Efficacy of a biosimilar ranibizumab monotherapy for the treatment of retinopathy of prematurity

Purpose: To evaluate the efficacy of a biosimilar ranibizumab (Razumab) on outcomes of retinopathy of prematurity (ROP) for the first time. Methods: This retrospective study included infants presenting with stage 3+ ROP either in zone 1 or zone 2 posterior or aggressive posterior ROP (APROP). All eligible infants received intravitreal razumab (0.25 mg/0.025 ml) monotherapy. Follow?up was continued monthly till complete retinal vascularization was achieved while retreatment with razumab was given when recurrent neovascularization was noted. In case of no recurrence but incomplete vascularization, laser photocoagulation was done to the residual avascular retina. Results: We included 118 eyes of 59 infants with a median gestational age of 30 weeks and median birth weight of 1250 grams. At presentation, APROP was found in 28 eyes (24%) of 14 babies while stage 3 disease was seen in zone 1 in another 28 eyes (24%) and the remaining 62 eyes (52%) had stage 3 ROP in zone 2 posterior region. Complete resolution of ROP along with complete vascularization was seen in 22 eyes (19%) at a median of 55 days (IQR = 31–56 days) and 42 eyes (35%) showed a recurrent neovascularization at a median of 51 days post razumab (IQR = 42– 55 days). The cumulative incidence of recurrence of neovascularization (21%, 95% CI = 14%–29%) peaked at seven weeks and was significantly higher in eyes with APROP (43%, 95% CI = 27%–63%) compared to eyes without APROP (13.4%, 95%CI, 8%?22%) (P < 0.001). Conclusion: Razumab appears to be safe and effective in treating ROP, with about a third requiring reinjection at seven weeks after the first dose.

Effects of acute-phase monotherapy and combination therapy on quality of life in patients with depressive disorders / 四川精神卫生

BackgroundThe treatment of patients with depressive disorders is short of targeted outcome assessment. As a secondary outcome that is guided by patient values， quality of life is thus of relatively high evaluative value. In China， there exists a lack of large sample prospective cohort studies evaluating the effect of different treatment protocols on quality of life in patients with acute depressive disorder. ObjectiveTo explore the effects of monotherapy and combination therapy on the quality of life of patients with depressive disorder in acute phase， so as to provide references for optimizing the outcome of treatment for such patients. MethodsA prospective follow-up cohort study from August 24， 2020 to November 29， 2021 was conducted， including 1 330 patients from 22 hospitals across 18 cities in China. All these patients met the diagnostic criteria for depressive episodes， recurrent depressive disorder from the Diagnostic and Statistical Manual of Mental Disorders， fifth edition （DSM-5）. Patients were divided into monotherapy group （n=969） and combination therapy group （n=361） according to the acute phase treatment protocol. At baseline， the end of the first half month as well as the 1st， 2nd， 3rd， 6th， 9th and 12th months of treatment， patients were assessed with Inventory of Depressive Symptomatology Self-report （IDS-SR30）， Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form （Q-LES-Q-SF）， Concise Health Risk Tracking Scale （CHRT） and Siehan Disability Scale （SDS）. Frequency， Intensity， and Burden of Side Effects Rating （FIBSER） was adopted for assessment at each visit time point of treatment. Spearman correlation analysis was adopted to examine the correlation of quality of life with suicide risk， adverse reactions and impaired social functioning among patients. ResultsAt the end of three months of treatment， the Q-LES-Q-SF score of monotherapy group was higher than that of combination therapy group， and the difference was statistically significant （Z=2.008， P<0.05）. The time effects of both treatment protocols possessed statistical significance （F=111.393， P<0.01）. At the end of three months of treatment， the Q-LES-Q-SF score was negatively correlated with CHRT and SDS scores， respectively， in both monotherapy group and combination treatment group （r=-0.660， -0.712， -0.634， -0.718， P<0.01）. ConclusionBoth monotherapy and combination therapy can facilitate the improvement of the life quality of patients with acute depressive disorder， but monotherapy may achieve better than the combination therapy in this aspect. ［Funded by The National Key Research and Development Program of China "Research on the Prevention and Control of Major Chronic Non-communicable Diseases" （number， 2017YFC1311101）］

