safety and efficacy of commonly used chemotherapeutic medications for gastric cancer management. In order to assist our client to develop a systematic review on this topic we screened 3956 studies for 1st pass, 384 studies for 2nd pass, 6 conference abstracts (American Society of Clinical Oncology and European Society for Medical Oncology etc.) and finally we abstracted data from 45 studies.

Colorectal cancer is a malignant tumor arising from the inner wall of the large intestine (colon) or rectum and treatment primarily depends on the location, size, and extent of cancer spread, as well as the health of the patient. Surgery is the preferred treatment method. However, treatment of patients with nonresectable and resectable colorectal cancer at an advanced stage is challenging and necessitates the initiation of chemotherapy, use of signaling inhibitors and monoclonal antibodies (mAbs) that can extend life and improve quality of life of the patients. Our client wanted to develop a systematic literature review on the efficacy and safety of monoclonal antibodies in colorectal cancer management. We assisted with 1st pass screening of 1974 studies, 2nd pass screening of 142 studies and finally extracted data from 15 studies.

Disease-modifying antirheumatic drugs (DMARDs) are a group of drugs often used for the treatment of rheumatoid arthritis (RA) as they suppress overactive immune and/or inflammatory systems of the body. The choice of DMARD is dependent on a number of factors, such as the stage and severity of the joint disease, possible side effects, desired outcomes and patient preference. A systematic literature review was aimed to update the body of evidence on the use of DMARDs in RA. To cater to this objective, we provided the client with data that was extracted from 65 studies.

Asthma is a chronic lung disease that inflames and narrows the airways in the lungs and affects a significant proportion of individuals across the world. Our client wanted to examine the current prevalence and available treatment for this condition. We screened 4972 studies for 1st pass, 647 studies for 2nd pass and finally data was extracted from 75 studies. We also provided the client with a complete shell report of the findings on this topic that could be used to generate a systematic literature review on this topic.

Atopic dermatitis (AD), also known as atopic eczema, is a type of skin inflammation resulting in itchy, red, swollen, and cracked skin. It is a pruritic condition that is generally treated with immunosuppress agents. Our client wanted to design a systematic literature review on the role of systemic immunosuppressive therapy for the treatment of AD. We screened approximately 2983 studies for 1st pass, 245 studies for 2nd pass and subsequently extracted data from 47 studies. Additionally, we determined the risk of bias of the included studies using the Cochrane Risk of Bias Tool. The data provided to the client resulted in two systematic literature reviews on this topic.

Overactive bladder is a condition characterized by a sudden urge to urinate (urge incontinence) and may even lead to the involuntary loss of urine (urinary incontinence). It affects the social life of the patients. However, suitable evaluation can aid in determining the specific cause for overactive bladder symptoms. Our client wanted to develop a systematic literature review on patient-reported outcomes in overactive bladder. The primary focus was to understand the general perception of this condition and the need to determine the clinical effectiveness of available treatment regimes. We assisted the client with relevant data extraction from 5 studies.

Breast cancer is the most common cancer in women with more than a million affected individuals across the world. The choice of treatment majorly depends on the type and stage of breast cancer, age and overall health. Often patients are recommended to undergo systemic treatment with chemotherapy. Our client wanted to determine the safety and efficacy of existing chemotherapy for breast cancer. We provided assistance by searching for relevant information from PubMed, EMBASE and Cochrane, followed by screening of approximately 6452 studies for 1st pass, 686 studies for 2nd pass and finally extracted data from 98 studies. The data provided was to be used by the client to generate a systematic literature review on the said topic.

Diabetes Mellitus (DM) is a metabolic disorder characterized by the presence of chronic hyperglycemia. DPP-4 inhibitors are a class of oral hypoglycemics commonly used for the treatment of DM. DPP-4 inhibitors block the action of the DPP-4 enzyme, which destroys the hormone incretin. Incretin in turn helps to maintain the desired insulin levels. Our client wanted to develop a systematic literature review on the clinical effectiveness of DPP4 inhibitors in DM management. We screened approximately 3467 studies for 1st pass, 438 studies for second pass and abstracted data from 86 studies. We provided the information to the client in a comprehensive format as a shell report.

Age-related macular degeneration (AMD) is an acquired degeneration of the retina that causes significant central visual impairment through a combination of non-neovascular and neovascular derangement. AMD is a disease of over 45 years of age and prevalence increases with age. Apart from risk factor modification and nutritional supplementation, intravitreal injections of anti-VEGF agents or laser therapy are also used for the treatment of AMD. A client wanted to determine the prevalence and available treatment regimens for AMD. We assisted with 1st pass screening of approximately 2865 studies, 2nd pass screening of 287 studies and subsequent data extraction from 47 studies. The data was used by the client to develop a systematic literature review.

