Efficacy and safety of ivabradine as an add-on to atenolol in patients with chronic stable ischemic heart disease

Background: Heart rate is the important key factor for determining the cardiac output, myocardial oxygen demand and coronary blood flow. Reduction in heart rate is the main stay of treatment for preventing and treating IHD. Due to the interactions with other drugs and adverse effects of the conventional drugs, the management of IHD focused on novel targets. Ivabradine is a novel specific and selective if current inhibitor of SA node. The objective of the study was to efficacy and safety of ivabradine as an add-on to atenolol in patients with chronic stable ischemic heart disease.Methods: Interventional, open label, prospective clinical study was done over a period of 1 year. Single centered study conducted in 50 patients in the Outpatient Department of cardiology, Tirunelveli Medical College Hospital, Tirunelveli. Endpoints noted were reduction in resting heart rate using 12 lead ECG and improvement in Canadian cardiovascular society (CCS) class of angina grading.Results: Ivabradine in reducing the heart rate at the end of 1 month (86.60±9.16) and at the end of 3 months (81.82±8.37) compared with baseline (93.08±11.67). CCS class of grade of angina also improved at the end of one month and 3 months compared with baseline. Grade IV (3 - 0 - 0), grade III (7 - 3 - 1) and grade II (40 - 8 - 9).Conclusions: Ivabradine is safe and effective in preventing and treating further anginal attacks in patients with chronic stable ischemic heart disease already on atenolol therapy

Knowledge, attitude, and practice of pharmacovigilance among health care professionals in a tertiary care hospital: a cross sectional study

Background: Spontaneous reporting of Adverse drug reactions (ADRs) has played an important role in the detection of serious, unsuspected, and unusual ADRs previously not detected during the clinical trials. However, underreporting remains a major obstacle in the implementation of pharmacovigilance program. The present cross-sectional study was conducted to assess the knowledge, attitude, and practice (KAP) related to pharmacovigilance among the health-care professionals (HCPs) in Tirunelveli Medical College Hospital, Tamilnadu.Methods: To assess KAPs of Health care professionals toward pharmacovigilance and ADR reporting; a predesigned, structured, 12 item questionnaire was used.Results: A total of 200 questionnaires were distributed among the HCPs including Postgraduate, Interns and Staff nurses. 72.7% postgraduates, 54.29% interns and 52.63% of staff nurses were aware regarding the existence of a National Pharmacovigilance Program of India. 72.7% postgraduates, 65.71% interns and 52.63% staff nurses felt that ADR reporting is a professional obligation for them .Only 37.14% interns, 15.79% staff nurses and 11.4% postgraduates have been trained for reporting adverse reactions. Although all staff nurses (100%) followed by 79.50% postgraduates and 48.57% interns experienced ADR in their practice, only 31.58% staff nurses, 20.50% postgraduates and 11.43% interns have ever reported ADR to pharmacovigilance centre.Conclusions: The deficiencies in knowledge and attitude require urgent attention not only to improve the rate of spontaneous reporting, but also for enhanced safety of the patients. Pharmacovigilance should be included in the nursing curriculum and workshops should be conducted for the undergraduate and postgraduate medical students regularly

A comparative study for evaluation of cognitive function in type-II diabetes mellitus patients and non-diabetics

Background: To evaluate the impact of type-II diabetes mellitus on cognitive function and to assess the factors associated with impaired function.Methods: This prospective study compared 100 type-II diabetic people attending the diabetic clinic of Tirunelveli Medical College Hospital with another 100 membered control group. The study group was selected randomly between the age group of 45-65 years. A neuro-cognitive assessment was done using Standardized Mini Mental State Examination (SMMSE), which is a simple and reliable screening test. This scale has 12 questions with time limits to assess orientation, memory, calculation, language, attention and construction. Magnitude and severity of cognitive decrement were analysed along with the possible factors affecting it.Results: Mean age of the study population was 54.6±7.24 years. Cognitive impairment was noted among 62 of cases and 48 of the control group, which means a 14% higher prevalence of cognitive impairment among the type 2 diabetics. The association of development of cognitive impairment and duration of diabetes mellitus was significant statistically (p value = 0.025443; p<0.05). Other demographic variables like gender, education and domicile were also seen to affect the results.Conclusions: Mild to moderate cognitive impairment was found significantly higher among the type-II diabetics than the non-diabetics. The cognitive impairment was found to be associated with the duration of diabetes. Hence the routine screening of cognition by SMMSE should be done in all type-II diabetic patients

An analysis of prescription pattern and adverse drug reaction profile in children treated with antiepileptic drugs in a tertiary care teaching hospital

