Knowledge of pharmacovigilance among healthcare professionals and the impact of an educational intervention.

Aim: To determine the knowledge regarding various aspects of pharmacovigilance among doctors and nurses of a tertiary care teaching hospital and to evaluate the effect of an educational intervention. Methods: A cross-sectional study was conducted among doctors and nurses of a tertiary care teaching hospital. The participants attended a one-hour educational session during which the concept of pharmacovigilance, the Pharmacovigilance Program of India, the need for reporting ADRs, and the method of reporting were explained by a subject expert. A 20-item questionnaire was used to assess their knowledge regarding pharmacovigilance before and after an educational session. The pre-post comparisons were done using Wilcoxon's signed-rank test. A p-value less than 0.05 was considered statistically significant. Results: Forty-two doctors and 115 nurses participated in the study. A significant improvement in the participant scores was seen following the educational intervention in both doctors (Z = -5.344, p < 0.001) and nurses (Z = -8.808, p < 0.001). Lack of knowledge/awareness was perceived as the major barrier for ADR reporting among nurses as well as doctors. Conclusion: There is need for education and training among doctors and nurses to enhance their knowledge about drug safety and reporting practices. Educational intervention is likely to improve the knowledge regarding pharmacovigilance, and thereby enhance reporting by healthcare professionals.

Role of Drug Transporters in Elucidating Inter-Individual Variability in Pediatric Chemotherapy-Related Toxicities and Response.

Pediatric cancer treatment has evolved significantly in recent decades. The implementation of risk stratification strategies and the selection of evidence-based chemotherapy combinations have improved survival outcomes. However, there is large interindividual variability in terms of chemotherapy-related toxicities and, sometimes, the response among this population. This variability is partly attributed to the functional variability of drug-metabolizing enzymes (DME) and drug transporters (DTS) involved in the process of absorption, distribution, metabolism and excretion (ADME). The DTS, being ubiquitous, affects drug disposition across membranes and has relevance in determining chemotherapy response in pediatric cancer patients. Among the factors affecting DTS function, ontogeny or maturation is important in the pediatric population. In this narrative review, we describe the role of drug uptake/efflux transporters in defining pediatric chemotherapy-treatment-related toxicities and responses. Developmental differences in DTS and the consequent implications are also briefly discussed for the most commonly used chemotherapeutic drugs in the pediatric population.

Spatiotemporal analysis of drug-resistant TB patients registered in selected districts of Karnataka, South India: a cross-sectional study.

BACKGROUND: Tuberculosis (TB) depicts heterogeneous spatial patterns with geographical aggregation of TB cases due to either ongoing person-to-person transmission or reactivation of latent infection in a community sharing risk factor. In this regard, we aimed to assess the spatiotemporal aggregation of drug-resistant TB (DR-TB) patients notified to the national TB program (NTP) from 2015 to 2018 in selected districts of Karnataka, South India. METHODS: This was a cross-sectional study among DR-TB patients notified from Dakshina Kannada, Udupi, and Chikamagalur districts of the state of Karnataka. Clinico-demographic details were extracted from treatment cards. The registered addresses of the patients were geocoded (latitude and longitude) using Google Earth. Using the QGIS software, spot map, heat maps and grid maps 25 km2 with more than the expected count of DR-TB patients were constructed. RESULTS: Of the total 507 patients studied, 376 (74%) were males and the mean (standard deviation) age of the study participants was 41.4 (13.9) years. From 2015 to 2018, the number of patients increased from 85 to 209 per year, the area of aggregation in square kilometers increased from 113.6 to 205.7, and the number of rectangular grids with more than the expected DR-TB patients (> 1) increased from 12 to 47. CONCLUSIONS: The increase in the number of DR-TB patients, area of aggregation, and grids with more than the expected count is a cause for concern. The NTP can use routine programmatic data to develop maps to identify areas of aggregation of disease for targeted TB control activities.

A Prospective Study of the Clinical and Demographic Profile of Type 2 Diabetes Mellitus Patients Receiving Antidiabetic Drug Combinations.