Endstage kidney or renal disease (ESRD) is the last stage of chronic kidney disease leading to permanent kidney damage. Diabetic or hypertensive individuals are at the highest risk of developing ESRD. Specific treatment for renal failure is determined based on the extent of the disease, overall health, and medical history of the patient. Erythropoiesis-stimulating agents are used for the treatment of ESRD as it maintains hemoglobin at the lowest level and minimizes transfusions. Our client wanted to conduct a network meta-analysis to evaluate the global estimate of comparative treatment effectiveness of erythropoiesis-stimulating agents in the management of ESRD. To cater to the client’s objective, we screen approximately 5978 studies for 1st pass, 643 studies for 2nd pass, 12 conference abstracts and finally extracted data from 94 studies. The information was provided to the client in a comprehensive format as a shell report.

Graft-versus-host disease (GVHD) is major complication of allogeneic stem cell transplant used as a treatment for leukemia or lymphoma. GVDH can be life threatening. Our client wanted to develop a systematic literature review on the general attributes of GVDH, focusing primarily on the prevalence and the quality of life of the patients. We extracted relevant information from 110 studies to meet the objective.

Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer accounting for approximately 85% of all lung cancers. Mostly surgery, radiofrequency ablation, radiation therapy, chemotherapy, immunotherapy are used to treat NSCLC. The client wanted to determine the clinical effectiveness of a monoclonal antibody for the immunotherapy (both mono and in combination) of advanced NSCLC. In order to assist our client to develop a systematic review on this topic we screened approximately 1473 studies for 1st pass, 482 studies for 2nd and subsequently extracted data from 194 studies.

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease characterized by obstructed airflow from the lungs. There are several recommendations for the management of COPD. Early diagnosis, lifestyle changes and treatment with appropriate medication can slow the progress of this condition. In order to support the global reimbursement of add-on treatment in COPD, a clinical research organization wanted to obtain the relevant economic evidence on COPD. We provided assistance by extracting data on the prior economic models, cost of illness and healthcare resource utilization from approximately 66 studies. The data abstracted was used by the client to generate a systematic literature review on the said topic.

Cytomegalovirus (CMV) is a common virus belonging to the order Herpesvirales and is globally widespread. The unique feature of this virus is that it can remain latent for long period and cause reinfection when the host is immuno-compromised. CMV is a concern for solid organ transplant (SOT) and stem cell transplant (SCT) recipients and can be life threatening. A clinical research organization wanted to develop a systematic literature review on the clinical effectiveness of anti‐CMV agents in the treatment of CMV infected individuals who have undergone solid organ transplantation (SOT) or stem cell transplantation (SCT). We provided assistance by abstracting relevant information from 85 studies.

Chronic kidney disease (CKD) is a condition characterized by gradual loss of kidney function over time. CKD is prevalent among the elderly population and associated with an increased risk of cardiovascular disease and chronic renal failure. It is a global health burden with a high economic cost to health systems. Our client wanted to develop a systematic literature review on the general attributes of CKD, with special focus on the overall quality of life of CKD patients and the cost-effectiveness of the existing treatment modalities. We assisted by abstracting relevant information from 87 studies.

VALUE STORY DEVELOPMENT

Multiple myeloma is a common hematologic malignancy that has been on rise in Asian countries. Our team aided a pharmaceutical client in generating evidence to demonstrate and support the value of a drug (a selective proteasome inhibitor) for the treatment of multiple myeloma in certain Asian nations. To strengthen the value story, we gathered relevant information through extensive literature search. Approximately 2384 studies were screened for 1st pass, 278 studies were screened for 2nd pass and data was abstracted from 56 studies. Additionally, we developed the value story of the pharmaceutical product of interest based on the data that characterized Natural history of disease in the particular Asian locations, Burden of illness in those regions, common patterns of care, unmet or under-addressed medical need and benefit-risk profile of the desired pharmaceutical agent

HEOR MEDICAL WRITING

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Treatment primarily aims at preventing pulmonary embolism (PE), reduce morbidity, and minimize the risk of post-thrombotic syndrome. So far the mainstay of medical therapy has been anticoagulation. A pharmaceutical company wanted to compare the cost-effectiveness of two anticoagulant drugs used for the treatment and prevention of VTE. The source document and the manuscript outline were provided to us and we assisted our client with drafting the manuscript. The abstract of the manuscript was presented at a conference.

Neurogenic bowel dysfunction (NBD) can be defined as the loss of normal bowel function due to nerve injury, neurological disease. It deteriorates the quality of life of the affected individuals. Transanal irrigation (TAI) is considered a good, non-invasive, and favorable treatment alternative for patients with NBD. Our client wanted to evaluate the cost-effectiveness of using TAI device (popularly used in the western world) in an Asian country. The translated version of the manuscript was provided and we assisted the client with editing the manuscript for clarity and proper use of English. The abstract was entirely drafted by us and we provided comments explaining all extensive revisions, logical gaps, and suggestions. Additionally, we formatted the manuscript to conform to the target journal guidelines.

