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Background: Diabetic kidney disease is a life threatening and disabling complication of uncontrolled diabetes mellitus. Clinical proteinuria is a well-established marker of renal dysfunction. A dual L/N-type calcium channel blocker cilnidipine dilates the afferent and efferent arterioles of the glomerulus decreasing the intraglomerular pressure and showing antiproteinuric effects. The present study was conducted to assess the antiproteinuric efficacy of cilnidipine in patients of diabetic kidney disease.Methods: This interventional study was conducted on 50 patients of both genders aged 18 years and above with diabetic nephropathy (stage-2 to stage 4) visiting the medicine OPD at HIMS, Dehradun over a period of six months, the patients were given tablet cilnidipine (5-20 mg) once or twice a day. Baseline urine protein creatinine ratio (UPCR), serum creatinine and the estimated glomerular filtration rate (eGFR) was recorded at baseline and repeated after a period of 12 weeks. The end point was the decrease in UPCR after a period of 12 weeks. Students-paired T test was used for analysing the intragroup data.Results: After 12 weeks of treatment with cilnidipine, a significant reduction was observed in the urinary protein creatine ratio (mean盨D) from 3.2�23 at baseline to 3.09�09 respectively (p<0.05). Along with this there was also a reduction in the in serum creatinine which was significant (p<0.05) as well as an increase in the eGFR value which was also statistically significant (p<0.001).Conclusions: Cilnidipine reduces the UPCR as well as improves the kidney function in patients with diabetic kidney disease.
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Background: Hypertension is an important worldwide public health challenge. It has changed from a trivial cause of death and disability to one of the global burden diseases. The biggest obstacle for inadequate therapeutic control of blood pressure is meagre knowledge, poor attitude, inadequate treatment practices and lack of adherence towards antihypertensive treatment. The present study was planned to assess the awareness of hypertension on various aspects and to evaluate treatment adherence in hypertensive patients.Methods: This cross-sectional study was conducted on 100 hypertensive patients of both genders visiting medicine OPD at HIMS, Dehradun over a period of six months. A structured and validated questionnaire was used to assess the knowledge, attitude and practice (KAP) among patients. Morisky 8-Item Medication Adherence Questionnaire was used to assess the adherence towards antihypertensive medications. For statistical analysis Chi square test was used.Results: Out of the 100 patients the median KAP scores were 6(5),5(1) and 10(4) respectively. Most of the subjects had high median scores on attitude but majority of the subjects had low knowledge and self-care practice scores. Further Analysis of data revealed that a poor score in self-care practice was significantly associated to the gender(p<0.004) as well as to the level of education(p<0.006).Only 40% patients were adherent to their medication, this result was statistically associated with the level of education (p<0.00001).Conclusions: Hypertensive patients in our community have good attitude but poor knowledge and self-care practices towards management of hypertension. Patients were also found to be non-adherent to their antihypertensive medications.
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Background: Diarrhoea is a major public health problem in children worldwide. It continues to be a major health challenge, especially in developing countries, despite the availability of regularly updated standard treatment guidelines. Non-compliance to such guidelines by the physicians has been a long standing story. The treatment is often marred with incapacitating prescription of drugs besides neglecting even the basic tenets of good prescribing. As a result, the quality of such prescriptions for diarrhoeal disorders in children remains poor. To gauge the magnitude of this problem in this setup towards possible corrective measures, the study was aimed to audit prescription practices in the management of acute and persistent diarrhoea in hospitalised children up to five years of age.Methods: An observational study was conducted in 100 patients of either gender in the age group up to 5 years admitted with acute and persistent diarrhoea. A detailed medical history from the parents/guardians and the details of prescription from the time of admission till the discharge of the patient were obtained. Quality of prescriptions was analysed using prescription quality index (PQI) tool, a validated comprehensive tool described by Hassan et al in 2010. Based on this tool, prescription with the total PQI score of ? 31 were interpreted as poor quality, scores with 32 to 33 as medium quality and scores 34 to 43 as high quality with a possible maximum score of ��.Results: Based on the PQI tool for 100 children, 60 prescriptions were found to be of poor quality. Only 2 prescriptions were of medium quality, whereas 38 prescriptions were in high quality range. Average mean盨D score of prescriptions with poor quality was 25.2�48, ranging from 21 to 31. The mean盨D of prescriptions with medium quality was observed to be 32�and for prescriptions of high quality was 38.07�28. The total average mean score of all prescriptions was 30.23�50. Poor quality prescriptions were particularly observed for the patients with the diarrhoea with No dehydration.Conclusions: Prescription appropriateness in spite of available guidelines continues to be a big challenge in the adequate management of patients with diarrhoeal disorders under the age group of five years in a tertiary care centre in India.
