FDA approves biosimilar version of bevacizumab

By Dr Deepu

FDA  has approved a “biosimilar version of” Avastin (bevacizumab). “Like the reference product, the biosimilar bevacizumab is approved for use in several types of cancer, including metastatic colorectal cancer, non-small cell lung cancer (NSCLC), renal cell carcinoma, cervical cancer, and glioblastoma.” “Like Avastin, the labeling for” the new product, has a boxed warning about an increased risk of: holes in the stomach and intestines; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding.”

Behavioral Interventions Help Prevent Anxiety Disorders (JAMA Psychiatry)

By Dr Deepu

Meta-analysis finds small, but significant benefit to these programs
Psychological and/or educational interventions showed a modest benefit for preventing anxiety disorders, a systematic review and meta-analysis found.Researchers  published the data  JAMA Psychiatry. The researchers examined 29 randomized controlled trials comprising over 10,000 patients from 11 countries, and found a small, but significant benefit from psychological and/or educational interventions on anxiety prevention compared to usual care. Most trials examined the benefit of cognitive behavioral therapy, either individualized or through a computerized self-help format. Other examined interventions included psycho-educational, acceptance and commitment therapy and psychosocial interventions.
The significance of the study is this being the first meta-analysis to examine the effectiveness of these methods in anxiety prevention, the authors quoted, and suggested that implementing prevention programs that target a large population could have significant benefit.
I feel this could have a significant contribution in management of stress and anxiety in COPD, which is an ignored entity as of now. Treating these problems will have a positive impact on patients life and he can cope up with his problems with ease.

Poor Sleep May Be Associated With An Increased Risk For Alzheimer’s, Small Study Suggests

By Dr Deepu

“Poor sleep may be an indication of increased risk for Alzheimer’s disease,” researchers found after studying “101 cognitively normal people, average age 63.” All participants had their “spinal fluid for the presence of indicators of the plaques and tangles that are characteristic of Alzheimer’s.” After controlling for confounding factors, the study authors found that “poor sleep quality, sleep problems and daytime sleepiness were associated with increased spinal fluid indicators of Alzheimer’s disease.”
The highlights of the study
They Investigated the relationship between sleep quality and CSF AD biomarkers in a cohort enriched for parental history of sporadic AD, the Wisconsin Registry for Alzheimer's Prevention.
101 participants (mean age 62.9 ± 6.2 years, 65.3% female) completed sleep assessments and CSF collection and were cognitively normal.
Sleep quality was measured with the Medical Outcomes Study Sleep Scale. CSF was assayed for biomarkers of amyloid metabolism and plaques (β-amyloid 42 [Aβ42]), tau pathology (phosphorylated tau [p-tau] 181), neuronal/axonal degeneration (total tau [t-tau], neurofilament light [NFL]), neuroinflammation/astroglial activation (monocyte chemoattractant protein–1 [MCP-1], chitinase-3-like protein 1 [YKL-40]), and synaptic dysfunction/degeneration (neurogranin).
Relationships among sleep scores and CSF biomarkers were assessed with multiple regression, controlling for age, sex, time between sleep and CSF measurements, and CSF assay batch.

Results: Worse subjective sleep quality, more sleep problems, and daytime somnolence were associated with greater AD pathology, indicated by lower CSF Aβ42/Aβ40 and higher t-tau/Aβ42, p-tau/Aβ42, MCP-1/Aβ42, and YKL-40/Aβ42.
No significant associations between sleep and NFL or neurogranin.

Conclusions: Self-report of poor sleep was associated with greater AD-related pathology in cognitively healthy adults at risk for AD. Effective strategies exist for improving sleep; therefore sleep health may be a tractable target for early intervention to attenuate AD pathogenesis.

The findings were published online July 5 in Neurology. 

Sleep Apnea May Increase Risk Of Patients With Type 2 Diabetes Developing Advanced Retinopathy, Study Suggests

By Dr Deepu

A study has revealed that patients with sleep apnea who also have type 2 diabetes “have more than double the risk of worsening retina disease compared to diabetics without the sleep breathing disorder,”. The study was published in the American Journal of Respiratory and Critical Care Medicine. Researchers found that 43% of the study participants who had type 2 diabetes and sleep apnea had diabetic retinopathy, compared to 24% of participants who had type 2 diabetes without sleep apnea.

Are WHO approved nucleic acid amplification tests causing large-scale "false identification" of rifampicin-resistant tuberculosis?

By Dr Deepu

The nucleic acid amplification tests (NAATs): Line probe assay and GeneXpert (Xpert) have evolved as the primary tool for identification of rifampicin (RIF)-resistant (RR) tuberculosis (TB) worldwide, primarily because of the ease and speed. They rechecked RR isolates identified by NAATs from presumptive RR TB cases belonging to South India by the Revised National TB Control Program, India using multiple RIF concentrations on Bactec MGIT system and compared the mutation patterns with the resistance levels.
Researchers state that they used standard protocol for Bactec MGIT system as given by the manufacturer modified for the multiple RIF concentrations. All the retests were done in a certified BSL3 laboratory.
Astonishingly they found that there is a mismatch of up to 20% (RIF breakpoint 0.5 mg/L); the NAATs probably overidentifying RR TB. Half of the cases with mismatch showed a sub-breakpoint rise in resistance level (0.125 mg/L to 0.5 mg/L RIF).
They finally concluded by stating probable reasons for the mismatch are "sub-breakpoint low-level resistance mutants," hetero-resistant bacterial populations, and other inherent test limitations along with the low RR TB prevalence in South India (<5%) among "presumptive multidrug-resistants." They also quoted, could be due to the incomplete selection pressure by an inadequate RIF exposure caused by various factors including a low-RIF dosage being used widely and poor Directly observed treatment.
They concluded"To prevent the false diagnosis of RR TB in a massive scale when using NAATs, we may need to enforce a carefully targeted testing approach and a phenotypic susceptibility testing with multiple RIF concentrations for confirmatory purposes".
Find the full text article here