Efficacy and safety of fixed dose combination of atorvastatin and hydroxychloroquine: a randomized, double-blind comparison with atorvastatin alone among Indian patients with dyslipidemia.

OBJECTIVE: To evaluate the efficacy and safety of atorvastatin + hydroxychloroquine fixed-dose combination tablets in comparison with atorvastatin alone in treatment of dyslipidemia. METHODS: This double-blind, randomized, out-patient study was conducted in 328 patients with primary dyslipidemia having low-density lipoprotein cholesterol (LDL-C) ≥ 130 mg/dL (3.37 mmol/L) to ≤ 250 mg/dL (6.48 mmol/L) and triglycerides ≤ 400 mg/dL (4.52 mmol/L). Eligible patients were randomized to receive either atorvastatin 10 mg (n = 167) or atorvastatin 10 mg + hydroxychloroquine 200 mg (n = 161) for 24 weeks. CLINICAL TRIAL REGISTRATION: CTRI/2010/091/006138. MAIN OUTCOME MEASURES: To compare percentage change in LDL-C, total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 12 and Week 24 between groups. To compare mean change in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), high-sensitivity C-reactive protein (Hs-CRP), and percentage of patients achieving lipid goals at Week 12 and Week 24. RESULTS: At Week 24, percentage reduction in LDL-C (-32.52 [-36.13 to -28.91] vs -39.54 [-43.25 to -35.83]; p = 0.008), TC (-24.41 [-27.10 to -21.72] vs -29.30 [-32.07 to -26.54]; p = 0.013), and non-HDL-C (-30.37 [-33.71 to -27.04] vs -36.76 [-40.18 to -33.33]; p = 0.009) was significantly greater in combination treated patients. Both the treatments showed a significant reduction in triglycerides at Week 24 from baseline, however, this reduction was not statistically significantly different between treatment groups. No significant change in HDL-C was observed in patients from both the treatment groups. At Week 24, change in HbA1c (0.22 [0.07 to 0.37] vs -0.13 [-0.28 to 0.03]; p = 0.002) and FBG was also statistically significant in favor of combination therapy (0.37 [0.07 to 0.67] vs -0.29 [-0.59 to 0.03]; p = 0.003), whereas no statistically significant difference was observed in change in Hs-CRP (p = 0.310). Significantly more patients from the combination group achieved LDL-C and TC goals. Exploratory analysis in patients with pre-diabetes showed development of diabetes in 8 patients (15.09%) from the monotherapy group and 1 patient (1.96%) from the combination group (p = 0.034). Study medications were generally safe and well tolerated. CONCLUSION: Based on study results and widely reported pleiotropic benefits, hydroxychloroquine could emerge as a potential drug for combination with statins for treatment of dyslipidemia. Long duration studies with larger sample sizes are required to further explore the role of hydroxychloroquine as adjunct to statins in reducing risk of cardiovascular events and prevention of statin-induced diabetes.

Study of clinical profile of falciparum malaria in a tertiary referral centre in Central India.

