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6. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: Data from the Italian AIFA Anti-diabetics Monitoring Registry

Author

Montilla, S, Marchesini, G, Sammarco, A, Trotta, M, Siviero, P, Tomino, C, Melchiorri, D, Pani, L, Sbraccia, P, Nicolucci, A, Brignoli, O, Coscelli, C, Dell'Aera, M, Mazzaglia, G, Giustini, S, De Rosa, M, Covezzoli, A, Rigazio, A, Roncadori, A, Montilla S, Marchesini G, Sammarco A, Trotta MP, Siviero PD, Tomino C, Melchiorri D, Pani L, Melchiorri D., Sbraccia P, Nicolucci A, Brignoli O, Coscelli C, Dell'Aera M, Mazzaglia G, Giustini SE, De Rosa M, Covezzoli A, Rigazio A, Roncadori A, Montilla, S, Marchesini, G, Sammarco, A, Trotta, M, Siviero, P, Tomino, C, Melchiorri, D, Pani, L, Sbraccia, P, Nicolucci, A, Brignoli, O, Coscelli, C, Dell'Aera, M, Mazzaglia, G, Giustini, S, De Rosa, M, Covezzoli, A, Rigazio, A, Roncadori, A, Montilla S, Marchesini G, Sammarco A, Trotta MP, Siviero PD, Tomino C, Melchiorri D, Pani L, Melchiorri D., Sbraccia P, Nicolucci A, Brignoli O, Coscelli C, Dell'Aera M, Mazzaglia G, Giustini SE, De Rosa M, Covezzoli A, Rigazio A, and Roncadori A

Abstract

Background and aims: In Italy, the reimbursed use of incretin mimetics and incretin enhancers was subject to enrollment of patients into a web-based system recording the general demographic and clinical data of patients. We report the utilization data of glucagon-like peptide 1 (GLP1) receptor agonists and dipeptidylpeptidase-4 (DPP4) inhibitors in clinical practice as recorded by the Italian Medicines Agency (AIFA) Monitoring Registry. Methods and results: From February 2008 to August 2010, 75,283 patients with type 2 diabetes were entered into the registry and treated with exenatide, sitagliptin, or vildagliptin. The treatment was administered to patients in a wide range of ages (≥75 years, n=6125 cases), body mass index (BMI) (≥35kg/m2, n=22,015), and metabolic control (HbA1c≥11% ((96mmol/mol), n=3151). Overall, 1116 suspected adverse drug reactions were registered, including 12 cases of acute pancreatitis (six on exenatide). Hypoglycemic episodes mainly occurred in combination with sulfonylureas. Treatment discontinuation for the three drugs (logistic regression analysis) was negatively associated with the male gender and positively with baseline HbA1c, diabetes duration, and, limitedly to DPP-4 inhibitors, with BMI. Treatment discontinuation (including loss to follow-up, accounting for 21-26%) was frequent. Discontinuation for treatment failure occurred in 7.7% of cases (exenatide), 3.8% (sitagliptin), and 4.1% (vildagliptin), respectively, corresponding to 27-40% of all discontinuations, after excluding lost to follow-up. HbA1c decreased on average by 0.9-1.0% (9mmol/mol). Body weight decreased by 3.5% with exenatide and by 1.0-1.5% with DPP-4 inhibitors. Conclusions: In the real world of Italian diabetes centers, prescriptions of incretins have been made in many cases outside the regulatory limits. Nevertheless, when appropriately utilized, incretins may grant results at least in line with pivotal trials

Published
2014

7. A Multicenter Study on the Prevalence of Diabetic Neuropathy in Italy

Author

Fedele, D, Comi, G, Coscelli, C, Cucinotta, Domenico Maria, Feldman, El, Ghirlanda, G, Greene, Da, Negrin, P, Santeusanio, F, Cavazzuti, P, Iotti, A, Preti, B, Simoncini, G, Tessari, F, Viaggi, S, Corigliano, G, Zarella, A, Siletti, A, Sorrenti, G, Kuppelwiieser, U, Deblasi, G, Spogler, F, Degiuli, Gc, Demaria, G, Legati, F, Valentini, U, Colosio, W, Donati, E, Dalpa, F, Dimaggio, G, Lisi, E, Mazzeo, P, Papalia, D, Pollicina, S, Leonardi, G, Lunetta, M, Scrofani, A, Luciano, M, Piro, Ga, Teti, Diana, Basso, F, Brambilla, L, Garozzo, M, Elli, P, and R. E. Z. Z. O. N. I. .