Study of Epilepsy and its Correlation with Neuroimaging and Drug Therapy

Background: Thousands of people in the world suffer from epilepsy. Inspite of modern advances, it can be controlled in only 80% of treated once. Diagnosis and treatment of epilepsy is still challenged. The present study is attempted to highlight the importance of clinical findings and role of EEG and CT scan and MRI in diagnosis of epilepsy2.Aim:To study the incidence and epidemiological profile, various types of epilepsy and correlation with MRI, CT SCAN, EEG and the effectiveness of various Anti epilepticdrugs in different types of epilepsy. Settings and Design: This is a prospective study carried out at Civil Hospital, Ahmedabad.Methods:All the patients having 2 and/or more unprovoked seizures and already enrolled patients in epilepsy clinic in 1 year duration from January 1,2020 to December 31,2020 were included.Results &Conclusions:Out of 6930 total admissions, 163 patients with epilepsy were enrolled in this study from age group of 1 month to 12 years. Out of 163 patients, 97 were male and 66 were female. Most common age group affected is of 1-5 years. 128 patients (78.62%) were of generalized epilepsy and 35 patients were of partial epilepsy. Most common precipitating factor in epilepsy is inadequate drug dosages (45%). 45 patients (22.7%) have developmental delay. Abnormal EEG findings were present in 123 patients (75.46%). Abnormal MRI findings were present in 37 patients (22.7%). CT scan was done in 56 patients, 20 were abnormal. 107 patients were on monotherapy and 56 patients were on polytherapy. Valproate is most commonly used drug (76.6%).

Real world evidence of the use of metamizole (dipyrone) by the Brazilian population. A retrospective cohort with over 380,000 patients

ABSTRACT Objective To determine under which health conditions metamizole (dipyrone) is used as a single drug or as fixed-dose combination. Methods Two retrospective cohorts of Brazilian patients treated with metamizole between January 2015 and December 2017 were analyzed: a metamizole-based cohort (Cohort 1) and a symptoms-based cohort (Cohort 2). Anonymized patient data was obtained from Amil Clinical Data Warehouse. The number of patients with symptoms was described by age and sex. Results The sample size of the two cohorts consisted of 384,668 patients. In patients using metamizole (Cohort 1), the most common reason for medication was the treatment of some form of pain (81%), followed by fever (19%). Headache was the most common (19%) specified pain class, followed by sore throat (8%), muscular pain (6%), and abdominal pain (5%). In adult patients (n=276,279; 71.8%), metamizole was used as a monotherapy or associated with another drug, for any sort of pain, in over 88% of the patients. General pain was the main reason for metamizole use in children (61%). Conclusion Real world evidence to evaluate Brazilian patients' therapeutic options is unusual and yet to be more explored using digital tools enabling better data registration. The present study confirmed that metamizole is widely used as a non-anti-inflammatory drug, and also showed the management of pain and fever as the most frequent indications in all age groups studied. Registry in Clinical Trials Database: REBEC Database: 10507

Evaluation of Response to Immune Checkpoint Inhibitor Monotherapy or Combination with Chemotherapy for Patients with Advanced Non-small Cell Lung Cancer and High PD-L1 Expression / 中国肺癌杂志

