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Year : 2011  |  Volume : 43  |  Issue : 7  |  Page : 205--208

U K Sheth Prize Paper Abstracts


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. U K Sheth Prize Paper Abstracts.Indian J Pharmacol 2011;43:205-208

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. U K Sheth Prize Paper Abstracts. Indian J Pharmacol [serial online] 2011 [cited 2021 Dec 2 ];43:205-208
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UK Sheth Prize -1

Pharmacovigilance study of ACE-inhibitors in patients visiting Department of medicine of a tertiary care hospital, Surendranagar, Gujarat

Trivedi MD , Savsani DD, Bavalia MK, Tilva BV, Mehta DS

Departments of Pharmacology, and Medicine, C. U. Shah Medical College and Hospital, Surendranagar, Gujarat - 363 001, India.

E-mail: [email protected]

Objectives: To evaluate incidence, patterns and severity of ACE inhibitor induced adverse drug reactions. Materials and Methods: Total 500 hypertensive patients taking ACE inhibitors were enrolled in the study by taking an informed consent. Reporting of all ACE inhibitors induced ADRs was done by filling CDSCO Adverse Drug Reaction Form. All ADR reports were evaluated according to 'WHO-UMC Causality Assessment Scale'. Results : A total of 53 ADRs (31 males and 22 females) were observed in 500 hypertensive patients taking ACEI. Out of 53 ADRs 22 (41.51%) were mild, 28 (52.83%) were moderate, and only 3 (5.66%) were classified as severe. 7 ADRs (13.21%) were classified as certain, 30 ADRs (56.60%) were in probable category, 8 (15.09%) were in possible category, 4 (7.55%) in unlikely category, 3 (5.66%) in conditional category (unclassified), and 1 ADR was in Unassessable(Unclassifiable) category. Among 53 ADRs 24 (4.80%%) patients developed dry cough, 8(1.60%) hypotension, 2(0.40%%) headache, 2(0.40%) dizziness, 3(0.60%) nausea/bowel upset, 3(0.60%)rashes, 2(0.40%) developed angioedema, 3(0.60%) dysguesia, hyperkalemia, ARF, proteinuria are rare. Conclusion : Incidence of ADRs by ACEIs is 10.60% with cough as most common ADR followed by hypotension. As Enalapril is most frequently used ACEI, ADRs due to Enalapril are more common.

UK Sheth Prize -2

A comparative study to evaluate efficacy, safety and cost effectiveness between oral balofloxacin vs. oral levofloxacin in patients of uncomplicated urinary tract infection coming at C U Shah Medical College & Hospital, Surendranagar

Acharya TA, Trivedi MD, Vekariya RS, Tilva BV, Mehta DS

Department of Pharmacology, and Medicine, C. U. Shah Medical College and Hospital, Surendranagar, Gujarat - 363 001, India.

Objectives : To compare efficacy, safety and cost effectiveness between oral Balofloxacin and oral Levofloxacin in acute uncomplicated urinary tract infections. Materials and Methods: Total 130 patients were enrolled for the study, out of them 119 patients completed the study. Patients were divided in to two groups randomly; 63 patients received Balofloxacin 100mg BID orally and 56 patients received Levofloxacin 500mg orally OD as a control group, for 5 days. Baseline evaluation of clinical features was done according to Antibacterial drug clinical research guidelines and urine culture was performed for isolation of causative Organism. After 5 days on completion of therapy above parameters were repeated and compared. Analysis of reported adverse drug reactions (ADRs) and cost effectiveness was carried out. Results: After completion of treatment clinical evaluation showed Cure rate was 82.54% and 85.71%, while Effective rate was 96.83% and 98.21% for Balofloxacin and Levofloxacin group patients respectively. Bacteriological evaluation revealed that Bacteriological clearance rate for Balofloxacin and Levofloxacin was 94.91% and 98.11% respectively. There was no statistical difference between both drugs for clinical and bacteriological cure (p>0.05). ADRs reported were nausea, vomiting, abdominal distension, skin rashes and QT prolongation, with incidence rate of 3.17% and 16.07% for Balofloxacin and Levofloxacin respectively, which was statistically significant (p<0.05). Cost effective analysis revealed that incremental cost (Δ C) was ` 30 and incremental effectiveness (Δ E) was -1%, which indicates that Levofloxacin is more cost effective as compared to Balofloxacin. Conclusion: Balofloxacin is as efficacious as and safer than Levofloxacin, while Levofloxacin is more cost effective for the treatment of acute uncomplicated urinary tract infection.