BACKGROUND: The specific treatment recommendations for type 2 diabetes mellitus (T2DM) differ based on a particular guideline. The goal of pharmacotherapy is to achieve the target HbA1c and fasting and postprandial blood glucose levels to avoid disease complications. OBJECTIVE: To evaluate the profile of T2DM patients on different antidiabetic treatment regimens and the factors leading to dose escalation in these patients. METHODS: A prospective descriptive study was conducted at Kasturba Medical College Hospital, Mangalore, a tertiary care teaching hospital, over a period of one year. The study population comprised of patients with T2DM for ≥5 years. The demographic and clinical data were collected during the baseline and follow-up visits. RESULTS: Of the 119 patients studied, 59.7% were males; 32.8% were ≥65 years of age. A significant decrease in the fasting blood glucose (FBG) on follow-up was seen (p = 0.028) in patients on sulfonylurea and metformin combination. A significant decrease in the glycated haemoglobin (HbA1c) was seen in patients on sulfonylurea with metformin and pioglitazone (p = 0.011); sulfonylurea with metformin, pioglitazone, and sitagliptin (p = 0.026); and metformin with insulin (p = 0.001). Patients who received dose escalation had a longer duration of the disease (p = 0.042), higher FBG (p = 0.039) and HbA1c (p = 0.05). CONCLUSION: A combination of metformin with sulfonylurea was the preferred first-line treatment; insulin was added when HbA1c was >9. Patients who received dose escalation had a longer duration of the disease and higher FBG and HbA1c.

Drug-drug interactions in patients undergoing chemoradiotherapy and the impact of an expert team intervention.

Background Several studies have examined the drug-drug interaction patterns in different patient populations and treatment settings; however, there is a need, particularly in the field of oncology and radiotherapy, for evaluating methods targeted towards preventing potential drug-drug interactions. One of the measures proposed is identifying potential interactions using computer programs and their evaluation by pharmacologists or clinical pharmacists, thereby providing clinically relevant information to the treating physician regarding the required prescription changes. Objective To determine the prevalence of potential drug-drug interactions in patients receiving chemoradiotherapy and assess the usefulness of expert team recommendations in minimizing interactions. Setting Patients admitted to the radiotherapy and oncology ward of a tertiary care teaching hospital in Karnataka, India. Method We conducted a prospective, cross-sectional study of prescriptions written for patients receiving chemoradiotherapy. Prescriptions containing two or more drugs, at least one of the drugs being an anticancer drug, were analyzed. They were screened for potential drug-drug interactions using the Lexicomp® drug interaction software. The interactions were classified as X, drug combination to be avoided; D, modification of therapy to be considered; and C, therapy to be monitored, as per the Lexicomp criteria. Main outcome measure The number of drug-drug interactions detected that were accepted by the treating radio-oncologist as requiring prescription change before and after the prescription review by an expert team. Results Two hundred twenty-three prescriptions were screened for the presence of drug-drug interactions; 106 prescriptions (47.53%) containing 620 drugs and 211 drug-drug interactions were identified. Of the 211 interactions identified, 6.64% (14/211), 18.48% (39/211), and 74.88% (158/211) drug-drug interactions belonged to category X, D, and C, respectively. Twenty-seven (50.94%) of the 53 category X and D interactions identified were accepted the oncologist as requiring a change in the prescription; an additional 13 (24.53%) interactions were identified as significant by the expert team, and 11 (84.62%) of these were accepted by the oncologist. Conclusion A system of alerting the treating physician to a potential drug-drug interaction leads to avoidance of prescription of the interacting drug combination, and the assistance by an expert team adds significantly to avoidance of clinically relevant drug interactions.

Comparative assessment of clinic-laboratory profile of different species of severe malaria in a tertiary care institute in southern India.