Subjects
Advanced and Specialized Nursing, medicine.medical_specialty, Diabetic neuropathy, medicine.diagnostic_test, business.industry, Endocrinology, Diabetes and Metabolism, Concordance, Neurological examination, medicine.disease, Surgery, Peripheral neuropathy, Diabetes mellitus, Internal medicine, Epidemiology, Internal Medicine, medicine, Age of onset, Complication, business
Abstract

OBJECTIVE The prevalence of neuropathy, a common complication of diabetes, was determined in diabetic patients recruited from 109 outpatient diabetes clinics in Italy. RESEARCH DESIGN AND METHODS Neuropathy was diagnosed using the Diabetic Neuropathy Index (DNI), a standardized examination developed for use in the outpatient setting. A total of 8,757 diabetic patients were studied, 51.2% men and 48.8% women, with average and median ages of 56 and 58 years, respectively. RESULTS Of the 8,757 patients, 32.3% had neuropathy, defined as a positive score of > 2 points on the DNI. A total of 2,033 (49.6% men and 50.4% women) were administered the Diabetic Neuropathy Score (DNS), the second component of the screening program, by a neurologist. This component consists of a quantitative neurological examination and nerve conduction studies that together provide a summated score. A total of 335 patients (16.5%) were not neuropathic, and 395 (19.4%) had borderline, 453 (22.3%) mild, 592 (29.1%) moderate, and 258 (12.7%) severe neuropathy. The concordance between a positive score on the DNI and a DNS indicating neuropathy was 83.5%. The severity of neuropathy increased with both age and disease duration. Of patients with neuropathy, 64.1% had an average age between 58 and 59 years with a disease duration between 12.4 ± 8.4 years (mild neuropathy) and 15.6 ± 9.7 years (severe neuropathy). CONCLUSIONS Neuropathy is a common complication of diabetes and, in this study, was present in 32.3% of all patients. An increased awareness of the high prevalence of neuropathy can lead to early therapeutic intervention and possible prevention of later neuropathic complications, such as infection and foot ulcers.

Published
1997
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12. Fourth Annual Meeting of the European Association for the study of diabetes: Louvain, Belgium, July 22–24, 1968