BACKGROUND@#Immunotherapy represented by immune checkpoint inhibitors (ICIs) has been widely used in the treatment of lung cancer. There are controversies in clinical practice for patients with advanced non-small cell lung cancer (NSCLC) and high programmed cell death-ligand 1 (PD-L1) expression receiving ICIs monotherapy or combination chemotherapy.@*METHODS@#This study retrospectively analyzed the clinical data of 49 patients with advanced NSCLC and high PD-L1 expression. Immunohistochemistry was performed with 22C3 antibody, and the expression level of PD-L1 was evaluated according to tumor proportion score (TPS). Objective response rate (ORR) and progression free survival (PFS) were compared by groups of different clinical characteristics.@*RESULTS@#ORR of monotherapy and combination therapy group was 47.1% (8/17) and 43.8% (14/32), respectively, without statistical difference (P=0.825). The median PFS of monotherapy and combination therapy group was 8.0 months and 6.8 months, respectively, without statistical difference (P=0.502). Statistical analysis of predictors of immunotherapy for the patients showed first-line immunotherapy had better ORR than subsequent immunotherapy (12/19, 63.2% vs 10/30, 33.3%, P=0.041), however no difference in PFS. And there were no differences in ORR or PFS among groups of age, gender, smoking status, performance status (PS), pathological type, tumor size and tumor-node-metastasis (TNM) stage.@*CONCLUSIONS@#The therapeutic effect is similar between ICIs monotherapy and combination chemotherapy for patients with advanced NSCLC and high PD-L1 expression. ORR of first-line immunotherapy was better in patients with advanced NSCLC and high PD-L1 expression. The optimal treatment for this population remains further prospective clinical studies.

Monoterapia con sildenafilo en pacientes con hipertensión pulmonar grave / Sildenafil monotherapy in patients with severe pulmonary hypertension

Introducción: El tratamiento con inhibidores de la fosfodiesterasa 5 a pacientes con cardiopatías adquiridas y congénitas, con hipertensión pulmonar, puede mejorar la calidad y pronóstico de vida, tanto en cardiopatías quirúrgicas como no quirúrgicas, con hipertensión pulmonar grave. Objetivos: Analizar los resultados de la monoterapia con sildenafilo en pacientes quirúrgicos y no quirúrgicos, con cardiopatías congénitas y adquiridas e hipertensión pulmonar grave. Método: Estudio descriptivo en 60 pacientes que recibieron sildenafilo para hipertensión arterial pulmonar grave, secundaria a cardiopatías adquiridas izquierdas, congénitas. Se observó: dosis, duración del tratamiento, tolerancia, evolución clínica y ecocardiográfica, clase funcional y tratamiento quirúrgico según resultados del cateterismo cardiaco. Resultados: En el período entre diciembre de 2017 a diciembre de 2018 se operaron con hipertensión arterial pulmonar grave, 20 enfermos con trastornos valvulares cardíacos izquierdos, 8 congénitos y 3 tumores cardíacos primarios, con administración de sildenafilo en dosis de 100 a 150 miligramos diarios. Hubo otros 29 pacientes con cardiopatías, que aunque no eran quirúrgicos, mejoraron su calidad y pronóstico de vida. Conclusiones: Resultó útil la indicación de sildenafilo, para mejorar la calidad y el pronóstico de vida, tanto en pacientes quirúrgicos como no quirúrgicos con cardiopatías e hipertensión pulmonar grave(AU)

Introduction: Treatment with phosphodiesterase 5 inhibitors in patients with acquired and congenital heart disease, with pulmonary hypertension, can improve the quality and prognosis of life, both in surgical and non-surgical heart disease, with severe pulmonary hypertension. Objectives: To analyze the results of sildenafil monotherapy in surgical and non-surgical patients, with congenital and acquired heart disease and severe pulmonary hypertension. Method: Descriptive study in 60 patients who received sildenafil for severe pulmonary arterial hypertension, secondary to congenital left acquired heart disease. It was observed: dose, duration of treatment, tolerance, clinical and echocardiographic evolution, functional class and surgical treatment according to cardiac catheterization results. Results: In the period between December 2017 and December 2018, 20 patients with left heart valvular disorders, 8 congenital and 3 primary cardiac tumors, with sildenafil daily administration doses of 100 to 150 milligrams, were operated with severe pulmonary arterial hypertension. There were 29 other patients with heart disease, which although they were not surgical, improved their quality and prognosis of life. Conclusions: The prescription of sildenafil was useful to improve the quality and prognosis of life, both in surgical and non-surgical patients with heart disease and severe pulmonary hypertension(AU)

