Publications by authors named "Giorgio Gentile"

81 Publications

The evolution in the surgical management of Peyronie's disease.

Urologia 2021 May 30;88(2):79-89. Epub 2021 Mar 30.

Department of Urology, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.

Peyronie's disease (PD) is due to a fibrotic alteration of the tunica albuginea of the penis. It is responsible of penile pain, angulation, and possible erectile dysfunction (ED). Despite almost three centuries have passed since the first description of the disease, etiology still remains uncertain. This fact has led to the lack of a truly effective medical therapy and to date the surgical treatment, although not yet standardized, is the only one that offers acceptable outcomes in terms of function and overall patient's satisfaction. Since the beginning of the surgical experience in this field, two different currents of thought have developed: the first, involved the proposal of a number of different plication techniques, applied on the healthy side of the penis, opposite to the sick side, with the sole purpose of correcting the curvature; on the other side, efforts have focused on treating the "focus" of the disease, thus developing the so called "plaque surgery." If with the passing of the decades neither of the two "philosophical" currents has prevailed, this probably depends on the fact that is still not clear which is the lesser of evils: the frequent onset of ED which may follows the plaque surgery or rather the penis shortening that inevitably occurs if any technique of plication has been applied. Our contribution aims to offer an historical retrospective of the surgical treatment of this disease as well as to discuss the latest international guidelines on this topic. The reader will also find some notes about our personal experience in this field.
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http://dx.doi.org/10.1177/03915603211005326DOI Listing
May 2021

Physical, Mental and Sexual Health Among Transgender Women. A comparative Study Among Operated Transgender and Cisgender Women in a National Tertiary Referral Network.

J Sex Med 2021 Mar 23. Epub 2021 Mar 23.

Urology Clinic, Department of Medical, Surgical and Health Science, University of Trieste, Trieste, Italy.

Background: Few studies have investigated how physical, mental and sexual function are associated with each other in operated transgender women (oTW).

Aim: To provide information on the physical, mental and sexual health of oTW in comparison with a group of cisgender women (cisW).

Methods: An age-matched control study was carried out, recruiting 125 oTW in 7 national referral centers and 80 volunteer women. Beck Depression Inventory Primary Care (BDI-PC), General Health Survey (SF-36), Female Sexual Function Index (FSFI) and operated Male to Female Sexual Function Index (oMtFSI) questionnaires were web-based administered. Data included: age, area of origin, educational level, sexual orientation, years since surgery and hormone therapy.

Outcomes: T-test was applied to inspect mean score differences between oTW and cisW, in mental, sexual and physical health; simple correlations and multiple regression analysis revealed how mental, sexual and physical health were concurrently associated in the two groups RESULTS: Response rate 60% (52% oTW, 71% cisW). oTW mean age 38.5 years (SD = 9.3), cisW 37.7 years (SD = 11.5). Both cisW and oTW reported average values in the range of mental, physical and sexual health. Statistical comparisons revealed no significant group differences in mental and physical health. oTW who referred a worse sexual function also reported worse overall mental well-being and higher levels of depressive symptoms. FSFI scores were negatively associated with years since surgery, but not with age. Multiple regression analysis showed that FSFI Pain accounted for a significant unique variance proportion of risk of depression in oTW. FSFI Sexual Pain was the strongest estimator of inter-individual differences in BDI-PC among oTW (P < .01).

Clinical Implications: No significant differences in the levels of depressive symptoms, physical and mental well- being were found in oTW and cis-W. The relation between depressive symptoms and sexual function in oTW is stronger than in cisW, and sexual pain substantially predicts risk of depression in oTW.

Strengths & Limitations: The evaluation of outcomes using validated questionnaires and the relatively large sample size. The convenience control group reported mental, physical and sexual health levels within the range of Italian normative data. Since this is a cross-sectional study, we must be careful in drawing conclusions from our results.

Conclusions: Sexual pain and lubrication difficulties are the main causes of worse sexual function in oTW, highlighting the importance of perioperative counseling to make surgical expectations realistic and to educate to a proper neovagina management. Vedovo F, Di Blas L, Aretusi F, et al. Physical, Mental and Sexual Health Among Transgender Women. A comparative Study Among Operated Transgender and Cisgender Women in a National Tertiary Referral Network. J Sex Med Rev 2021;xx:xxx-xxx.
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http://dx.doi.org/10.1016/j.jsxm.2021.02.006DOI Listing
March 2021

Italian experiences in the management of andrological patients at the time of Coronavirus pandemic.

Arch Ital Urol Androl 2021 Mar 22;93(1):111-114. Epub 2021 Mar 22.

Department of Clinical and Specialist Sciences, Division of Urology, Polytechnic University of the Marche Region Medical School, Ancona.

The SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) was first reported in December 2019, then its rapid spread around the world caused a global pandemic in March 2020 recording a high death rate. The epicenter of the victims moved from Asia to Europe and then to the United States. In this Pandemic, the different governance mechanisms adopted by local health regional authorities made the difference in terms of contagiousness and mortality together with a community strong solidarity. This document analyzes the andrological urgencies management in public hospitals and in private practice observed in Italy and in particular in the most affected Italian Regions: Emilia-Romagna and Marche.
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http://dx.doi.org/10.4081/aiua.2021.1.111DOI Listing
March 2021

Successful treatment of severe COVID-19 pneumonia and hyperinflammatory syndrome with tocilizumab.

BMJ Case Rep 2021 Jan 8;14(1). Epub 2021 Jan 8.

Nephrology, Royal Cornwall Hospitals NHS Trust, Truro, UK.

As of 28 October 2020, there are over 44 000 000 confirmed COVID-19 infections and over 1 000 000 deaths worldwide, including 945 367 infections and 45 765 deaths in the UK. Acute respiratory distress syndrome occurs in 50% of patients with secondary haemophagocytic lymphohistiocytosis, a hyperinflammatory syndrome characterised by a surge of cytokines, including interleukin 6 (IL-6). Here we describe the case of the first patient with severe COVID-19 pneumonia successfully treated with tocilizumab, a humanised monoclonal antibody against the IL-6 receptor, in the UK. Early treatment (after 7-10 days from the onset of symptoms) with tocilizumab could (1) reduce the risk of requiring non-invasive or invasive ventilation; (2) offer a chance of survival to people who are not fit for escalation or have refused to be ventilated; and (3) potentially increase the chance of survival in some patients who are already ventilated but fail to improve with supportive treatment.
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http://dx.doi.org/10.1136/bcr-2020-238210DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7798428PMC
January 2021

Percutaneous tumor ablation versus partial nephrectomy for small renal mass: the impact of histologic variant and tumor size.

