Ellis Hospital

Real-world evidence on atogepant remains limited. GIANT2 explores the 24-week real-life effectiveness of atogepant in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) under routine clinical conditions. GIANT2 is a 24-week, prospective, multicenter, real-world, study including consecutive patients with HFEM or CM with ≥3 preventive treatment failures, treated with atogepant 60 mg once daily. Co-primary endpoints: proportions achieving ≥50% and ≥75% reductions in monthly migraine days for HFEM or monthly headache days for CM at weeks 21–24 versus baseline. Secondary endpoints: changes in migraine/headache days, analgesic intake, pain intensity, disability, patient global impression of change, 100% response rates, tolerability and safety. Response rates at weeks 21–24 were also evaluated in patients with prioranti-CGRP mAb failure. Exploratory analyses: proportion of >50% responders achieving >30% reduction in NRS scores and response rates in subgroups combining psychiatric comorbidities, CM, and medication overuse headache (MOH). Of 233 patients enrolled, 156 completed >24 weeks of treatment, with 37.2% having failed prior anti-CGRP mAbs. At weeks 21–24, 76.9% achieved a ≥ 50% response and 45.5% a ≥ 75% response, with ≥50% response more frequent in HFEM than CM (p = 0.005). A 100% response occurred in 5.1% of patients. All secondary endpoints improved significantly (p < 0.001) with greater benefits at week 24 than week 12. No difference in effectiveness was observed between mAb-naïve patients and those with prior mAb failures, who achieved ≥50% and ≥75% response rates of 70.7% and 39.7%. A combined ≥50% frequency reduction and ≥30% pain reduction was achieved by 54.5% of patients. Among patients with psychiatric comorbidities, 63.0% were ≥50% responders, while among CM patients rates were 62.1% in those with MOH and 40.0% in those with both psychiatric comorbidities and MOH (≥75% responder rates 42.4%, 37.0%, and 28.0%). Adverse events occurred in 11.2% of patients and led to discontinuation in 1.3%. GIANT2 shows that atogepant effectiveness increases from week 12 to 24 with a high proportion of responders and super-responders regardless of prior anti-CGRP mAb failure and reduces pain intensity in residual headaches in most patients. It is also effective in migraine subgroups combining psychiatric comorbidities, CM and MOH. NCT06136442.

Background/Objectives: The use of vaginal mesh for pelvic organ prolapse (POP) repair remains controversial following global restrictions due to safety concerns. This study evaluated intra- and perioperative morbidity following a standardized single-incision, six-point fixation approach using an ultralight vaginal mesh in primary surgery for anterior/central POP. Methods: We conducted a retrospective multicenter study including 426 women who underwent primary POP repair with the InGYNious mesh system between May 2016 and February 2024. All surgeries followed a uniform technique across seven Italian centers. Data were collected on perioperative complications, urinary function, postoperative pain, and catheter duration. Results: The overall morbidity rate was 7.3% (31/426), primarily due to hematomas (4.5%), bladder injuries (1.4%), and ureteral injuries (0.7%). Median surgery duration was 40 min with minimal blood loss. Early postoperative pain was associated with higher POP-Q scores, longer surgical duration, and lower BMI. No cases of de novo urinary incontinence or urinary tract infection were reported in the perioperative period. Conclusions: This large multicenter case series suggests that, in experienced hands, this standardized vaginal mesh approach is associated with a low perioperative complication rate. However, the absence of a control group and the short follow-up are major limitations. Long-term outcome data, particularly regarding mesh-related complications, are essential before drawing firm conclusions on the broader safety or role of vaginal mesh in POP repair.

Osteoporosis is a common skeletal disease that leads to increased bone fragility, associated with increased risk of fracture and consequent significant morbidity and mortality, and is a global public health problem. It results from a chronic imbalance in bone remodeling, where bone resorption by osteoclasts exceeds bone formation by osteoblasts. Aging, hormonal changes, comorbidities, and drugs influence the process that leads to osteoporosis. In this review, we delve into the pathogenesis of primary and secondary osteoporosis after a summary of the normal physiology of bone homeostasis. Primary osteoporosis includes postmenopausal osteoporosis, driven largely by estrogen deficiency, and age-related (senile) osteoporosis, associated with reduced bone formation. An insight into male osteoporosis and osteoporosis treatment is also provided. Secondary osteoporosis can derive from underlying conditions, such as endocrine disorders, chronic inflammatory and genetic diseases, or prolonged use of glucocorticoids. Clinically, osteoporosis is often unacknowledged, underlining the importance of early risk assessment and diagnosis. A thorough understanding of the disease, its subtypes, and its underlying pathogenetic mechanisms is essential for early diagnosis and individualized treatment, all targeted to effective fracture prevention.

For many years, cardiac pacing has been based on the stimulation of right ventricular common myocardium to correct diseases of the conduction system. The birth and the development of cardiac resynchronization have led to growing interest in the correction and prevention of pacing-induced dyssynchrony. Many observational studies and some randomized clinical trials have shown that conduction system pacing (CSP) can not only prevent pacing-induced dyssynchrony but can also correct proximal conduction system blocks, with reduction of QRS duration and with equal or greater effectiveness than biventricular pacing. Based on these results, many Italian electrophysiologists have changed the stimulation target from the right ventricular common myocardium to CSP. The two techniques with greater clinical impact are the His bundle stimulation and the left bundle branch pacing. The latter, in particular, because of its easier implantation technique and better electric parameters, is spreading like wildfire and is representing a real revolution in the cardiac pacing field. However, despite the growing amount of data, until now, the European Society of Cardiology guidelines give a very limited role to CSP.

Temporary cardiac pacing (TCP) is a 50-year-old technique but it is still young. It is used in all cardiology departments for saving lives of patients with bradycardia and hemodynamic instability. The know-how of TCP cannot miss in clinical competence of cardiologists that work in the cardiac intensive care unit. However, despite its wide diffusion, the scientific evidence supporting TCP is not so strong and in Italian hospitals the management of some aspects of TCP is highly variable, including indications as well as antibiotic and anticoagulant prophylaxis. Due to the high risk of TCP-related complications, the 2021 European guidelines on cardiac pacing recommend whenever possible to avoid TCP before cardiac implantable electronic device implantation and, in all cases, TCP duration should be as short as possible. In the last years, if on the one hand, TCP indications have gradually decreased, on the other hand high-frequency TCP during aortic valvuloplasty or transcatheter aortic valve implantation procedures have progressively increased.