Management of treatment-naïve diabetic macular edema patients: Review of real-world clinical data.

The high prevalence of Diabetic macular edema (DME) is a real global health problem. Its complex pathophysiology involves different pathways. Over the last decade, the introduction of intravitreal treatments has dramatically changed the management and prognosis of DME. Among the different treatment options, inhibitors of vascular endothelial growth factor (anti-VEGF) and intravitreal steroids implants represent the first-line therapy of DME. We conducted a review of electronic databases to compile the available evidence about the clinical management of DME in a clinical setting, with a special focus on treatment-naïve patients. Anti-VEGF therapies represent a valuable option for treating DME patients. However, many patients do not respond properly to this treatment and, due to its administration regimen, many patients receive suboptimal treatment in real life. Current evidence demonstrated that in patients with DME, DEX-i improved significantly both anatomic and visual outcomes. Besides eyes with insufficient anti-VEGF respond or recalcitrant DME cases, DEX-i can be effectively and safely used in treatment-naïve DME patients as first line therapy. DEX-i may be considered first line therapy in different clinical scenarios, such as DME eyes with a greater inflammatory component, patients with cardiovascular events, vitrectomized eyes, or those requiring cataract surgery. In conclusion, there are still many points for improvement pending in the clinical management of the patient with DME. Since DME treatment must follow a patient-tailored approach, selecting the best therapeutic approach for each patient requires a good understanding of the pathophysiology of DME.

Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature.

Although topical medical therapy and selective-laser-trabeculoplasty represent the treatments of choice to reduce intraocular pressure, many patients do not achieve adequate glaucoma control; therefore, they require further options and eventually surgery. Trabeculectomy is still considered the gold standard, but the surgical management of glaucoma has undergone continuous advances in recent years, XEN-gel-stent has been introduced as a safer and less traumatic means of lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG). This study aimed to review the effectiveness and safety of clinical data on XEN-stent in OAG patients with a Synthesis-Without-Meta-analysis (SWiM) methodology. A total of 339 studies were identified following a literature search adhering to PRISMA guidelines and, after evaluation, 96 studies are discussed. XEN63 and XEN45 device data were collected both short and long term. In addition, this document has evaluated different aspects related to the XEN implant, including: its role compared to trabeculectomy; the impact of mitomycin-C dose on clinical outcomes; postoperative management of the device; and the identification of potential factors that might predict its clinical outcomes. Finally, current challenges and future perspectives of XEN stent, such as its use in fragile or high myopia patients, were discussed.

Real-World Analysis on the Characteristics, Therapeutic Paths and Economic Burden for Patients Treated for Glaucoma in Italy.

This real-world analysis was performed on administrative databases to evaluate characteristics, therapies, and related economic burden of glaucoma in Italy. Adults with at least 1 prescription for ophthalmic drops (ATC class S01E: antiglaucoma preparations, miotics) during data availability period (January 2010-June 2021) were screened, then patients with glaucoma were included. First date of ophthalmic drops prescription was the index date. Included patients had at least 12 months of data availability before index-date and afterwards. Overall, 18,161 glaucoma-treated patients were identified. The most frequent comorbidities were hypertension (60.2%), dyslipidemia (29.7%) and diabetes (17%). During available period, 70% (N = 12,754) had a second-line therapy and 57% (N = 10,394) a third-line therapy, predominantly ophthalmic drugs. As first-line, besides 96.3% patients with ophthalmic drops, a small proportion reported trabeculectomy (3.5%) or trabeculoplasty (0.4%). Adherence to ophthalmic drops was found in 58.3% patients and therapy persistence reached 78.1%. Mean total annual cost per patient was €1,725, mostly due to all-cause drug expenditure (€800), all-cause hospitalizations (€567) and outpatient services (€359). In conclusion, glaucoma-treated patients were mostly in monotherapy ophthalmic medications, with an unsatisfying adherence and persistence (<80%). Drug expenditures were the weightiest item among healthcare costs. These real-life data suggest that further efforts are needed to optimize glaucoma management.

Tenofovir-induced renal toxicity in 324 HIV-infected, antiretroviral-naïve patients.

To better evaluate the renal safety profile of tenofovir, we performed a retrospective study of HIV-infected antiretroviral-naïve patients starting a first antiretroviral therapy between July 2004 and July 2008, and followed-up for 24 months. The glomerular filtration rate (GFR) was calculated using the MDRD formula, and tubular dysfunction was diagnosed with 2 or more of the following: proteinuria, glucosuria, hypouricemia, hypophosphatemia and hypokalemia. Overall, 324 patients were enrolled: 201 were tenofovir-exposed and were compared with 123 tenofovir-unexposed subjects. In both the unadjusted and adjusted analyses, tenofovir-exposed subjects had a significantly greater decline in GFR and a significantly higher incidence of proximal tubular dysfunction through 24 months. Reduced glomerular and tubular functions were significantly associated with older age, diabetes, hypertension and concomitant therapy with a protease inhibitor.