Chikungunya (CHIK) is a mosquito-borne viral infection.  The acute infection phase is usually followed by chronic arthralgia or myalgia characterized by swelling and debilitating chronic joint pain that mimics rheumatic arthritis. There are no published guidelines for the treatment of such condition and therapy is often limited to the use of analgesics and steroids for symptomatic care. Our client wanted to publish a review to highlight the need for appropriate pharmacologic treatment guidelines to manage pain. The outline of the review was provided to us. We drafted the manuscript based on extensive literature search and formatted it in accordance with the target journal guidelines. The manuscript is currently under peer review.

SYSTEMATIC REVIEWS AND META-ANALYSIS

The role of Calcium Channel Blockers (CCBs) in the reduction of Parkinson’s Disease (PD) has gained increasing attention. The client wanted to examine the protective role of CCBs use in reducing PD. PubMed, EBSCO, and Cochrane library was searched for observational studies on the association between CCBs use and incidence of PD. Based on the selection criteria, out of 626 articles, only six studies (three cohort studies and three case-control studies) involving a total of 27,67,990 subjects including 11,941 cases of PD were selected for the meta-analysis. The random-effects model was used to determine the pooled relative risk (RR) estimates and 95% confidence intervals (CIs). Additionally, subgroup analyses, sensitivity analysis, and cumulative meta-analysis were also performed. Pooled analysis of the observational studies strongly indicated the neuroprotective role of CCBs in significantly reducing the risk of PD.

 

Results of this MA were published in a peer reviewed journal.

In patients with primary hyperparathyroidism (PHPT), vitamin D deficiency is a common occurrence that often worsens the patients’ condition. The safety of vitamin D replacement therapy in such patients is not well studied. Our client wanted to evaluate the safety of vitamin D replacement therapy in patients with PHPT. Medline, EMBASE, Cochrane CENTRAL and abstracts form annual scientific meetings of various international bone and mineral societies were searched for relevant information. Out of 310 publications and 90 abstracts identified, only 10 studies enrolling 340 PHPT patients were included in the meta-analysis. The biochemical data was expressed as pooled mean difference (with 95% CI) and sensitivity analysis was conducted after exclusion of studies reporting outlying data. Alongside, the use of random effects model and test for heterogeneity using the I2 statistic, funnel plots were also constructed to determine any publication bias. It was found that vitamin D replacement therapy in mild PHPT with coexistent vitamin D deficiency results in increased 25 (OH) D and significant reduction of parathyroid levels without demonstrating any signs of hypercalcaemia or hypercalciuria.

 

Results of this MA were published in a peer reviewed journal.

A semisynthetic ergot derivative has been widely used in more than 50 countries for the treatment of the older population suffering from cognitive, affective and behavioural disorders. However, safety concerns for its use wereraised by the European Medicines Agency’s(EMEA) as it is an ergot derivative. Our client was keen on assessing the safety profile of the semisynthetic ergot derivative as compared to placebo and other active agents reported in published randomized controlled trials (open-label or blinded). A comprehensive search strategy was designed to retrieve relevant clinical information from MEDLINE, Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Cochrane Methodology Register (CMR). Only head-to-head comparisons between interventions were considered for this meta-analysis. Literature search yielded 437 separate references, out of which 56 potentially relevant references were identified after first pass that was further narrowed down to 29 references based on the inclusion criteria. This systematic review and meta-analysis suggested that despite being an ergot derivative the agent is a safe and well-tolerated drug.

 

Results of the SR and MA were published in a peer reviewed journal.

A particular drug belonging to the janus kinase inhibitor class is approved for the treatment of rheumatoid arthritis (RA). However, there have been increasing concerns regarding the associated adverse effects. Our client was keen on determining the efficacy and safety of the drug for the treatment of RA. PubMed, ClinicalTrials.gov, and Cochrane Library were searched to retrieve relevant information from Phase II and Phase III randomized clinical trials. Based on the inclusion criteria a total of 8 studies (4 studies each of Phase II and Phase III trials) were included in the review. The results revealed the effectiveness of the drug in the management of moderate to severe RA in patients who responded inadequately to methotrexate and tumor necrosis factor inhibitors.

 

Results of the SR and MA were published in a PubMed indexed journal.

