Painful Diabetic Polyneuropathy (DPN) is one of the commonest microvascular complications, affecting nearly 26% of diabetic patients. Amitriptyline, Duloxetine and Pregabalin are all approved internationally for managing neuropathic pain apart from strict glycaemic control.
OBJECTIVESTo compare efficacy and safety of Pregabalin, Duloxetine and Amitriptyline in reducing neuropathic pain as well as improving quality of sleep among patients of DPN.
METHODOLOGYWe performed an open label, prospective, randomized, 12 week, observational study, at the Neurology OPD at B. S. Medical College. A total of 93 DM patients with baseline pain score >4 in numeric pain rating scale were enrolled and randomized to receive Pregabalin (n=31), Duloxetine (n=31) and Amitriptyline (n=31). Severity of neuropathic pain as assessed by NPSI score was recorded at baseline after 4 weeks and 12 weeks interval along with measurement of glycaemic control. We also measured improvement in sleep quality using PSQI score at all visits. Safety assessment was done by comparing treatment emergent adverse effects and by comparing laboratory parameters.
RESULTFinal assessment was done in 87 patients excluding 6 dropouts. Status of glycaemic control among all three groups was not significantly different. A significant decrease in mean pain score was seen in all three groups across time (p<0.05), but no significant difference was noted between the groups. The decrease in pain severity occurred more slowly during first 4 weeks with Amitriptyline than other two drugs. Sleep quality improved in all three groups in the first 4 weeks significantly, but no further significant improvement happened at 12 weeks in any groups. ADRs were mostly mild, occurring in 24.1% of cases, with highest incidence in patients receiving Amitriptyline.
CONCLUSIONAll these three drugs showed similar efficacy in reducing pain in diabetic polyneuropathy as well as improving the sleep quality. Amitriptyline, relatively inexpensive, may be preferred over the other two in this rural financially disadvantaged population. A large, blinded, multi-centric trial is being planned to find out superiority in safety or efficacy of these drugs.
BACKGROUND & OBJECTIVES:Bleomycin, Etoposide and Cisplatin (BEP) are commonly used combination for the treatment germ cell tumor. Among them cisplatin is a highly nephrotoxic drug. Proper therapy and continuous assessment of renal function is necessary to prevent nephrotoxicity. Our goal is to assess renal function following cisplatin containing combination chemotherapy. SETTINGS METHODS AND MATERIAL: This is a nonrandomized, uncontrolled open label prospective observational study carried out in the Department of Radiotherapy and Department of Pharmacology of Burdwan Medical College, West Bengal. Assessment of renal function was done by measurement of serum urea, creatinine, eGFR. Parameters were measured before starting chemotherapy, after 2 nd cycle and at the end of chemotherapy RESULTS: Analysis was done by using mean, standard deviation and percentage and paired t test. It was found that serum urea and serum creatinine was significantly (p<0.000) increased from the pretreatment level and Estimated GFR was decreased from the base line significantly (p<0.000) in spite of pretreatment hydration therapy. CONCLUSIONS: Cisplatin causes reversible renal failure. Nephrotoxicity can occur in spite of adequate pretreatment hydration therapy. So other measures are required to prevent cisplatin induced renal damage.
Type-2 DM patients, with uncontrolled plasma glucose, determined by anyone of FBS >130mg/dl, PPBS >180mg/dl, and HbA1c >7% with a combination therapy of Metformin (1000mg) & Glimepiride (2mg) for at least 4wks and then treated with either additional Metformin (500mg) or Pioglitazone (15mg) as add-on therapy were included in the study. HbA1C levels were measured twice, first baseline level during inclusion and then after 12 weeks of follow up. Any adverse effects and/or drug intolerance, if present, were reported to the clinician by the subjects and were noted. Study population was 92. RESULTS: Group 1 (Getting additional Metformin 500mg) consisted of 45 subjects, Group 2 (Getting pioglitazone 15mg) with age and sex matched. Mean baseline FBG was slightly higher among the participants of group 1 (158.29mg/dl) than group 2 (154.43mg/dl) and also for PPBG. After 4 week follow up, the mean PPBG was slightly higher among the participants of group 1 than group 2. After 12 week follow up the results were reverse is the case of mean FBG & PPBG. Mean HbA1C at the initiation of study was 8% (group 1) and 7.86% (group 2). After 12 week follow up, the mean HbA1C among the participants of group 1 was 7.7mg/dl and that of the participants among group 2 was 7.63mg/dl, CONCLUSIONS: At the end of 12 week, statistically significant higher proportion of subjects of Pioglitazone group (71.1%) attained target blood glucose level (both FBS and PPBS) whereas 46.8% of subjects of Metformin group attained the same.
BACKGROUNDPharmacology forms the backbone of rational therapeutics. The primary objective of teaching pharmacology is to enable undergraduate medical students to prescribe rationally. Hence, a survey was carried out at Medical Colleges of West Bengal to assess whether any change is needed in Pharmacology curriculum.
BACKGROUNDEpilepsy is the second most common neurological disorder affecting fifty million people globally. Antiepileptic Drugs (AEDs) are the mainstay of management in epilepsy. Use of AEDs over prolonged duration makes occurrence of multiple Adverse Drug Reactions (ADRs) frequently, especially with polytherapy.
OBJECTIVESTo estimate the incidence of all the ADRs among patients taking AEDs and to assess their causalities and to quantify their severity.
MATERIAL AND METHODSThis prospective, observational study was carried out at an Outpatient Referral Epilepsy Clinic at Neurology Department at Bankura Sammilani Medical College, West Bengal, between 1st June and 30th September 2015. The demographic data, diagnosis, drugs prescribed and ADRs experienced by the patients were recorded. Causality and severity assessment was done using Naranjo's Scale and Hartwig's Severity Assessment Scale respectively.
RESULTSIncidence of ADRs among the patients who attended the clinic was 3.3% (105 patients among 3146 experienced at least one ADR). Total 161 ADRs were detected, among which 55.3% were CNS adverse events followed by 15.5% gastrointestinal, 14.3% endocrine, 10.6% psychiatric abnormalities and 4.3% related to dermatological and allergic manifestations. Nearly one-third of the ADRs (32.3%) were found to be possible and 109 (67.7%) are of probable category, whereas none were deemed to be doubtful or definite. The most commonly implicated suspect drug was valproate (51.5%) followed by Phenytoin (22.9%). Most of the ADRs were mild (93.2%), 5.6% were moderate and only 1.2% were deemed severe.
CONCLUSIONIncidence of ADRs is found to be common in patients on AEDs. Though rare, but they can be life-threatening. Routine safety assessments and pharmacovigilance is necessary in this set up to reduce the incidence and also improve pharmacotherapy and patient compliance.
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