Minerva Urol Nefrol 2020 Dec 1. Epub 2020 Dec 1.

Department of Urology, Sant' Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.

Background: To investigate recurrence rates in patients with T1 renal cell carcinoma (RCC) undergone partial nephrectomy (PN), radiofrequency ablation (RFA) or cryoablation (Cryo).

Methods: We retrospectively evaluated data from 665 (81.4%), 68 (8.3%) and 83 (10.3%) patients who underwent PN, RFA and Cryo, respectively. Kaplan-Meier curves depict recurrence-free survival (RFS) rates in the overall population and after stratifying according to tumor's histology (namely, clear cell RCC and non-clear RCC) and size (namely < 2 cm and 2-4 cm). Multivariable Cox regression model was used to identify predictors of recurrence. Cumulative-incidence plots evaluated disease recurrence and other causes of mortality (OCM).

Results: Patients referred to PN experienced higher RFS rate compared to those treated with RFA and Cryo at 60-month in the overall population (96.4% vs. 79.4 % vs. 87.8%), in patients with clear cell RCC (93.3% vs 75% vs. 80.4%) and in those with tumor of 2-4 cm (97.3% vs 78% and 84.4%; all p≤0.01). In patients with non-clear cell RCC and with tumor <2cm, PN showed higher RFS rate at 60-month as compared to RFA (97.9% vs 84.4% and 95.1% vs 78.1%, respectively; all p≤0.02). At multi-variate analysis, ablative techniques (RFA [HR=4.03] and Cryo [HR=3.86]) were independent predictors of recurrence (all p<0.03). At competing risks analysis, recurrence rate and OCM were 7.3% and 1.3% vs 25% and 7.2% vs 19.9% and 19.9% for PN, RFA and Cryo, respectively.

Conclusions: PN and Cryo showed similar RFS rates in patients with non-clear cell RCC and with renal mass < 2cm.
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http://dx.doi.org/10.23736/S0393-2249.20.03983-1DOI Listing
December 2020

Penile-scrotal flap vaginoplasty versus inverted penile skin flap expanded with spatulated urethra: A multidisciplinary single-centre analysis.

Arch Ital Urol Androl 2020 Oct 1;92(3). Epub 2020 Oct 1.

Andrology Unit, University Hospital S.Orsola-Malpighi, Bologna.

This study is aimed to compare outcomes of penile-scrotal flap vaginoplasty to inverted penile skin flap expanded with spatulated urethra as a singlecentre experience. Data regarding vaginoplasty performed between May 2003 and January 2014 were reviewed. Subjects were divided into two groups according to the surgical technique performed: perineal- scrotal flap vaginoplasty (Group A), and inverted penile skin flap expanded with spatulated urethra vaginoplasty (Group B). All patients underwent to psychological analysis before surgery. Functional follow-up was based on a modified validated Female Sexual Function Index. Overall, 67 patients with a mean (SD) age of 34 (±9.38) years underwent to surgery. 41 patients were included into the Group A and 26 into the Group B. Mean operative time among Groups A and B was 316 (±101.65) and 594 (±89.06) minutes, respectively (p<0.0001). Longer postoperative hospitalization was shown in Group B (14 days ± 4,51) than in Group A (10 days ± 2,49); (p<0.0001). Group B patients showed a higher anemization rate requiring blood transfusion (p=0.00014) as well as compressive neuropathy (p=0.038). In addition to this, necrosis of the skin flap was reported in 8 patients of Group B (p<0.0001). Comprehensive functional follow-up data was included; spontaneous vaginal lubrication was not reported in 82.4% of Group A vs 12.5% cases of Group B (p=0.0085). When compared to penile-scrotal flap vaginoplasty, inverted penile skin flap expanded with spatulated urethra technique shows an increased risk of complications with comparable satisfaction rates whereas a higher spontaneous vaginal lubrication is reported. Sexological support is of utmost importance in this setting.
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http://dx.doi.org/10.4081/aiua.2020.3.186DOI Listing
October 2020

Long-term outcomes after plaque incision and grafting for Peyronie's disease: comparison of porcine dermal and bovine pericardium grafts.

Andrology 2021 01 11;9(1):269-276. Epub 2020 Oct 11.

Department of Andrology, S.Orsola University Hospital, Bologna, Italy.

Background: Plaque incision and grafting (PEG) is one of the mainstays in surgical therapy for severe penile curvature in Peyronie's disease (PD). Different kinds of grafts are available for covering albugineal defects during PEG, both allografts and xenografts. However, to date, none of these proved superior to others.

Objectives: To compare two different types of xenograft, porcine dermal matrix and bovine pericardium matrix in PEG for PD.

Materials And Methods: From 2010 to 2019, 63 patients with PD underwent PEG, using porcine dermal (n = 25; Group 1) and bovine pericardium (n = 38; Group 2) grafts. Long-term outcomes were evaluated through multi-disciplinary questionnaires administration by phone interview. The following items were considered: correction of penile bending, quality of erection, intercourse ability, penile shortening, and sensitiveness. Overall satisfaction and impact of surgery on sexual activity and quality of life were also investigated.

Results: Plaque median (IQR) size was 29 (22-33) mm and was smaller in Group 1 (27.5 vs. 31 mm; P = .03). Complete follow-up data were available for 53 patients (84%). Considering post-operative outcomes, no differences were found when considering ED rates, penile shortening, sensitiveness, complications, and penile straightening (all P > .1). Patients in Group 2 were more likely to have palpable penile nodules at follow-up (20.6 vs. 0%; P = .03). However, patient's post-operative sexual life satisfaction was consistent between the two groups, with just 1 (5.3) and 8 (23.5) patients in Group 1 and 2 respectively referring a worsening in sexual life satisfaction (P = 0.2). At follow-up, 84.9% of patients that would still undergo surgery for PD, with no statistical difference between the two groups (P = .4).

