Objectives:Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting elderly males, often associated with lower urinary tract symptoms (LUTS). α1-blockers are the mainstay in symptomatic therapy of BPH. Because of their greater uroselectivity and minimal hemodynamic effects, alfuzosin, tamsulosin, and silodosin are generally preferred. The aim of this study was to compare the efficacy and tolerability of alfuzosin, tamsulosin, and silodosin in patients with BPH and LUTS.Methods:Ninety subjects with BPH and LUTS were randomized into three groups of thirty in each, to receive alfuzosin sustained release (SR) 10 mg, tamsulosin 0.4 mg, or silodosin 8 mg for 12 weeks. The primary outcome measure was a change in the International Prostate Symptom Score (IPSS), and the secondary outcome measures were changes in individual subjective symptom scores, quality of life score (QLS), and peak flow rate (Qmax) from baseline. The treatment response was monitored at 2, 4, 8, and 12 weeks.Results:IPSS improved by 88.18%, 72.12%, and 82.23% in alfuzosin SR, tamsulosin and silodosin groups (P < 0.001) at 12 weeks. Improvement in QLS was >75% in all the three groups (P < 0.001). A significant improvement in Qmax was seen with alfuzosin and tamsulosin (P = 0.025 and P < 0.001) but not with silodosin (P = 0.153). However, the intergroup differences in IPSS, QLS, and Qmax were not significant. Ejaculatory dysfunction was more common with silodosin and corrected QT (QTc) prolongation occurred only with alfuzosin (two subjects) and tamsulosin (three subjects).Conclusion:Alfuzosin, tamsulosin, and silodosin showed similar efficacy in improvement of LUTS secondary to BPH, with good tolerability, acceptability, and minimum hemodynamic adverse effects. Alfuzosin, tamsulosin, and silodosin are comparable in efficacy in symptomatic management of BPH. The occurrence of QTc prolongation in three subjects with tamsulosin in the present study is an unexpected adverse event as there are no reports of QTc prolongation with tamsulosin in any of the previous studies.

BackgroundAlcohol withdrawal syndrome (AWS) is a distressing condition, generally controlled by benzodiazepines (BZD's). Baclofen, a gamma-aminobutyric acid-B (GABAB) agonist, has also shown promising results in controlling AWS. As there are few studies comparing the efficacy and tolerability of chlordiazepoxide with baclofen, the present study was taken up. The objective of this study was to compare efficacy and tolerability of baclofen with chlordiazepoxide in uncomplicated AWS.MethodsSixty subjects with uncomplicated AWS were randomized into two groups of 30 each, to receive baclofen (30 mg) or chlordiazepoxide (75 mg) in decremented fixed dose regime for 9 days. Clinical efficacy was assessed by Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale (CIWA-Ar) and tolerability by the nature and severity of adverse events. Lorazepam was used as rescue medication. Secondary efficacy parameters were Clinical Global Impression scores, symptom-free days, and subject satisfaction as assessed by visual analog scale. This study was registered with Clinical Trial Registry-India (CTRI/2013/04/003588), also subsequently registered with WHO's ICTRP clinical trial portal.ResultsBoth baclofen and chlordiazepoxide showed a consistent reduction in the total CIWA-Ar scores. However, chlordiazepoxide showed a faster and a more effective control of anxiety and agitation requiring lesser lorazepam supplementation, and also showed a better subject satisfaction compared to baclofen. Both the drugs showed good tolerability with mild self-limiting adverse events.ConclusionThe present study demonstrates that baclofen is not as good as chlordiazepoxide in the treatment of uncomplicated AWS. However, baclofen might be considered as an alternative.

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This post-authorization study was conducted to evaluate the safety of insulin degludec/insulin aspart (IDegAsp) in adult patients with diabetes mellitus (DM) during routine clinical care under a real-world setting in India. Eligible patients received IDegAsp for a minimum of 12 months during routine clinical management. Data were collected at 0, 3, 6, and 12 months. In total, 1029 adult patients with DM were included; 65.2% (n = 671) were men; mean age was 55.0 ± 12.2 years, and the mean duration of diabetes mellitus was 10.8 ± 7.4 years. Thirty adverse events were reported in 23 patients (2.2%) during the follow-up: two adverse events in two patients were serious with fatal outcomes, which were unrelated to IDegAsp use. At baseline, there were 176 confirmed hypoglycemic events in 67 (6.7%) patients while they were on their previous treatment options. At 12 months of treatment with IDegAsp, 11 confirmed hypoglycemic events were reported in 11 (1.1%) patients since the previous visit; there were no reported episodes of severe hypoglycemia. Mean glycosylated hemoglobin value reduced from 9.5% ± 1.8% at baseline to 7.7% ± 1.1% at 12 months. This study showed the safety of IDegAsp in patients with diabetes mellitus over a period of 1 year during routine clinical care.

IntrOductIOnBenign prostatic hyperplasia (BPH) is the most common prostate disease, characterized by nonmalignant enlargement of the prostate gland in aging men. It is a major health issue among elderly men. BPH increases markedly after the 4 th decade of life. Its incidence increases to 90% in men over 80 years [1]. Although the exact pathogenesis of BPH is not completely understood, aging, testosterone levels, lower urinary tract infections, inflammation, alteration in cell signaling are considered significant risk factors for the development of BPH [2]. Of these factors, testosterone is said to be the major factor since it is known to play an important role in growth of prostate gland. The effects of several growth factors involved in the development of BPH like fibroblast growth factors (FGFs), vascular endothelial growth factors (VEGFs), and insulin like growth factors (IGFs) are modulated by dihydrotestosterone (DHT), a derivative of testosterone [3].The relative length of 2 nd and 4 th digit is a marker for prenatal androgen exposure. A low 2D:4D ratio is associated with a high prenatal androgen exposure. Since there are practical difficulties in measurement of testosterone exposure in the fetus, researchers have adopted a non-invasive method in the form of measurement of 2D:4D ratio, a widely accepted retrospective biomarker for prenatal androgen exposure [4]. It has been shown that alterations in digit ratio (2D:4D) is associated with a wide range of physiological & psychological characteristics like alcoholism [5], attention deficit disorder [6], visuo-spatial ability [7], susceptibility to coronary artery disease [8], assertiveness and aggression [9], homosexuality [10] and depression [11]. It is also found to be linked with prostatic cancer [12].Testosterone is implicated in the development of prostate gland as it promotes prostate cell proliferation [13]. DHT is found to be a critical mediator of prostatic growth [14]. However, relatively low levels of serum testosterone are found in patients with BPH [15]. Exposure to varying levels of androgens in fetal life is found to affect several attributes of masculinity in males. This may also be true with respect to the growth of prostate in adult life and its subsequent hyperplasia in old age. Studies have not been conducted till date to determine the effect of prenatal androgen exposure on the growth of prostate gland and BPH. The present study is an indirect measure of prenatal testosterone exposure and its relation to development of BPH. The main objective of the present study was to assess the causal relationship between the 2D:4D ratio and incidence of BPH. MAterIAls And MethOdsThe present study recruiting 105 participants was conducted between June 2013 and February 2014 in the Department of Urology, Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bangalore. They were divided into three groups -BPH, non BPH and controls with 35 participants in each group. Written informed consent was obtained from all the study subjects/ legal...