Author

Abrams, M. E., Boyns, D. R., Crossley, J. R., Jarrett, R. J., Keen, H., Andreani, D., Menzinger, G., Fallucca, F., Alibebti, A., Tamburrane, G., Andreev, D., Ditzov, S., Dashev, G., Strashimirov, D., Appels, A., Willms, B., Söling, H. D., Asfeldt, V. H., Bacanu, Gh., Bakker, B., Roerdink, F. H., Bouman, P. R., Coert, A., Jaspers, N. M. V., Barta, L., Beckmann, R., Berger, W., Beringer, A., Geyer, G., Mösslacher, H., Tragl, K. H., Waldhäusl, W., Beyer, J., Schöffling, K., Ditschuneit, H., Raptis, S., Wolf, E., Güntert, E., Pfeiffer, E. F., Bilic, N., Felber, J. P., Bojanowicz, K., Zubowski, A., Rybarczyk, Z., Bonessa, C., Cremonini, L., Borrebaek, B., Spydevold, Ø., Botterman, P., Dieterle, P., Scriba, P. C., Schwarz, K., Boucher, B. J., Mashiter, K., Stimmler, L., Vince, F., Walters, P., Csorba, T. R., Butterfield, W. J. H., Whichelow, M. J., Boyns, A. R., Mahler, R., Pearce, N., Bruni, B., Büber, V., Felber, J. -P., Vannotti, A., Buchanan, K. D., Vance, J. E., Dinstl, K., Williams, R. H., Cox, B. D., Cohen, N. M., Alexander, D. P., Britton, H. G., Nixon, D. A., Parker, R. A., Cegrell, L., Chance, G. W., Albutt, E. C., Chlouverakis, C., White, P., Christensen, N. Juel, Contesse, G., Pathé, G., Crabbé, J., Scarlata, J., Crepaldi, G., Muggeo, M., Tiengo, A., Enzi, G., Federspil, G., Trisotto, A., Czyżyk, A., Gregor, A., Dawidowicz, A., de Gasparo, M., Malherbe, Che., Thomas, K., Hoet, J. J., De Leeuw, I., Dérot, M., Rathery, M., Rosselin, G., Devlin, James G., Duggan, Marion, Dubach, U. C., Forgò, I., Fellin, R., Muggeo, H., Fagerberg, S. B., Axelsson, A., Fankhauser, S., Morell, B., Federlin, K., Flad, H. -D., Kriegbaum, D., Rivier, D. A., Fellmann, E., Glaubitt, D., Hönlinger, U., Ulrich, I., Wulff, K., Förster, H., Brauch, K., Mehnert, H., Dittmar, F., Frerichs, H., Creutzfeldt, W., Fbeytag, G., Schabschmidt, W., Klöppel, G., Friedler, Denise, Benhamou, J. P., Lubetzki, J., Azerad, E., Gnudi, A., Coscelli, C., Palmari, V., Valenti, G., Btttturini, U., Gomez, F., Guidoux-Grassi, L., Maerki, J., Guidoux, R., Groen, J. J., Grüneklee, D., Liebermeister, H., Schilling, W. H., Solbach, H. G., Herberg, L., Daweke, H., Guy-Grand, B., Tutin, M., Bour, H., Hadden, D. R., Harley, J. M. G., Montgomery, D. A. D., Mackay, J. S., Heding, Lise G., Hellerström, C., Stork, H., Westman, S., Schmidt, F. H., Boehringer, C. F., GmbH, Söhne, Hepp, Dieter, Challoner, David R., Williams, Robert H., Berger, M., Gries, F. A., Preiss, H., Jahnke, K., Herman, J. B., Keynam, A., Hill, D. M., Munro-Faure, A. D., Anderson, J., Horn, Z., Jakob, A., Humbel, R. E., Buxtorf, U., Froesch, E. R., Track, N. S., Kaeding, A., Karmann, H., Mialhe, P., Kasemir, H., Paulus, U., Steinhilber, S., Kerp, L., Kohner, E. M., Oakley, N. W., Fraser, T. Russell, and Kühnau, Jr., J.

Published
1968
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13. Seventh Annual Meeting of the European Association for the Study Of Diabetes Southampton, England, September 15–17, 1971 Abstacts, Part 1