BACKGROUND & OBJECTIVES: Majority of the studies on severe malaria in India have concentrated on falciparum and have been done in northern part. The objective of the study was to compare the clinical spectrum and laboratory profile among severe Plasmodium vivax, P. falciparum and mixed malaria patients admitted at a tertiary care center in southern India. METHODS: This prospective, observational study was done in adult patients with severe malaria hospitalized in a tertiary care centre in southern India. Malaria was diagnosed by either quantitative buffy coat test or peripheral blood smear. In the cases of P. vivax malaria, an antigen detection test was done to rule out coexistent falciparum infection. Severe malaria was defined as per the WHO guidelines. The malaria severity score (MSS) was calculated for all patients based on the clinical features and laboratory parameters. RESULTS: A total of 204 cases of severe malaria were studied. Among them, 105 (51.5%) had vivax infection, 30 (14.7%) had falciparum and 69 (33.8%) patients had mixed malaria. The mean age of the study population was 39.8±15.7 yr. The majority were males (71.6%). Hypotension and prostration were the most common complications noted in the patients, irrespective of species. The maximum mean MSS was found to be highest in falciparum malaria, followed by mixed malaria and vivax. In vivax malaria, majority of patients (71.4%) had one or two complications and only 28.57% of patients had three more complications, whereas in falciparum malaria, the majority (53.33%) had three or more complications. Around 44.93% of mixed infection malaria patients had three or more complications. The number of patients with multi-organ dysfunction (>2 complications) was significantly more in patients with falciparum infections compared to the remaining patients. INTERPRETATION & CONCLUSION: Severe malaria in south India is predominantly due to vivax. Hypotension and prostration were the most common complication of severe malaria irrespective of the plasmodium species. The entire spectrum of severe malaria complications described for falciparum are seen in severe vivax malaria.

Evaluation of Potential Drug-Drug Interactions with Medications Prescribed to Geriatric Patients in a Tertiary Care Hospital.

BACKGROUND AND OBJECTIVES: The drugs most commonly implicated in major potential interactions are those used in the day-to-day clinical management of elderly patients with chronic diseases. This study is planned to evaluate the profile of drug-drug interactions in the medications prescribed to elderly population and also to identify the possible predictors for potential drug-drug interactions in the elderly. METHODS: This cross-sectional study included patients aged above 60 years with a minimum of two drugs in the prescriptions. Data were collected from medical prescriptions and patients' medical records. The data collected included demographic characteristics such as age, gender, height, weight, educational status, socioeconomic status, medical history, and medications prescribed. The prescriptions were analyzed for the potential drug interactions using Lexi-Interact™ Online, an online software to check drug-drug interactions. RESULTS: A total of 209 patients were included in the study, among them 104 (49.8%) were males and 105 (50.2%) were females. The mean number of medications received was 6.53 ± 2.15 per prescription. Around 138 (66%) patients received more than six medications. The mean number of potential drug interactions seen in the prescription of these patients was 3.17 ± 2.78. Around 18.2% patients had more than five drug interactions. Major drug interactions were observed in 21.42% of cases. Around 3.02% of drug interactions belonged to risk category X, i.e., to be avoided. Logistic regression analysis showed that age above 70 years was associated with the presence of drug interactions. Increased number of medication was independently associated with the occurrence of drug interactions. The presence of drug interactions was not associated with increased number of comorbidities. CONCLUSION: A significant number of potential drug-drug interactions were seen in the prescriptions of elderly patients. Increasing age and polypharmacy were identified as the predictors of potential drug interactions.

Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy.

BACKGROUND AND OBJECTIVES: The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. METHODS: This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. RESULTS: 171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the 'probable' category (60.1%), and the rest were "possible". ADRs to zidovudine and nevirapine superseded all others. INTERPRETATION AND CONCLUSION: Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.

Evaluation of polypharmacy and appropriateness of prescription in geriatric patients: A cross-sectional study at a tertiary care hospital.

OBJECTIVES: To assess the polypharmacy and appropriateness of prescriptions in geriatric patients in a tertiary care hospital. METHODS: An observational study was done in geriatric patients (>60 years) of either gender. The data collected from patients included: Socio-demographic data such as age, gender, marital status, educational status, socioeconomic status, occupation, nutritional status, history of alcohol/smoking, exercise history, details of comorbid diseases, medication history, findings of clinical examination etc. In this study, polypharmacy was considered as having 5 or more medications per prescription. Medication appropriateness for each patient was analysed separately based on their medical history and clinical findings by applying medication appropriateness index, screening tool to alert to right treatment (START) and Beers criteria and STOPP criteria. RESULTS: A total of 426 patients, 216 (50.7%) were males and 210 (49.3%) were females. Polypharmacy was present in 282 prescriptions (66.2%). Highest prevalence of polypharmacy was seen in 70-79 years age group compared to the other two groups and it was statistically significant. Out of 426 patients, 36 patients were receiving drugs which were to be avoided as per Beers criteria. Among the total patients, 39 patients were overprescribed as per MAI, 56 patients were under prescribed as per START criteria and 85 out of 426 prescriptions were inappropriate in accordance with beers criteria, stop criteria, start criteria and MAI index. CONCLUSION: Around 66.19% patients were receiving polypharmacy. Significant number of patients were receiving drugs which are to be avoided as well as overprescribed and under prescribed. Inappropriate prescription was seen in a good number of patients.