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Background: Cognitive decline with AEDs (Anti-epileptic drugs) is associated with learning and memory deficits especially in the younger age group. The data regarding the impact of levetiracetam and valproic acid as monotherapy on cognition in epileptic patients is scarce. The present study was done for evaluation of cognitive decline associated with the use of AEDs.Methods: Present study was a prospective study on 60 patients on AEDs for a period of 12 weeks. Patients were enrolled from the Department of Neurology, Swami Rama Himalayan University, Dehradun, Uttarakhand, India and divided into group A (levetiracetam) and group B (valproic acid) with 30 patients in each group. Permission from the institutional ethics committee and written informed consent was taken from all the patients. They were analyzed for cognitive impairment using MMSE and MoCA scales at baseline and 12 weeks.Results: The mean duration of disease was 2.13�1 years and 2.08�1 years and mean age of the patients was 14.67�9 years in group A and 16.20�6 years in group B. GTCS was present in 31 patients (52%) followed by partial seizures in 29 patients (48%). The mean change in the MMSE scores from baseline to 12 weeks was significant in group A 1.30�1 (p value <0.05) and change group B was -0.20�4 not statistically significant. The mean change was observed in MoCA scores from baseline to 12 weeks was significant in both groups A and B by 1.17�1 and -0.70�1 respectively (P value <0.05).Conclusions: Patients on levetiracetam showed cognitive improvement, whereas patients on valproic acid showed a decline in the MMSE and MoCA scores.
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Background: Neuropathic pain is associated with prolonged disability and is usually not responsive to conventional analgesics like NSAIDs and opioids. Even the recommended first-line drugs are effective in less than 50% patients. Thus, drugs with different mechanisms of action are needed. Baclofen, a GABA-B agonist has shown benefit in different types of neuropathic pains and is compared against pregabalin.Methods: The sciatic nerve was ligated in 2 groups of 6 rats each as per the chronic constriction injury model of neuropathic pain on day 0. After 14 days the effect of single doses of pregabalin (30mg/kg) and baclofen (5mg/kg) intraperitoneally were assessed over a 2 hours period. Thermal and mechanical hyperalgesia were assessed as measures of neuropathic pain by the hotplate and pin-prick method respectively.Results: Significant thermal and mechanical hyperalgesia was produced 14 days after sciatic nerve ligation in both the groups (p <0.05). Both pregabalin (p <0.001) and baclofen (p <0.01) were effective in decreasing thermal hyperalgesia throughout the two hours study period, but pregabalin was more effective as compared to baclofen (p <0.05) at 30, 60 and 120minutes. Both the drugs produced a significant decrease in mechanical hyperalgesia (p <0.01) throughout the study period. Again, pregabalin was the more effective drug (p <0.05) at all time points.Conclusions: Significant thermal and mechanical hyperalgesia was seen 14 days after sciatic nerve ligation. Both pregabalin and baclofen were effective in reversing the hyperalgesia, but pregabalin was the more effective of the two drugs at all time points.
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Background: Prescription pattern studies are a tool for assessing the prescribing, dispensing and distribution of medicines. The main aim of assessing prescribing pattern is to facilitate rational use of medicines. So the main aim of the study was to assess the prescribing pattern of oral anti-diabetic agents in type 2 diabetes mellitus, to assess the rationality of the prescribed drugs and also to assess the pattern of co-morbid conditions associated with type 2 diabetes mellitus in a tertiary care hospital.Methods: This cross sectional study was conducted in the Department of Pharmacology in collaboration with Department of General Medicine. Study was conducted from 1st June 2016 to 31st Aug 2016 (3 months). A total of 100 patients were enrolled after taking written informed consent. A structured case recording form was used to record demographic details and prescription details. The rationality of prescriptions was assessed using American Diabetes Association guidelines 2015.Results: Majority of the patients were prescribed combination therapy (54%) followed by monotherapy (46%). Oral anti-diabetic agents used as monotherapy other than metformin were inappropriate. Among the patients receiving combination therapy majority were receiving a fixed dose combination which were inappropriate.Conclusions: Majority of the patients were receiving fixed dose combinations without justifiable pharmacokinetic/pharmacodynamic benefits. Such kinds of studies are required to improve rationality of prescription of drugs, decreasing morbidity and mortality of patients and decreasing the cost of treatment.
