Long-term Efficacy Studies Research Articles

A Comparative NLP-Based Study on the Current Trends and Future Directions in COVID-19 Research.

COVID-19 is a global health crisis that has altered human life and still promises to create ripples of death and destruction in its wake. The sea of scientific literature published over a short time-span to understand and mitigate this global phenomenon necessitates concerted efforts to organize our findings and focus on the unexplored facets of the disease. In this work, we applied natural language processing (NLP) based approaches on scientific literature published on COVID-19 to infer significant keywords that have contributed to our social, economic, demographic, psychological, epidemiological, clinical, and medical understanding of this pandemic. We identify key terms appearing in COVID literature that vary in representation when compared to other virus-borne diseases such as MERS, Ebola, and Influenza. We also identify countries, topics, and research articles that demonstrate that the scientific community is still reacting to the short-term threats such as transmissibility, health risks, treatment plans, and public policies, underpinning the need for collective international efforts towards long-term immunization and drug-related challenges. Furthermore, our study highlights several long-term research directions that are urgently needed for COVID-19 such as: global collaboration to create international open-access data repositories, policymaking to curb future outbreaks, psychological repercussions of COVID-19, vaccine development for SARS-CoV-2 variants and their long-term efficacy studies, and mental health issues in both children and elderly.

Long-term safety and efficacy study of a medical device containing xyloglucan, pea protein reticulated with tannins and xylo-oligosaccharides, in patients with diarrhoea-predominant irritable bowel syndrome.

Background:Irritable bowel syndrome with diarrhoea (IBS-D) is a frequent problem associated with a significant socioeconomic implication. Increased gut permeability is an important pathophysiological mechanism. A medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape-seed extract, and xylo-oligosaccharides (XOS) has proven restoration of intestinal barrier function. Our objective was to evaluate the efficacy and safety of treatment with the medical device XG + PPT + XOS (XG-PPT-XOS) in adult patients with IBS-D in a clinical setting for 6 months.Material and methods:This was a multicentre, open-label, prospective, observational study conducted to evaluate long-term safety and efficacy of XG-PPT-XOS. IBS-D adult patients (Rome IV criteria) were included and received two tablets twice daily for 6 months. IBS Symptom Severity Score (IBS-SSS) and bowel habit were registered at baseline and monthly, until the end of follow up. Efficacy was evaluated by comparison of mean scores at each time point.Results:50 patients were included, of which 19 completed the 6 months. IBS-SSS score decreased from 312.2 ± 82.2 to 213.6 ± 109.9 (p < 0.0001) at 1 month and 192.0 ± 108.9 at the last visit completed; diarrhoea score decreased from 45.6 ± 17.9 to 25.7 ± 17.7 and 25.3 ± 17.2 at 1 month and at the last visit completed, respectively. Pain score decreased from 107.8 ± 49.9 at baseline to 73.2 ± 57.3 (p < 0.0001) at 1 month and bloating score from 56.4 ± 28.8 at baseline to 42.8 ± 32.6 (p < 0.001) at 1 month, reaching 62.4 ± 56.0 and 40.4 ± 34.3, respectively, at the last visit completed. Adverse effects were mild and mostly not related to treatment.Conclusion:Treating IBS-D patients with XG-PPT-XOS is effective and safe in the long term within a clinical setting, improving all IBS-D symptoms from the first month of treatment and showing a sustained response over the term of therapy.

Vagus nerve stimulation in patients with Lennox-Gastaut syndrome: A meta-analysis.

ObjectivesLennox‐Gastaut syndrome (LGS) is among the most severe epileptic and developmental encephalopathies. A meta‐analysis was performed to evaluate the effectiveness of adjunctive vagus nerve stimulation (VNS Therapy) in patients with LGS.Materials & MethodsPubMed database was queried (January 1997 to September 2018) to identify publications reporting on the efficacy of VNS Therapy in patients with LGS, with or without safety findings. Primary endpoint of the meta‐analysis was the proportion of responders (≥50% reduction in seizure frequency). Random‐effects analysis was used to calculate weighted mean estimates and confidence intervals. Heterogeneity was evaluated by statistical tests including I 2.ResultsOf 2752 citations reviewed, 17 articles (480 patients) were eligible including 10 retrospective studies and seven prospective studies. A random‐effects model produced a pooled proportion of 54% (95% confidence intervals [CI]: 45%, 64%) of patients with LGS who responded to adjunctive VNS Therapy (p for heterogeneity <0.001, I 2=72.9%). Per an exploratory analysis, the calculated incidence of serious adverse events associated with VNS Therapy was 9% (95% CI: 5%, 14%); the rate was higher than in long‐term efficacy studies of heterogeneous cohorts with drug‐resistant epilepsy and likely attributed to variable definitions of serious adverse events across studies.ConclusionsThe meta‐analysis of 480 patients with LGS suggests that 54% of patients responded to adjunctive VNS Therapy and that the treatment option was safe and well‐tolerated. The response in patients with LGS was comparable to heterogeneous drug‐resistant epilepsy populations. A clinical and surgical overview has been included to facilitate the use of VNS in LGS.