Conclusions: Corporoplasty with PEG is an effective treatment for men with PD. Porcine dermal and bovine pericardium xenografts seem to have similar long-term outcomes.
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http://dx.doi.org/10.1111/andr.12912DOI Listing
January 2021

High-flow priapism after T-shunt and tunneling in a patient with ischemic priapism.

Turk J Urol 2020 Nov 21;46(6):488-491. Epub 2020 Sep 21.

Andrology Unit, PoliclinicoS.Orsola-University Hospital,Bologna, Italy.

Priapism is defined as an erection lasting for more than 4 hours without sexual stimulation. It is grouped into 3 subtypes: ischemic (low-flow), nonischemic (high-flow), and stuttering priapism. Herein we describe a rare event of high-flow state as a result of conversion from a delayed ischemic priapism after a T-shunt with tunneling. To our knowledge, there is a paucity of reported cases, and the pathophysiology is still unclear. Clinicians should be aware of this uncommon but known scenario in case of penile tumescence after shunting procedure for ischemic priapism; penile Doppler ultrasound and selective pudendal angiography represent essential tools for diagnosis and treatment of this rare condition. In delayed ischemic priapism persisting for >36 hours, patients should be counseled about the irreversible damages of the cavernosal muscle and erectile dysfunction to consider an early penile prosthesis implantation with a satisfactory long-term functionaloutcome, decreasing the risks related to a distal shunt procedure.
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http://dx.doi.org/10.5152/tud.2020.20144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7608539PMC
November 2020

Performance of creatinine- and cystatin C-based formulas to estimate glomerular filtration rate.

Eur J Intern Med 2020 10 13;80:16-17. Epub 2020 Aug 13.

Department of Medicine, University of Perugia, Perugia, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.ejim.2020.08.011DOI Listing
October 2020

Rates of hypogonadism forms in Klinefelter patients undergoing testicular sperm extraction: A multicenter cross-sectional study.

Andrology 2020 11 3;8(6):1705-1711. Epub 2020 Jul 3.

Division of Experimental Oncology/Unit of Urology, URI; RCCS Ospedale San Raffaele, Milan, Italy.

Introduction And Objectives: Adult patients with Klinefelter syndrome (KS) may present with testicular volume loss and a decrease in circulating testosterone (T) levels. However, the actual rate of hypogonadism in adult KS men is unknown. We aimed to (a) assess the prevalence of different forms of hypogonadism in a cohort of KS patients with non-obstructive azoospermia (NOA); and (b) investigate potential preoperative predictor of positive sperm retrieval (SR) at surgery in the same cohort of men.

Methods: Complete data from 103 KS men with NOA who underwent testicular sperm extraction (TESE) between 2008 and 2019 at five centers were analyzed. Comorbidities were scored with the Charlson Comorbidity Index (CCI). Patients were categorized into four groups of hypogonadism as follows: eugonadism [normal total T (tT) (≥3.03 ng/mL) and normal luteinizing hormone (LH) (≤9.4 mUI/mL)], secondary hypogonadism [low tT (≤3.03 ng/mL) and low/normal LH (≤9.4 mUI/mL)], primary hypogonadism [low tT (≤3.03 ng/mL) and elevated LH (≥9.4 mUI/mL)], and compensated hypogonadism [normal tT (≥3.03 ng/mL) and elevated LH (≥9.4 mUI/mL)]. Descriptive statistics tested the association between clinical characteristics and laboratory values among the four groups.

Results: Median (IQR) patients age was 32 (24, 37) years. Baseline follicle-stimulating hormone and tT levels were 29.5 (19.9, 40.9) mUI/mL and 3.8 (2.5, 11.0) ng/mL, respectively. Eugonadism, primary hypogonadism, and compensated hypogonadism were found in 16 (15.6%), 34 (33.0%), and 53 (51.4%) men, respectively. No patients had secondary hypogonadism. Positive SR rate at TESE was 21.4% (22 patients); of 22, 15 (68.2%) patients underwent assisted reproductive technology and five (22.7%) ended in live birth children. Patients' age, BMI, CCI, FSH levels, and positive SR rates were comparable among hypogonadism groups. No preoperative parameters were associated with positive SR at logistic regressions analysis.

Conclusions: Findings from this cross-sectional study showed that 15.6% of adult KS men have normal tT values at presentation in the real-life setting. Most KS patients presented with either compensated or primary hypogonadism. Sperm retrieval rates were not associated with different forms of hypogonadism.
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http://dx.doi.org/10.1111/andr.12843DOI Listing
November 2020

Operated Male-to-Female Sexual Function Index: Validity of the First Questionnaire Developed to Assess Sexual Function after Male-to-Female Gender Affirming Surgery.

J Urol 2020 07 31;204(1):115-120. Epub 2020 Jan 31.

Department of Urology, ASUITS, Trieste, Italy.

Purpose: No questionnaire is currently available to evaluate sexual function after male-to-female gender affirming surgery. Such a limit leads to a suboptimal evaluation in postoperative sexual function in these patients. We developed and validated a new questionnaire, the oMtFSFI (operated Male-to-Female Sexual Function Index), for assessing sexual function in male-to-female patients after surgery.

Materials And Methods: A panel of experts in gender dysphoria defined the main content areas to be assessed, including genital self-image, desire, arousal, lubrication, orgasm, satisfaction and sexual pain. After a pretest on 10 patients the oMtFSFI was applied in the main study to 65 operated male-to-female patients, recruited at 7 Italian centers, and 57 women. The participants provided self-ratings on online oMtFSFI, Female Sexual Function Index, Beck Depression Inventory for Primary Care and Short Form Health Survey questionnaires. Operated male-to-female patients completed the oMtFSFI twice, 4 weeks apart.

Results: Principal component analysis performed on self-ratings provided by operated male-to-female patients on oMtFSFI items yielded a 3-domain structure of sexual dissatisfaction, sexual pain and genital self-image. The 3 domains were internally consistent and test-retest reliable. Convergent associations with Female Sexual Function Index scales emerged for sexual dissatisfaction and sexual pain but not for genital self-image. Male-to-female patients reported lower sexual function levels than cisgender women.