Assessing the impact of hepatitis C virus coinfection on lopinavir/ritonavir trough concentrations in HIV-infected patients.

PURPOSE: Chronic hepatitis C is an emerging issue in the management of human immunodeficiency virus (HIV) disease because both diseases have the same route of transmission, leading to a very high prevalence of hepatitis C virus (HCV)-coinfection in the HIV-positive patient population. Lopinavir is extensively metabolized by the hepatic cytochrome P450 3A4, and the pharmacokinetics of this protease inhibitor (PI) could be influenced by liver impairment. However, data currently available on the impact of HCV-coinfection on lopinavir plasma concentrations are both limited and conflicting. METHODS: This was an observational, open-label study in which adult HIV-infected outpatients on stable antiretroviral treatment that included two nucleoside reverse transcriptase inhibitors (NRTIs) plus lopinavir/ritonavir for at least 4 weeks were asked to participate. The trough plasma concentration (C (trough)) of lopinavir and ritonavir was assessed at steady state by a validated high-performance liquid chromatography-tandem mass spectrometry method. RESULTS: A total of 65 HIV-positive patients were enrolled in the study. These patients were stratified into two groups based on the absence/presence of HCV-coinfection: 45 were monoinfected (HIV+/HCV-) and 20 were coinfected (HIV+/HCV+). The lopinavir C (trough) in plasma was comparable between HIV+/HCV+ and HIV+/HCV- patients, without any statistically significant difference (geometric mean ratio 0.89, 95% confidence interval 0.61-1.42; p = 0.581). The mean ritonavir C (trough) was also comparable in the two groups. Almost all samples were found to be within the therapeutic plasma level range (97% in HIV+/HCV- group and 100% in HIV+/HCV+ group). No correlation was found between lopinavir plasma levels and adverse events (such as diarrhoea and hypertriglyceridaemia) or immune-virological parameters of HIV disease. CONCLUSIONS: Among the HIV-positive patients participating in this study, the pharmacokinetics of lopinavir/ritonavir did not significantly change in those HIV-positive patients coinfected with HCV and in the absence of liver cirrhosis.

Amiodarone-related pneumonitis and peripheral neuropathy in an elderly patient.

Amiodarone, which has been used since 1967 as an antiarrhythmic drug, gives rise to a variety of cardiac and extracardiac adverse side-effects. Among these, pulmonary toxicity is considered the most frequent and serious extracardiac side-effect, since it may occur in various atypical forms and often limits the drug's clinical use. We encountered a 67-year-old white male patient with suspected amiodarone pneumonitis characterized by multiple lung nodules associated with pleural and pericardial effusion and peripheral neuropathy. Because differential diagnosis with pulmonary infectious diseases may be extremely difficult, the attending physician should therefore bear in mind the possibility of amiodarone pneumonitis whenever the drug is given.

Tubercular disease caused by Bacillus of Calmette-Guérin as a local adjuvant treatment of relapsing bladder carcinoma.

Two (2) exemplary case reports of respiratory granulomatous infection caused by Bacillus of Calmette-Guérin (BCG), in patients who were repeatedly treated with local, intravesical adjuvant BCG therapy for a relapsing transitional bladder carcinoma, are outlined and discussed on the grounds of the cumbersome diagnostic and differential diagnostic process (especially when a prior tuberculosis and a concurrent chronic obstructive pulmonary disease are of concern), along with an updated literature revision. Only 4 cases of respiratory BCG-itis (pulmonary tuberculosis-like forms) have been reported, to date, to the best of our knowledge (2 of them following the bladder instillation of BCG). One (1) episode of ours represents the first described case with a dual, concomitant granulomatous localization of BCG-itis, also involving the genitourinary tract.

Tubercular disease caused by bacillus of Calmette-Guerin administered as a local adjuvant treatment of relapsing bladder carcinoma: Pathogenetic, diagnostic and therapeutic issues, and literature review

Two exemplary case reports of respiratory granulomatous infection caused by bacillus of Calmette-Guérin (BCG) in patients who were repeatedly treated with local, intravesical adjuvant BCG therapy for a relapsing transitional bladder carcinoma, are outlined and discussed, on the ground of the cumbersome diagnostic and differential diagnostic process (especially when a prior tuberculosis and a concurrent chronic obstructive pulmonary disease are of concern), and an updated literature revision. Only four cases of respiratory BCG-itis (pulmonary tuberculosis-like forms), have been reported until now to the best of our knowledge (two of them following bladder instillation of BCG). One episode of ours represents the first described case with a dual, concomitant granulomatous localization of BCG-itis, also involving the genitourinary tract