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Background: Adverse drug reaction (ADR) under-reporting is a hindrance to the implementation of Pharmacovigilance Program of India. This is essentially due to lack of ADR reporting culture among healthcare professionals. Thus, study was conducted to assess and enhance awareness about ADRs and strengthen reporting among medical undergraduates.Methods: This is an interventional crossover study. A total of 140 students of 2nd professional, MBBS were included and divided into two groups of 70 each. In phase 1, group A was given a didactic lecture (DL) on ADR and pharmacovigilance. Group B was also given DL with an addition of a case narrative exercise and they were asked to fill an ADR form. Both groups were assessed based on an MCQ questionnaire for knowledge and skill. After 15 days of washout period, groups were crossed and reassessed. Feedback from students was taken on a 5 point Likert抯 scale.Results: The mean scores of batch A without case was 17.5�out of a total score of 25 marks, which showed improvement with case narrative and mean increased to 19.6� 2.4 (p 0.05). Similarly, Batch B showed improvement as well and the mean 17.7�1 score without case narrative increased to 19.2�7 (p <0.05). Student抯 perception of the effectiveness of module-based teaching was positive.Conclusions: Case narrative in addition to didactic lecture enhanced awareness and may strengthen ADR reporting culture among the medical students.
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Background: Diabetes mellitus (DM) is a spectrum of metabolic disorders as a consequence of different pathogenic mechanisms resulting in hyperglycemia. A genetic predisposition to develop ?-cell dysfunction synergizes with insulin resistance to lead to type 2 DM. Adequate management of type 2 DM requires institution of non pharmacological treatment followed by pharmacological treatment. Monotherapy is started initially followed by combination therapy (dual/triple). Sitagliptin, a DPP-4 inhibitor and voglibose, an ?-glucosidase inhibitor has been implicated as an add on therapy to metformin and glimepiride. So, we aimed to assess the efficacy and safety of the sitagliptin and voglibose as add on therapy to metformin and glimepitide in type 2 DM.Methods: This open label randomized control trial was conducted in the department of Pharmacology among patients attending medicine OPD of a tertiary care hospital. 80 patients were randomly divided into two groups of 40 patients each. group A:sitagliptin + metformin + glimepiride and group B:voglibose + metformin + glimepiride. Patients were followed every week for a period of 12 weeks. Data was analysed using paired t test, unpaired t test and chi square test.Results: There was a significant decrease in HbA1c, FPG and PPG in both the groups. Intergroup comparison at 4, 8 and 12 weeks showed a better improvement in glycemic control in group A as compared to group B.Conclusions: Sitagliptin showed a better glycemic control than that with voglibose in patients with uncontrolled type 2 DM on metformin and glimepiride.
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Background: Quality of life plays an important role in patients of epilepsy and is the most neglected part during management. The antiepileptic drugs treatment results in seizure control but adversely affect the quality of life in patients.Methods: An observational analytical study was conducted in the Department of pharmacology with Department of Neurology of Himalayan Institute of Medical Sciences, Dehradun over 12 months. 85 patients fulfilling the inclusion criteria with diagnosis of generalized tonic clonic seizures (GTCS) were enrolled and divided into two groups based on physicians discretion and followed up for 12 weeks. Patients were evaluated for quality of life by QOLIE-10 self administered questionnaire at 0 and 12 weeks, assessed for seizure control and drug related adverse effects.Results: 85 patients were enrolled and divided into two treatment arms as per physician discretion, levetiracetam (41) and valproic acid group (44). Study drugs showed significant improvement in quality of life, levetiracetam showed mean change that was significantly greater than valproic acid (p=0.003) at 12 weeks. Patients who failed to achieve seizure control at 6 weeks were 17% patients in levetiracetam and 20% in valproic acid group, reason being non-adherence which was 17% and 20% respectively. Adverse events recorded with Levetiracetam (10), most common being increased sleep and with valproic acid (18), with most common being increased sleep and weight gain.Conclusions: Levetiracetam treatment resulted in better quality of life, with similar seizure control but decreased number of adverse effect then Valproic acid.
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To evaluate student opinion on use of CAL in the MBBS 2nd professional experimental practical pharmacology curriculum.Also to get their views on the advantages and disadvantages of using CAL over traditional methods. A cross-sectional questionnaire based study was conducted at HIMS, Dehradun and Uttarakhand. After explaining the purpose of the study, voluntary inform consent was taken from the subjects before the start of the study. Students were instructed on experiments followed by computer simulation of the same. Thereafter avalidated self-designed questionnaire form was duly filled by each respondent.Out of the total 98 students, 88 (90%) of these thought that CAL is an effective method of teaching practical aspects. They also agreed to the fact that CAL should be conducted as an adjuvant to practical classes. Majority of students agreed that using CAL was advantageous to them .CAL is accepted as a welcome change byundergraduate students. However on the other hand practical knowledge of how to do the experiment is lost.
