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Efficacy and Clinical Outcomes of mRNA COVID-19 Vaccine in Pregnancy: A Systematic Review and Meta-Analysis.
Santimano, AJ, Al-Zoubi, RM, Al-Qudimat, AR, Al Darwish, MB, Ojha, LK, Rejeb, MA, Hamad, Y, Elrashid, MA, Ruxshan, NM, El Omri, A, et al
Intervirology. 2024;(1):40-54
Abstract
BACKGROUND The world has witnessed one of the largest pandemics, dubbed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As of December 2020, the USA alone reported 98,948 cases of coronavirus disease 2019 (COVID-19) infection during pregnancy, with 109 related maternal deaths. Current evidence suggests that unvaccinated pregnant women infected with SARS-CoV-2 are at a higher risk of experiencing complications related to COVID-19 compared to nonpregnant women. This review aimed to provide healthcare workers and non-healthcare workers with a comprehensive overview of the available information regarding the efficacy of vaccines in pregnant women. SUMMARY We performed a systematic review and meta-analysis following PRISMA guidelines. The search through the database for articles published between December 2019 and October 2021 was performed. A comprehensive search was performed in PubMed, Scopus, and EMBASE databases for research publications published between December 2019 and October 2021. We focused on original research, case reports, case series, and vaccination side effect by authoritative health institutions. Phrases used for the Medical Subject Heading [MeSH] search included ("COVID-19" [MeSH]) or ("Vaccine" [MeSH]) and ("mRNA" [MeSH]) and ("Pregnant" [MeSH]). Eleven studies were selected and included, with a total of 46,264 pregnancies that were vaccinated with mRNA-containing lipid nanoparticle vaccine from Pfizer/BioNTech and Moderna during pregnancy. There were no randomized trials, and all studies were observational (prospective, retrospective, and cross-sectional). The mean maternal age was 32.2 years, and 98.7% of pregnant women received the Pfizer COVID-19 vaccination. The local and systemic adverse effects of the vaccination in pregnant women were analyzed and reported. The local adverse effects of the vaccination (at least 1 dose) such as local pain, swelling, and redness were reported in 32%, 5%, and 1%, respectively. The systemic adverse effects such as fatigue, headaches, new onset or worsening of muscle pain, chills, fever, and joint pains were also reported in 25%, 19%, 18%, 12%, 11%, and 8%, respectively. The average birthweight was 3,452 g. Among these pregnancies, 0.03% were stillbirth and 3.68% preterm (<37 weeks) births. KEY MESSAGES The systemic side effect profile after administering the COVID-19 mRNA vaccine to pregnant women was similar to that in nonpregnant women. Maternal and fetal morbidity and mortality were lowered with the administration of either one or both the doses of the mRNA COVID-19 vaccination.
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2.
Cardiovascular Disease, Hypogonadism and Erectile Dysfunction: Early Detection, Prevention and the Positive Effects of Long-Term Testosterone Treatment: Prospective Observational, Real-Life Data.