REAL WORLD DATA/ORIGINAL RESEARCH

Rheumatoid arthritis (RA) is a medical condition characterized by inflammatory joints and disease‑modifying antirheumatic drugs (DMARDs) are commonly used for treatment. Methotrexate (MTX) is the most effective DMARD and other DMARDs are not as effective in MTX-refractory patients. Recent use of biologic response modulators (BRMs) for RA therapy has been reported to be clinically superior and leads to significant improvement in clinical outcomes. Our client wanted to compare the clinical outcomes of using different BRMs for patients showing no or limited response to DMARD therapy. The study was conducted at a reputed hospital in Mumbai (india) and 19 patients were selected based on the eligibility criteria. Treatment with BRMs improved clinical outcomes and different BRM agents were equally effective in patients with RA.

 

The findings were published in a leading Indian journal.

Systemic sclerosis (SSc) is a highly prevalent connective tissue disorder across the world. Although thyroid dysfunction, hypothyroidism, and antibody positivity are associated with this condition, limited studies have focused on link between thyroid volume and thyroid functions in patients with SSc. Our client wanted to correlate thyroid dysfunction with thyroid volume in patients with SSc. A single-center, prospective, cross-sectional study was carried out at a tertiary care hospital in North India and a total of 106 patients were included in this study. One-sample Kolmogrov-Smirnov test for normality was used for measurable data. Mean ± SD was used to present normally distributed data and interquartile range (IQR) was used for skewed data. Coefficient of correlation for normally distributed and skewed data was determined using Pearson’s and Spearman’s method, respectively. The study found thyroid volume was correlated with disease severity and absence of antithyroid antibodies indicated thyroid dysfunction to be a consequence of thyroid fibrosis.

 

The results were published in a PubMed indexed journal.

Patients with systemic lupus erythematosus (SLE) are at a high risk of developing subclinical atherosclerosis. Changes in endothelial function have been linked to the development of atherosclerotic lesions. Carotid intima-media thickness (CIMT) and flow-mediated dilation (FMD) of the brachial artery are two popular non-invasive techniques that aids in examining different aspects of endothelial function. Our client hypothesized an increased risk of atherosclerosis in SLE patients. Their objective was to determine the CIMT and endothelial dysfunction using FMD, and correlate the findings with the disease activity index. A single-center, cross-sectional study was conducted in accordance with the ICH-GCP and ICMR guidelines at a reputed medical institute in India. ANOVA /independent sample t-test followed by Tukey’s post-hoc test was performed and Pearson’s test was used to measure correlation. It was found that the disease severity was high in SLE patients with nephritis, which leads to increased risk of arterial stiffening and endorgan damage. Overall, FMD was found to be a non-invasive and efficient method to assess endothelial dysfunction.

 

Results of this study were published in a PubMed indexed journal.

Vitamin D deficiency has often been linked to chronic low back pain (CLBP). In many patients, vitamin D deficiency remains undiagnosed therefore untreated leading to persistent, musculoskeletal pain as observed in CLBP. So far no prospective studies have focused on the prevalence of vitamin D deficiency in Indian patients with CLBP. The client wanted to determine the prevalence of vitamin D deficiency in Indian patients and its role in CLBP. Data were obtained from a controlled, open label, single arm clinical trial that assessed the effectiveness of vitamin D supplementation in patients with CLBP. The study was conducted in an outpatient pain clinic of a tertiary care hospital. The findings were reported in accordance with the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) guidelines. Pain and functional disability was determined. Chi-square test and independent t-test was used for the categorical and continuous variables, respectively. Multivariate logistic regression model, univariate analysis of variance (ANOVA) and post hoc Bonferroni test was also used for statistical analysis. The study revealed increased prevalence of vitamin D deficiency among Indian patients with CLBP and indicated the importance of determining the vitamin D status for effective management of CLBP.

 

The results were published in a PubMed indexed journal.

A drug belonging to the class of statins has been reported to successfully reduce low-density lipoprotein cholesterol (LDL-C) and is considered the most efficacious lipid-lowering agent. However, limited studies have compared the efficacy and safety of three commonly used doses of this drug in Indian patients with hyperlipidemia. Hence, our client conducted a multi-center, open-label, non-randomized, parallel group study, in which a total of 219 hyperlipidemic patients of Indian origin were subjected to different doses of the drug. Efficacy endpoints were determined as percentage change from baseline in LDL-C, total cholesterol, high-density lipoprotein cholesterol (HDL-C) and triglycerides. The starting doses of the drug was found to improve the lipid parameters in hyperlipidemic patients in real world clinical settings and the effectiveness of the drug in Indian patients was consistent with that observed in the Western and other Asian populations.

 

The findings were published in a leading Indian journal.