Author

Aboulker, J. P., Valleron, A. J., Papoz, L., Rathery, M., Adams, P. W., Munday, M. J., Oakley, N. W., Wynn, V., Andreani, D., Fallucca, F., Stirati, G., Tamburrano, G., Cinotti, G. A., Andreev, D., Tarkolev, N., Ditzov, S., Pencev, I., Ancreev, D., Sirskov, L., Arnold, R., Creutzfeldt, C., Deuticke, U., Frerichs, H., Track, N. S., Creutzfeldt, W., Asmal, A. C., Butterfieid, W. J. H., Karamanos, B., Whichelow, M. J., Butterfield, W. J. H., Cox, B. D., Ashcroft, S. J. H., Bassett, J. M., Randle, P. J., Asplund, K., Hellerström, C., Brolin, S. E., Berne, C., Edwards, John C., Petersson, B., Taylor, K. W., Assan, R., Hanoune, J., Attali, J. B., Tchobroutsky, G., Gross, G., Assimacopoulos, F., Orci, L., Rouiller, Ch., Jeanrenaud, B., Cameron, D. P., Amherdt, M., Mira, F., Stauffacher, W., Heindel, J. J., Cushman, S. W., Austoni, M., Federspil, G., Casara, D., Sieolo, N., Scandellari, C., Mastrogiacomo, I., Aynsley-Green, A., Alberti, K. G. M. M., Bacanu, Gh., Stoichescu, L., Nistor, F., Turcanu, V., Anghelescu, L., Bacchus, R. A., Meade, L. G., London, D. R., Baiasse, E. O., Barta, L., Brooser, G., Molnár, Maria, Belfiore, F., Vecchio, L. Lo, Napoli, E., Beyer, J., Cordes, U., Sell, G., Krall, N., Schöffling, K., Biebuyck, J. F., de Haan, B. Bierens, Scherrer, J. R., Pometta, D., Björntorp, P., Sjöström, L., Blach, R. K., Cheng, Hung, Bloom, S. R., Bojanowicz, K., Boquist, L., Brachet, E., Bruni, B., Capra, E., Büber, V., Felber, J. P., Buchanan, K. D., Connon, J. J., Buckle, R. M., Campeami, S., Campeanu, L., Ionesou, M., Cerasi, E., Luft, R., Efendic, S., Chabot, V., Gomez, F., Chiumello, G., del Guercio, M. J., Carnelutti, M., Christensen, Niels Juel, Iversen, J., Christiansen, Aa. Hein, Rasmussen, S. Munkgaard, Vø1und, Aa., Vólund, Aa., Clausen, T., Czyzyk, A., Szadkowski, M., Rogala, H., Lawecki, J., Davies, W. H., Martin, L. B., Mills, J. G., Vardey, C. J., Deckert, T., Lauridsen, U. Birk, Linde, J., Madsen, S. Nistrup, De Leeuw, I., Middelheim, A. Z., de Mowbray, R. R., Turner, J. J., Garner, S. D., Bruck, E., Nye, L., Triggs, S., Devlin, J. G., Varma, M., Kuti, J., Dumitrescu, C., Bolea-Feldman, M., Eschwege, E., Warnet, J. M., Richard, J. L., Menzinger, G., Javicoli, M., Fankhauser, S., Michl, J., Piemonte, G., Sicolo, N., Frezzato, S., Reffo, G. C., Luyckx, A., Lefebvre, P., Zaccaria, M., De Palo, C., Fernandes-Cruz, Jr., A., Lopiz-Quijada, C., Fernandez-Cruz, Jr., A., Otero, M. Luque, Fiedler, H., Hahn, H. J., Ziegler, Brigitte, Ziegler, M., Jutzi, E., Michael, R., Fischer, U., Hommel, H., Bibergeil, H., Förster, O., Rippel, W., Rudas, B., Franckson, J. R. M., Vanroux, R., Leclercq, R., Brunengraber, H., Ooms, H., Freytag, G., Klöppel, G., Fussgänger, R. D., Goberna, R., Schröder, K. E., Laube, H., Pfeiffer, E. F., Gazzola, G. C., Franchi, R., Ronchi, P., Saibene, E., Guidotti, G. G., Geldermans, C., Terpstra, J., Krans, H. M. J., Geser, C. A., Rattenhuber, E., Girard, J., Bal, D., Gligore, V., Mosora, N., Fekete, T., Beraru, T., Pipilian, V. V., Olteanu, L., Serban, A., Calusera, I., Holan, T., Miclutia, M., Gnudi, A., Coscelli, C., Ballerio, G., Palmari, V., Alpi, O., Cavazzini, G., Jéquier, E., Goth, E., Fövenyi, J., Hegedüs, A., Greco, A. V., Ghirlanda, G., Fedeli, G., Fenici, R., Gambassi, G., Grüneklee, D., Hessing, J., Daweke, H., Herberg, L., Gries, F. A., Guder, W., Wieland, O., Guillon, J., Bodic, L., Charbonnel, B., Hadden, D. R., Montgomery, D. A. D., Mayne, Elizabeth, Weaver, J. A., George E, Hahn, J., Richter, O., Steinhilber, S., Kerp, L., Heaney, S. J., Varma, S. K., Whyte, W. G., Walker, R. S., Hepp, K. D., Hellman, B., Lernmark, A., Sehlin, J., Täljedal, I. -B., Hinz, M., Katsilambros, N., Rahman, Y. Abdel, Schatz, H., Maier, V., Schröder, B., Howells, D. P. M., Jackson, R. A., Perry, G., Rogers, J., Advani, U., Jafflol, C., Baldet, L., Vierne, Y., Mirouze, J., Jansen, F. K., Jarrett, R. J., Keen, H., Kaeding, A., Kaffarnik, H., Heink, U., Gassel, W. D., Zöfel, P., Mylarch, K., Keller, U., and Froesch, E. R.