Conclusions: The present preliminary results support reliability and psychometric validity of the oMtFSFI in the assessment of key sexual function domains in transgender women, further revealing that genital self-image represents an assessment area to be considered in male-to-female patients, in addition to domains that are salient for cis women as well.
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http://dx.doi.org/10.1097/JU.0000000000000791DOI Listing
July 2020

Sperm retrieval rates in non-mosaic Klinefelter patients undergoing testicular sperm extraction: What expectations do we have in the real-life setting?

Andrology 2020 05 16;8(3):680-687. Epub 2020 Feb 16.

Department of Urology, Foundation IRCCS Ca' Granda - Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.

Background: A recent meta-analysis (Human Reproduction Update 23, 2017 and 265) reported positive sperm retrieval rates (SRR) in 50% of patients with Klinefelter syndrome (KS) undergoing testicular sperm extraction (TESE). However, these results do not reflect the rates of SR that we observe in clinical practice. We assessed the rate and potential predictors of SR in Klinefelter patients in the real-life setting.

Materials And Methods: We reviewed clinical data of 103 KS men who underwent TESE between 08/2008 and 03/2019 at five tertiary referral Andrology centers. Patients underwent testis ultrasound, hormonal evaluation, and genetic testing. All patients were azoospermic based on the 2010 WHO reference criteria. Conventional TESE (cTESE) or microsurgical TESE (mTESE) was performed based on the surgeon's preference. We used descriptive statistics and logistic regression models to describe the whole cohort.

Results: Median (IQR) patient's age was 32 (24-37) years. Baseline serum FSH and total testosterone levels were 29.5 (19.9-40.9) mUI/mL and 3.8 (2.5-11.0) ng/mL, respectively. Conventional TESE and mTESE were performed in 38 (36.5%) and 65 (63.5%) men, respectively. The sperm retrieval rate was 21.4% (22/103 men). Fifteen patients used spermatozoa for ICSI and five ended in live birth children. Patients with positive SR were similar to those with a negative TESE in terms of clinical, hormonal, and procedural parameters (all P > .05). Logistic regression analyses confirmed the lack of association between clinical, hormonal, and procedural parameters with SR outcome.

Discussion: Given the conflicting results in the literature regarding SRR in KS, patients should be carefully counseled regarding TESE outcomes based on data from published literature and local results.

Conclusions: In the real-life setting, we observed a lower SRR (21.4%) than that reported in meta-analyses in our cohort of KS patients. No associations between clinical, hormonal, and procedural variables with TESE success were found.
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http://dx.doi.org/10.1111/andr.12767DOI Listing
May 2020

Testis Sparing Surgery of Small Testicular Masses: Retrospective Analysis of a Multicenter Cohort.

J Urol 2020 04 3;203(4):760-766. Epub 2019 Oct 3.

Sapienza University of Rome, Rome, Italy.

Purpose: We evaluated possible factors predicting testicular cancer in patients undergoing testis sparing surgery.

Materials And Methods: We retrospectively analyzed the records of all patients who underwent testis sparing surgery for a small testicular mass at a total of 5 centers. All patients with 1 solitary lesion 2 cm or less on preoperative ultrasound were enrolled in the study. Testis sparing surgery consisted of tumor enucleation for frozen section examination. Immediate radical orchiectomy was performed in all cases of malignancy at frozen section examination but otherwise the testes were spared. Univariate and multivariate analysis were performed and ROC curves were produced to evaluate preoperative factors predicting testicular cancer.

Results: Overall 147 patients were included in the study. No patient had elevated serum tumor markers. Overall 21 of the 147 men (14%) presented with testicular cancer. On multivariate analysis the preoperative ultrasound diameter of the lesion was a predictor of malignancy (OR 6.62, 95% CI 2.26-19.39, p=0.01). On ROC analysis lesion diameter had an AUC of 0.75 (95% CI 0.63-0.86, p=0.01) to predict testicular cancer. At the best cutoff of 0.85 the diameter of the lesion had 81% sensitivity, 58% specificity, 24% positive predictive value and 95% negative predictive value.

Conclusions: Our study confirms that small testicular masses are often benign and do not always require radical orchiectomy. Preoperative ultrasound can assess lesion size and the smaller the nodule, the less likely that it is malignant. Therefore, we suggest a stepwise approach to small testicular masses, including tumorectomy, frozen section examination and radical orchiectomy or testis sparing surgery according to frozen section examination results.
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http://dx.doi.org/10.1097/JU.0000000000000579DOI Listing
April 2020

Pregabalin-induced urticarial rash and neutropenia in a renal transplant recipient: a case report.

BMC Nephrol 2019 06 6;20(1):207. Epub 2019 Jun 6.

Department of Nephrology, Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, UK.

Background: Pregabalin is a medication used to treat epilepsy, neuropathic pain and generalised anxiety disorder. The most common side effects of pregabalin include dizziness, drowsiness, weight gain, ataxia and diplopia. On the other hand, neutropenia and rash are rare side effects of pregabalin, and at the time of writing, there are only two documented cases of neutropenia and one of rash in the literature, none of which involved renal transplant recipients.

Case Presentation: We present a 37-year-old renal transplant recipient who was admitted with lethargy, sore throat, urticarial rash and neutropenia after recently being commenced on pregabalin. On physical examination, he had erythematous urticarial rash near his renal transplant scar, on his right elbow, left knee and left wrist. Bacterial/viral serology and immunology were all negative. A blood film confirmed neutropenia and revealed reactive lymphocytes and neutrophil left shift, and those features were compatible with drug reaction. After cessation of the pregabalin, the neutropenia resolved. No other causes of neutropenia or urticarial rash were identified.

Conclusion: To the best of our knowledge, we have described the first case of concomitant pregabalin-induced neutropenia and urticarial rash in a kidney transplant patient. This case report highlights the importance of close monitoring when starting any new medications, particularly in the immunosuppressed population, and is relevant because of the growing usage of pregabalin for treating neuropathic pain in such patients and the risk that a missed pregabalin-related neutropenia could lead to unnecessary modifications of the immunosuppressive treatment.
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http://dx.doi.org/10.1186/s12882-019-1401-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6554987PMC
June 2019

European and US guidelines for arterial hypertension: similarities and differences.

Eur J Intern Med 2019 05 4;63:3-8. Epub 2019 Feb 4.