Cryotherapy: A Successful Monotherapy for Earlobe Keloids

@#A keloid represents an excessive overgrowth of skin beyond the boundaries of an injury. Earlobe keloids usually follow ear piercing and can become large, sometimes producing remarkable disfigurement. Surgical excision, pressure dressing, intralesional corticosteroid injection, cryosurgery, radiation, and lasers have all been used to treat earlobe keloids. However, none has produced uniformly satisfactory results. Combinations of more than one modality have also been employed to yield successful outcomes. We describe cryotherapy as a single modality to treat sevenyear-old, multiple earlobe keloids. Three cryotherapy sessions with two freezing-thawing cycles of 30-40 seconds’ freezing time and two minutes’ thawing time, undertaken one month apart, resulted in complete flatness of the keloids and no recurrence after 5 years. We also evaluate keloid-related and operational factors that determine the success of cryotherapy as a monotherapy for earlobe keloids.

Characteristics Of Cognitive Status Of Epilepsy Patients Treated With Monotherapy Of First-Generation Antiepileptic Drugs

@#Epilepsy is one of the main health problems in neurology that can lead to cognitive decline. Generally, the epilepsy-associated cognitive decline is influenced by demographic, clinical, and treatment characteristics. This study aimed to determine the characteristics of cognitive status of epilepsy patients who received monotherapy using first-generation antiepileptic drugs (AEDs), namely phenytoin, carbamazepine, and valproic acid. It involved 93 epilepsy patients of Mutiara Sukma Mental Hospital (n=38) and Mataram General Hospital (n=55). Besides, 93 healthy patients were assigned as healthy control group (HC) subjects (n=93). Demographic characteristics collected from epilepsy and HC groups were age, gender, and years of education. Clinical characteristics taken from both groups were MoCA-Ina score. Clinical characteristics taken from epilepsy group were age at epilepsy onset, type of seizure (partial vs generalized), etiology (idiopathic vs structural), first-generation AED used, years of treatment, and cognitive status. The result of the study revealed that there were no significant different between the two groups in the means of age and years of education as well as the frequency of male gender (p>0.05). The mean of MoCA-Ina score of epilepsy group was significantly lower compared with HC group (p<0.05). The frequency of cognitive decline among epilepsy patients was 75.3%. The cognitive functions of epilepsy patients using monotherapy with carbamazepine, phenytoin, or valproic acid was significantly lower compared with healthy subjects. We conclude that there was high prevalence of epilepsy-associated cognitive impairment which was associated with male gender.

Effects of L-carnitine Monotherapy in the Treatment of Male Infertility ：A Meta-analysis / 中国药房

OBJECTIVE：To systematically evaluate clinical efficacy of L-carnitine in the treatment of male infertility ，and to provide evidence-based reference for clinical treatment of male infertility. METHODS ：Retrieved from CNKI ，Wanfang database ， VIP，CBM，PubMed，Embase and the Cochrane library ，randomized controlled trials （RCTs）about L-carnitine and other chemical drugs in the treatment of male infertility were collected during the inception to Apr. 12th，2020. After data extraction of included literatures and quality evaluation with modified Jadad scale ，Meta-analysis was conducted by using RevMan 5.3 software. RESULTS：A total of 8 RCTs were included ，with 520 patients. The results of Meta-analysis showed that compared with other chemical drugs ，L-carnitine could significantly enhance the semen volume [MD＝0.55，95％CI（0.20，0.91），P＝0.002] and sperm mortality rate [MD＝1.60，95％CI（0.50，2.69），P＝0.004] of male infertility patients ，with statistical significance. There was no statistical significance in sperm count [MD＝4.00，95％ CI（－3.15，11.15），P＝0.27]，the percentage of forward motile sperm [MD＝12.58，95％CI（－3.87，29.03），P＝0.13]，and the percentage of inducing pregnancy rate [OR＝0.85，95％CI（0.47，1.52），P＝ 0.58] of male infertility patients. CONCLUSIONS ：L-carnitine can significantly improve the semen volume and sperm mortality of male infertility patients ，and has the same effects as other drugs on improving sperm count ，percentage of forward motile sperm and percentage of inducing pregnancy rate.

