The utility of Vibratip in accurate identification of loss of protective sensation in the contralateral foot of patients admitted with a diabetic foot ulcer.

BACKGROUND AND AIMS: Diabetic foot ulcer (DFU) is a debilitating complication of type 2 DM. Complexity of foot examination often precludes proper clinical assessment of the foot during routine evaluation. We assessed the utility of novel device, vibratip, both singly and in combination with standard bedside tools for assessment of loss of protective sensation. METHODS: 75 patients admitted with DFU were included in the study. Clinical examination of the contralateral foot was done - temperature perception, vibration, pinprick sensation, Achilles tendon reflex and Neuropathy disability score were assessed. Testing using 10 g Monofilament, Vibratip and biothesiometer were also done. Considering the biothesiometer as the reference standard, three bedside tests (Vibratip, 10 g monofilament and 128 Hz tuning fork) were compared against it singly and in combinations. RESULTS: When compared against biothesiometer, vibratip performed significantly well with a positive predictive value of 90.3% and specificity of 84.2%. Sensitivity, however, was only 50%. On combining bedside tests, the best combination strategy was seen with vibratip and 10 g monofilament, which improved the sensitivity to 62.5%. Combining all three bedside tests further improved sensitivity to 64.3%. CONCLUSION: All the patients with an at-risk foot may not be identified with vibratip alone. Nevertheless, an abnormal result is almost always associated with loss of protective sensation, and such persons should be suitably educated. LIMITATIONS: Due to small size of the study population, it is not possible to generalize the findings to all patients with diabetes mellitus. A larger study would be required to provide more confirmatory findings.

Prevalence, treatments and outcomes of coronary artery disease in Indians: A systematic review.

AIM: To conduct a systematic review on the prevalence, risk factors, treatments and outcomes of Coronary Artery Disease (CAD) in Indians. METHODS AND RESULTS: We conducted a systematic review of studies in Indians with CAD from Jan 1969 to Oct 2012. Initial search yielded 3885 studies and after review 288 observational studies were included. The prevalence of CAD in urban areas was 2.5%-12.6% and in rural areas, 1.4%-4.6%. The prevalence of risk factors was: smoking (8.9-40.5%), hypertension (13.1-36.9%) and diabetes mellitus (0.2-24.0%). The median time to reach hospital after an MI was 360 min. In hospital rates of drug use were: antiplatelets 68%-97.9%, beta blockers 47.3%-65.8% and ACEIs 27.8-56.8%. CONCLUSIONS: In this first systematic review of CAD in India, prevalence of risk factors is high, treatments delayed and use of evidence based treatments variable.

Age- and gender-related differences in drug utilisation and adverse drug reaction patterns among patients in a coronary care unit.

INTRODUCTION: This study aimed to examine age- and gender-related differences in the comorbidities, drug utilisation and adverse drug reaction (ADR) patterns of patients admitted to a coronary care unit (CCU). METHODS: The present study was a retrospective cohort study. Two trained physicians independently reviewed the case records of CCU patients over a period of one year (Jan-Dec 2008). The demographic, clinical, and drug prescription data of the patients were analysed according to age group (18-59 years vs ≥ 60 years) and gender. RESULTS: A total of 574 patients were admitted to the CCU during the study period. Of these 574 patients, 65.2% were male, and 48.4% were ≥ 60 years old. No significant gender-based differences were found for the prescription of cardiovascular and non-cardiovascular drugs, and ADR patterns (p > 0.05). Male patients aged ≥ 60 years were found to have a higher rate of polypharmacy than those aged 18-59 years (p = 0.001). The duration of hospital stay was longer in male than female patients (p = 0.008), and the duration of CCU stay was longer for male patients aged ≥ 60 years than males aged 18-59 years (p = 0.013). Compared to patients aged 18-59 years, a greater number of patients aged ≥ 60 years were prescribed cardiovascular (p = 0.006) and non-cardiovascular drugs (p = 0.015). Patients aged ≥ 60 years also had a higher rate of polypharmacy (p = 0.001) and ADRs (p = 0.013), and a longer duration of CCU stay (p = 0.013). Renal (p = 0.047) and cutaneous (p = 0.003) ADRs were found to be more common in patients aged ≥ 60 years. CONCLUSION: No major gender-related differences were observed in the prescription, drug utilisation and ADR patterns of our study cohort. Higher drug utilisation, ADR rates, and longer duration of CCU stay were noted in patients aged ≥ 60 years.