Fondazione Umbra Cuore e Ipertensione-ONLUS and Division of Cardiology, Hospital S. Maria della Misericordia, Perugia, Italy.

Hypertension is one of the most common chronic diseases in adults and a leading cause of disability and mortality worldwide. Recently, new Guidelines for the diagnosis and management of hypertension have been released in Europe and in the United States, with changes regarding how to diagnose and treat the condition, and the extent to which intensive blood pressure control should be pursued. Important differences between the Guidelines exist in the classification of blood pressure levels and definition of treatment goals. Diagnosis of hypertension starts at 140/90 mmHg for the European Guidelines, and 130/80 mmHg for the US Guidelines. Besides, the European guidelines introduced the concept of "safety boundaries", consisting of BP thresholds not to be exceeded towards lower levels (120 mmHg for age < 65 years, 130 mmHg for older people) because of the fear of important adverse events associated with overtreatment. Such discrepancies can indeed have an impact on treatment attitudes and outcome incidence. Hence, we appraised facts in favor and against each of these controversial issues. In conclusion we believe that, instead of fixing rigid BP targets and boundaries, modern hypertension management should be aimed to achieve in each patient an optimal balance between intensive BP reduction and treatment safety.
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http://dx.doi.org/10.1016/j.ejim.2019.01.016DOI Listing
May 2019

Management of self-inflicted orchiectomy in psychiatric patient. Case report and non-systematic review of the literature.

Arch Ital Urol Androl 2018 Sep 30;90(3):220-223. Epub 2018 Sep 30.

Department of Urology, Sant'Orsola Hospital - University of Bologna, Bologna.

Introduction: Self-inflicted orchidectomy and auto-castration, also known as "Eshmun complex" is a rare phenomenon. The aim of our study it to present the management of a patient who performed a self orchiectomy and propose a non-systematic review of literature about self-orchiectomy.

Material And Method: A 27-years old male Patient with psychiatric disorder was admitted to our ward to have been cutted his scrotum with scissors and cut away his left testicle causing active bleeding from the left spermatic artery. The patient underwent emergency surgery with clamping of the spermatic cord and hemostasis of the wound.

Results: After surgery the clinical condition of the patient remained good during whole hospitalization. Urgent psychiatric evaluation was performed in order to administer proper therapy for acute management. To best of our knowledge, only 11 cases of self-orchidectomy are reported in literature and all of them except 1 case, underwent surgical exploration.

Conclusions: Self-orchidectomy is an extremely rare phenomenon, often associated with psychiatric disorders, compounded by the use of drugs. In our opinion, emergency surgery should be the first choice of treatment, offering diagnostic and hemostatic purpose in a single act, aimed to prevent acute and postacute complications.
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http://dx.doi.org/10.4081/aiua.2018.3.220DOI Listing
September 2018

The 2018 ESC/ESH hypertension guidelines: Should nephrologists always stop at the lower boundary?

J Nephrol 2018 Oct 30;31(5):621-626. Epub 2018 Aug 30.

Fondazione Umbra Cuore e Ipertensione-ONLUS e Struttura Complessa di Cardiologia, Ospedale S. Maria della Misericordia, Perugia, Italy.

In patients with chronic kidney disease (CKD), hypertension is a major challenge because of its high prevalence, the consequent increase in cardiovascular morbidity and mortality, and the risk it confers specifically to the progression of kidney disease. Hence, establishing evidence-based blood pressure targets and treatment strategies is a clinical priority of paramount importance. Over the last few years, different guidelines have advocated different blood pressure treatment thresholds and goals in CKD patients, including a target < 140/90 mmHg and a more intensive target-lower than 130/80 mmHg-in the presence of albuminuria ≥ 300 mg/daily. Aim of this article is to critically appraise the evidence base of the freshly released 2018 ESC/ESH European Guidelines, which recommend to lower systolic BP to a range 130 to < 140 mmHg in patients with diabetic or non-diabetic CKD, also in view of the 2017 US guidelines, which favor a more intensive strategy with a BP target lower than 130/80 mmHg.
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http://dx.doi.org/10.1007/s40620-018-0526-yDOI Listing
October 2018

Role and prognostic value of individual ambulatory blood pressure components in chronic kidney disease.

J Hum Hypertens 2018 09 13;32(8-9):625-632. Epub 2018 Jun 13.

Department of Medicine, University of Perugia, Perugia, Italy.

Hypertension is a key risk factor for chronic kidney disease (CKD), but can also be a detrimental consequence of established CKD. Unsurprisingly, the majority of subjects with abnormal creatinine in the general population are also hypertensive, with a huge toll on national health care systems worldwide due to a staggering increase in the risk of cardiovascular complications and end-stage renal disease requiring renal replacement therapy. In this setting, a comprehensive and careful assessment of the whole 24-h blood pressure (BP) profile could be of paramount importance in ensuring a timely diagnosis of hypertension and an optimal therapeutic control. Hence, ambulatory BP monitoring (ABPM) has the potential to become the preferred method for optimal clinical management of CKD patients. ABPM might better define the relationship between BP, target organ damage (TOD), and clinical outcomes. Current evidence suggests that specific day-night BP components, along with average BP values, may have clinical relevance in such patients, despite the suboptimal statistical power of available studies and inconsistencies on the prognostic value of individual BP components. The main aim of our review is to scrutinize the evidence for the usage of ABPM in CKD patients, including the relationship between ambulatory BP recordings and cardiovascular events, and the distinctive features of ABPM in these subjects.
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http://dx.doi.org/10.1038/s41371-018-0081-yDOI Listing
September 2018

Is Kt/V useful in elderly dialysis patients? Pro and Con arguments.

Nephrol Dial Transplant 2018 05;33(5):742-750

Department of Nephrology "Dr CI Parhon" Hospital, Iasi, Romania.