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Background & Objective: To know the student’s opinion about the current tutorial classes held in department of pharmacology of HIMS Methodology: The study was conducted on 250, second professional students of HIMS attending pharmacology department. A validated questionnaire of 15 questions was prepared. Each question had 3-5 options and lastly about their suggestions and comments. Students were briefed about the study before giving them the feedback form. They were given sufficient time to fill the form and were asked not to reveal their identity for unbiased opinion. Results: 97% of students agreed that tutorial helps them in understanding the topic better. Majority of students (68%) will attend tutorial classes even if attendance is not compulsory. When asked about the environment during the tutorial, 72% of the respondents said that it is strict but interactive. Majority of students were in favour that tutorial’s topic should run parallel with lecture topic and should be taken by postgraduate students only. When asked about the structure of tutorial, majority of students (52%) felt that discussing whole topic will help them most. Many students suggested that tutorials should be well planned, organized and cover difficult topics in pharmacology i.e General, ANS and CNS. Conclusion: Teaching is a novel teaching technique which enhances interest among students. With some modifications and suggestions we can enhance the effectiveness of our current tutorials.
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To study the pattern of adverse drug reactions (ADR) in patients attending psychiatry OPD of a tertiary care teaching hospital. Patients attending psychiatry OPD with ADRs due to drugs prescribed for various psychiatric illnesses over a period of 1year were included in the study. Adverse event history, medication history and other relevant details were entered in the PvPI format. Causality was assessed by WHOUMC criteria. A total of 103 ADRs were reported from 85 prescriptions with a female preponderance. Majority of ADRs (45.7%) were seen with antidepressants as they were the commonly prescribed drugs followed by antipsychotics (33.3%) and others by sedative hypnotics and anticonvulsants. ADRs like somnolence topped the list (21.9%) followed by weight gain (18.4%), akathesia (6.8%) and drug induced restless legs syndrome (RLS) (5.8%). The reported ADRs were assessed for causality and maximum (80.6%) belong to the "possible" category. Maximum ADRs were seen with antidepressants followed by antipsychotics. Sedation and weight gain were the most commonly occurring ADRs.
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To study & compare the effect of glitazones and DPP-IV inhibitors as add on therapy on Insulin sensitivity and serum hs-CRP levels in type 2 diabetes mellitus patients.Thirty patients (previously known cases of type 2 DM), aged above 18 years, were randomly included in the study. Group A, Glimepiride + Metformin + Pioglitazone (G + M + P) and Group B, Glimepiride + Metformin + Sitagliptin (G + M+ S). The study drugs were given on the basis of physician's discretion and the doses of study drugs were fixed according to their clinical presentation & followed up for a period of 3 months.The glycosylated haemoglobin (HbA1c) at the start of study (day 0) of group A was 10.39 ± 0.67 and in group B was 10.10 ± 0.62.The mean value of HbA1c at the end of the study period (day 90) in group A was 9.46 ± 0.61 and in group B was 9.04 ± 0.58. Insulin resistance at the start of the study (day 0) in group A, was 5.549 ±0.59 and in group B was 6.66 ± 0.76, The mean values of IR at the day 90, in group A was 3.42 ± 0.37 and in group B was 3.82 ± 0.61. The mean value of hs-CRP at the start of study (day 0) in group A was 4.34 ± 0.77 and in group B was 6.78 ± 1.18. The mean value of hs-CRP at the end of the study period (day 90) in group A was 2.8 ± 0.63 and in group B was 4.51 ± 0.73. There was no significant intra group or intergroup difference found in the above mentioned study paramaters .Both the study drug groups reduced HbA1c, insulin resistance, though there was no any significant difference. There was decrease in hs-CRP levels in both the groups. Moreover these combination therapies were safe and no serious adverse effects were reported.
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A double-blind, randomized, parallel study was done to compare sumatriptan, ergotamine, naproxen and rizatriptan in 40 outpatients treating a single migraine attack of moderate to severe intensity. Among these groups, significantly more number of patients had headache relief at 2 hours postdose in naproxen and rizatriptan group as compared to ergotamine. Naproxen, rizatriptan and sumatriptan were better than ergotamine in causing freedom from the associated symptoms of nausea, vomiting, photophobia and phonophobia at 2 hour postdose. Naproxen, rizatriptan and sumatriptan were also efficacious in causing functional normalization at 2 hours postdose as compared to ergotamine. The overall results of the study suggest that naproxen is as efficacious as triptan group of drugs but better than ergotamine group in treatment of moderate-severe acute migraine attack. It is more cost effective than triptans and also a well tolerated drug.
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The present prospective study was planned and conducted in the Department of Pharmacology and in Orthopaedics OPD of a tertiary care teaching hospital, Himalayan Institute of Medical Sciences (HIMS), Dehradun during year 2003-04. The aim of the study was to analyze the prescribing pattern of NSAIDs in patients attending Orthpaedics OPD and to correlate the use of selective COX-2 inhibitors and older conventional NSAIDs in practice in the present scenario. The result of present study suggests frequent use of selective COX-2 inhibitors although conventional non-selective NSAIDs topped the list of various selective and non-selective NSAIDs. Concomitant gastroprotectives were also used. Fixed dose combinations were also prescribed.