Prevalence of Vitamin B12 and folic acid deficiency in HIV-positive patients and its association with neuropsychiatric symptoms and immunological response.

BACKGROUND: Deficiency of micronutrients is prevalent even before the development of symptoms of HIV disease and is associated with accelerated HIV disease progression. AIMS: This study evaluates the prevalence of folate and Vitamin B12 deficiency in HIV-positive patients with or without tuberculosis (TB) and its association with neuropsychiatric symptoms and immunological response. SETTINGS AND DESIGN: Cross-sectional, observational study in an outpatient setting. PATIENTS AND METHODS: Four groups of HIV-positive patients with TB (Group I), HIV-positive patients with neuropsychiatric symptoms (Group II), HIV-positive patients without neuropsychiatric symptoms or TB (Group III), and HIV-negative controls with neuropsychiatric symptoms (Group IV). Vitamin B12 and folate estimation was done using carbonyl metallo-immunoassay method. STATISTICAL ANALYSIS USED: ANOVA, Kruskal-Wallis and Mann-Whitney, Pearson's correlation. RESULTS: The prevalence of folic acid deficiency was 27.1% in the Group I, 31.9% in the Group II, 23.4% in the Group III, and 32% in the Group IV being higher in patients with neuropsychiatric symptoms in both HIV and non-HIV patients. The prevalence of Vitamin B12 deficiency was 18.8% in Group I, 9.1% in Group II, 4.8% in Group III, and 16.7% in Group IV. The patients with folate deficiency had more severe depression and anxiety. CONCLUSION: Nearly, 30% of the HIV patients had a folic acid deficiency, and about 10% of the HIV patients had Vitamin B12 deficiency. The folate deficiency was highest among neuropsychiatric patients with or without HIV infection and Vitamin B12 deficiency was higher among HIV patients with TB.

Effect of Vitamin B12 and folic acid supplementation on neuropsychiatric symptoms and immune response in HIV-positive patients.

BACKGROUND: Micronutrients such as B12 and folic acid deficiencies are found in higher number in HIV-infected patients. OBJECTIVE: We conducted a study to examine the effect of Vitamin B12 and folic acid supplementation on neuropsychiatric manifestations, CD4 count, and anthropometric measurements in HIV-positive patients. MATERIALS AND METHODS: Three different groups of HIV patients, namely, HIV patients with tuberculosis, HIV patients with neuropsychiatric manifestations, and asymptomatic HIV patients with 50 patients in each group were included in the study. Baseline and follow-up CD4 count, anthropometric measurements, neuropsychiatric assessments, Vitamin B12, and folic acid estimation were done. RESULTS: The prevalence of folic acid deficiency was 27.1% in Group I, 31.9% in Group II, and 23.4% in Group III. The prevalence of Vitamin B12 deficiency was 8.16% in Group I, 6.12% in Group II, and 4.16% in Group III. HIV patients with neuropsychiatric manifestations were noted to have the lowest mean mini-mental score. After the supplementation of vitamins, anthropometric measurements, MMSE as well as Hamilton depression scores, improved in all the three groups whereas Hamilton anxiety scores improved only in Group III. The CD4 count also improved in Groups I and II after the supplementation of vitamins. CONCLUSION: Folic acid deficiency was highest among neuropsychiatric patients. The majority of people who had a folic acid deficiency have shown improvement in their neuropsychiatric assessment scores as well as CD4 count after its supplementation.

Evaluation of acute effects of melatonin on ethanol drinking in ethanol naïve rats.