Current guidelines for dialysis specify a minimum Kt/V. For haemodialysis (HD) patients, minimum treatment time and frequency is also specified. The guidelines allow for modification to take account of renal function. The guidelines are not specifically aimed at the elderly and may not be appropriate for all patients in this group. Increasing age is accompanied by physiological and pathological changes that may modify the patient's response to uraemia and dialysis. Frailty and multi-morbidity are likely, but to a variable extent. Elderly patients could be more susceptible to the effects of uraemia and require a higher dose of dialysis. Conversely, the generation rate of uraemic toxins is lower in elderly patients, potentially reducing the need for dialysis. In the elderly, quality of life may be more adversely affected by multimorbidity than uraemic symptoms, thus the dose of dialysis may be less relevant. Higher doses of dialysis may be more difficult to achieve in the elderly and may be less well tolerated. We conclude that the prescription of dialysis in the elderly should be individualized, taking multiple factors into account. An individualized Kt/V may be useful in controlling dialysis dose and detecting problems in delivery. However, achievement of a specified Kt/V may not result in any benefit to an elderly patient and could be counterproductive.
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http://dx.doi.org/10.1093/ndt/gfy042DOI Listing
May 2018

Frozen section analysis of unusual small testicular tumor masses: report of 3 cases.

Tumori 2016 Nov 11;102(Suppl. 2). Epub 2016 Nov 11.

 Pathology Service, Addarii Institute of Oncology, S-Orsola-Malpighi Hospital, Bologna - Italy.

Purpose: Nonpalpable tumors of the testis are generally incidental findings on ultrasound examination. Most of these tumors are benign but some turn out to be germinal tumors at histology. Therefore, intraoperative histopathologic analysis of nonpalpable testicular lesions is pivotal for guiding a testis-sparing surgical approach.

Methods: We report clinical and pathologic characteristics of 3 small nodules of the testis with challenging histologic features at intraoperative frozen section examination and peculiar histology. One was a known testicular mass, undertreated for 5 years, whose enlargement worried the patient, while the other 2 were incidental findings during clinical testicular examination for non-neoplastic diseases.

Conclusions: The 3 cases reported are characterized by small size, which limited the accuracy of preoperative ultrasound diagnosis. Intraoperative frozen section examination was able to rule out a diagnosis of germ cell malignancy in all cases, but diagnosis was conclusive only at histology. Knowledge of unexpected rare testicular lesions is of great relevance at the time of frozen section examination in view of conservative surgical strategy.
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http://dx.doi.org/10.5301/tj.5000477DOI Listing
November 2016

More Versus Less Intensive Blood Pressure-Lowering Strategy: Cumulative Evidence and Trial Sequential Analysis.

Hypertension 2016 09 25;68(3):642-53. Epub 2016 Jul 25.

From the Department of Medicine, Hospital of Assisi, Italy (P.V.); Cardiology and Cardiovascular Pathophysiology, Hospital S.M. della Misericordia, Perugia, Italy (F.A.); Royal Cornwall Hospitals, NHS Trust, Truro, Cornwall, UnitedKingdom (G.G.); and Department of Medicine, University of Perugia, Italy (G.R.).

Several randomized trials compared a more versus less intensive blood pressure-lowering strategy on the risk of major cardiovascular events and death. Cumulative meta-analyses and trial sequential analyses can establish whether and when firm evidence favoring a specific intervention has been reached from accrued literature. Therefore, we conducted a cumulative trial sequential analysis of 18 trials that randomly allocated 53 405 patients to a more or less intensive blood pressure-lowering strategy. We sought to ascertain the extent to which trial evidence added to previously accrued data. Outcome measures were stroke, myocardial infarction, heart failure, cardiovascular death, and all-cause death. Achieved blood pressure was 7.6/4.5 mm Hg lower with the more intensive than the less intensive blood pressure-lowering strategy. For stroke and myocardial infarction, the cumulative Z curve crossed the efficacy monitoring boundary solely after the SPRINT (Systolic Blood Pressure Intervention Trial) study, thereby providing firm evidence of superiority of a more intensive over a less intensive blood pressure-lowering strategy. For cardiovascular death and heart failure, the cumulative Z curve crossed the conventional significance boundary, but not the sequential monitoring boundary, after SPRINT. For all-cause death, the SPRINT trial pushed the cumulative Z curve away from the futility area, without reaching the conventional significance boundary. We conclude that evidence accrued to date strongly supports the superiority of a more intensive versus a less intensive blood pressure-lowering strategy for prevention of stroke and myocardial infarction. Cardiovascular death and heart failure are likely to be reduced by a more intensive blood pressure-lowering strategy, but evidence is not yet conclusive.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.116.07608DOI Listing
September 2016

Patient's satisfaction after 2-piece inflatable penile prosthesis implantation: An Italian multicentric study.

Arch Ital Urol Androl 2016 Mar 31;88(1):1-3. Epub 2016 Mar 31.

Andrology-Unit, University Hospital S.Orsola-Malpighi, Bologna; Department of Urology, University of Bologna, Bologna.

Introduction: Penile prosthesis implant represents a valuable solution for pts with severe erectile dysfunction (ED), non-responders to medical management. The aim of our study was to evaluate the satisfaction of patients (pts) after 2-pieces inflatable penile prosthesis (IPP).

Aim Of The Study: to evaluate safety, reliability and post-operative patient's satisfaction after implantation of two-pieces IPP.

Materials And Methods: This retrospective multicentric analysis concerns a group of 42 patients undergone 2-pieces IPP implantation from November 2005 to November 2013, in four Centers of proven experience. As a first step, a detailed review of all clinical reports was performed. Secondly, every patient was asked to fill the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) specifically modified, in order to assess their own satisfaction after surgery and, its impact on patient's quality of sexual life.

Results: 42 pts were evaluated (AMS-Ambicor: 28; Coloplast-Excell: 14); mean age, at time of operation: 60,7 years; mean follow up: 27,6 months; etiology of ED: vascular 23,8%, diabetes 19%, La Peyronie D. 7,1%, consequence of radical prostatectomy 31%, consequence of other pelvic surgery 11,9%, spinal trauma 7%. Mean operative time: 117 ± 58 min, mean postoperative hospital stay 3 ± 1,6 days. Post operative short-term complications: 4 pts (9,5%). Post operative long-term complications: 4 pts (9,5%). Long-term functional results (Questionnaire): 71% of pts (30) reported regular use of the prosthesis, at least 1 time/week, the satisfaction was good in 42% of pts (18), quite good in 33,3% (14), quite bad in 2,4% (1), very bad in 7,1% (3), 6 pts (14,4%) didn't answer.