Updates in uterine artery embolization for leiomyomas.

Uterine leiomyomas are a common condition estimated to affect 70-80% of reproductive-aged women. An evolving body of evidence continues to guide our understanding of various surgical and interventional treatment options, such as uterine artery embolization (UAE). This article provides an updated review of novel findings regarding UAE. Despite an abundance of observational studies and several small randomized controlled trials, large scale long-term comparative efficacy studies are lacking. Although short-term outcomes continue to be favorable, recent trials show reoperation rate of up to 35% in 10 years and may raise some concerns regarding ovarian reserve, fertility and pregnancy outcomes. UAE remains a safe and effective alternative to surgery in the management of leiomyomas. A deeper investigation into understanding this treatment's optimal use in various patient populations is needed.

0595 Obstructive Sleep Apnea Characteristics in Younger Versus Older Women

Abstract Introduction There are few large studies of obstructive sleep apnea (OSA) comparing the clinical and polysomnographic characteristics between men and women, and between younger and older women. Methods The current study involves retrospective analyses of data from the Apnea Positive Pressure Long-term Efficacy Study (APPLES), a prospective multicenter randomized controlled trial in persons with OSA. The mean age of the 1105 participants was 51.6 ± 12 years (range 18-83 years). The participants included 723 men (65.4%) and 382 women (34.6%). Of all women, 25% were &amp;lt;=45 years of age (likely pre-menopausal) and 50% were above &amp;gt;=53 years of age (likely post-menopausal). We used these 2 groups to define younger women and older women, respectively. Results The overall mean body mass index (BMI) and apnea hypopnea index (AHI) were 32.2 ± 7.1 Kg/m2 and 40.1 ± 25.2 (range 6-156/hour), respectively. Women had a higher BMI and Epworth Sleepiness Scale (ESS) than men but a lower AHI and lower arousal index (AI). The Hamilton Rating Scale for Depression (HAMD) score was also significantly higher in women. Younger men and women had no other PSG differences including total sleep time (TST), Sleep Efficiency (SE), Sleep Onset Latency (SOL). Older women had lower AHI, higher TST and higher SE than older men. Morningness-Eveningness Questionnaire (MEQ) scores were lower in women than in men in all age groups (suggestive of eveningness). Compared to the older women, younger women had higher BMI, HAMD score and ESS, but lower MEQ score. On PSG, younger women had higher TST and SE but similar SOL, AHI and AI. Conclusion In this cohort with OSA, the prevalence of sleepiness and depression is higher in women than in men despite a lower AHI and lower AI. Sleepiness and depression are more common in younger compared to older women with OSA despite similar AHI and AI and a higher SE. Women with OSA demonstrate more ‘eveningness’ compared to men with OSA, as do younger women compared to older women. Support Contract 5UO1-HL-068060 from the National Heart, Lung and Blood Institute

Long-term safety and efficacy studies of epinephrine HFA metered-dose inhaler (Primatene® Mist): a two-stage randomized controlled trial

