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.

Metastatic breast cancer is unlikely to be cured, but there have been meaningful improvements in survival due to the availability of more effective systemic therapies, including endocrine therapy in the treatment of hormone-sensitive disease. Breast cancer can be further broken down into three subgroups and can be directed according to there treatment choices: 1) the estrogen receptor (ER) expression, 2) the human epidermal growth factor receptor 2 (HER2 [with or without ER expression]), and 3) triple-negative. Patients with ER-positive metastatic breast cancer often respond to endocrine therapy alone or in combination with targeted agents, which can reduce tumour burden and symptoms with generally fewer side effects and toxicities than chemotherapy. Our client wanted to determine the safety and efficacy of existing chemotherapy for breast cancer. In order to assist our client to develop a systematic review on this topic, we screened 1000 studies for the 1st pass and 200 studies for the 2nd pass.

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related mortality both in the United States and worldwide. The usual treatments for patients with NSCLC, such as advanced lung adenocarcinoma, are unspecific and aggressive and include lung resection, radiotherapy and chemotherapy. Recently, treatment with monoclonal antibodies and biological inhibitors has emerged as an effective alternative, generating effective results with few side effects. Our client wanted to evaluate efficacy and safety of a monoclonal antibody in combination with radiotherapy in patients with advanced NSCLC. We extracted relevant information from 100 studies to meet the objective.

Rotator cuff tears (RCT) are one of the most frequent shoulder diseases and their incidence increases with advancing age. The tendons of your rotator cuff can tear much like a piece of leather. Sometimes, the tendon is only slightly damaged or irritated. Sometimes, the tendon has a complete tear, which means that the tendon has torn away from the bone. Tears of the rotator cuff tendons may cause shoulder pain and can limit shoulder function. Our client wanted to determine the effectiveness of available treatment on Rotator cuff repair. We extracted relevant information from 40 studies to meet the objective.

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.

In India, the average cost of cancer treatment ranges from Rs. 2.5 L to Rs. 20 L for six months leading the families into huge economic burden. On the demand of one of our clients,, the information was gathered on the sources of funding for cancer; the services availability in hospitals and clinics; government and non-government schemes for cancer; the process of incentivizing the healthcare providers; the role of drug manufacturer, wholesalers, distributors and providers in drug costing; and reimbursement strategy for cancer treatment in India. It also reports on the complications Indians are facing during cancer treatment.

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 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

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.

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.

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.

Treatment with chimeric mAb often results in the formation of human anti-chimeric antibodies (HACA) that may worsen the condition in axial spondyloarthritis (AS) and rheumatoid arthritis (RA) patients. In this case, our client’s KOL wanted to investigate the effect of infliximab therapy on both AS and RA patients. We did the data analysis and manuscript writing for the client. It was found that HACA was formed in AS patients treated with infliximab, but not in RA patients following same treatment. HACA-positive AS patients treated with chimeric mAb showed a higher post-treatment disease activity as measured by BASDAI and were associated with lesser post-treatment reduction in BASDAI than HACA-negative patients.

The paper go published in PubMed indexed journal. 

The correlation of osteoporosis and associated factors with systemic sclerosis is not yet understood clearly. As per the demand of our client, a study on bone mineral density was performed in patients with systemic sclerosis to find its correlation with organ involvement. We undertook the data analysis and manuscript writing aspect of the project. It was found out that low bone mass significantly occurs in patients with systemic sclerosis and correlates inversely with serum iPTH levels. Serum iPTH could thus be an important biomarker for early diagnosis of osteoporosis in these patients and may help predict the fractures.

CASE SERIES

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.

