Effects of add-on ultramicronized n-palmitol ethanol amide in patients suffering of migraine with aura. a pilot study

Background: Palmitoyl ethanol amide (PEA) is an endogenously produced substance showing anti-nociceptive effect through both receptor and non-receptor mediated effects at the level of different cellular and tissue sites. This study showed the results of a single blind study that was conducted to evaluate both the safety and the efficacy of ultramicronized PEA (umPEA; 1,200 mg/day) for up 90 days in patients suffering of Migraine with Aura (MA) treated with NSAIDs. Methods: A total of 20 patients, 8 male (33-56-years, average 41.4 ± 7.8) and 12 female (19-61-years, average 38.5 ± 11.9) with MA were admitted to our observation and diagnosed according to ICHD-3 criteria, they received umPEA (1,200 mg/day) in combination with NSAIDs for up to 90 days. They were revaluated at 30, 60, and 90 days after treatment. Results: umPEA administration induced a statistically significant and time dependent pain relief. In particular, these effects were evident at 60 days (male P = 0.01189; female P = < 0.01) and they lasted until the end of the study (male P = 0.0066; female P = 0.01473). Conclusion: Although further studies are needed, our findings indicate that in patients suffering of MA treatment with umPEA had good efficacy and safety which candidate this compound as a therapeutic tool in pain migraine management

An Expert Opinion on the Role of the Rosuvastatin/Amlodipine Single Pill Fixed Dose Combination in Cardiovascular Prevention

Current cardiovascular disease prevention strategies are based on the management of cardiovascular risk as a continuum, redefining the therapeutic goals for each individual based on the estimated global risk profile. Given the frequent clustering of the principal cardiovascular risk factors, such as hypertension, diabetes and dyslipidaemia, in the same individual, patients are required to take multiple drugs to achieve therapeutic targets. The adoption of single pill fixed dose combinations may contribute to achieve better control of blood pressure and cholesterol compared to the separate administration of the individual drugs, mostly due to better adherence related to therapeutic simplicities. This paper reports the outcomes of an Expert multidisciplinary Roundtable. In particular, the rational and potential clinical use of the single pill fixed dose combination "Rosuvastatin-Amlodipine" for the management of concomitant hypertension/hypercholesterolemia in different clinical fields are discussed. This Expert Opinion also illustrates the importance of an early and effective management of total cardiovascular risk, highlights the substantial benefits of combining blood pressure and lipid-lowering treatments in a single-pill fixed dose combination and attempts to identify and overcome the barriers to the implementation in clinical practice of the fixed dose combinations with dual targets. This Expert Panel identifies and proposes the categories of patients who may benefit the most from this fixed dose combination

Long-term outcome of renal transplantation in adults with focal segmental glomerulosclerosis

P>Little information is available about the long-term results of kidney transplantation in adults with focal segmental glomerulosclerosis (FSGS). The outcomes of 52 renal transplants performed between 1988 and 2008 in 47 adults with FSGS were compared with those of 104 matched controls (median follow-up 93.4 vs. 109.4 months respectively). At 15 years, patient survival was 100% and graft survival 56% in FSGS patients vs. 88.3% and 64% respectively in controls (P = NS). FSGS recurred in 12 out of 52 grafts (23%) and led to graft failure in seven within 10 months (median). In the other five cases, proteinuria remitted and grafts are functioning 106 months (median) after transplantation. A second recurrence developed in five out of eight re-transplanted patients (62.5%) who lost their first graft because of recurrence; only one graft was lost. Patients with recurrence were more frequently male subjects (83% vs. 40%, P = 0.02), younger at diagnosis of FSGS (16.3 +/- 6.8 vs. 24.1 +/- 11.5 years, P = 0.03) and of younger age at transplantation (28.4 +/- 7.8 vs. 35.8 +/- 12.2 years, P = 0.05). Treatment with plasmapheresis plus ACE inhibitors achieved either complete or partial remission in 80% of the cases. Long-term patient and renal allograft survivals of adults with FSGS were comparable to those of controls. Recurrence was more frequent in young patients and in patients who lost a previous graft from recurrence. Graft loss resulting from a second recurrence is lower than expected