Objective: A new epinephrine hydrofluoroalkane (HFA) asthma metered-dose inhaler (MDI) was reformulated to replace the previously marketed epinephrine chlorofluorocarbon (CFC) MDI. In addition to the HFA propellant change, several enhanced modifications (i.e. changed from solution to suspension, 43% dose reduction, etc.) were made to the formulation of epinephrine HFA MDI. This study evaluates the 6-month long-term safety and efficacy profile of the new epinephrine HFA MDI.Method: The long-term safety study consists of two 3-month, multi-center, double- or evaluator-blinded, parallel-group, placebo, and active controlled stages. In each stage, subjects aged ≥12 years with intermittent or mild-to-moderate persistent asthma were randomized to receive epinephrine HFA (2 × 125 mcg/inhalation), placebo HFA, or epinephrine CFC (2 × 220 mcg/inhalation). Bronchodilator efficacy was assessed in Stage 1 and was determined primarily by the change in the forced expiratory volume in 1 s (ΔFEV1) at Week 12, relative to the same day baseline.Results: The primary efficacy endpoint (AUC0-6hrs of %ΔFEV1 at Week 12) for epinephrine HFA (47.3 ± 54.2) closely paralleled those for the active control, epinephrine CFC (41.0 ± 43.4). Both groups were found to be overall comparable in bronchodilator efficacy. Both also showed low incidence rates of AEs with tremor being most commonly reported for epinephrine HFA. All AEs found were non-serious and non-significant. The observed changes in vital signs, ECG, serum glucose, and potassium were minimal and not clinically relevant.Conclusion: This study demonstrated that the new epinephrine HFA is overall comparable, in both safety and efficacy, to the previous epinephrine CFC.

The effect of CPAP on HRQOL as measured by the Quality of Well-Being Self Administered Questionaire (QWB-SA).

To examine the effect of continuous positive airway pressure (CPAP) on Health-related quality of life (HRQoL) as measured by the Quality of Well Being Self-Administered questionnaire (QWB-SA). Participants from The Apnea Positive Pressure Long-term Efficacy Study (APPLES); a 6-month multicenter randomized, double-blinded intention to treat study, were included in this analysis. The participants with an apnea-hypopnea index >10 events/hour initially randomized to CPAP or Sham group were asked to complete QWB-SA at baseline, 2, 4, and 6-month visits. There were no group differences among either the CPAP or Sham groups. "Mean age was 52±12 [SD] years, AHI 40±25 events/hr, BMI 32±7.1 kg/m2, and Epworth Sleepiness Score (ESS) 10±4 of 24 points." QWB-SA scores were available at baseline, and 2, 4 & 6 months after treatment in CPAP (n 558) and Sham CPAP (n 547) groups. There were no significant differences in QWB scores among mild, moderate or severe OSA participants at baseline. Modest improvement in QWB scores was noted at 2, 4 and 6- months among both Sham and CPAP groups (P <0.05). However, no differences were observed between Sham CPAP and CPAP at any time point. Comparison of the QWB-SA data from the current study with published data in populations with chronic illnesses demonstrated that the impact of OSA is no different than the effect of AIDS and arthritis. Although the QoL measured by the QWB-SA was impaired in OSA it did not have direct proportionality to OSA severity.ClinicalTrials.gov. Identifier: NCT00051363.

Prevalence and correlates of periodic limb movements in OSA and the effect of CPAP therapy.

We sought to assess the prevalence, correlates, and consequences of periodic limb movements of sleep (PLMS) in persons with obstructive sleep apnea (OSA) and the effect (worsening or improvement) of continuous positive airway pressure (CPAP) therapy on PLMS in a large prospective multicenter randomized controlled trial. We performed retrospective analyses of data from the Apnea Positive Pressure Long-term Efficacy Study, a prospective multicenter randomized controlled trial. A total of 1,105 persons with OSA enrolled in this study underwent a polysomnographic investigation at baseline, another one for CPAP titration, and another study 6 months after randomization to either active CPAP or sham CPAP. Of all participants, 19.7% had PLM index (PLMI) ≥10/hour, 14.8% had PLMI ≥15/hour, 12.1% had PLMI ≥20/hour, 9.3% had PLMI ≥25/hour, and 7.5% had PLMI ≥30/hour. The odds of having a PLMI ≥10 were higher in older participants (odds ratio [OR] 1.03, p < 0.001), men (OR 1.63. p = 0.007), those using antidepressants (OR 1.48. p = 0.048), and those with higher caffeine use (OR 1.01, p = 0.04). After controlling for OSA and depression, PLMS were associated with increased sleep latency, reduced sleep efficiency, and reduced total sleep time. No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test). There was no differential effect of CPAP in comparison to sham CPAP on PLMS after 6 months of therapy. PLMS are common in patients with OSA and are associated with a significant reduction in sleep quality over and above that conferred by OSA. Treatment with CPAP does not affect the severity of PLMS.