Patterns and determinants of cardiovascular drug utilization in coronary care unit patients of a tertiary care hospital.

BACKGROUND: A wide variation exists in the patterns of pharmacotherapy among patients admitted with cardiovascular diseases. Very few studies have evaluated the potential determinants of drug utilization. Our objective was to evaluate the clinical characteristics and patterns of cardiovascular drug utilization among patients in coronary care unit (CCU) and assess the determinants of cardiovascular drug use among patients with coronary artery disease (CAD). METHODS: In this retrospective cohort study, the medical records of CCU patients were reviewed independently by two trained physicians over one year. Patients were analyzed as two groups - those with CAD and without CAD. Multivariate logistic regression was done to identify the determinants of cardiovascular drug utilization in the CAD group. RESULTS: Of 574 patients, 65% were males, 57% were <60 years. The five commonly prescribed drug classes were platelet inhibitors (88.7%), statins (76.3%), ACE-inhibitors/Angiotensin receptor blockers (72%), beta-blockers (58%) and heparin (57%). Poly-pharmacy (>5 drugs) was noticed in 71% of patients. A majority of patients had diagnosis of CAD (72.6%). CAD patients received significantly higher median number of drugs and had longer duration of CCU stay (p < 0.0001). Renal dysfunction for ACE-inhibitors [0.18 (0.09-0.36)], ST-elevation myocardial infarction for calcium channel blockers [0.29 (0.09-0.93)] and brady-arrhythmias for beta-blockers [0.3 (0.2-0.7)] were identified as determinants of decreased drug use in CAD group. CONCLUSION: Predominance of male gender, age <60 and poly-pharmacy was observed in CCU. Antithrombotics, statins, ACE-inhibitors/Angiotensin receptor blockers and beta-blockers were the most frequently prescribed drugs. Clinical co-morbidities (renal dysfunction, arrhythmias) decreased the utilization of ACE-inhibitors, beta-blockers among CAD patients.

Evaluation of efficacy and safety of gabapentin, duloxetine, and pregabalin in patients with painful diabetic peripheral neuropathy.

AIM: To compare the efficacy and safety of gabapentin (GBP), duloxetine (DLX), and pregabalin (PGB) in patients with painful diabetic peripheral neuropathy (DPNP). METHODS: A prospective, randomized, open label, 12-week study was conducted. A total of 152 patients with history of pain attributed to DPNP with a minimum 40-mm score on visual analogue scale (VAS) were randomized to receive GBP, DLX, or PGB. The primary efficacy measure was pain severity as measured on 11 point VAS. Secondary efficacy measures included sleep interference score, Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC). Assessment of safety was done by recording the occurrence of adverse drug reactions. Data was analyzed using descriptive statistics, Chi square test, analysis of variance (ANOVA), and repeated measures ANOVA. RESULTS: Of total 152 patients, 50 patients received GBP, DLX each while 52 received PGB. A significant reduction in pain score (VAS), sleep interference score, PGIC, and CGIC was seen in all the three treatment groups across time (P<0.05) with no statistically significant difference between the groups. There was a significant interaction between the time and treatment groups (P<0.001) for pain score (VAS), sleep interference score, and PGIC. The improvement in pain scores (VAS) and sleep interference score was higher with PGB compared to DLX and GBP. Adverse drug reactions were mild and occurred in 9.2% of all cases. CONCLUSIONS: Monotherapy with GBP, DLX, or PGB Produced a clinically and subjectively meaningful pain relief in patients with DPNP with onset of pain relief being faster and superior with PGB.

Patterns, predictors and preventability of adverse drug reactions in the coronary care unit of a tertiary care hospital.