Diabetes affects a major proportion of the Indian population. Single anti-diabetic agents are not always effective in controlling this condition. Our client wanted to determine the combined effectiveness of two anti-hyperglycemic agents with complementary mechanisms of action in managing diabetes. An open, prospective, multicenter, single-arm, non-interventional study was conducted across several sites in India. The study was registered under the ClinicalTrials.gov and the Clinical Trial Registry of India. Postprandial glucose, fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c) levels were measured to determine the clinical effectiveness of the drugs. This study found that the combination of the two anti-hyperglycemic agents was well tolerated, safe and efficacious in Indian patients and could be considered a treatment option for diabetes management.

 

The results were published in a PubMed indexed journal.

Hyperglycemia over a prolonged period can damage peripheral nerves and result in increased risk of hand and foot ulcers even resulting in amputations. Such peripheral nerve dysfunction is referred to as diabetic peripheral neuropathy (DPN), a major complication of type 2 diabetes mellitus. While several studies have focused on the prevalence of DPN among the Western population, there is limited data on the prevalence of this condition among the Asian populations, specifically the north Indian population. Our clients not only wanted to assess DPN prevalence in general but also compare the prevalence among populations with established diabetes mellitus and newly detected diabetes mellitus. They also wanted to identify the associated risk factors and possible sex-specific variations. A cross-sectional epidemiological study was conducted at a tertiary care hospital. Student’s t-test, Mann–Whitney U-test or χ2-test, multivariate logistic regression and Kaplan–Meier survival curves were used as a part of the statistical analysis.  The study indicated a high prevalence of DPN among the type 2 diabetes mellitus patients and indicated the importance of early diagnosis and timely screening to prevent DPN progression.

The results were published in a PubMed indexed journal.

Patients undergoing major surgeries or trauma often suffer from metabolic or immunologic imbalances leading to immune suppression and consequential susceptibility to infections. Lipid-derived fatty acids, such as polyunsaturated omega-3 fatty acids, have been reported to demonstrate pharmacological properties that can improve post-surgery healing. However, there is limited information on preoperative omega-3 fatty acid administration and its role in inhibiting inflammatory responses. Our client wanted to examine the anti-inflammatory effects of intravenous supplementation of omega-3 fatty acids from fish oil in elderly patients subjected to hip surgery. A controlled, randomized, single center, comparative, phase IV study was conducted in accordance with the ICH GCP standards. Standard statistical methods including paired and unpaired t-test were used to analyze the data. This study suggested short-term anti-inflammatory role of omega-3 fatty acids in patients subjected to hip surgery.

 

The results were published in a PubMed indexed journal

Diabetes is a growing health concern across the world and is an increasing health burden in India. Certain anti‑diabetic agents play a direct role in carbohydrate uptake and an indirect role in the optimization of glucose metabolism. Our client wanted to evaluate the efficacy of an alpha glucosidase inhibitor in diabetes management. A prospective, non‑interventional, non‑controlled, multicenter, observational study was conducted. Outcome measures such as postprandial glucose, fasting blood glucose and glycosylated hemoglobin levels were recorded at each visit in accordance with the standard procedures. Although data was collected from 15 countries/regions, the results focused on the sub‑analysis data of the Indian population. The study confirmed the safety and efficacy of the non‑insulinotropic oral anti‑diabetic agent in Indian diabetic patients and also reported that the drug was successful in reducing the weight of patients with T2DM.

 

The findings were published in a PubMed indexed Indian journal.

Breast cancer is a common malignancy in women across the world. Paclitaxel is a cytotoxic drug used in combination with doxorubicin and carboplatin to treat metastatic breast cancer. The similarity of two regularly used brands of paclitaxel had not been examined in a clinical trial setting. The client wanted to compare the efficacy and safety of the two brands when administered in combination with other cytotoxic agents, in patients with metastatic breast cancer. A prospective, controlled, randomized, multicentre, open-label phase IV study was conducted, which included 49 patients. Kaplan–Meier method was used to assess the patient data and Fisher’s exact test and ANOVA was used for statistical analyses. The study did not find any difference between the two brands of paclitaxel in terms of safety and efficacy when used in combination with other cytotoxic agents for the treatment of metastatic breast cancer.

 

The results were published in a PubMed indexed journal.

Topical non-steroidal anti-inflammatory drugs (NSAIDs) are a preferred over topical steroids to control inflammation post cataract surgery and a preservative-free variation is considered the most effective. While the clinical effectiveness of the preservative-free NSAID in reducing cystoid macular edema (CME) and macular thickening in patients with cataract surgery is well established across many countries, its safety and efficacy was not studied in Indian patients. The client wanted to evaluate the safety, tolerability and efficacy of the preservative-free NSAID in controlling inflammation in Indian patients who were subjected to cataract surgery. A retrospective, open-labeled, single-arm study was conducted and data was obtained from the records of 96 cataract patients. The results confirmed that the preservative-free NSAID successfully reduced ocular inflammation and was well-tolerated in patients after cataract surgery.

The findings of the study were orally presented at an international conference.