Dietary practices in methylmalonic acidaemia: a European survey.

Background The dietary management of methylmalonic acidaemia (MMA) is a low-protein diet providing sufficient energy to avoid catabolism and to limit production of methylmalonic acid. The goal is to achieve normal growth, good nutritional status and the maintenance of metabolic stability. Aim To describe the dietary management of patients with MMA across Europe. Methods A cross-sectional questionnaire was sent to European colleagues managing inherited metabolic disorders (IMDs) (n=53) with 27 questions about the nutritional management of organic acidaemias. Data were analysed by different age ranges (0-6 months; 7-12 months; 1-10 years; 11-16 years; >16 years). Results Questionnaires were returned from 53 centres. Twenty-five centres cared for 80 patients with MMA vitamin B12 responsive (MMAB12r) and 43 centres managed 215 patients with MMA vitamin B12 non-responsive (MMAB12nr). For MMAB12r patients, 44% of centres (n=11/25) prescribed natural protein below the World Health Organization/Food and Agriculture Organization/United Nations University (WHO/FAO/UNU) 2007 safe levels of protein intake in at least one age range. Precursor-free amino acids (PFAA) were prescribed by 40% of centres (10/25) caring for 36% (29/80) of all the patients. For MMAB12nr patients, 72% of centres (n=31/43) prescribed natural protein below the safe levels of protein intake (WHO/FAO/UNU 2007) in at least one age range. PFAA were prescribed by 77% of centres (n=33/43) managing 81% (n=174/215) of patients. In MMAB12nr patients, 90 (42%) required tube feeding: 25 via a nasogastric tube and 65 via a gastrostomy. Conclusions A high percentage of centres used PFAA in MMA patients together with a protein prescription that provided less than the safe levels of natural protein intake. However, there was inconsistent practices across Europe. Long-term efficacy studies are needed to study patient outcome when using PFAA with different severities of natural protein restrictions in patients with MMA to guide future practice.

Vaccination strategy is an important determinant in immunological outcome and survival in Arctic charr (Salvelinus alpinus) when challenged with atypical Aeromonas salmonicida

Arctic charr (Salvelinus alpinus) farming is an emerging component in today's aquaculture sector; however, intensive aquaculture sites provide optimal conditions for disease. Although vaccines have been developed and tested for other major cultured salmonids, such as Atlantic salmon (Salmo salar), it is unknown if such vaccines provide protection in Arctic charr. Therefore, the present study aimed to evaluate the efficacy of two vaccines, Forte Micro® and Renogen®, administered solely or in combination, in the prevention of atypical furunculosis in Arctic charr after challenge with atypical Aeromonas salmonicida (RPC strain FFA-43). Furthermore, vaccination efficacy was assessed after short or long post-vaccination periods prior to bacterial challenge. Improved survival was observed in charr vaccinated with both single and combined vaccines in the short-term efficacy study, and this positively correlated with increased circulating IgM specific for atypical A. salmonicida. However, circulating IgM was reduced in the long-term study. Forte Micro® provided improved protection when Arctic charr were exposed to infection in the short-term vaccine efficacy compared to the long-term vaccine efficacy, where no significant protection was observed. Gene expression analysis revealed upregulation of complement, acute phase, and cellular signalling post-vaccination and post-challenge for fish in the short-term vaccine efficacy study, with similar to muted responses observed in fish in the long-term vaccine efficacy study. This study provides insight on the efficacy and molecular mechanisms of protection of two commercial salmonid vaccines in Arctic charr during infections with atypical A. salmonicida.

Effects of continuous positive airway pressure on blood pressure in obstructive sleep apnea patients: The Apnea Positive Pressure Long‐term Efficacy Study (APPLES)