BACKGROUND AND OBJECTIVE: Malaria, a disease with protean manifestations is endemic in India with an estimated 70-100 million cases each year. Of these 45-50% are plasmodium falciparum. The present study is aimed at to study clinical features, complications, response to treatment and outcome in a tertiary care hospital. METHODOLOGY: This hospital based cross sectional study was done on 80 confirmed cases of falciparum malaria (either by peripheral smear or rapid diagnostic test) more than 12 years of age admitted in NKPSIMS and LMH from December 2009 to December 2010.A case sheet proforma was prepared and data (demographic profile, clinical feature, investigation, treatment, and complication) from all indoor patients was collected and analyzed. RESULT: Out of 80 patients, 60 (75%) were males and 20 (25%) were females. Most of the patients were between the age group 21-40 years with the highest incidence between the age group of 21-30. The numbers of admissions due to malaria increased from June onward with maximum number of cases were found in the month of September. Fever was the most common symptom followed by impaired consciousness. Anemia was present in 52 (65%) patients, out of which 5 (6.25%) patients had severe anemia. Thrombocytopenia was present in 46 (57.5%) patients. Abnormal liver function tests were observed in 28 (35%) subjects while abnormal kidney function tests were observed in 26 (32.5%) patients. As per WHO definition of severe falciparum malaria, 37 patients suffered from severe falciparum malaria (46.25%) in the form of impaired consciousness or unarousable coma, clinical jaundice plus evidence of other organ dysfunction, severe renal impairment, severe anemia, circulatory collapse and ARDS. Maximum number, 62 (77%) patients received the combination of artesunate and clindamycin. This also showed that the combination of artesunate and clindamycin in severe Plasmodium falciparum malaria is a very good therapeutic option. Apart from being effective in seriously ill patients it is quite safe also. Mortality rate was 6.25%.Cause of death was acute renal failure with metabolic acidosis, aspiration pneumonia secondary to seizure, cerebral malaria and circulatory shock. CONCLUSION: Early diagnosis, anticipation of complications, close monitoring of vital parameters and combination therapy to overcome drug resistance perhaps helped to curtail the extent of mortality in this study.

Oral versus intravenous steroids in acute exacerbation of asthma--randomized controlled study.

BACKGROUND: Use of corticosteroids in asthma is a must however the route of administration of steroid in acute exacerbation is a matter of debate. Intravenous steroids used very frequently in clinical practice may not offer any advantage over oral steroids. AIM: To compare to the efficacy of oral vs intravenous steroids in adults admitted with acute exacerbation of bronchial asthma. METHODS: Adults admitted to hospital with acute exacerbation of asthma were randomized to receive oral prednisolone 100 mg once daily or hydrocortisone 100 mg i.v. 6 hourly for 72 hrs following admission. All patients concurrently received inhaled corticosteroids and bronchodilators. Improvements in peak expiratory flow rate (PEF) from baseline were compared for 72 hrs. RESULTS: A total of 65 patients were randomized, 34 received oral prednisolone and 31 received intravenous hydrocortisone. Both groups were matched at baseline for age (40 +/- 13.11 vs 44 +/- 16.23, p 0.27) and percentage prediction both pre (20.11% +/- 6.17 vs 20.58% +/- 4.78, p 0.73) and post bronchodilator (24.35% +/- 5.43 vs 25.38% +/- 5.01, p 0.43). After 72 hrs both groups had improvement in PEF which was statistically insignificant (53.23% +/- 9.54 vs 55.87% +/- 10.34, p 0.28). CONCLUSION: Corticosteroids administered orally and IV had similar efficacy in the treatment of adults hospitalized with acute exacerbation of bronchial asthma.

Idiopathic mediastinal fibrosis presenting as mediastinal compression syndrome.

Mediastinal compression syndrome is a commonly seen entity. Mediastinal compression, mostly due to a space-occupying lesion, is distinct and different from mediastinitis/mediastinal fibrosis, which could also lead to superior vena cava syndrome. Idiopathic mediastinal fibrosis should also be considered as differential diagnosis of mediastinal structures with various radiological, CT and MRI and histological features if feasible. Medical therapy is disappointing while surgical cure has limitations. This interesting patient presented as mediastinal compression syndrome, which on investigation was postulated as idiopathic mediastinal fibrosis, as a diagnosis on exclusion of other causes, which is rare, hence is being reported.

Evaluation of QRS score as an index of infarct size and prognosis.

Present study comprises of 44 patients with Acute Myocardial Infarction. Their QRS score was correlated with Infarct Size by estimating the CPKMB levels and the post infarction complications during hospital stay. A statistically significant correlation was found between the 2 parameters of QRS score and infarct size (r = 0.75). It was better in anterior wall infarction (r = 0.96) than in inferior wall infarction (r = 0.64). The interobserver agreement between 2 observers for QRS score was excellent (rho = 0.99) QRS score was found to be a good prognostic indicator in the post infarction phase.