Early Nutritional Support is considered important for ICU management. Previous observational studies have indicated adverse clinical outcomes as a consequence of cumulative calorie debt. Our client hypothesized that early and goal directed enteral nutrition (EN) support to meet the calorie debt could lead to better outcomes. A retrospective observational study was conducted at a multidisciplinary ICU in a tertiary health care facility in India. The data obtained indicated that early initiation and goal directed EN could improve clinical outcome and thus aid in effective ICU management.

The findings of the study were presented as a poster at an international conference.

Diabetic nephropathy can lead to end stage renal disease (ESRD). Patients with chronic kidney diseases are put on low protein and very low protein diets to improve associated metabolic disorders and uremic symptoms. However, it is important to ensure that the diet fulfills the essential amino acid and energy requirements of the patients.  Our client wanted to determine the efficacy and safety of low protein diet supplemented with keto-analogues of essential amino acids and its superiority over low protein diet without such supplementation. A randomized control trial was conducted at a reputed hospital in Mumbai and a total of 48 patients with diabetic nephropathy were included in this study. The demographic features, post-treatment survival probability etc. were studied. The results suggested the clinical effectiveness of supplemented low protein diet in delaying kidney complications that leads to ESRD. Additionally, the supplemented diet was found to be safe, improve metabolic conditions, and met the nutritional requirement of the patients.

 

The findings were presented as a poster at an international conference.

A diterpenoid natural product is a well-established chemotherapy medication owing to its anti-cancer properties. The drug is usually hydrophobic that restricts its usage as an anti-cancer agent. Also, commonly used formulations of this drug are responsible for serious side effects such as hypersensitivity, nephrotoxicity, and neurotoxicity, which necessitate the use of improved formulations. There are reports on nanoparticle carriers that enhance drug solubility and improve its delivery to the target cells or organs. Our client wanted to examine the advantages of a nanoparticle-based drug delivery system to improve tumor targeting efficiency of the anticancer drug. The drug of interest was delivered as nanomicelles with a polymeric carrier that specifically targeted tumors (breast, ovary and non-small cell lung carcinoma). The efficacy of this nano-formulation was compared to two regular formulations of the anti-cancer drug. The results revealed the superiority of the nanoparticle-based formulation as a tumor targeting agent.

 

Results were published in a peer reviewed journal.

CASE SERIES

Pancreatic cancer is responsible for a large proportion of cancer related deaths across the world. Radical complete resection is considered the best available treatment, however, resectable forms are observed in only 10-20% of the patients during diagnosis. A chemotherapy drug, gemcitabine is commonly used for the treatment of advanced/ metastatic pancreatic cancer. Another anticancer agent, nab-paclitaxel has been reported to improve overall survival in phase III trials. Our client wanted to evaluate the response of patients with advanced pancreatic cancer to treatment with nab-paclitaxel in combination with gemcitabine. The results revealed that the efficacy of gemcitabine improved when used in combination with nab-paclitaxel.

 The findings were published in a peer reviewed journal.

Ovarian cancer is considered as one of the lead causes of cancer related deaths in women world-wide. An albumin-bound anticancer drug increases intra-tumoral concentration of the agent via a receptor-mediated transport process. Our client wanted to test the efficacy of the albumin-bound anticancer agent in treating ovarian cancer under three different settings: 1) albumin-bound anticancer agent in combination with carboplatin in adjuvant setting, 2) albumin-bound anticancer agent in combination with carboplatin and bevacizumab as second line chemotherapy for relapsed ovarian cancer, and 3) albumin-bound anticancer agent with cisplatin add-on as third line chemotherapy. It was found that the albumin-bound anticancer drug was well-tolerated by patients in all the three settings.

 

The findings were published in a PubMed indexed journal.

Autoimmune inner-ear disease (AIED) is a rare autoimmune disorder characterized by progressive hearing loss. Of the several medical therapies proposed for the treatment of AIED, corticosteroid therapy is considered the most effective. Commonly tumor necrosis factor-α inhibitors are administered in combination with corticosteroids for favorable outcomes. The client examined the use of a popular anti-TNF drug in an AIED patient who developed inflammatory polyarthritis (IPA) and was non-responsive to therapy with steroids. The findings confirmed that the anti-TNF agent was successful in managing IPA in the patient with AIED.

The findings were presented at the Indian Rheumatology Association Conference.

REVIEWS

Hypertension is considered a global epidemic and is a major risk factor for stroke, myocardial infarction, vascular disease, and chronic kidney disease. A significant proportion of the Indian population is affected with hypertension. It has been found that along with blood pressure (BP) reduction it is important to control hypertension related blood pressure variability (BPV) to reduce the risk of stroke. A particular calcium channel blocker has been considered as an effective antihypertensive agent and is popularly used as it dilates blood vessels and improves blood flow. Our client wanted to review the efficacy of the particular calcium channel blocker in controlling BPV in hypertensive patients. The review suggested that the calcium channel blocker of interest could effectively control hypertension related BP, BPV and reduce the risk of stroke.