Alwani, M, Yassin, A, Talib, R, Al-Qudimat, A, Aboumarzouk, O, Al-Zoubi, RM, Saad, F, Haider, KS, Al Ansari, A
Vascular health and risk management. 2021;:497-508
Abstract
PURPOSE Erectile dysfunction (ED) is associated with testosterone deficiency and is a symptom of functional hypogonadism. A correlation between ED and cardiovascular disease (CVD) has been recognized, and ED has been proposed as an early marker of CVD. However, the relationship between ED and CVD risk in hypogonadism requires clarification and whether testosterone therapy (TTh) can be a beneficial treatment strategy, but long-term data are limited. This study investigates long-term TTh in men with hypogonadism and ED with a history of CVD. METHODS Seventy-seven patients with a history of CVD and diagnosed with functional hypogonadism and erectile dysfunction (erectile function domain score <21 on the International Index of Erectile Function questionnaire (IIEF questions 1-5)) were enrolled and TTh effects on anthropometric and metabolic parameters investigated for a maximum duration of 12 years. All men received long-acting injections of testosterone undecanoate at 3-monthly intervals. Eight-year data were analysed. Data collection registry started in November 2004 till January 2015. RESULTS In hypogonadal men receiving TTh, IIEF increased by 5.4 (p<0.001). Total weight loss was 23.6 ± 0.6 kg after 8 years. HbA1c had declined by an average of 2.0% (P<0.0001). Total cholesterol levels significantly declined following TTh after only 1 year (P<0.0001), and HDL increased from 1.6±0.5 at baseline to 2±0.5 mmol/L following 8 years of TTh (P<0.0001). SBP decreased from 164±14 at baseline to 133±9 mmHg, signifying a reduction of 33±1 mmHg (P<0.0001). CONCLUSION In hypogonadal men with a history of CVD, TTh improves and preserves erectile function over prolonged periods with concurrent sustained improvements in cardiometabolic risk factors. Measuring ED and testosterone status may serve as an important male health indicator predicting subsequent CVD-related events and mortality and TTh may be an effective add-on treatment in secondary prevention of cardiovascular events in hypogonadal men with a history of CVD.
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3.
Vitamin D Supplementation As a Potential therapeutic Mediator in Asthma: Does Dose Really Matter? a Critical Review of the Literature.
Canguven, O, El Ansari, W, Yassin, A
The aging male : the official journal of the International Society for the Study of the Aging Male. 2020;(4):300-307
Abstract
Around 400 million people across the globe will suffer from asthma in the next 10 years. Although most asthmatics use asthma medications regularly, they occasionally visit the emergency department for aggressive treatment amidst family anxiousness. Vitamin D (VD) not only regulates the expression of genes associated with calcium homeostasis, but also the genes associated with cancers, autoimmune diseases, and infection. VD has also non-genomic activities e.g. it is a potentially safe and effective novel strategy for decreasing the asthma episodes and controlling exacerbations. Our review assessed the dose, serum level, duration of administration and outcomes of VD in cases of asthmas. Although a body of research evidences the effectiveness of VD supplementation in asthma, other studies showed the insignificant response of VD to asthma either with low dose or low achieved serum VD levels. Nevertheless, recent reviews suggest that manipulating VD status holds promise for primary prevention and treatment of asthma. Future research on the relationship between VD and asthma should consider utilizing adequate doses of VD preparations for sufficient duration (likely to be >12 months) aiming to achieve appropriate level of serum VD (25-hydroxyvitamin D) concentration (likely to be at least >40 ng/mL).
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4.
Testosterone Therapy in Men With Hypogonadism Prevents Progression From Prediabetes to Type 2 Diabetes: Eight-Year Data From a Registry Study.
Yassin, A, Haider, A, Haider, KS, Caliber, M, Doros, G, Saad, F, Garvey, WT
Diabetes care. 2019;(6):1104-1111
Abstract
OBJECTIVE Type 2 diabetes (T2D) is a public health threat. Prediabetes represents a window of opportunity for intervention to prevent T2D. Men with T2D and prediabetes often have low testosterone. Since testosterone improves glycemic control in T2D, we investigated whether testosterone therapy (TTh) in men with hypogonadism and prediabetes prevents progression to T2D. RESEARCH DESIGN AND METHODS Three hundred and sixteen men with prediabetes (defined as HbA1c 5.7-6.4%) and total testosterone levels ≤12.1 nmol/L combined with symptoms of hypogonadism were analyzed. Two hundred and twenty-nine men received parenteral testosterone undecanoate (T-group), and 87 men with hypogonadism served as untreated control subjects. Metabolic and anthropometric parameters were measured twice yearly for 8 years. RESULTS HbA1c decreased by 0.39 ± 0.03% (P < 0.0001) in the T-group and increased by 0.63 ± 0.1% (P < 0.0001) in the untreated group. In the T-group, 90% achieved normal glucose regulation (HbA1c <5.7%). In the untreated group, 40.2% progressed to T2D (HbA1c >6.5%). TTh was also associated with significant improvements in fasting glucose, triglyceride:HDL ratio, triglyceride-glucose index, lipid accumulation product, total cholesterol, LDL, HDL, non-HDL, triglycerides, and Aging Males' Symptoms (AMS) scale. Significant deterioration in all these parameters was seen in the untreated group. Mortality was 7.4% in the T-group and 16.1% in the untreated group (P < 0.05). The incidence of nonfatal myocardial infarction was 0.4% in the T-group and 5.7% in the untreated group (P < 0.005). CONCLUSIONS Long-term TTh completely prevents prediabetes progression to T2D in men with hypogonadism and improves glycemia, lipids, and AMS score. TTh holds tremendous potential for the large and growing population of men with prediabetes and hypogonadism.