UK Sheth Prize -3

Evaluation of the therapeutic effectiveness of magnesium valproate in renal complications associated with type-1 diabetic rats

Damle D., Rabadiya S., Rayabarapu N., Bhadada SV., Patel BM.

Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad - 382 481, Gujarat, India.

Objective : To evaluate the therapeutic effectiveness of Magnesium Valproate in renal complications associated with type-1 diabetic rats. Materials and Methods: Diabetes was induced by single tail vein injection of Streptozotocin (STZ) (45 mg/kg, iv) in Sprague Dawley rats. The animals were divided in four groups and treatment of Magnesium Valproate (MgV) (210mg/kg,p.o.) was given for 8 weeks after which, various biochemical, renal and histological parameters were estimated. Results: STZ produced significant hyperglycaemia, increased C-reactive protein (CRP) and renal biomarkers and enzyme levels in serum viz. alkaline phosphatase, uric acid, Blood Urea Nitrogen (BUN), creatinine, BUN: Creatinine ratio and decreased serum albumin levels. Treatment with MgV significantly reduced Alkaline Phosphatase, uric acid, Blood Urea Nitrogen, creatinine, BUN: Creatinine ratio and increased albumin levels. STZ increased urine excretion and decreased electrolyte levels which was reversed by MgV treatment. There was a significant increase in urinary levels of creatinine, albumin, total proteins and uric acid by STZ and MgV reduced these levels. STZ also increased renal collagen levels and produced oxidative stress and treatment with MgV reduced renal collagen levels and prevented oxidative stress as evident from reduction in total protein, malondialdehyde and nitrate levels and increase in superoxide dismutase and glutathione levels. Histopathological studies reveled that treatment with MgV prevented STZ-induced renal pathological changes. Conclusions: Magnesium Valproate produces beneficial effects on renal complications associated with type-1 diabetes.

UK Sheth Prize -4

A prospective study to assess the effect of pantoprazole on muscle relaxant activity of vecuronium used in patients undergoing surgery

Patil R.R ., Worlikar P.S, Chaudhari A.B., Dewda P.R., Kamle M., Vijay N., Komma R, Panditrao M.M.

Department of Pharmacology, Padmashree Dr. D.Y. Patil Medical College, Pimpri, Pune-18, India.

Introduction : Results of numerous pre-clinical studies have demonstrated that proton pump inhibitors (PPI) have a direct neuromuscular blocking activity & a potential for interaction with non depolarizing neuromuscular blocking agents (NMBA). There is lack, though of any such clinical interaction between PPI & NMBA. The present study is designed to test this hypothesis in a clinical setting. Materials and Methods : Patients were randomly allocated to either test group (pantoprazole 0.8 mg/kg i.v. 1 hour before the surgery along with other standard pre-anaesthetic medications) or control group (standard pre-anaesthetic medications excluding PPI class of drugs). Muscle relaxation was done using vecuronium in a loading dose of 0.08mg/kg & later maintained via top-up doses of 4:1 ratio with loading dose as and when the surgical condition required. Skeletal muscle relaxation activity was assessed by 'train-of-four' [TOF] protocol using a peripheral nerve stimulator as well as clinically. All other intra-operative procedures remained similar as per standard institutional practice. Parameters : Comparison of dose requirement of vecuronium per hour between the two groups; Time of recovery taken by every patient based on time interval between two doses of vecuronium; Comparison of time of recovery required for patients in control & test group. Results: 20 eligible patients undergoing elective surgery under inhalational general anaesthesia were included of which results of 18 patients were analysed (9 in each group). The mean dose of vecuronium required during the surgery in control group was 3.89 (+ 0.66) mg/hour & 2.82 (+ 0.8) mg/hour in test group. This difference among test & control groups was statistically significant (p = 0.003). The mean time interval between two doses of vecuronium in control group was 20.4 (+ 2.7) mins & in test group was 33.4 (+ 11.5) mins. (p = 0.002). Discussion & Conclusion : The findings demonstrate a statistically significant reduction in the dose requirement of vecuronium used during surgery in patients pre-treated with pantoprazole. Similarly the duration of effect of vecuronium was also significantly longer in patients of test group than in control group. It suggests a pharmacodyanamic interaction between pantoprazole & vecuronium given to patients undergoing elective surgery under inhalational general anesthesia.