 The review was published in a leading pubmed indexed Indian journal.

Cognitive function disorders (CFDs) are a group of neurocognitive disorders that majorly impairs the cognitive function of an individual owing to disruption in one or more of the cognitive domains. Such disorder progress subtly and significantly impedes the quality of life of the affected individuals. Cholinesterase inhibitors are popularly used for the treatment of cognitive disorders. A semisynthetic ergot alkaloid derivative is commonly prescribed for dementia as it is responsible for selective inhibition of acetyl cholinesterase, decreases vascular resistance and increases arterial blood flow in the brain. It has also been reported to enhance norepinephrine and dopamine turnover in certain areas of the brain. However, as an ergot derivative there are concerns regarding its safety. Our client wanted to review the pharmacology of the concerned ergot derivative with special emphasis on the safety of this compound, especially when used in patients with cognitive disorders. The review revealed that despite the concerns raised the ergot derivative had a good safety profile, was well tolerated and effective for therapeutic management of CFD.

The review was published in a PubMed indexed journal.

Vitamin D deficiency is a common occurrence and has been linked to several medical conditions including rickets in children to osteoporosis in adults. It also contributes to diabetes, metabolic disorders and cardiovascular disease. Our client wanted to review the pathophysiology of vitamin D deficiency and the associated clinical complications. A detailed review indicated the requirement for novel guidelines on Vitamin D supplementation to achieve better treatment outcomes, improve morbidity and patient health.

 The findings were published in a PubMed indexed journal.

Insomnia is a highly prevalent sleep disorder that regularly affects millions of individuals across the world. Several physical and psychological factors can contribute to insomnia. Despite the common occurrence, diagnosis and treatment of this condition is not adequate. Benzodiazepines are psychoactive drugs that were commonly used for the treatment; however, recently non-benzodiazepine drugs have been suggested for therapy. Our client wanted to focus on the role of one such non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class for the treatment of insomnia. The review indicated that the non-benzodiazepine medication was well tolerated and effective for the management of insomnia.

 The review was published in a PubMed indexed journal.

Toxic reactive oxygen species (ROS), such as hydrogen peroxide, organic hydro peroxides, nitric oxide, superoxide and hydroxyl radicals etc. are constantly produced under physiological conditions and results in oxidative stress. The resultant imbalance in pro-oxidant/antioxidant homeostasis is responsible for the pathogenesis of different diseases. Our client wanted to obtain clinical evidence from global studies on the critical role of ROS in deteriorating human health and the importance of superoxide dismutase (SOD) in ameliorating the ROS toxicity. Electronic databases (Medline, Pubmed) were searched to identify relevant studies (peer reviewed case studies, observational studies, case control and cohort studies). Extensive data suggested the major role of ROS in the causation of several diseases. It also indicated that in order to maintain defense against ROS, SOD as an exogenous source would be necessary for anti-oxidative defenses.

The paper presented as a poster at an Indian conference.

Diabetic individuals are at increased risk of peripheral arterial disease and neuropathy. Long-term diabetes can cause nerve damage and poor blood flow leading to diabetic foot (DF). It is a major complication that increases the risk of infection, gangrene and amputation in affected individuals. Our client wanted to review the recent advances and evidences that could improve DF management. Medline and Pubmed were searched for relevant information (peer reviewed case studies, observational studies, case control and cohort studies) on DF as a major complication of diabetes. Data obtained indicated major gaps in novel approaches for DF prevention. It was concluded that appropriate awareness regarding diabetes related foot complications, importance of footwear and  regular checkups can help to reduce diabetes related DF.

 The findings were presented as a poster at an Indian conference.

Polycystic ovary syndrome (PCOS) is a common endocrine disorder among women of reproductive age. Our client wanted to summarize the underlying causes and common symptoms of PCOS and suggest suitable guidelines for effective management. It was evident that successful treatment of PCOS required proper diagnosis. Therapy mostly depended on the symptoms, age and future pregnancy plans. It was concluded that with accurate diagnosis, appropriate lifestyle interventions, and suitable PCOS treatment (birth control pills to regulate menstruation and insulin-sensitizing or androgen-blocking medications), this medical condition and the associated overwhelming health problems can be controlled.

The poster was presented in an internal meeting at client site.