Efficacy evaluation of antidepressant drugs utilized at tertiary care centre in North Karnataka in psychiatric outpatient department

Background: Depression is the major psychotic disorder affecting 9.5% of population worldwide. Present study investigates the prescribing patterns of different antidepressants evaluating their efficacy.Methods: This was a prospective, observational study which was conducted in the out-patient department of Psychiatry and Pharmacology in Gulbarga Institute of Medical Sciences, Kalaburagi. A total of 200 cases were enrolled for the present study. Statistical analysis for efficacy was done using Wilcoxson抯 signed rank test.Results: Predominantly, females suffered from depression when compared to male counterparts. In our study, monotherapy was practiced more frequently than polytherapy with 2 or more drugs. Selective serotonin reuptake inhibitors (SSRIs) like Escitalopram was found out to be the most widely used antidepressant drug.Conclusions: Among antidepressant medications, SSRIs are preferred over others because of their better side effect profile.

An observational study on the prescription pattern of antihypertensive drugs in a private health care centre, Chennai

Background: Hypertension is a public health problem worldwide. Elevated systolic blood pressure ?140 mm Hg or diastolic blood pressure ?90 mmHg are defined as Hypertension. The choice of an antihypertensive drug is based on its efficacy, side-effects, effects on other systems and cost. The objective of this study is to evaluate the prescription pattern of antihypertensive drugs in a private health care centre.Methods: A retrospective observational study was carried out in the out-patient department of a private health care centre, Chennai from November 2018 to December 2018.Results: In the present study, 104 prescriptions were selected based on the inclusion criteria. In which 62 (59.61%) were males and 42 (40.38%) were females. Prescriptions belonging to age group of <40 years were 11 (10.57%), 40–59 years were 48 (46.15%) and >60 years were 45 (43.26%). Monotherapy was received by 62 hypertensive patients and as combination therapy by 42 patients.Conclusions: Even though the prescription pattern of antihypertensive drugs in this study complied with the recommended guidelines, clinicians should always be vigilant and consider change of regimen whenever necessary.

Evolution of Lymphedema in an Obese Diabetic Patient Using Grosgrain Stockings as Monotherapy

The objective of this study was to show the evolution of lymphedema in an obese diabetic patient using grosgrain stockings as monotherapy. A 51-year-old obese male with diabetes since childhood did not perform adequate control of the condition, progressing to vision loss and diabetic neuropathy. About 10 years ago, he began to have edema in the left leg, which progressed. Therefore, bioimpedance analysis was used, which demonstrated generalized lymphedema. The use of compression stockings made of grosgrain fabric was proposed to which the patient presented good tolerability for 1 year. At one of the evaluations, the generalized edema had returned but subsequently improved again. However, the lymphedema of the trunk and lower limbs remained, despite the weight loss. Systemic clinical lymphedema evaluated by electrical bioimpedance analysis was reduced with the weight loss of the patient throughout treatment.

Prospective observational study of drug utilization in neonatal seizure at a tertiary care hospital with Pharmacoeconomics

Background: Seizures are the most common indicator of significant neurologic dysfunction in neonatal period with incidence of 11.7/1000 live births. Phenobarbitone is used as first line of treatment since 1900s. Newer anti-epileptic drugs (AED) available are Levetiracetam, Topiramate etc. Present study focused on utilization pattern of AED, treatment outcomes and to study economic burden of disease.Methods: An observational study was done on 100 neonates admitted to Neonatal Intensive Care Unit in Basaveshwara hospital, Kalaburagi (June 2016-May 2017). Prescription data was entered into specially designed proforma, WHO core indicators were determined. The data was analyzed using descriptive statistics and presented as means and percentages.Results: Majority of neonates were male (58%) and 63% were diagnosed with subtle seizure. Out of 458 drugs prescribed, 201 were antiepileptics. 41% cases were successfully managed by monotherapy. Most commonly used drug was phenobarbitone (82%) and phenytoin (31%). Leviteracetam, newer AED was used in 3 refractory cases. The major combination of drugs used was Phenobarbitone-Phenytoin (24%). AED were rationally prescribed, but antibiotic was over-utilized(68%). 31% cases had adverse drug reaction. On average per prescription, number of drugs used were 4.6 and drug cost was Rs.3803/-. The total cost of illness per patient was Rs.16363/-.Conclusions: AED utilization in neonatal seizures was in accordance to guidelines, with phenobarbitone being extensively used despite its potential neurotoxicity. The utilization of newer AED would increase if clinicians are supported with the safety and efficacy data. Although monotherapy was preferred with respect to AED, antibiotics were highly prescribed; hence awareness is needed to curb this practice.

Recomendaciones latinoamericanas para el manejo de la hipertensión arterial en adultos (RELAHTA 2)

RESUMEN Se presenta la segunda parte de las recomendaciones latinoamericanas para el manejo de la Hipertensión Arterial (HTA) en adultos. En una primera fase se han descripto los aspectos más relevantes de la epidemiología, aspectos fisiopatológicos, cómo hacer diagnóstico, pautas terapéuticas, urgencias y emergencias hipertensivas, poblaciones especiales, hipertensión refractaria y la aplicación de las guías en la vida real. En esta segunda parte, se emiten recomendaciones respondiendo a preguntas específicas para prevención primaria, secundaria, terciaria y cuaternaria. En general pocas recomendaciones al respecto del manejo de la hipertensión arterial surgen desde la clínica médica/ medicina interna, a pesar de dos situaciones: la mayoría de los pacientes con hipertensión arterial son evaluados y manejados por los clínicos, y la clínica médica es la especialidad que permite la mirada holística e integrada de los problemas de salud del adulto, permitiendo agregar el enfoque biográfico al biológico, comprender e interpretar no solo el problema de salud sino sus causas y consecuencias (que muchas veces suelen corresponder a diferentes parénquimas, lo cual en el modelo fragmentado haría transitar al paciente por distintas especialidades). El bajo porcentaje de pacientes hipertensos controlados obliga a todos los profesionales involucrados en el manejo de los mismos a optimizar recursos y detectar problemas que se asocien a un control deficitario como la sub utilización del tratamiento farmacológico, baja tasa de pacientes tratados con estrategia combinada (la mayoría de los pacientes actualmente recibe monoterapia), falta de prescripción adecuada de los cambios en el estilo de vida, baja adherencia terapéutica e inercia clínica. En la presente publicación se presentan recomendaciones efectuadas por especialistas en clínica médica / medicina interna para el manejo de la hipertensión arterial en adultos, respondiendo preguntas de prevención primaria, secundaria, terciaria, y cuaternaria.

ABSTRACT The second part of the Latin American recommendations for the management of Arterial Hypertension (HTA) in adults is presented. In a first phase, the most relevant aspects of epidemiology, physiopathological aspects, how to diagnose, therapeutic guidelines, hypertension emergencies, special populations, refractory hypertension and the application of guides in real life have been described. In this second part, recommendations are issued answering specific questions for primary, secondary, tertiary and quaternary prevention. In general, few recommendations regarding the management of arterial hypertension arise from the medical clinic / internal medicine, despite two situations: the majority of patients with hypertension are evaluated and managed by the clinicians, and the medical clinic is the specialty that allows the holistic and integrated look of the health problems in adults, allowing to add the biographical approach to the biological, to understand and interpret not only the health problem but its causes and consequences (which often correspond to different parenchyma, which in the fragmented model would make the patient move through different specialties). The low percentage of controlled hypertensive patients forces all the professionals involved in the management of them to optimize resources and detect problems that are associated with a deficit control such as the under utilization of pharmacological treatment, low rate of patients treated with combined strategy (the most patients currently receive monotherapy), lack of adequate prescription of changes in lifestyle, low therapeutic adherence and clinical inertia. This publication presents recommendations made by specialists in medical clinic/internal medicine for the management of hypertension in adults, answering primary, secondary, tertiary and quaternary prevention questions.