Published
1971
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15. The Italian multicentric study on the prevalence of distal symmetric polyneuropathy: correlation between clinical variable and nerve conduction paramenters

Author

COMI , GIANCARLO, FEDELE D, COSCELLI C, CUCINOTTA D, FELDMAN E. L, GHIRLANDA G, NEGRIN P, SANTEUSANIO F, MADERNA L, the Italian Diabetic Neuropathy Comnmittee, Comi, Giancarlo, Fedele, D, Coscelli, C, Cucinotta, D, FELDMAN E., L, Ghirlanda, G, Negrin, P, Santeusanio, F, Maderna, L, and the Italian Diabetic Neuropathy, Comnmittee

Published
1999

16. A multicenter study on the prevalence of diabetic neuropathy in Italy

Author

FEDELE D, COSCELLI C, CUCINOTTA D, FELDMAN EL, GHIRLANDA G, GREENE DA, NEGRIN P, SANTEUSANIO S, THE ITALIAN DIABETIC NEUROPATHY COMMITTEE, COMI , GIANCARLO, Fedele, D, Comi, Giancarlo, Coscelli, C, Cucinotta, D, Feldman, El, Ghirlanda, G, Greene, Da, Negrin, P, Santeusanio, S, and THE ITALIAN DIABETIC NEUROPATHY, Committee

Published
1997

19. Prevenzione del diabete di tipo 2

Author

Corigliano, G., Coscelli, C., DE FEO, Pierpaolo, Giorgino, R., Giorda, C, Rivellese, A, Rotella, C, and Vaccaro, O.

Published
2006

20. Cardiovascular risk factors and metabolic control in type 2 diabetic subjects attending outpatient clinics in Italy: the SFIDA (survey of risk factors in Italian diabetic subjects by AMD) study

Author

Comaschi, M, Coscelli, C, Cucinotta, Domenico Maria, Malini, P, Manzato, E, Nicolucci, A, and SFIDA Study Group Italian Association of Diabetologists

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Waist, Endocrinology, Diabetes and Metabolism, Population, Medicine (miscellaneous), Type 2 diabetes, Body Mass Index, Sex Factors, Risk Factors, Internal medicine, Diabetes mellitus, medicine, Outpatient clinic, Humans, Obesity, education, Aged, Glycated Hemoglobin, education.field_of_study, Nutrition and Dietetics, business.industry, Middle Aged, medicine.disease, Surgery, Blood pressure, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Italy, Cardiovascular Diseases, Hypertension, Population study, Microalbuminuria, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Summary Background and aim To perform an observational, cross-sectional study aiming to assess multiple cardiovascular risk factors and metabolic control in a very large and representative sample of type 2 diabetic subjects attending diabetes outpatient clinics (DOCs) in Italy. Methods and results Two hundred and sixty-one clinics were involved, representing about one-third of the whole number of DOCs in the Country. Each clinic recruited on a random basis from 50 to 100 type 2 diabetic patients aged 35–70 years, diagnosed more than six months before the start of the study. Demographic and clinical data were collected and blood pressure, lipids, HbA 1c , fasting blood glucose (FBG), and microalbuminuria were measured. Overall, 12,222 type 2 diabetic patients were recruited in 253 DOCs. Female subjects showed higher FBG, HbA 1c , blood pressure, lipid levels, and a longer duration of disease. The proportion of patients with BMI≥30 was 33.3% among males and 45.9% among females; 40.9% of male patients had a waist circumference greater than 102cm, while 79% of female patients had a waist circumference over 88cm. More than two-third of the patients (74.4%) had systolic blood pressure values of ≥130mmHg, and one-third (33.2%) had diastolic values≥85mmHg. The mean value of HbA 1c was 7.6±1.6, and 23.7% of the observed population had an HbA 1c level>8.5%. More than half of the study population had total cholesterol levels≥5.2mmol/l, 47% had LDL cholesterol values of 3.3mmol/l or greater and 9.6% had HDL cholesterol level lower than 0.90mmol/l. The presence of multiple lipid alterations was associated with markedly higher HbA 1c levels, in both subjects treated with lipid lowering drugs and untreated subjects. Finally, even moderate increases in HbA 1c levels (i.e. HbA 1c >7.5%) were associated with a statistically significant greater risk of systolic blood pressure levels≥160mmHg in women (OR=1.40; 95% CI 1.09–1.80) but not in men (OR=1.21; 95% CI 0.96–1.54). Conclusions The SFIDA study provides a clear indication of the need to orient diabetes care towards the control of global cardiovascular risk. Only a stricter adherence to the existing guidelines and a much stronger attention to the attainment of the desired therapeutic goals will allow a decrease in morbidity and mortality as well as in the costs related to diabetes.

Published
2004

22. A feasibility study in Reggio Emilia, Italy

Author

Manicardi, V., Graziella BRUNO, Luberto, F., Rodolfi, R., and Coscelli, C.

Subjects
Italy, Data Collection, Diabetes Mellitus, Prevalence, Feasibility Studies, Humans, Length of Stay, Delivery of Health Care, Patient Readmission, Diagnosis-Related Groups, Patient Discharge
Published
2003

28. A multicenter study on the prevalence of diabetic neuropathy in Italy. Italian Diabetic Neuropathy Committee

Author

Fedele, D., Comi, G., Coscelli, C., Cucinotta, Domenico Maria, Feldman, E. L., Ghirlanda, G., Greene, D. A., Negrin, P., F. Santeusanio Appendix: Italian Diabetic Neuropathy Committee: …. …. . Carducci D., Cucinotta, D., and Girlanda, Paolo

Subjects
Adult, diagnosis/epidemiology/physiopathology, Male, Neurologic Examination, Age Factors, Neural Conduction, Middle Aged, Adult, Age Factors, Age of Onset, Aged, Diabetes Mellitus, Type 1, physiopathology, Diabetes Mellitus, Type 2, physiopathology, Diabetic Neuropathies, diagnosis/epidemiology/physiopathology, Female, Humans, Italy, epidemiology, Male, Middle Aged, Neural Conduction, Neurologic Examination, Outpatients, Prevalence, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Neuropathies, Italy, Outpatients, Diabetes Mellitus, Prevalence, Humans, Female, epidemiology, Age of Onset, physiopathology, Aged
Abstract

The prevalence of neuropathy, a common complication of diabetes, was determined in diabetic patients recruited from 109 outpatient diabetes clinics in Italy.Neuropathy was diagnosed using the Diabetic Neuropathy Index (DNI), a standardized examination developed for use in the outpatient setting. A total of 8,757 diabetic patients were studied, 51.2% men and 48.8% women, with average and median ages of 56 and 58 years, respectively.Of the 8,757 patients, 32.3% had neuropathy, defined as a positive score of2 points on the DNI. A total of 2,033 (49.6% men and 50.4% women) were administered the Diabetic Neuropathy Score (DNS), the second component of the screening program, by a neurologist. This component consists of a quantitative neurological examination and nerve conduction studies that together provide a summated score. A total of 335 patients (16.5%) were not neuropathic, and 395 (19.4%) had borderline, 453 (22.3%) mild, 592 (29.1%) moderate, and 258 (12.7%) severe neuropathy. The concordance between a positive score on the DNI and a DNS indicating neuropathy was 83.5%. The severity of neuropathy increased with both age and disease duration. Of patients with neuropathy, 64.1% had an average age between 58 and 59 years with a disease duration between 12.4 +/- 8.4 years (mild neuropathy) and 15.6 +/- 9.7 years (severe neuropathy).Neuropathy is a common complication of diabetes and, in this study, was present in 32.3% of all patients. An increased awareness of the high prevalence of neuropathy can lead to early therapeutic intervention and possible prevention of later neuropathic complications, such as infection and foot ulcers.

Published
1997

36. Functioning human insulinomas. An immunohistochemical analysis of intracellular insulin processing.

Author

Azzoni, C, D'Adda, T, Tamburrano, G, Coscelli, C, Madsen, O D, Scopsi, L, and Bordi, C

Abstract

Sixty-seven insulinomas were investigated by immunohistochemistry using site-directed antibodies against insulin, proinsulin, chromogranin A, HISL-19, and four proteins directly or indirectly involved in the proteolytic processing of proinsulin: the prohormone convertases PC2 and PC3, carboxypeptidase H (CPH) and 7B2. Results were expressed in a six-grade score according to the frequency of immunoreactive tumour cells. Insulin was expressed by all tumours, appearing in either a diffuse or a polarized pattern and being detected in more than 30% of tumour cells in all cases but three. Proinsulin was also expressed in all tumours, with more than 50% of tumour cells immunoreactive in all cases but 5. It was consistently localized in the Golgi apparatus. In about half the cases, moreover, it also showed diffuse cytoplasmic staining, usually with a very sparse distribution. Trabecular and solid insulinomas did not present specific, homogeneous patterns of insulin immunostaining. However, insulin immunoreactivity was much more abundant in trabecular than in solid neoplasms, being present in virtually all tumour cells (score 6) in 50% and 8% of cases, respectively. Virtually all insulinomas expressed PC2, PC3, CPH and 7B2, usually in 30-100% of tumour cells, with a frequency significantly related to that of insulin. However, detection of PC2 and 7B2 was slightly less frequent than that of PC3 and CPH. In consecutive sections these proteins were found to be mostly co-localized with insulin and chromogranin A but not with proinsulin. They were heavily expressed in all 10 tumours with more than 10% of cells showing cytoplasmic proinsulin immunoreactivity, indicating that the leakage of proinsulin from the Golgi compartment is not associated with faulty expression of converting enzymes and possibly reflects a saturated processing capacity. HISL-19 immunoreactivity was found in both Golgi apparatus and insulin stores, indicating that the relevant antigen is different from all other proteins investigated. These results do not support a defect in expression or localization of proinsulin-processing enzymes in most insulinomas. [ABSTRACT FROM AUTHOR]

Published
1998

39. Erectile dysfunction in type 1 and type 2 diabetics in Italy. On behalf of Gruppo Italiano Studio Deficit Erettile nei Diabetici.

Author

Fedele, D, Bortolotti, A, Coscelli, C, Santeusanio, F, Chatenoud, L, Colli, E, Lavezzari, M, Landoni, M, and Parazzini, F

Abstract

Several studies reported data on the increased risk of erectile dysfunction (ED) in populations of diabetic men, but few presented data separately for Type 1 and Type 2 subjects. No comparison data for these diabetic subgroups are available with regard to risk factors for ED.

Published
2000

40. Combined sulphonylurea-biguanide therapy for non-insulin dependent diabetics. Metabolic effects of glibenclamide and metformin or phenformin in newly diagnosed obese patients

Author

Capretti, L., Bonora, E., Coscelli, C., and Butturini, U.

Abstract

SummaryFasting, pre-prandial and post-prandial blood glucose levels and blood lactate, blood pyruvate, serum cholesterol, serum triglycerides and body weight were measured in 30 obese, newly diagnosed, non-insulin-dependent diabetics at the end of 4 subsequent periods of different regimens, each lasting for 5 days. In the first period, patients remained on free diet; in the second period, a hypocaloric diet (20 kcal/kg IBW) was followed; in the third period, glibenclamide (2.5 mg 3-times daily) was added to hypocaloric diet. During the last period, the patients were divided into two groups: Group A (15 patients) received, in addition to diet and glibenclamide, phenformin (25 mg 3-times daily) and Group B (15 patients) received, in addition to diet and glibenclamide, metformin (500 mg 3-times daily). Five similar patients served as controls and, at the end of the free-diet period, were put on hypocaloric diet and continued this regimen throughout the study period. The results showed that biguanides allowed a better glycaemic control when added to glibenclamide and that metformin, when compared to phenformin, had the same hypoglycaemic effect and a less marked hyperlactataemic action. Changes in body weight and triglycerides levels were similar in Groups A, B and controls, suggesting that the variations were a direct consequence of dietetic therapy. The serum total cholesterol level was significantly reduced when patients received metformin treatment and this is probably correlated with the reported hypolipidaemic effect of the drug. In view of these findings, it is suggested that metformin should be preferred to phenformin in association with glibenclamide when this drug alone fails to permit a good metabolic control.

Published
1982
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41. Preprandial combination of lispro and NPH insulin improves overall blood glucose control in type 1 diabetic patients: A multicenter randomized crossover trial

Author

Annuzzi, G., Stefano Del Prato, Arcari, R., Damato, A. B., Benzi, L., Bruttomesso, D., Calderini, M. C., Coscelli, C., Fedele, D., Galluzzo, A., Giordano, M., Giorgino, R., Lapolla, A., Orsini, P., Pagano, G., Santoro, D., Riccardi, G., Annuzzi, Giovanni, Del Prato, S., Arcari, R, Bellomo Damato, A, Benzi, L, Bruttomesso, D, Calderini, Mc, Coscelli, C, Fedele, D, Galluzzo, A, Giordano, M, Giorgino, R, Lapolla, A, Orsini, P, Pagano, G, Santoro, D, and Riccardi, Gabriele

Subjects
Adult, Blood Glucose, Male, Cross-Over Studies, Insulin Lispro, Time Factors, Adolescent, Body Weight, Insulin, Isophane, Blood Pressure, Middle Aged, Lipids, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Insulin, Female
Abstract

While lispro insulin has been reported to lower postprandial blood glucose concentrations, less consistent effects have been shown for glycosylated hemoglobin (HbA1c) levels. Aim of this study was to determine whether pre-meal association of NPH, an intermediate-acting insulin, with lispro improves overall glycemic control in type 1 diabetic patients.Eighty-five type 1 diabetic patients were studied in a multicenter randomized comparative (human regular vs lispro insulin) crossover (3-month) study in which NPH insulin was given as a dinner or bedtime injection and at breakfast and lunch if necessary. The number of injections was kept constant: 42% and 58% of patients injected insulin 3 and 4 times per day, respectively. Fasting and preprandial blood glucose levels were similar, while postprandial levels improved after lispro compared to human regular insulin (breakfast: 8.28 +/- 2.39 vs 9.28 +/- 2.72 mmol/l; lunch: 8.33 +/- 2.67 vs 9.06 +/- 2.67 mmol/l, dinner: 8.06 +/- 2.72 vs 9.28 +/- 2.44 mmol/l, ANOVA: p = 0.003). HbA1c also improved after lispro: 8.1 +/- 0.9 vs 8.3 +/- 0.8%, p0.05. The rate of hypoglycemia was similar. Patients showed better acceptance of lispro treatment (p0.001).Lispro improves overall blood glucose control in type 1 diabetic patients without increasing the incidence of hypoglycemia. This can be achieved by an optimal combination of lispro insulin with NPH whenever the time intervals between meals are too long.

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