OBJECTIVE: The objective was to evaluate the acute effect of melatonin on ethanol drinking in ethanol naïve rats and to determine the specificity of the effect of melatonin on ethanol intake as compared to an intake of plain tap water or sugar water. MATERIALS AND METHODS: A total of three experiments (2 weeks duration each) using different drinking solutions (ethanol, plain tap water, sugar water) was conducted in individually housed male wistar rats of 5 weeks age. Each animal had access to bottles containing drinking solutions for 2 h a day. In each experiment, on day 1, day 2, day 4, day 5, day 8, day 9, day 11, day 12 rats received drinking solutions. Each individual rat received single doses of saline, melatonin (50 mg and 100 mg/kg), and naltrexone on day 2, 5, 9, and 12, 1-h before receiving drinking solution. The order of drug administration is permuted such a way that each animal received the drugs in a different order in different experiments. RESULTS: Melatonin has significantly decreased ethanol consumption by the rats and effect is dose-dependent. Naltrexone also has caused a significant reduction in the ethanol consumption. The maximum reduction in ethanol consumption was seen with melatonin 100 mg/kg dose compared to melatonin 50 mg/kg and naltrexone. There was no statistically significant effect of melatonin on plain water and sugar solution intake. CONCLUSIONS: Melatonin decreases ethanol consumption in ethanol naïve rats. The effect of melatonin is similar to naltrexone affecting selectively ethanol consumption, but not plain water and sugar water consumption.

Evaluation of adverse drug reactions in HIV positive patients in a tertiary care hospital.

CONTEXT: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs) in HIV patients. AIMS: The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. SETTINGS AND DESIGN: Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo's scale. RESULTS: Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5%) were males and 20 (46.5%) were females. A total of 53 (16.21%) AEs were reported. Antitubercular drugs caused the maximum AEs (28.3%) followed by zidovudine (20.7%), nevirapine (15.0%) and efavirenz (5.6%). Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo's scale revealed that 66.04% AEs were 'probable' and 33.96% were 'possible'. CONCLUSIONS: Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.

Effects of botropase on clotting factors in healthy human volunteers.

OBJECTIVE: To evaluate the effects of botropase on various clotting factors in human volunteers. MATERIALS AND METHODS: It was a prospective open label study conducted on human healthy volunteers. After the baseline screening, subjects fulfilling inclusion criteria were enrolled. On the study day, 1 ml of botropase was administered intravenously and after an hour same dose of botropase (1 ml) was given by intramuscular (IM) route. The efficacy and safety parameters were monitored up to 72 h from the time of intravenous (IV) administration. RESULTS: A total of 15 volunteers, belonging to 24-35 years of age were included in the study. Botropase significantly reduced the plasma level of fibrinogen and fibrin degradation products after 5 min of IV administration (P < 0.05). In addition, factor X was observed to reduce constantly by botropase administration suggesting enhanced turnover between 5 and 20 min of IV administration. Although botropase reduced clotting and bleeding time in all the volunteers, the data remains to be statistically insignificant. CONCLUSION: Present study demonstrated the safety and efficacy of botropase in human healthy volunteers. The study has shown that it is a factor X activator and reduces effectively clotting and bleeding time.

Evaluation of the adverse reactions of antiretroviral drug regimens in a tertiary care hospital.

OBJECTIVES: Antiretroviral toxicity is an increasingly important issue in the management of HIV-infected patients. The objective of our study was to evaluate the toxicity profile of currently used antiretroviral regimens and to compare these toxicities among males and females. MATERIALS AND METHODS: A retrospective analysis with a one year follow-up was done at a tertiary care hospital by reviewing the record. Patients who were >18 years of age attending the hospital and were initiated an antiretroviral drug regimen were included in the analysis. Data regarding demographic details, medical history, details of human immunodeficiency virus (HIV) infection including most recent CD4 count, details of antiretroviral therapy (ART) collected from patient's records. Adverse drug reactions were recorded by reviewing patient records. RESULT: A total of 99 patients were included in study. Among them, 71 (71.7%) were males and 28(28.3%) were females. Common adverse effects observed included anemia (58.6%), pruritus(23.2%), skin rash(18.2%), hypertriglyceridemia(15.2%), and hepatitis (60.6%), peripheral neuropathy (14.1%). Prevalence of skin rash was more in females than males, the difference being statistically significant. Pruritus was also commonly seen in females than males though the difference observed in our study is statistically insignificant. Hypertriglyceridemia was more in males compared to females, the difference is statistically significant. CONCLUSION: The most common adverse effects associated with currently used ART regimens are anemia, hepatic toxicity, itching, skin rash, elevated triglycerides, and peripheral neuropathy. Gender differences were seen mainly with skin rash, which was significantly more in females.

The Evaluation of Carotid Atherosclerosis in Patients with the HIV-1 Infection: The Role of the Antiretroviral Therapy.