UK Sheth Prize -5

Efficacy of pantaprozole versus pantaprozole plus itopride in gastroesophageal reflux disease patients - A pilot study

Krishnakanth K, Siddalingappa CM, Kudagi BL, Amitabh Kumar, Amarnath BR, Ram Mohan Pathapati 1

Departments Pharmacology, and 1 Clinical Pharmacology, Narayana Medical College and Super Specialty Hospital, Nellore, Andhra Pradesh, India.

Objectives: Reflux of gastric contents from stomach into esophagus and esophageal motor dysfunction play a major role in the pathogenesis of Gastro esophageal reflux disease (GERD). The synergistic combination of pantoprazole and itopride has become the drug of choice for empirical treatment in GERD patients. To this purpose, we conducted a 4-wk study to compare the efficacy of empirical monotherapy with pantaprazole and dual therapy with pantaprazole plus itopride in GERD patients using frequency scale for the symptoms of GERD (FSSG). Materials and Methods: 60 Patients with history of epigastric pain, epigastric burning, vomiting, nausea and FSSG score of >7 points were enrolled in this open label study. Patients received either Pantaprozole or fixed dose combination of pantoprazole plus itopride once daily for a period of 4 weeks. FSSG Scores were recorded at the end of week-2 and week-4. The primary end point was absolute change in FSSG score at end of week -4 Results: Both pantaprozole and Combination of Pantaprozole plus Itopride showed a significant reduction in symptom score independently. The symptom relief was significantly more in Pantaprozole plus Itopride (-23.83 ± 3.08 (-74%)) group than pantaprozole alone (-12.53 ± 2.30 (-70%)) after 4 weeks (P< 0.0001). Percentage of non-responders defined as patients with FSSG score more than 7, 16(53%) in Pantaprozole and 19 (63%) in Pantaprozole+ Itopride were similar, P=0.60. Conclusion: Pantaprozole and pantaprozole + Itopride have proven their efficacy in symptom relief, and endoscopic healing of esophagitis independently. Pantaprozole plus Itopride is more effective than pantaprozole alone for GERD associated symptoms.

UK Sheth Prize -6

A study of antimicrobial therapy prescribed for opportunistic infections in HIV positive patients at civil hospital Ahmedabad

Kapadia JD , Desai CK, Shah AN, Dikshit RK

Departments of Pharmacology, and Medicine, Civil Hospital, Ahmedabad, Gujarat, India.

To study the utilization pattern of the antimicrobials used to treat opportunistic infections (OIs) in HIV positive patients and to assess the safety of these drugs. Materials and Methods: In this observational, prospective, single centre study, a purposive sampling of the study population was carried out based on the previous data about the prevalence of different OIs occurring in HIV positive patients at the study site. The selected patients were followed up for a period of one year to record the OIs, their clinical course and outcome and to evaluate the antimicrobials used. Results: At the time of interim analysis, 117 patients have been evaluated. A total of 149 OIs were observed during this period. Majority (72.65%) of patients were men. The most common age group was 30 to 40 years (40 patients) with an average age of 35.6 years. The OIs observed were tuberculosis (85), oropharyngeal candidiasis (27), chronic diarrhea (16), herpes zoster (7), other herpes virus infections (3), bacterial infections (6) and others (5). The antimicrobial agents were prescribed in accordance with the NACO guidelines in majority of the cases and were effective in most patients. Death occurred in 10 patients out of which 8 suffered from extrapulmonary tuberculosis. Serious ADRs due to these agents were observed in 3 patients. Recurrence of OI was seen in three patients. Conclusion: Tuberculosis, oral candidiasis and chronic diarrhea are the commonest OIs. Extrapulmonary TB is associated with increased mortality in these patients. NACO guidelines for treatment of OIs are followed in most cases, however, identification of causative organism could ensure a rational treatment of chronic diarrhea. Early diagnosis and treatment are the most favorable prognostic factors for OIs like CMV retinitis and P. carinii pneumonia. The antimicrobial agents used are relatively well tolerated in most patients.

UK Sheth Prize -7

Drug Utilization pattern and Cost Analysis in Rheumatoid Arthritis Patients - A Cross sectional study in Tertiary Care Hospital, Mumbai

Gawde SR , Shetty YC, Merchant S, Kulkarni UJ, Nadkar MN

Department of Pharmacology and Therapeutics, 1 st Floor, Main Building, Above Dean's Office, Seth G.S. Medical College, KEM Hospital, Parel, Mumbai - 400 012, India.