Background: Epilepsy is a clinical diagnosis made after a child has had two (or) more unprovoked seizures. Ideal goal in the management of childhood epilepsy is complete control with minimal side effects. The incidence of adverse effects is an important issue with antiepileptic drugs (AEDs). We took up this study to analyse the pattern of AEDs prescribed and adverse drug reaction (ADR) profile in children with epilepsy being treated at a tertiary care Teaching hospital of South Tamil Nadu.Methods: Children of both sexes, 1 to 12 years of age and on AEDs for at least 3 months were included for the study. Patients with febrile seizures, status epilepticus, seizures associated with paralytic stroke, head injury and cerebral palsy were excluded. Demographic data, treatment history and adverse drug events were recorded. Serum liver function tests, complete blood count and peripheral smear and causality analysis of ADRs were done.Results: Out of 203 patients 122 (60.1%) were males. Average number of AED prescribed per patient was 1.37. About 68% received monotherapy. 26.6% required two drugs and 5.4% patients required triple drugs. Out of 75 ADRs reported 3 are probable and 72 are possible reactions. The prevalence of ADRs (p=0.014*) and anorexia (p=0.0004*) were more in patients on polytherapy.Conclusions: ADRs were more common in patients with combination therapy which insists the need for a newer AED with less toxicity especially for paediatric patients

Antiproteinuric effects of cilnidipine and amlodipine as add on therapy in hypertensive patients with chronic renal disease: a comparative study

Background: Cilnidipine is a dual blocker of L type and N type calcium channel and dilates both afferent and efferent arterioles. Hence it increases renal blood flow and reduces glomerular pressure ultimately reducing proteinuria. Thus, it may exert renoprotective effects. The present study was designed to compare the antiproteinuric effects of cilnidipine and amlodipine in hypertensive patients with chronic kidney disease as add on therapy to patients on losartan.Methods: This is a randomized, open label, prospective, parallel group study conducted in the out patient Department of Nephrology. The trial enrolled Diabetic CKD patients with hypertension and with spot urine protein creatinine ratio (PCR) ≥0.2 who were being treated with T. Losartan 50mg/day for >2 months. The subjects were then randomly assigned to 2 groups to receive either cilnidipine 10-20mg/day (Group A-46) or amlodipine 5-10mg/day (Group B- 50). The drugs were given for a duration of 6 months for each patient. The dose of losartan (50mg/day) was not adjusted throughout the study.Results: After 6 months, a significant reduction in systolic and diastolic blood pressure was seen in both the groups. The decrease in urinary protein creatinine ratio was significantly higher in cilnidipine group rather than amlodipine group. Thus, cilnidipine exerted greater antiproteinuric effect than amlodipine.Conclusions: Cilnidipine has antihypertensive effect equivalent to amlodipine but addition of cilnidipine rather than amlodipine to losartan decreased urine protein excretion in diabetic chronic kidney disease patients

Active surveillance of adverse drug reactions in patients with rheumatoid arthritis in a tertiary care teaching hospital

Background: Drugs used in the treatment of rheumatoid arthritis show significant toxicity and morbidity. The objective of the study was to evaluate the nature and incidence of adverse drug reaction in patients with rheumatoid arthritis on anti-rheumatic drugs and to assess the causality and severity of the documented adverse drug reactions.Methods: The prospective observational study was done for two months in rheumatology outpatient department. All patients were interviewed for basic details, treatment history and adverse drug reactions and were recorded. Causality assessment and severity assessment of the recorded adverse drug reactions were done.Results: About 283 patients attended the rheumatology out-patient department during the two months period out of which 57 patients had one or more adverse drug reaction. The incidence of adverse drug reaction observed in rheumatology out-patient department to anti rheumatic drug was 20.14%. A total of 145 adverse drug reactions were noted in 57 patients. The most common adverse drug reaction reported was epigastric pain (6.89%) followed by headache and dyslipidemia (6.25%). The most common system associated with adverse drug reaction was gastrointestinal system (29.66%) followed by central nervous system and cardiovascular system (15.86%). Reported adverse drug reactions were assessed for causality and maximum belonged to probable (66.9%). Severity assessment revealed that most of the adverse drug reactions were mild (74.48%) in nature.Conclusions: Active surveillance for adverse drug reactions to anti rheumatic drug in patients with rheumatoid arthritis will allow early detection of adverse drug reactions and timely intervention to provide maximum benefit to the patients

Prescribing pattern and adverse drug reactions of cardiovascular drugs in out-patient department of a tertiary care hospital