Conclusions: 2 pieces IPP appears to be associated with a low complication rate and good satisfaction of pts especially in the elderly. It also assures satisfactory rates of aesthetics and functional results.
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http://dx.doi.org/10.4081/aiua.2016.1.1DOI Listing
March 2016

Novel Biomarkers for Renal Diseases? None for the Moment (but One).

J Biomol Screen 2016 Aug 12;21(7):655-70. Epub 2016 Feb 12.

IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Clinical Research Center for Rare Diseases Aldo e Cele Daccò, Bergamo, Italy Unit of Nephrology and Dialysis, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy

Recent years have witnessed the unprecedented development and integration of genomics, epigenetics, transcriptomics, proteomics, and metabolomics, as well as a growing interest in novel single biomarkers and process-specific biomarker panels in human renal diseases. In a scenario currently dominated by kidney biopsy and established biomarkers such as serum creatinine, albuminuria, and proteinuria, novel biomarkers could potentially provide vital diagnostic and prognostic information and help to predict response to treatment in several clinical settings, including acute kidney injury, renal transplant, autosomal dominant polycystic kidney disease, and glomerulopathies. However, it is still uncertain whether and to what extent novel biomarkers will succeed in this difficult task. To date, they have generally failed to provide relevant information over and above what is already granted by established, cheap, and easily available biomarkers such as proteinuria, while the complexity and costs of these technology platforms are an important obstacle to their wide adoption. On the other hand, the successful implementation of anti-phospholipase A2 receptor antibodies as a diagnostic and prognostic biomarker of membranous nephropathy, as well as the huge number of ongoing collaborative efforts worldwide, should induce the nephrology community to be rather optimistic about a potential breakthrough in the management of kidney diseases over the next few decades.
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http://dx.doi.org/10.1177/1087057116629916DOI Listing
August 2016

Effect of Sirolimus on Disease Progression in Patients with Autosomal Dominant Polycystic Kidney Disease and CKD Stages 3b-4.

Clin J Am Soc Nephrol 2016 05 22;11(5):785-94. Epub 2016 Feb 22.

Clinical Research Center for Rare Diseases "Aldo e Cele Daccò," IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Bergamo, Italy; Units of Nephrology and Dialysis, Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy

Background And Objectives: The effect of mammalian target of rapamycin (mTOR) inhibitors has never been tested in patients with autosomal dominant polycystic kidney disease (ADPKD) and severe renal insufficiency.

Design, Setting, Participants, & Measurements: In this academic, prospective, randomized, open label, blinded end point, parallel group trial (ClinicalTrials.gov no. NCT01223755), 41 adults with ADPKD, CKD stage 3b or 4, and proteinuria ≤0.5 g/24 h were randomized between September of 2010 and March of 2012 to sirolimus (3 mg/d; serum target levels of 5-10 ng/ml) added on to conventional therapy (n=21) or conventional treatment alone (n=20). Primary outcome was GFR (iohexol plasma clearance) change at 1 and 3 years versus baseline.

Results: At the 1-year preplanned interim analysis, GFR fell from 26.7±5.8 to 21.3±6.3 ml/min per 1.73 m(2) (P<0.001) and from 29.6±5.6 to 24.9±6.2 ml/min per 1.73 m(2) (P<0.001) in the sirolimus and conventional treatment groups, respectively. Albuminuria (73.8±81.8 versus 154.9±152.9 μg/min; P=0.02) and proteinuria (0.3±0.2 versus 06±0.4 g/24 h; P<0.01) increased with sirolimus. Seven patients on sirolimus versus one control had de novo proteinuria (P=0.04), ten versus three patients doubled proteinuria (P=0.02), 18 versus 11 patients had peripheral edema (P=0.04), and 14 versus six patients had upper respiratory tract infections (P=0.03). Three patients on sirolimus had angioedema, 14 patients had aphthous stomatitis, and seven patients had acne (P<0.01 for both versus controls). Two patients progressed to ESRD, and two patients withdrew because of worsening of proteinuria. These events were not observed in controls. Thus, the independent data and safety monitoring board recommend early trial termination for safety reasons. At 1 year, total kidney volume (assessed by contrast-enhanced computed tomography imaging) increased by 9.0% from 2857.7±1447.3 to 3094.6±1519.5 ml on sirolimus and 4.3% from 3123.4±1695.3 to 3222.6±1651.4 ml on conventional therapy (P=0.12). On follow-up, 37% and 7% of serum sirolimus levels fell below or exceeded the therapeutic range, respectively.

Conclusions: Finding that sirolimus was unsafe and ineffective in patients with ADPKD and renal insufficiency suggests that mTOR inhibitor therapy may be contraindicated in this context.
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http://dx.doi.org/10.2215/CJN.09900915DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4858487PMC
May 2016

Sex-related penile fracture with complete urethral rupture: A case report and review of the literature.

Arch Ital Urol Androl 2015 Sep 30;87(3):260-1. Epub 2015 Sep 30.

Department of Urology, University of Bologna, S.Orsola-Malpighi Hospital, Bologna.

Objective: To present the management of a patient with partial disruption of both cavernosal bodies and complete urethral rupture and to propose a non-systematic review of literature about complete urethral rupture. MATERIAL AND METHOD - CASE REPORT: A 46 years old man presented to our emergency department after a blunt injury of the penis during sexual intercourse. On physical examination there was subcutaneous hematoma extending over the proximal penile shaft with a dorsal-left sided deviation of the penis and urethral bleeding. Ultrasound investigation showed an hematoma in the ventral shaft of the penis with a discontinuity of the tunica albuginea of the right cavernosal corporum. The patient underwent immediate emergency surgery consisted on evacuation of the hematoma, reparation the partial defect of both two cavernosal bodies and end to end suture of the urethra that resulted completely disrupted.

Results: The urethral catheter was removed at the 12-th postoperative day without voiding symptoms after a retrograde urethrography. 6 months postoperatively the patients was evaluated with uroflowmetry demonstrating a max flow rate of 22 ml/s and optimal functional outcomes evaluated with validated questionnaires. 8 months after surgery the patients was evaluated by dynamic magnetic resonance (MRI) of the penis showing only a little curvature on the left side of the penile shaft.