Hidradenitis suppurativa (HS), also known as acne inversa, is a rare and long-term skin inflammatory condition diagnosed by small and painful swollen lumps, typically affecting the armpits, the groin, area between the buttocks, and under the breast. The unresponsive routine multiple treatment modalities necessitated a more efficacious treatment for HS. On demand of our clients, the effect of a novel TNF-α inhibitor was studied on two adult patients who were severely affected by HS (Hurley stage III). These two cases were the first of its kind demonstrating the success of this particular TNF-α inhibitor treatment on patients of Indian origin suffering from HS.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a delayed type of systemic hypersensitivity reaction caused by the intake of anti-convulsants, allopurinol, sulfasalazine, NSAIDs and other drugs. It is characterized by maculopapular rashes, fever and eosinophilia affecting the systemic features. This syndrome is severe and fatal than acute drug reaction as it affects internal organs as well. Intake of certain antibiotics, especially the β-lactams such as amoxicillin, may trigger the reaction in the patients of DRESS syndrome. Our client needed a case study for their KOL on a patient who was suffering from DRESS syndrome induced by sulfasalazine and aggravated by ceftriaxone. A prompt withdrawal of sulfasalazine along with intake of systemic corticosteroids and N-acetyl cysteine was found to be useful for a such life-threatening condition.

REVIEWS

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.

The hypoglycemic efficacy of dipeptidyl peptidase-4 inhibitor has been demonstrated as monotherapy or in combination of other anti-hyperglycemic drugs. The SAVOR-TIMI 53 trial have raised the concerns about the increased risk of hospitalization due to heart failure following this particular dipeptidyl peptidase-4 inhibitor administration. As per the demand of our clients, all the relevant research articles along with reviews and other data was systematically reviewed.  This systematic study showed that increase in hospitalizations due to heart failure have not been demonstrated by other trials as well as by real-world data analyses from insurance claims data involving a huge number of patients. The vast available evidences favour the clinical usage and safety of this dipeptidyl peptidase-4 inhibitor in various clinical conditions.

Biosimilar is a biologic drug that is structurally and functionally similar to an original drug molecule of biological origin that has already been authorized for use. Generation of evidences for comparing a biosimilar with original biomolecule using direct head-to-head randomized controlled trials can be expensive, time-consuming and laborious. The client wanted a review about the indirect treatment comparison (ITC) for biosimilar that would provide useful evidence for judiciously selecting the best choice of treatment. A well-designed and appropriately conducted ITCs, being increasingly used for biosimilar approval in the EU, can be a valid alternative and means for efficacy and safety evidence generation.

KOL MAPPING AND SURVEYS

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.

Venous thromboembolism (VTE) is a global health concern with substantial morbidity and mortality. It is often asymptomatic and under-diagnosed, leading to long-term complications and reduced survival.  VTE has also been identified as an immediate threat to patients undergoing major orthopedic procedures such as total hip arthroplasty (THA) and total knee arthroplasty (TKA). National Orthopedic Advisory Committee meeting was conducted to gain understanding of the clinical relevance of the International VTE prevention guidelines for orthopedic patients in India and to derive expert consensus to enhance optimal implementation of thromboprophylaxis after major orthopedic surgery for Indian population. We helped the client to have guided discussion for better VTE prevention after TKR and THR in Indian patients such as: 1) Thromboprophylactic agents, 2) Minimal duration of thromboprophylaxis, 3) Anticoagulation protocol with neuraxial anesthesia and indwelling epidural catheters, and 4) Bleeding management guidance. The guideline also focused on expert opinion on VTE prevention in patients with renal impairment, bilateral TKR / Revision surgery, mobilization and patient convenience, tolerability and adherence to therapy.

This particular anti-TNF-α factor, is considered effective not only in improving clinical symptoms of psoriasis but also in terms of quality of life. Our client wanted the current evidence from the systematic reviews, post-hoc analyses, registries and real-world data that would represent the associated benefit-risk of this anti-TNF-α factor and other biologics such as anti-T cell agents for psoriasis patients. It was found to be cost-effective and efficacious with no increased incidence of adverse events with escalated dosing. The proven post-marketing safety and efficacy phase, and ease of administration over infliximab are the additional benefits of  the molecule.