Obstructive sleep apnea is associated with hypertension, and short-term studies have demonstrated a modest reduction in blood pressure with continuous positive airway pressure therapy. We evaluated the effects of continuous positive airway pressure versus sham continuous positive airway pressure on blood pressure in 1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study, a randomized, sham-controlled double-blinded study designed to assess the impact of continuous positive airway pressure on neurocognition. Participants with apnea-hypopnea index ≥10 were randomly assigned to continuous positive airway pressure or sham continuous positive airway pressure. Blood pressures measured in the morning and evening at baseline, 2months and 6months were analysed post hoc using a mixed-model repeated-measures analysis of variance. The largest magnitude reduction was approximately 2.4mmHg in morning systolic pressure that occurred at 2months in the continuous positive airway pressure arm as compared with an approximate 0.5mmHg reduction in the sham group (continuous positive airway pressure effect -1.9mmHg, p=.008). At 6months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9mmHg, p=.12). Sensitivity analysis with use of multiple imputation approaches to account for missing data did not change the results. Treatment with continuous positive airway pressure for obstructive sleep apnea reduces morning but not evening blood pressure in a population with well-controlled blood pressure. The effect was greater after 2 than after 6months of treatment.

Updated Results from the Single-Arm, Open-Label, Long-Term Efficacy and Safety Study of Subcutaneous (SC) Romiplostim in Children with Immune Thrombocytopenia (ITP)

Updated Results from the Single-Arm, Open-Label, Long-Term Efficacy and Safety Study of Subcutaneous (SC) Romiplostim in Children with Immune Thrombocytopenia (ITP)

"Ground-Truthing" Efficacy of Biological Control for Aflatoxin Mitigation in Farmers' Fields in Nigeria: From Field Trials to Commercial Usage, a 10-Year Study.

In sub-Saharan Africa (SSA), diverse fungi belonging to Aspergillus section Flavi frequently contaminate staple crops with aflatoxins. Aflatoxins negatively impact health, income, trade, food security, and development sectors. Aspergillus flavus is the most common causal agent of contamination. However, certain A. flavus genotypes do not produce aflatoxins (i.e., are atoxigenic). An aflatoxin biocontrol technology employing atoxigenic genotypes to limit crop contamination was developed in the United States. The technology was adapted and improved for use in maize and groundnut in SSA under the trademark Aflasafe. Nigeria was the first African nation for which an aflatoxin biocontrol product was developed. The current study includes tests to assess biocontrol performance across Nigeria over the past decade. The presented data on efficacy spans years in which a relatively small number of maize and groundnut fields (8–51 per year) were treated through use on circa 36,000 ha in commercially-produced maize in 2018. During the testing phase (2009–2012), fields treated during one year were not treated in the other years while during commercial usage (2013–2019), many fields were treated in multiple years. This is the first report of a large-scale, long-term efficacy study of any biocontrol product developed to date for a field crop. Most (>95%) of 213,406 tons of maize grains harvested from treated fields contained <20 ppb total aflatoxins, and a significant proportion (>90%) contained <4 ppb total aflatoxins. Grains from treated plots had preponderantly >80% less aflatoxin content than untreated crops. The frequency of the biocontrol active ingredient atoxigenic genotypes in grains from treated fields was significantly higher than in grains from control fields. A higher proportion of grains from treated fields met various aflatoxin standards compared to grains from untreated fields. Results indicate that efficacy of the biocontrol product in limiting aflatoxin contamination is stable regardless of environment and cropping system. In summary, the biocontrol technology allows farmers across Nigeria to produce safer crops for consumption and increases potential for access to premium markets that require aflatoxin-compliant crops.

Pennisetum ciliare: a review of treatment efficacy, competitive traits, and restoration opportunities

AbstractBuffelgrass [Pennisetum ciliare (L.) Link] is a drought-tolerant invasive grass that is a threat to native biodiversity in the drylands of the Americas and Australia. Despite efforts from land managers to control P. ciliare, management approaches tend to have mixed success, treatment results can be poorly communicated among entities, and there are few long-term controlled studies. In this literature review, we synthesize data from both peer-reviewed and “gray” literature on the efficacy of management techniques to control P. ciliare and the secondary impacts to native plant communities. Our search resulted in 42 unique sources containing a total of 229 studies that we categorized into 10 treatment types, which included herbicide, seeding, manual removal, fire, grazing, biocontrol, fire + additional treatments, manual removal + additional treatments, herbicide + additional treatments, and herbicide + manual removal. We found that treatments that used multiple techniques in tandem along with follow-up treatments were the most effective at controlling P. ciliare. Fewer than one-third of the studies reported impacts of management on native species, and the most commonly studied treatment (herbicide, N = 130) showed detrimental impacts on native plant communities. However, the average time between treatment and outcome measurement was only 15 mo; we suggest the need for more long-term studies of treatment efficacy and secondary impacts of treatment on the ecosystem. Finally, we conducted a second literature review on P. ciliare biology and traits for mechanisms that allows P. ciliare to alter the invaded environment to facilitate a competitive advantage over native species. We found evidence of self-reinforcing feedbacks of invasion being generated by P. ciliare through its interactions with water availability, nutrient cycling, and disturbance regimes. We developed a conceptual model of P. ciliare based on these feedback loops and offer management considerations based on its invasion dynamics and biology.