Objectives: To study the current prescription pattern and to analyze the cost of the treatment prescribed to RA patients referred to rheumatology OPD in KEM hospital. Materials and Methods: The study protocol was approved by the institutional ethics committee. Patients attending Rheumatology OPD for existing RA disease were recruited as per inclusion criteria. Written informed consent was sought. It's a cross-sectional study. Total 100 consecutive rheumatoid arthritis patients (fulfilling the American College of Rheumatology Criteria 1987) were recruited from 1 st April to 1 st September 2011. Results: Majority of patients (67%) in the study population were on combination of two DMARDs. Most frequently prescribed two DMARD combination was methotrexate and hydroxychloroquine (64%). Average total cost per prescription was found to be ` 763.39, while average hospital and out of pocket expense were ` 281.12 and ` 482.88 Cost of medicines to treat disease was ` 416.60 and to prevent or treat ADR was ` 349.56. The monitoring cost per month per patient was ` 115 and consultation and hospital charges are minimal (` 10 per month). Conclusion: The drug use pattern in RA was found to be DMARDs based and majority of the cost was borne by the patient. The total cost increased was due to administration of drugs to treat to adverse drug reaction. Prospective studies in a larger number of patients are needed to assess the utility of prescription audit and cost analysis of drugs used in RA.

UK Sheth Prize -8

Completeness of project application forms submitted to institutional ethics committees of a tertiary care hospital

Shetty YC , MarathePA, Billa GV

Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Parel, Mumbai - 400 012, India.

Objectives : To review completeness of Ethics Committee(EC) application forms and to find out similarities and differences in content of forms of 5 ECs in India. Materials and Methods: The completeness was assessed on the following themes: title, study team, sponsor responsibility, scientific aspects, patient safety, regulatory permissions, Informed Consent process from 2008 -2009. Application forms (available online) of 5 ECs were studied and compared with respect to information required. Results : A total of 445 application forms were analyzed, 382 were academic, 63 were sponsored. The common deficiencies in academic studies were inappropriate titles (25.13%), lack of budget details (90.31%).More than 90% of the studies had not mentioned the method of recruitment. The issue of vulnerability was poorly addressed in >50% studies. Compensation for participation/injury was poorly stated in academic (1.05%) studies. 100% of industry sponsored studies were compliant with regulatory permissions and 41.27% were CTRI registered. The information pertaining to Informed Consent was mentioned by all. Comparative analysis of application forms of 5 ECs showed that the requirements for submission were similar except 1-2 ECs asked for additional information like percentage of time allotted by investigator for ongoing studies, GCP training of study team, certification by investigator regarding accuracy of local versions of Informed consent. Conclusion: Our study recommends that increased awareness and vigilance by investigators of academic studies regarding submission of applications to EC will increase efficiency and speed of review process. A common application form for all ECs across India would be an important step to achieve uniformity in functioning of ethics committees

UK Sheth Prize -9

A comparative, single-blind, placebo-controlled, clinical trial of efficacy of proton pump inhibitor (omeprazole 40mg) add-on therapy along with cancer chemotherapy: A novel anticancer strategy

Banga P.V. , Chandaliya K.C., Baig M.S., Doifode S.M.

Department of Pharmacology, Government Medical College, Aurangabad - 431 001, Maharashtra, India.

Objective : This study attempts to identify the efficacy, safety and tolerability of Proton pump inhibitor (Omeprazole 40mg) add on therapy with cancer chemotherapy in improving treatment outcomes of solid organ malignancy (Eg.: adenocarcinoma, breast cancer, sarcoma, etc.) Materials and Methods: A prospective study was conducted from June 2011 to August 2011, on 60 patients with histologically proven solid organ malignancy, receiving chemotherapy. Test arm received add-on therapy of Omeprazole 40 mg orally OD for 8 weeks. Assessment of tumour size was done every 15 days with radiological techniques appropriate for the tumour. Final percentage regression of tumour size was done at end of 8 weeks. Results : The tumour regression rates in group receiving Omeprazole were significantly higher (P < 0.001) as compared to the group receiving placebo. Maximum difference was observed during last 15 days of therapy. Few patients receiving PPI had adverse effects like dizziness, headache but could be managed with supportive therapy Conclusion : Proton Pump Inhibitors appear to be a highly promising and effective add-on therapy and associated with better tumour regression rates compared to Placebo for solid organ malignancies. Larger multi-centric trials needed. Key words: Cancer chemotherapy, proton pump inhibitor, solid organ malignancy, tumour regression.