Biomarkers in post-reperfusion syndrome after acute lower limb ischaemia

Ischaemia reperfusion (I/R) injury refers to tissue damage caused when blood supply returns to the tissue after a period of ischaemia. Matrix metalloproteinases (MMPs), neutrophil gelatinase-associated lipocalin (NGAL) and cytokines are biomarkers involved in several vascular complications. The aim of this study was to evaluate the role of MMPs, NGAL and inflammatory cytokines in I/R syndrome. We conducted an open label, multicentric, parallel group study, between January 2010 and December 2013. Patients with acute limb ischaemia were enrolled in this study and were divided into two groups: (i) those subjected to fasciotomy and (ii) those not subjected to fasciotomy, according to the onset of compartment syndrome. Plasma and tissue values of MMPs and NGAL as well as plasma cytokines were evaluated. MMPs, NGAL and cytokine levels were higher in patients with compartment syndrome. Biomarkers evaluated in this study may be used in the future as predictors of I/R injury severity and its possible evolution towards post-reperfusion syndrome

The long-term outcome of 93 patients with proliferative lupus nephritis

Background. Few data are available about the very long-term outcome of patients with proliferative lupus nephritis. Methods. Ninety-three Italian patients with biopsy-proven proliferative lupus nephritis (15 with class III, 9 with class III + V, 64 with class IV and 5 with class IV + V) followed for a median follow-up of 15 years in a single renal unit were considered for this observational study. Patients were treated with an induction treatment consisting of high doses of corticosteroids plus immunosuppressive agents in the more severe cases. This treatment was repeated in the event of a renal flare. Then corticosteroids and immunosuppressive agents were reduced to the minimal effective dose for maintenance. Results. Renal survival including death was 97% at 10 years and 82% at 20 years. At the last follow-up visit, 59 patients were in complete renal remission, 18 were in partial renal remission, four patients had chronic renal insufficiency, six had entered end-stage renal disease and six patients had died. At multivariate analysis the lack of achievement of complete renal remission and the occurrence of nephritic flares were significantly correlated both with the risk of doubling plasma creatinine and death or dialysis. Those patients who entered complete renal remission had significantly less probability of developing nephritic flares. Conclusion. The long-term prognosis of Caucasian patients with proliferative lupus nephritis may be better than usually thought. Favorable factors for good long-term outcome are the achievement of complete renal remission, the absence of nephritic flares and their complete reversibility after therapy

Omalizumab decreases exacerbation frequency, oral intake of corticosteroids and peripheral blood eosinophils in atopic patients with uncontrolled asthma.

Omalizumab is a humanized monoclonal anti-IgE antibody approved in 2005 by the European Medicine Agency (EMA) for the treatment of severe persistent allergic asthma, which remains inadequately controlled despite optimal therapy with high doses of inhaled corticosteroids and long-acting β2-adrenergic agonists. Within this context, the present observational study refers to 16 patients currently treated with omalizumab at the Respiratory Unit of "Magna Græcia" University Hospital located in Catanzaro, Italy, whose anti- IgE therapy was started in the period included between March 2007 and February 2010, thus lasting at least 10 months. After 40 weeks of add-on treatment with omalizumab, very relevant decreases were detected, in comparison with pre-treatment mean (± standard deviation) values, in monthly exacerbation numbers (from 1.1 ± 0.6 to 0.2 ± 0.4; p < 0.01) and oral corticosteroid consumption (from 22.6 ± 5.0 to 1.2 ± 2.9 mg/day of prednisone; p < 0.01). These changes were associated with stable improvements in lung function, expressed as increases of both FEV1 (from 53.6 ± 14.6% to 77.0 ± 14.9% of predicted values; p < 0.01) and FEV1/FVC ratio (from 56.3 ± 9.5% to 65.8 ± 9.2%; p < 0.01). Moreover, in 5 patients who persistently had increased numbers of eosinophils (mean ± SD: 15.9 ± 8.0% of total WBC count; absolute number: 1,588.0 ± 956.9/μl) despite a long-lasting therapy with inhaled and systemic corticosteroids, the peripheral counts of these cells decreased down to near normal levels (mean ± SD: 6.3 ± 2.3% of total WBC count; absolute number: 462.0 ± 262.3/μl) after 16 weeks of treatment with omalizumab. Therefore, this descriptive evaluation confirms the efficacy of add-on omalizumab therapy in selected patients with exacerbation-prone, chronic allergic uncontrolled asthma, requiring a continuous intake of oral corticosteroids