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5.
A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate.
Saad, F, Gooren, LJ, Haider, A, Yassin, A
Journal of andrology. 2008;(1):102-5
Abstract
The objective of this study was to observe the dose-response effects of testosterone (T) treatment on symptoms of sexual dysfunction and the metabolic syndrome. Two cohorts of elderly men with late-onset hypogonadism were followed over 9 months. Group 1, consisting of 28 men (mean age, 61 years; mean T level, 2.07 +/- 0.50 ng/mL), received long-acting T undecanoate (TU; 1000 mg); group 2, composed of 27 men (mean age, 60 years; mean T level, 2.24 +/- 0.41 ng/mL), received T gel (50 mg/day) for 9 months. In patients treated with T gel, plasma T levels rose from 2.24 +/- 0.41 to 2.95 +/- 0.52 (statistically significant) at 3 months, 3.49 +/- 0.89 (statistically significant) at 6 months, and 3.80 +/- 0.73 ng/mL at 9 months (T level at 6 months was compared with T level at 3 months). With TU, plasma T levels rose from 2.08 +/- 0.56 to 4.81 +/- 0.83 (statistically significant) at 3 months, 5.29 +/- 0.91 at 6 months, and 5.40 +/- 0.77 ng/mL at 9 months. With TU, the plasma T levels were statistically significantly higher than with T gel With TU, there was a greater improvement in sexual symptoms and in symptoms of the metabolic syndrome. With both treatments, changes in waist circumference correlated with changes in total, low-density, and high-density lipoprotein cholesterol. Parameters of safety were not different between the 2 treatments. T administration had a beneficial effect on sexual dysfunction and symptoms of the metabolic syndrome in elderly men. The higher plasma levels of T generated with TU than with T gel were clearly more effective, indicating that there is a T dose-effect relationship.
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6.
Effects of testosterone gel followed by parenteral testosterone undecanoate on sexual dysfunction and on features of the metabolic syndrome.
Saad, F, Gooren, L, Haider, A, Yassin, A
Andrologia. 2008;(1):44-8
Abstract
The effects of administration of testosterone (T) gel, resulting in plasma T levels in the low range of reference values, followed by testosterone undecanoate (TU), producing plasma T levels in the mid-normal range, were measured in 27 hypogonadal men aged 47-74 years. T gel had positive effects on the International Index of Erectile Function, the Aging Males' Symptoms Scale and International Prostate Symptoms Score and on the metabolic syndrome. The improvement was larger when TU was administered and plasma T levels were higher. The reduction in waist circumference and plasma cholesterol were larger with TU than with T gel, while the increases in plasma high-density lipoprotein and sex hormone binding globulin (an indicator of the severity of the metabolic syndrome) were larger with TU than with T gel. Both T gel and TU appeared safe on prostate parameters. Plasma haemoglobin and haematocrit were elevated but remained in the normal range. The assumption that treatment with T is adequate when achieved plasma levels of T are within the reference range is no longer tenable. Some androgen-dependent biological functions require higher plasma T levels than others, and, moreover, these thresholds differ among men.