AIM: To determine the frequency of occurrence, risk factors, clinical spectrum and drugs associated with adverse drug reactions (ADRs) occurring in the coronary care unit (CCU) of a tertiary care hospital. METHODS: This was a retrospective cohort study based on evaluation of the medical records of consecutive patients admitted to the CCU between January 2008 and December 2008. Each prescription was monitored for ADRs, and each ADR was assessed for causality, severity, predictability and preventability by two physicians using relevant scales. The chi-square test and independent t test were used to compare the ADR and non-ADR groups. Multiple binary logistic regression was used to identify risk factors for developing ADRs in the CCU. RESULTS: Of 595 patients, 152 (25.5%) developed ADRs, of which 45% were potentially preventable. Severe ADRs constituted 28.6% of the total ADRs. Patients who developed an ADR had a longer duration of stay in the hospital (2.8 extra days) (p < 0.05). Hypokalemia/hyperkalemia (22%), bleeding (11%) and cardiac arrhythmias (11%) were the commonest ADRs. The highest rates of ADRs were seen with streptokinase (59.4%). The predictors for developing an ADR in the CCU included renal dysfunction [odds ratio (OR) 1.66, 95% confidence interval (CI) 1.007-2.72], arrhythmias (OR 1.74, 95% CI 1.052-2.87) and polypharmacy with more than ten drugs (OR 11.3, 95% CI 1.45-87.44). CONCLUSION: A high frequency of ADR occurrence was identified, with many of the ADRs being potentially preventable. Patients with renal dysfunction or cardiac arrhythmias and those receiving polypharmacy were at an increased risk for developing an ADR in the CCU.

Utilization patterns of central nervous system drugs: A cross-sectional study among the critically ill patients.

INTRODUCTION: Critically ill patients often receive central nervous system drugs due to primary disorder or complications secondary to multiorgan failure. The aim of the study was to evaluate the current utilization pattern of central nervous system drugs among patients in the medical intensive care unit. MATERIALS AND METHODS: A prospective observational study carried out over a period of 1 year. The relevant data on drug prescription of each patient was collected from the inpatient case record. Drugs were classified into different groups based on WHO-ATC classification. The demographic data, clinical data, and utilization of different classes of drugs as well as individual drugs were analyzed. RESULTS: A total of 325 consecutive patients were included for the analysis; 211 (65%) patients were males; 146 patients (45%) were above 55 years of age. Encephalopathy [63(19.38%)] and stroke [62(19%)] were the common central nervous system diagnoses. In a total of 1237 drugs, 68% of the drugs were prescribed by trade name. Midazolam (N05CD08) 142 (43.69%), morphine (N02AA01) 201 (61.84%), and atracurium (M03AC04) 82 (25.23%) were the most commonly used sedative, analgesic, and neuromuscular blocker, respectively. Phenytoin (N03AB02) 151 (46.46%) had maximum representation among antiepileptic agents. CONCLUSIONS: Utilization of drugs from multiple central nervous system drug classes was noticed. Rational use of drugs can be encouraged by prescription by brand name.

Effect of fixed dose combinations of metoprolol and amlodipine in essential hypertension: MARS--a randomized controlled trial.

AIM: To compare two strengths of a fixed drug combination (FDC) containing metoprolol XL and amlodipine (metoprolol/amlodipine 50/5; and metoprolol/amlodipine 25/2.5) with its components in hypertension. METHODS: We conducted this multicentre, randomized, open-label, trial in Indian patients with hypertension (140-180 mmHg/90-114 mmHg) in 11 centres from nine cities. Eligible patients (n = 402) were randomized into one of five treatment groups (metoprolol XL 50 mg + amlodipine 5 mg, metoprolol XL 25 mg + amlodipine 2.5 mg, metoprolol XL 50 mg, metoprolol XL 25 mg or amlodipine 5 mg) and treated for 8 weeks with five follow-up visits to record blood pressure (BP) and clinical status. RESULTS: At baseline, treatment groups were well balanced; mean +/- SD BP was 154.87 +/- 11.91/96.63 +/- 6.97 mmHg. The greatest reduction in BP from baseline to 8 weeks was seen in the high-dose FDC group (23.61/14.91 mmHg; p<0.001). The remaining 4 groups too demonstrated a significant reduction (p< 0.001): low-dose FDC - 22.29/ - 14.66; metoprolol 50, - 23.17/ - 13.37; metoprolol 25,- 18.41/ 12.50 and amlodipine 5, - 23.01/- 13.08. BP reductions by FDCs, however, were not statistically superior to monotherapies. Responder rates (sitting diastolic BP< 90 mmHg or reduction > or =10 mmHg) were 93% in the high-dose FDC group and 97% in the low-dose FDC group, and control rates (sitting BP < 140/90 mmHg) were 66% and 58%, respectively. These rates were higher than that seen in individual components. There were no reports of serious adverse events related to study medications. One each from the low-dose FDC and metoprolol 25 mg group discontinued because of adverse events. CONCLUSIONS: FDCs of metoprolol and amlodipine are effective and safe in mild to moderate hypertension.