Conclusion: Penile fracture is an extremely uncommon urologic injury with approximately 1331 reported cases in the literature till the years 2001. To best of our knowledge from 2001 up today, 1839 more cases have been reported, only in 159 of them anterior urethral rupture was associated and in only 22 cases a complete urethral rupture was described. In our opinion, in order to prevent long term complications, in case of clinical suspicion of penile fracture, especially if it is associated to urethral disruption, emergency surgery should be the first choice of treatment.
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http://dx.doi.org/10.4081/aiua.2015.3.260DOI Listing
September 2015

Low-dose RATG with or without basiliximab in renal transplantation: a matched-cohort observational study.

Am J Nephrol 2015 23;41(1):16-27. Epub 2015 Jan 23.

IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Clinical Research Center for Rare Diseases 'Aldo e Cele Daccò', Bergamo, Italy.

Background/aims: In renal transplantation, peri-operative low-dose rabbit-antithymocyte-globulin (RATG) plus basiliximab induction prevented acute allograft rejection more effectively than post-operative RATG plus basiliximab induction. We investigated the specific antirejection contribution of basiliximab in this context.

Methods: This single-center, observational, matched-cohort study evaluated allograft rejections (primary outcome), steroid exposure and side effects, GFR (iohexol plasma clearance) and treatment costs in 16 deceased-donor renal transplant recipients induced with RATG (0.5 mg/kg/day) and 32 age-, gender- and treatment-matched reference-patients given RATG plus basiliximab (20 mg on days 0 and 4).

Results: Induction was well tolerated. At 18 months, 8 patients (50%) vs. 3 reference-patients (9.4%) rejected the graft [HR (95% CI): 6.53 (1.73-24.70), p = 0.006]. Difference was significant (p < 0.01) even after adjusting for recipient/donor age and gender, cold ischemia time and HLA mismatches. There were 1 antibody-mediated rejection and 2 moderate cellular rejections in patients vs. none in reference-patients (p = 0.032). The median (interquartile range) prednisone cumulative dose was remarkably higher in patients than reference-patients [4.78 (1.12-6.10) vs. 0.19 (0.18-3.81) grams, p = 0.002]. Three patients vs. 24 reference-patients were off-steroid at study end (p < 0.001). Three patients vs. no reference-patient developed new-onset diabetes (p = 0.003). Both inductions similarly depleted B-cells. Outcomes of AZA- vs. MMF-treated participants were similar. GFR was similar in all groups. Compared to MMF, AZA therapy saved ≈ EUR 2,500/year and by month 14.3 post-transplant compensated basiliximab costs.

Conclusion: In renal transplantation, basiliximab plus peri-operative low-dose RATG more efficiently prevented allograft rejection than RATG monotherapy, and minimized steroid exposure and toxicity. AZA- vs MMF-based maintenance immunosuppression largely compensated the extra costs of basiliximab.
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http://dx.doi.org/10.1159/000371728DOI Listing
September 2015

Dual renin-angiotensin system blockade for nephroprotection: still under scrutiny.

Nephron 2015 16;129(1):39-41. Epub 2014 Dec 16.

In experimental diabetic and non-diabetic chronic kidney disease (CKD), angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) combination therapy reduces proteinuria and prevents structural lesions more effectively than either drug alone. Consistently, in humans, a multidrug individually tailored antiproteinuric treatment based on combination therapy with maximum tolerated doses of ACEi and ARB (Remission Clinic protocol) reduced proteinuria and prevented end-stage renal disease (ESRD) more effectively than ACEi/ARB monotherapy, in particular in subjects with non-diabetic CKD. Fixed doses of an ACEi or renin inhibitor added to losartan failed to exert any additional renoprotective effect as compared with losartan monotherapy in patients at increased cardiovascular risk (ONTARGET study) or with type 2 diabetes and overt nephropathy (ALTITUDE study). The VA NEPHRON D study found that losartan and lisinopril combination therapy reduced by 34% the risk of predefined reductions in estimated glomerular filtration rate, ESRD or death as compared to losartan in 1,448 type 2 diabetes patients with overt nephropathy. Unfortunately, the treatment effect failed to achieve the nominal significance (p = 0.07) because of premature trial interruption. Thus, the Remission Clinic protocol is the most powerful tool to prevent progression to ESRD in non-diabetic proteinuric CKD. Results of the ongoing VALID trial will show whether this approach can be safely extended to type 2 diabetes patients.
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http://dx.doi.org/10.1159/000368331DOI Listing
September 2015

Novel effective drugs for diabetic kidney disease? or not?

Expert Opin Emerg Drugs 2014 Dec 7;19(4):571-601. Epub 2014 Nov 7.

IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Clinical Research Center for Rare Diseases "Aldo e Cele Daccò" , Villa Camozzi, Via Giambattista Camozzi 3, 24020, Ranica, Bergamo , Italy +39 03545351 ; +39 0354535371 ;

Introduction: Diabetes mellitus is increasingly common worldwide and is expected to affect 592 million people by 2035. The kidney is often involved. A key goal in treating diabetes is to reduce the risk of development of kidney disease and, if kidney disease is already present, to delay the progression to end-stage renal disease (ESRD). This represents a social and ethical issue, as a significant proportion of patients reaching ESRD in developing countries do not have access to renal replacement therapy.

Areas Covered: The present review focuses on novel therapeutic approaches for diabetic nephropathy (DN), implemented on the basis of recent insights on its pathophysiology, which might complement the effects of single inhibition of the renin-angiotensin-aldosterone system (RAAS), the cornerstone of renoprotective interventions in diabetes, along with glycemic and blood pressure control.

Expert Opinion: Although a plethora of new treatment options has arisen from experimental studies, the number of novel renoprotective molecules successfully implemented in clinical practice over the last two decades is disappointingly low. Thus, new investigational strategies and diagnostic tools - including the appropriate choice of relevant renal end points and the study of urinary proteome of patients - will be as important as new therapeutic interventions to fight DN. Finally, in spite of huge financial interests in replacing the less expensive ACE inhibitors and angiotensin II receptor blockers with newer drugs, any future therapeutic approach has to be tested on top of - rather than instead of - optimal RAAS blockade.
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http://dx.doi.org/10.1517/14728214.2014.979151DOI Listing
December 2014