Colchicine in managing skin conditions. a systematic review

(1) Background: Colchicine is a natural alkaloid with anti-inflammatory properties used to treat various disorders, including some skin diseases. This paper aims to incorporate all the available studies proposing colchicine as a treatment alternative in the management of cutaneous conditions. (2) Methods: In this systematic review, the available articles present in various databases (PubMed, Scopus-Embase, and Web of Science), proposing colchicine as a treatment for cutaneous pathological conditions, have been selected. Exclusion criteria included a non-English language and non-human studies. (3) Results: Ninety-six studies were included. Most of them were case reports and case series studies describing colchicine as single therapy, or in combination with other drugs. Hidradenitis suppurativa, pyoderma gangrenosum, erythema nodosum, erythema induratum, storage diseases, perforating dermatosis, bullous diseases, psoriasis, vasculitis, acne, urticaria, stomatitis, actinic keratosis, and pustular dermatosis were the main diseases discussed in literature. Although the therapeutic outcomes were variable, most of the studies reported, on average, good clinical results (4) Conclusions: Colchicine could be, as a single therapy or in combination with other drugs, a possible treatment to manage several skin diseases

Long-term outcome of renal transplantation in patients with idiopathic membranous glomerulonephritis (MN)

Methods. The outcomes of 35 first renal transplants performed between 1975 and 2008 in patients with MN were compared with those of 70 controls transplanted in the same period and matched for sex, age and source of donors. Results. The mean post-transplant follow-up was 117 +/- 86 months for MN patients and 123 +/- 83 months for controls. At 15 years, patient survival was 96% in patients with MN and 88% in the controls (P = ns), while graft survival rates were respectively 40% and 69% (P = 0.06). MN recurred in 12 patients (34%), namely in 4/8 (50%) patients who received the kidney from related living donors and in 8/27 (29.6%) who received the kidney from a deceased donor. Recurrence led to graft failure in six patients, all deceased donor kidney recipients, within 54 +/- 33 months. The other six grafts are functioning 134 +/- 73 months after transplantation. Patients with recurrence were more frequently females (42% vs 4.3%, P = 0.02). The recurrence occurred earlier (4.8 +/- 3.0 vs 45.6 +/- 46.9 months, P = 0.05), and there was a trend to develop a higher proteinuria (7.1 +/- 5.5 vs 3.67 +/- 2.6 g/24 h, P = 0.1) in grafts eventually lost because of recurrence. Conclusions. The long-term patient survival was similar in renal transplant recipients with MN and in controls. The graft survival was lower in MN patients than in controls, although the difference was at borderline significance. Recurrence occurred in one-third of the patients and caused graft loss in half of them

Renal transplantation in adults with Henoch-Schonlein purpura: long-term outcome

Background. Little information is available about the long-term outcome of renal transplantation in adults with Henoch-Schonlein purpura (HSP). Methods. We compared the outcomes of 17 patients with HSP who received 19 renal transplants with those of 38 controls matched for time of transplantation, age, gender and source of donor. The mean post-transplant follow-up was 109 +/- 99 months for HSP patients and 110 +/- 78 months for controls. Results. The actuarial 15-year patient Survival was 80% in HSP patients and 82% in controls, and the death-censored graft survival was 64% in FISP patients and in controls. The risks of acute rejection, chronic graft dysfunction, arterial hypertension and infection were not different between the two groups. In eight grafts (42%) recurrence of HSP nephritis was found (0.05/patient/year). In spite of therapy, one patient died and four eventually restarted dialysis respectively 10, 32, 35 and 143 months after renal transplant. Seventy-one percent of grafts transplanted in patients with necrotizing/crescentic glomerulonephritis of the native kidney had HSP recurrence in comparison to 12% of recurrences in patients with mesangial nephritis (P = 0.05) Conclusions. Long-term patient and allograft survival of HSP patients was good. However, 42% of HSP patients, particularly those with necrotizing/crescentic glomerulonephritis of the native kidneys, developed a recurrence of HSP nephritis that eventually caused the loss of the graft function in half of them

Drug–drug interactions in vestibular diseases, clinical problems, and medico-legal implications

Peripheral vestibular disease can be treated with several approaches (e.g., maneuvers, surgery, or medical approach). Comorbidity is common in elderly patients, so polytherapy is used, but it can generate the development of drug–drug interactions (DDIs) that play a role in both adverse drug reactions and reduced adherence. For this reason, they need a complex kind of approach, considering all their individual characteristics. Physicians must be able to prescribe and deprescribe drugs based on a solid knowledge of pharmacokinetics, pharmacodynamics, and clinical indications. Moreover, full information is required to reach a real therapeutic alliance, to improve the safety of care and reduce possible malpractice claims related to drug–drug interactions. In this review, using PubMed, Embase, and Cochrane library, we searched articles published until 30 August 2021, and described both pharmacokinetic and pharmacodynamic DDIs in patients with vestibular disorders, focusing the interest on their clinical implications and on risk management strategies