BACKGROUND AND OBJECTIVE: The recognition and the assessment of the carotid intimal thickness helps in predicting the risk of the cardiovascular events in Human Immunodeficiency Virus (HIV) infected patients who are on Antiretroviral Therapy (ART). The objective of this study was to assess and compare the carotid intimal thickness in HIV positive individuals who were on antiretroviral therapy with HIV positive individuals who were not on anti-retroviral therapy. SUBJECTS AND METHODS: All the HIV positive individuals who were 20 years old and above, who had been diagnosed by the National AIDS Control Organization (NACO) guidelines were included in the study. The HIV positive individuals who were diagnosed with diabetes mellitus and hypertension were excluded from the study. The study subjects were divided into 2 groups i.e. HIV patients who were on anti-retroviral therapy and HIV patients who were not on anti-retroviral therapy. The patients had to be on anti-retroviral therapy for a minimum of 6 months for them to be included in the first group. The data was collected by using a semi structured, pre-tested proforma, which included the demographic details, the duration of the HIV infection, details of the antiretroviral treatment, a history of smoking/ alcohol consumption and details on the assessments of the metabolic syndrome. RESULTS: A total of 42 patients were included in the study. Among them, 28 were males (66.7%) and 14 were females (33.3%). Twenty six patients were on ART and the remaining patients were treatment naive. There were significant differences with regards to their age and the duration of the HIV infection, which was longer in the patients who were on ART (p= 0.049, p=0.003 respectively). The Body Mass Index (BMI), the waist: hip ratio, the mid-arm circumference, the waist circumference, the skin fold thickness and the carotid intimal-media thickness were higher in the HIV patients who were on ART as compared to those in the treatment naive patients, though the difference was statistically insignificant. CONCLUSION: The carotid intimal thickness was higher in the HIV patients who were on ART as compared to those in the treatment naïve HIV infected patients.

The development of metabolic risk factors after the initiation of the second line anti- retroviral therapy.

BACKGROUND AND OBJECTIVE: A Highly Active Anti-Retroviral Therapy (HAART) is accompanied with several metabolic effects like adipose redistribution and insulin resistance. In this study, we evaluated the association between a HAART and lipodystrophy. METHODS: A cross sectional study, whose subjects were Human Immunodeficiency Virus (HIV) infected patients, was conducted at a tertiary care hospital in south India. Among these, 27 were on protease inhibitors for at-least 6 months and 13 were drug naive patients. The assessments of lipodystrophy, fasting blood sugar and the fasting lipid profile were done and these parameters were compared in the two groups. RESULTS: The analysis of the data which was collected, showed an elevation in the total cholesterol levels in the individuals who were on the protease inhibitors versus the drug naive patients. There was a significant elevation in the Low Density Lipoprotein (LDL) cholesterol levels and a decrease in High Density Lipoprotein (HDL) cholesterol levels in the individuals who were on protease inhibitors. It was also observed that the HDL cholesterol levels decreased with an increase in the duration of the therapy. The LDL cholesterol levels increased with the duration of the therapy. CONCLUSION: The human immunodeficiency virus infection is itself related to the metabolic complications which are aggravated on the use of second line anti retroviral therapy. Therefore, after initiating the treatment with protease inhibitors, a periodic evaluation of the serum lipid levels and the blood sugar profile should be done as a standard care.

Carbamzepine-induced toxic epidermal necrolysis.

Toxic epidermal necrolysis (TEN), also known as Lyell's syndrome, is a widespread life-threatening mucocutaneous disease where there is extensive detachment of the skin and mucous membrane. Many factors involved in the etiology of TEN including adverse drug reactions. Here we are reporting a case of toxic epidermal necrolysis in an adult male patient after receiving carbamazepine in a 38 year old male. On the 18(th) day of carbamazepine, patient developed blisters which first appeared on the trunk, chest and arms. The erythematous rash was covering almost all over the body with epidermal detachment of 70% body surface area. There was loss of eye lashes, congestion of conjunctiva with mucopurulent discharge and exposure keratitis. The clinical impression was TEN induced by carbamazepine. Carbamazepine was stopped immediately. He was treated with high dose intravenous betamethasone and systemic and topical antibiotics. After one month, the progression of the skin lesions halted and he was discharged.