ABSTRACT
Bevacizumab, a humanized antibody against VEGF, is effective in the treatment of patients with many cancers. However, as with many therapeutic agents, significant side effects are associated with bevacizumab, Hypertension is one of the predominant toxicity. We performed a systematic review and meta-analysis of published clinical trials of bevacizumab to quantify the risk of hypertension. 15 studies following PRISMA guidelines and matching inclusion and exclusion criteria were collected in which a group of patients were either treated with Bevacizumab and a concurrent chemotherapy and another group treated with Placebo and the same chemotherapy. Relative risk (RR) was calculated. P<0.05 was considered statistically significant. RevMan 5.3 software was used for the analysis. A total of 13,070 patients were included. Bevacizumab was associated with a significant increased risk of overall hypertension (RR=3.509; 95% C.I:2.451 to 5.023). 11 trials are included for determining the risk of Grade 3 hypertension including 8799 patients with a significant increased risk (RR=3.909; 95%C.I:1.983 to 7.707). 7 trials are included for determining the risk of hypertension at low dose (2.5 mg/kg/cycle) including 3691 patients associated with a significant increased (RR=2.640; 95%C.I: 1.408 to 4.950). 10 trials are included for determining the risk of hypertension at high dose (5 mg/kg/cycle) including 9379 patients associated with a significant (RR=4.036; 95%C.I: 2.948 to 5.525). Our meta-analysis has demonstrated that bevacizumab may be associated with a significantly increased risk of hypertension in patient with a variety of metastatic solid tumors irrespective of dosing.
ABSTRACT
background & objectives: Improving quality of life (QOL) of healthy people living with HIV (PLHIV) is critical needing home-based, long-term strategy. Sudarshan Kriya yoga (SKY) intervention is acknowledged for its positive impact on health. It is hypothesised that SKY would improve PLHIV’s QOL, justifying an evaluation. Methods: In this open label randomized controlled pilot trial, 61 adult PLHIV with CD4 count more than 400 cells/μl and Karnofsky scale score above 70 were enrolled. Those with cardiac disease, jaundice, tuberculosis, or on antiretroviral therapy/yoga intervention were excluded. All were given standard care, randomized to SKY intervention (31: I-SKY) and only standard of care in control (30: O-SOC) arms. The I-SKY participants were trained for six days to prepare for daily practice of SKY at home for 30 min. A validated 31-item WHOQOL-HIVBREF questionnaire was used to document effect in both arms from baseline to three visits at 4 wk interval. Results: Baseline QOL scores, hypertension and CD4 count were similar in both arms. An overall 6 per cent improvement of QOL scores was observed in I-SKY group as compared to O-SOC group, after controlling for baseline variables like age, gender, education and occupation (p=0.016); 12 per cent for physical (p=0.004), 11 per cent psychological (p=0.023) and 9 per cent level of independence (p=0.001) domains. Improvement in I-SKY observed at post-training and in the SKY adherence group showed increase in these two domains. Conclusions: A significant improvement in QOL scores was observed for the three health related QOL domains in SKY intervention arm. This low cost strategy improved physical and psychological state of PLHIV calling for upscaling with effective monitoring for sustainability of quality of life.