Background: The main objective of prescription pattern analysis is to assess the rationality of drug use. It has been found that cardiovascular disease is the most frequent cause of morbidity and mortality throughout the world. This study is to estimate the prescribing pattern and adverse drug reactions in patients with cardiovascular diseases.Methods: This prospective observational study was conducted for a period of 2 months in cardiology outpatient department.100 patients who fulfilled the study criteria were observed. The central drug standard control organisation (CDSCO) reporting forms were used for the collection of adverse drug reactions. Causality assessment was done by using the World Health Organization Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (WHO-UMC) scoring system and severity assessment by modified Hartwig and Siegel scale.Results: The study group consists of 79% male and 21% females. Average number of drugs per prescription was 4.65. Most commonly prescribed drugs were antiplatelets (32%) followed by statins (18.27%) and the least common were calcium channel blockers (1.72%) and cardiac glycosides (0.86%). A total of 174 adverse drug reactions were reported out of which 24.7% were myalgia due to statins, 15.5% were cough due to angiotensin converting enzyme inhibitors and 14.3% were gastritis due to antiplatelets.Conclusions: Antiplatelets, statins and angiotensin converting enzyme inhibitors dominated the prescribing pattern. Myalgia, cough, gastritis, insomnia by atorvastatin, enalapril, aspirin, beta blockers respectively were found to be the most commonly reported ADRs among the cardiovascular drugs

Assessment of knowledge about post exposure prophylaxis of HIV among medical, nursing and paramedical students in hospital and laboratory practice

Background: India has 2.1 million of people living with HIV, and places in third-largest population of people infected with the HIV after South Africa and Nigeria. It is thus important for health care providers including medical, nursing and paramedical students to have adequate knowledge on PEP for HIV to protect themselves prior to starting their life long career.Methods: Cross-sectional study was conducted among 200 medical, nursing and paramedical students in Tirunelveli medical college from December 2016 to February 2017. A pre-designed questionnaire was used to collect data. Results were summarized in percentages and presented in tables.Results: A total of 96 (48%) males and 104 (52%) females responded in the study. Though many (87%) had heard about PEP, just 31 (15.5%) had received formal training on PEP for HIV. Only 81 (40.5%) knew the ideal PEP regimen and 88 (44%) knew the correct drug regimen. The majority 196 (98%) considered PEP was important and significant 178 (89%) considered themselves to be at risk of acquiring HIV at work, with 46 (23%) having experienced an exposure in the past. Of those exposed, only 21 (45.7%) received PEP.Conclusions: This study shows that knowledge, attitude and practice towards PEP for HIV is inadequate. A formal PEP training centre with proper guidelines is recommended for medical, nursing and paramedical students

Prescribing pattern and adverse drug reactions monitoring in patients with rheumatoid arthritis in a tertiary care hospital

Background: Rheumatoid arthritis is a chronic inflammatory arthritis which requires lifelong treatment to prevent the damage to joints and to maintain day to day functioning of patients. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is very important that their use require regular monitoring for adverse reactions. The present study is designed to estimate the prescribing pattern and the occurrence of adverse drug reactions in patients with rheumatoid arthritis.Methods: This prospective observational study was conducted from July 2014 to September 2014 in rheumatology outpatient department.75 patients who fulfilled the study criteria were observed for 3 months. Their prescriptions were collected and analysed. The CSDCO reporting forms were used for the collection of adverse drug reactions. Causality assessment was done by using WHO-UMC scoring system and severity assessment by modified Hartwig and Siegel scale.Results: The study group consists of 85.6 % female. Majority of them were in age group 40-49 years. Average number of drugs per prescription was 4.97.Out of 75 patients, 57.33% were on single DMARD, and 33.33% required 2 DMARDs and 9.33% were prescribed 3 DMARDs. A total of 64 adverse drug reactions were reported out of which 29.6% was due to glucocorticoids, 25% was due to the use of NSAIDS and steroids. Chloroquine maculopathy occurred in 2 patients and elevated liver enzymes occurred in 6 patients due to methotrexate which necessitated DMARD withdrawal. Eight percent of the ADRs were severe.Conclusions: Treatment of rheumatoid arthritis is based on DMARDs and glucocorticoids where it is difficult to prevent the occurrence of ADRs. Consistent monitoring of therapy is needed for early recognition of ADRs and prompt action

Digital detox, the need of the hour: a cross-sectional study on psychometric evaluation of college students using smart phones

Aim: The aim of the study was to analyse the pattern of mobile usage and its impact on behaviour among college students. Methods: A cross-sectional, semi-structured questionnaire based study was conducted among 275 students of various colleges of Tamil Nadu after obtaining IEC clearance. Quantitative data is expressed as mean ± standard deviation and compared by independent sample t test or ANOVA. Qualitative data is expressed in percentages. Results: Out of the 275 study participants, 140 were from medical college and 135 were from non- medical colleges. Around 42.8% participants were using mobile phones for 3-6 hours per day and 58% were using social media more frequently in a day. The estimated mean of the behavioural analysis score with the social media usage and mobile phone usage revealed that the mean score increased if the usage of social media or mobile increased (p < 0.001). Conclusion: The pattern of mobile phone use among the college students reported in this study appears to have some behavioural influence on them. This has to be recognized at an earlier stage and measures must be taken to reduce it