Telangiectatic osteosarcoma (TO) is an uncommon variant of an intramedullary high grade osteosarcoma that accounts for 2.5-12% of all osteosarcomas. There is limited understanding regarding the incidence, clinical presentation, treatment, and prognosis of this medical condition. The client wanted to systematically study the available literature to obtain detailed information on this high grade osteosarcoma. Literature review revealed poor prognosis of TO patients in earlier studies, however, recent use of neoadjuvant chemotherapy with surgery was reported to improve survival rates of the patients. The finding of this study corroborates the importance of early diagnosis and optimal treatment for improved outcomes.

The findings were published in a PubMed indexed journal.

KOL MAPPING AND SURVEYS

Osteoporosis is a progressive bone disease characterized by low bone mass and deterioration of bone tissue. Although both genders can be affected by this condition, there is a prevalence of this condition in women across the world. Our client conducted a survey to gather information on the epidemiology, diagnostic approaches and preferred methods for osteoporosis management from the perspective of Indian healthcare practitioners. A pre-validated structured questionnaire was distributed among Indian orthopaedicians. A total of 84 orthopaedicians participated in the survey. Data from the completed questionnaires were recorded and further analyses were carried out using Microsoft Excel. The data revealed that various clinical practice guidelines are followed for osteoporosis management across India. Patient compliance was lowest in case of long-term treatment with bisphosphonates. It was suggested that improvement in patient compliance could be achieved when treated once yearly with a bisphosphonate drug and intranasal administration of a linear polypeptide hormone.

The findings were published in a PubMed indexed journal.

Malnutrition is quite prevalent in patients with chronic kidney disease (CKD) on dialysis. These patients are often provided with oral nutritional supplements to fulfill their energy requirements. Our client wanted to examine if a particular predialytic oral supplementation improved the nutritional status of CKD patients on dialysis. A high energy feed with modified micronutrient levels and fructo-oligosaccharides was given to 77 CKD patients. Effectiveness and safety of the supplementation was determined in terms of improved levels of albumin, haemoglobin, mean body weight, serum potassium and phosphorus levels. Additionally, subjective global assessment and malnutrition inflammation score was also evaluated. The predialytic oral supplementation was found to fulfill the nutritional requirements of CKD patients on dialysis.

 

The findings were published in a PubMed indexed journal.

Prediabetes increases the risk of developing Type 2 Diabetes Mellitus and is associated with other serious consequences such as insulin resistance and cardiovascular disease. Mostly ACE and AACE guidelines suggest lifestyle modification for prediabetes management.  However, a meta-analysis suggested that treatment with thiazolidinediones and α-glucosidase inhibitors resulted in better management of prediabetic condition. Our client wanted to conduct a survey on the effectiveness of a particularα-glucosidase inhibitor in prediabetes management from the perspective of diabetologists, general practitioners and other specialists in India. A well-structured questionnaire catering to the objective of the study was circulated amongst 117 physicians across India. Based on the data from the filled questionnaire it was concluded that most physicians prescribed antidiabetic medication as diet and exercise alone were insufficient to manage prediabetes. In India, the α-glucosidase inhibitor of interest was found to be the most preferred second-line drug after another popular antidiabetic drug.

 

The findings were published in a PubMed indexed journal.

Diabetes is a serious health burden and is on the rise across the world. India is no exception with a large population being affected with this condition and newer therapeutic regimes are required for better control. Our client wanted to conduct a survey to understand the view of Indian physicians and endocrinologists regarding the available therapeutic considerations for type 2 diabetes treatment. A questionnaire focusing on issues pertaining to lifestyle intervention prior to initiation of medication was distributed among the physicians working at several primary secondary and tertiary care centers across India. Based on the data from the questionnaires, it was concluded that for newly diagnosed type 2 diabetes, lifestyle intervention was most preferred before pharmacological therapy. Additionally, most physicians preferred metformin as the OHA of initial choice. Drugs of second choice included one of the α-glucosidase inhibitors and DPP4 inhibitor, which were preferred over sulfonylureas.

 

The findings were presented as a poster at an international conference.

CLINICAL PRACTICE GUIDELINES

Combined Hormonal Contraceptives (CHCs) belongs to a group of hormonal contraceptives. CHCs have been successfully used to reduce undesired pregnancies. With this clinical guideline the client wanted to promote awareness among Indian doctors regarding contraception methods and provide an update on the effectiveness and safety of CHC. We obtained clinical evidence from global studies, which was subsequently reviewed by the FOGSI expert committee before finalization of the guidelines. The final guideline addressed issues such as: 1) the unmet need for CHCs, 2) their usage (as contraceptive as well as non-contraceptive), 3) associated side effects, and 4) the importance of structured patient counseling. The guidelines also stressed on the CHC-associated safety concerns including contraception in special situations and provided information on patient counseling tips as well as ways to tailor CHC usage as per the patients’ need.

This guideline was considered the FOGSI Position Statement on the use of Progestogens. Combined Hormonal Contraceptives: Counselling and Use in Clinical Practice.