Effectiveness and safety of Vildagliptin Monotherapy or in combination with other Antihyperglycemic agents in patients with T2DM: A real-world observational study in the Philippines

Introduction@#There is an ever-increasing prevalence of type 2 diabetes mellitus (T2DM) in the Philippines. This observational study aimed to evaluate the effectiveness and safety of vildagliptin as monotherapy or combination therapy in patients with T2DM in a real-life setting from the Philippines.@*Methods@#This 24-week, non-interventional study enrolled adult T2DM patients, receiving vildagliptin either as monotherapy or dual/triple combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. The secondary endpoints included proportion of patients achieving the glycemic goals HbA1c ≤6.5% and ≤7.0%, and safety assessment at week 24.@*Results@#Of the 385 patients enrolled, 267 (69.35%) completed the study. The mean±standard deviation age was 54.72±11.06 years, HbA1c, body mass index, and diabetes duration were 8.54±1.81%, 27.35±5.58 kg/m2 and 3.04±4.88 years, respectively. Overall, treatment with vildagliptin resulted in HbA1c reduction of 2.02±1.68 (p<0.0001) from baseline to week 24. At week 24, 60.64% and 74.47% of the patients achieved the glycemic target of HbA1c ≤6.5% and ≤7.0% respectively. Seven serious adverse events (AEs) unrelated to the study drug were reported, most of which (24/28) were mild or moderate in severity; 85.71% of the AEs reported were not drug related. One hypoglycemic event (with vildagliptin/metformin single pill combination [SPC]) and one death (with vildagliptin/metformin free dose and SPC, due to severe pneumonia) were reported at week 12.@*Discussion@#This observational study showed that treatment with vildagliptin monotherapy or combination therapy for 24 weeks in patients with T2DM in the Philippines provided statistically significant reductions in HbA1c. Overall, vildagliptin (mono or dual/triple therapy) was well-tolerated and demonstrated a favorable safety profile with no new safety signal.@*Conclusion@#Treatment with vildagliptin as monotherapy or in combination with other antihyperglycemic agents resulted in good glycemic control and was well-tolerated in patients with T2DM in the Philippines, under real-world settings.

Utilization Pattern Study Of Oral Antihyperglycemic Drugs In Type 2 Diabetes Mellitus In Diabetic Outpatient Care

Aim:The Aim of the present study is to analyze prescription pattern of the antihyperglycemic drugs in patients with type 2 diabetes mellitus (T2DM). Methodology:The study included 620 T2DM out patients aged between 41 to 60 years. Sociodemographic data included mean age, educational status, marital status, duration of diabetes mellitus and BMI. Results:Women (54.8%) shared higher percentage in study population. Metformin (44.1%) was prescribed significantly in higher cases than other antihyperglycemic drugs. Glimepiride (30%) is second most common drug prescribed in monotherapy followed by glibenclamide (9.3%), gliclazide (6.6%) in treatment of T2DM. Conclusion:The prescription pattern study of antihyperglycemic drugs in T2DM can serve as a guide to clinicians to select the monotherapy drug, combination drugs and insulin preparations. The findings of current study also help to the phar-maceutical companies to understand the percentage of utilization of antidiabetic drugs before developing and mar-keting any new drug.

A study of drug utilization pattern and pharmacoeconomic of antidiabetic drugs in patients attending a teaching hospital

Background: Drug utilization research establishes the current trend in the use of antidiabetic drugs including the new drug and to identify irrational prescription.Methods: A cross-sectional study was conducted for a period of one year (between August 2013 to August 2014) at outpatient department of Medicine, Sree Mookambika Institute of Medical Sciences, Kulasekharam, Kanyakumari District, Tamil Nadu.Results: A total of 169 prescriptions were evaluated during the study period. Diabetes mellitus was predominant among the female population in this region. Demographic details of the patient included in the study were mean weight 67.56kg, mean height 155cm and average body mass index 27.82kg/m2. All the patients were diagnosed and were known case of type 2 diabetes mellitus. Systemic hypertension was the frequently encountered co-morbid conditions associated with this endocrine disorder. Metformin was the drug chosen for managing diabetes as monotherapy and 73% of the patients were on combination of antidiabetic drugs. Glimepiride with metformin was the combination therapy frequently prescribed during the study period. Pharmacoeconomic analysis identified that drugs prescribed by brand name were costlier compared to generic equivalent.Conclusions: Utilization of antidiabetic drug therapy in this region has shown a changing trend compared to the previous studies. There is a gradual increase in the prescription of metformin and dramatic increase in the use of newer drugs like pioglitazone, voglibose and sitagliptin. Pharmaeconomic analysis revealed that glibenclamide was least expensive while sitagliptin was most expensive in this study.

Efficacy and safety of spironolactone in mono-therapy versus low dose spironolactone in combined-therapy for the treatment of idiopathic hyperaldosteronism / 中华内分泌代谢杂志

Objective The aim of this study was to compare the efficacy and safety of spironolactone in mono-therapy versus low dose spironolactone in combined-therapy for the treatment of idiopathic hyperaldosteronism (IHA). Methods This was a prospective and randomized study. After 2 weeks wash out period, 48 patients confirmed IHA were assigned to either spironolactone mono-therapy or low dose spironolactone combined-therapy groups. All patients underwent adrenal venous sampling and showed no lateralization. The primary outcome was the percentage of patients with blood pressure<140/90 mmHg(1 mmHg＝0.133 kPa) at 16 weeks. The other observatory parameters were: the occurrence of gynecomastia, renal insufficiency, and hyperkalemia. Results At the end of 16 weeks, the patients′blood pressure were normalized in 17 out of 24 patients(70.8%) in mono-therapy group and in 23 out of 24 patients ( 95. 8%) in combined-therapy group ( P<0. 05). There was no hyperkalemia in both groups. 2 patients and 5 patients in mono-therapy group were observed renal insufficiency and gynecomastia respectively, while no patients in combined-therapy group presented with those side effects. Conclusion Low dose spironolactone combined-therapy group is more effective to control blood pressure and hypokalemia without increase the occurrence of renal insufficiency or gynecomastia.

Survey of Drug Prescription Patterns Among Patients with Nontuberculous Mycobacterial Disease Using the Database of Health Insurance Claims / 薬剤疫学

In recent years, the number of patients with non-tuberculosis mycobacteria (NTM) has rapidly increasing.According to the nationwide survey conducted in 2014, the number of patients with NTM was reported to increase 9.7 times compared to the survey in 1980. Among them, the patients with Mycobacterium avium complex (MAC) account for about 88.8% of them. It is the main cause of the rapid increase of NTM patients mainly in middle-aged and elderly woman. To treat patients with MAC, it is common to do chemotherapy over one year after the bacteria becomes negative. Among experts of NTM, it is recommended to do chemotherapy preventing generation of resistant bacteria by using clarithromycin (CAM) and rifampicin and ethambutol (EB) in combination. Meanwhile, a monotherapy of CAM and high-dose EB administration over a long period are not currently recommended due to side effects. However, it has not been clarified so far how many such drug prescriptions had existed. Therefore, in this study, we investigated the actual drug prescription of 571 patients who were presumed to be NTM in health insurance data collected from 2015 to 2016. As a result, about 5.1% (29 cases) of CAM monotherapy and 4.4% (15 cases) of EB high-dose prescription over 3 months were observed. In general, because NTM is a case where a long-term antibiotic treatment is required, it increases the possibility of any disadvantages exerting on patients. Hence, we consider it is an important and urgent matter to inform the correct information widely to clinical workers and sites.