Efficacy and Safety of Oral and IV Levonadifloxacin Therapy in Management of Bacterial Infections: Findings of a Prospective, Observational, Multi-center, Post-marketing Surveillance Study.

Background Antimicrobial resistance by bacteria poses a substantial threat to morbidity and mortality worldwide, and treatment of resistant infections is a challenge for the treating clinician. Levonadifloxacin is a novel broad-spectrum agent belonging to the benzoquinolizine subclass of quinolone, which can be used by both oral and intravenous administration for the treatment of infections caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methods This prescription event monitoring study captured data from 1266 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of various bacterial infections. The duration of the study was 18 months. Study outcomes were clinical success and microbial success at the end of therapy. Global assessments were done for safety and efficacy at the end of therapy using a 5-point Likert scale (excellent, very good, good, satisfactory, and poor). Results The mean (median) duration of therapy was 7.2 (7.0) days, with a median time to clinical improvement of four days. Oral therapy was administered to 224 patients; 940 received IV, and 102 received IV followed by oral therapy. Patients were prescribed levonadifloxacin for gram-positive infections, skin and soft tissue infections, diabetic foot infections, septicemia, catheter-related blood-stream infections, bone and joint infections, febrile neutropenia, and respiratory infections, including COVID-19 pneumonia. The clinical cure on the eighth day was 95.7%, whereas the microbial success on the eighth day was 93.3% (n=60). For different types of infections, the clinical success rates ranged from 85.2% to 100%. There were only 30 treatment-emergent adverse events reported in 29 patients. Overall, about 95.6% of patients rated the efficacy as good to excellent, whereas only 3.8% of patients rated it satisfactory; for safety, 95.7% of patients rated it as good to excellent, with only 3.9% of patients rated it as satisfactory. Conclusions The excellent safety and efficacy profile of levonadifloxacin, when administered as an oral or intravenous therapy, makes it a desirable treatment modality for the management of various bacterial infections, including those caused by resistant pathogens such as MRSA and quinolone-resistant Staphylococcus aureus (QRSA). Features of levonadifloxacin, such as availability in both IV and oral form, minimal drug-drug interactions, lack of the need to adjust dosages in renal and hepatically impaired patients along with a broad spectrum of coverage, make it a suitable agent that meets several unmet clinical needs of physicians.

Ivabradine: Evidence and current role in cardiovascular diseases and other emerging indications.

Increased heart rate (HR) is associated with deleterious effects on several disease conditions. Chronic heart failure (CHF) is one of the cardiovascular diseases with recurrent hospitalization burden and an ongoing drain on health-care expenditure. Despite advancement in medicine, management of CHF remains a challenge to health-care providers. Ivabradine selectively and specifically inhibits the pacemaker I(f) ionic current which reduces the cardiac pacemaker activity. The main effect of ivabradine therapy is the substantial lowering of HR. It does not influence intracardiac conduction, contractility, or ventricular repolarization. As shown in numerous clinical studies, ivabradine improves clinical outcomes and quality of life and reduces the risk of death from heart failure (HF) or other cardiovascular causes. Recently updated HF guidelines recommend ivabradine as a class II indication for reduction of HF hospitalizations. Based on the principle of benefits of reduced HR, the ivabradine in patients with ischemic heart disease, sepsis, and multiple organ dysfunction syndrome has also been studied. It can also be a useful agent for HR reduction in patients with contraindications to use beta-blockers or those who cannot tolerate them. In this review, we provide an overview of efficacy and safety of ivabradine and its combination with currently recommended pharmacological therapy in different conditions.

Demographic characteristics of epilepsy patients and antiepileptic drug utilization in adult patients: Results of a cross-sectional survey.

BACKGROUND: Through this cross-sectional study, we examined the demographic parameters, comorbidities, and antiepileptic drug (AED) utilization in patients with epilepsy. MATERIALS AND METHODS: We collected data of 973 adult patients with epilepsy and analysed AED utilization according to the epilepsy type, age group and gender. RESULTS: The study included 973 patients (males, 61.3%) with a mean age of 35.6 years. Only 3.6% patients were not educated whereas 45.3% patients were employed. Only 1.2% patients had a history of brain injury. The mean frequency of seizures during the previous 6 months was 24.0 ± 49.1 whereas the mean duration of epilepsy was 5.8 ± 5.8 years. Electroencephalogram was the most common (59.7%) investigation performed. A total of 109 (11.2%) patients had comorbid medical illness, with hypertension being observed in 3.3% patients. Levetiracetam was used in 583 (59.9%) patients whereas valproate, clobazam, and phenytoin were used in 16.3%, 14.8%, and 13.6% patients, respectively. Effectiveness and safety/tolerability profile were the two most important considerations for selecting the AED. A total of 924 (95%) patients had seizure control with the current therapy during the previous 6 months whereas the mean seizure-free interval was 7.1 ± 4.1 months. Levetiracetam was used in 34.9%, 45.7%, and 61.1% patients and valproate in 15.2%, 10.9%, and 4.6% patients in the age group of 18-30, 31-50 and 51-75 years, respectively. Levetiracetam was used in 57.7% and 63.4% whereas valproate was used in 19% and 12.2% male and female patients, respectively. The adverse event rate was only 0.1%. CONCLUSION: Epilepsy is common in adult patients. Hypertension is the most common comorbidity. Levetiracetam is the most commonly used AED across all studied age groups and both genders. Control of epilepsy with current treatment is satisfactory with no major adverse events.

Detection, Management Approach of Depression and Antidepressant Utilization in Adult Patients: Results of a Cross-Sectional Survey.

AIM: The study was conducted to understand the demographics, prevalence of co-morbid conditions and treatment modalities of depression. METHODS: A cross-sectional, nationwide observational study was conducted to understand the management pattern of depression in India. Depression was majorly diagnosed with DSM-IV TR criteria. RESULTS: The data of 2276 Indian patients across 18 states were collected through 135 mental health professionals. The study population was predominantly from urban (81.2%) area. The prevalence of uneducated and employed patients in the study was 7.2% and 54.6% respectively. The main co-morbidities observed were diabetes, hypertension, anxiety and insomnia. Overall, escitalopram monotherapy was used in 67.2% patients. Escitalopram was found to be the preferred antidepressant in patients with co-morbid conditions including hypertension and diabetes. Counseling was the most common non-pharmacological therapy practiced. CONCLUSIONS: This large cross sectional study in real life settings demonstrates high prevalence of depression among employed and educated adult Indian patients. Hypertension and diabetes are the two most common co-morbidites in patients with depression. Escitalopram is commonly used and preferred antidepressant in all studied age groups and even in co-morbid depression.