Adverse drug reactions in medical intensive care unit of a tertiary care hospital.

PURPOSE: Patients in the intensive care unit (ICU) have multiorgan dysfunction as well as altered pharmacokinetic parameters. Hence they are susceptible to adverse drug reactions (ADRs). The objective of the study is to assess the characteristics of ADRs among inpatients in the medical ICU and to compare the same with patients who have not experienced ADRs. METHODS: Prospective, observational study for a period of 1 year in medical ICU of a tertiary care hospital. Relevant data of patients with ADRS were analysed. Characteristics of patients with and without ADRs were compared. RESULTS: Of 728 patients admitted in medical ICU, 222 (28.4%) had ADRs. Multiple ADRs (38.7%) implicated by the same drug and serious ADRs (37%) were noticed. Renal/electrolyte system (21%) was most commonly involved. Clinical spectrum included acute renal failure (ARF, 11.4%), hepatic injuries (5.4%), haematological dysfunction (4.2%), seizures (3.3%), upper gastrointestinal bleed (3.3%) and cutaneous ADRs (3.3%). Antimicrobials (27%) were the commonly implicated drug class. The most commonly implicated drug was furosemide (6.8%). Infrequently reported ADRs included azithromycin-induced erythema multiforme, leflunamide-induced erythema multiforme and vasculitis, ceftazidime-induced seizures and ceftriaxone-induced hepatitis. Co-morbidity, polypharmacy and duration of stay were significantly higher in patients with ADRs compared to those who have not experienced ADRs. Three patients died. CONCLUSION: High incidence of serious and multiple ADRs noticed. A wide clinical spectrum of ADRs and infrequently reported ADRs to newer drugs were also observed.

Adverse drug reactions in nephrology ward inpatients of a tertiary care hospital.

BACKGROUND: Adverse drug reactions (ADRs) are important causes of hospital admissions and inpatient complications. Renal dysfunction has a role in occurrence of ADRs. AIMS: (1) To study the characteristics of ADRs among inpatients in Nephrology ward of a tertiary care hospital and (2) to compare these characteristics between patients with renal dysfunction and patients with normal renal function in same population of patients with ADRs. MATERIALS AND METHODS: A retrospective study of inpatients with ADRs (July 2005-June 2006) in Nephrology ward of a tertiary care hospital. STATISTICAL ANALYSIS: ADR characteristics were analyzed using descriptive statistics. Comparisons were made between normal renal function group and renal dysfunction group by t-test and Chi-square test. RESULTS: Of 1,464 case records, 244 (17%) patients were included. Two hundred sixty-seven drugs contributed to 294 ADRs. Serious ADRs accounted for 12% of the total ADRs. Renal/ electrolyte system (44%) was the most common organ system involved. Major clinical spectrum of ADRs included acute renal failure (22%), hypo/ hyperglycemia (13%), hyper/ hypokalemia (13%), bone marrow suppression (5%) and hepatic injuries (4%). Prednisolone (12%) was the most commonly implicated drug. Mean time to revert was 13+/-7.2 days. Three patients died. On comparing patients with normal renal function (n=80) with those suffering from renal dysfunction (n=164), polypharmacy, serious ADRs, multiple ADRs, longer time to recover, longer period of hospitalization were found to be more frequent among the renal dysfunction group (P CONCLUSIONS: High incidence of ADRs, especially serious and life-threatening ADRs, was noticed. A wide spectrum of ADRs was observed. Renal dysfunction showed a significant impact on various characteristics of ADRs.