High Proliferation Rate and a Compromised Spindle Assembly Checkpoint Confers Sensitivity to the MPS1 Inhibitor BOS172722 in Triple-Negative Breast Cancers.

BOS172722 (CCT289346) is a highly potent, selective, and orally bioavailable inhibitor of spindle assembly checkpoint kinase MPS1. BOS172722 treatment alone induces significant sensitization to death, particularly in highly proliferative triple-negative breast cancer (TNBC) cell lines with compromised spindle assembly checkpoint activity. BOS172722 synergizes with paclitaxel to induce gross chromosomal segregation defects caused by MPS1 inhibitor-mediated abrogation of the mitotic delay induced by paclitaxel treatment. In in vivo pharmacodynamic experiments, BOS172722 potently inhibits the spindle assembly checkpoint induced by paclitaxel in human tumor xenograft models of TNBC, as measured by inhibition of the phosphorylation of histone H3 and the phosphorylation of the MPS1 substrate, KNL1. This mechanistic synergy results in significant in vivo efficacy, with robust tumor regressions observed for the combination of BOS172722 and paclitaxel versus either agent alone in long-term efficacy studies in multiple human tumor xenograft TNBC models, including a patient-derived xenograft and a systemic metastasis model. The current target indication for BOS172722 is TNBC, based on their high sensitivity to MPS1 inhibition, the well-defined clinical patient population with high unmet need, and the synergy observed with paclitaxel.

Durvalumab Long-Term Safety and Efficacy Study

Durvalumab Long-Term Safety and Efficacy Study

A long-term safety and efficacy study of trifarotene 50 μg/g cream in subjects with facial and truncal acne vulgaris

A long-term safety and efficacy study of trifarotene 50 μg/g cream in subjects with facial and truncal acne vulgaris

Long-term safety and efficacy study of Cohesive Polydensified Matrix® hyaluronic acid filler for lips shape and volume correction

Long-term safety and efficacy study of Cohesive Polydensified Matrix® hyaluronic acid filler for lips shape and volume correction

Clinical and Polysomnographic Correlates of Subjective Sleepiness in Mild Obstructive Sleep Apnea.

The decision to treat mild obstructive sleep apnea (OSA) often hinges on the presence of subjective daytime sleepiness. This study was done to identify clinical and polysomnographic features which correlate with subjective sleepiness in mild OSA. Utilizing data from the Apnea Positive Pressure Long-term Efficacy Study, 199 participants with mild OSA were identified. Participants were grouped as "sleepy" or "non-sleepy" based on their responses to a question regarding excessive daytime sleepiness, and Epworth Sleepiness Scores. We compared demographic, clinical and baseline polysomnographic data between the groups. The prevalence of subjective sleepiness was 74.4%. The sleepy group was younger (46.1 ± 12.6 vs. 53.3 ± 13.1 years, p=0.001), reported lower quality of life (4.5 ± 0.69 vs. 4.9 ± 0.61, p=0.0002), had higher depression scores (5.4 ± 4.7 vs. 3.1 ± 3.5, p=0.003) and reported more naps per week (2.6 ± 2.9 vs. 1.3 ± 1.9, p=0.01). Total sleep time and sleep efficiency were notably higher in the sleepy (254.2 ± 106 vs. 220.4 ± 114 min, p=0.08) and (80.2 ± 12.6 vs. 75.7 ± 14.9 %, p=0.06), approaching statistical significance. The non-sleepy group had slightly higher apnea hypopnea index (AHI: 12.2 ± 1.5 vs. 11.2 ± 2.4 events/hour, p=0.01) and worse desaturation indices. Subjective sleepiness in mild OSA is associated with younger age, worsened mood and quality of life. This study suggests that evidence of increased sleep drive on polysomnography may correlate with subjective sleepiness in mild OSA.

Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus

Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus