- Email: [email protected]
Sildenafil (viagra) improves the QOL of diabetic patients with erectile dysfunction
Track 2. Clinical Research & Care been demonstrated to be active in inducing penile erection (PE), but comparative studies are not available. Aim: to evaluate efficacy, safety and compliance to the two drugs of patients with diabetic ED. Patients: 140 diabetic men (NIDDM) with medically documented ED from at least 6 months with HbAlc < 8%. Protocol: the study was designed as randomized, flexible dose (25-100 mg sildenafil and 10-20 ]g alprostadil) with 4 week no-treatment run-in phase, followed by a 8 week randomized treatment period. Patients were instructed to a correct use of sildenafil and alprostadil. The efficacy of treatment was assessed by using the International Index of Erectile Function questionnaire (IIEF) and a quality of life questionnaire (QLQ) were administered before and after each treatment period. Results: a similar efficacy of treatments was observed (57.5% OS and 55.6% IIA), but a significantly higher (p<0.001) number of subjects withdrawn lIA (28.9%) than OS (6.4%). No serious side effects were recorded for both drugs, but the majority of the patients withdrawn IIA for penile pain (11), penile hematoma (3) and 19 for psychogenic problems directly related to the need to perform an injection before a sexual approach, even though with an informed and stable female partner. The median number of doses taken was 26 (range 5-46) for sildenafil and 9 (range 2-20) for alprostadil. A significant (p<0.01) improvement of quality of life questionnaire was observed after OS (+12%) than IIA (+72%). Conclusion: even though the efficacy on ED of OS and HA is similar, the probability of successful is largely limited in the second treatment for a relevant incidence of local side effects as well as for psychological problems, conditioning the quality of life of the patients.
Pl165 Diabetic Erectile Dysfunction: Vascular or Neurological? SATYAN M. RAJBHANDARI, Lesley A. Brady, Nigel D. Harris, Simon Eaton, Solomon Tesfaye, John D. Ward. Diabetes Research, Royal
Hallamshire Hospital, Sheffield, United Kingdom Aim of study: Both vascular and neurological dysfunction can independently cause erectile dysfunction (ED). The aim of the stiudy was to define their role in diabetic ED. Methods: We studied 20 patients (Mean age 55.7 years 4- 10.4) with diabetes (7 type 1) of 16.1 4- 9.9 years duration, who had ED for 5.5 4- 4.4 years. Each subject underwent neurological assessment including clinical examination, peroneal motor and sural sensory nerve conduction, warm temperature discrimination threshold (TDT) and vibration perception threshold (VPT) in their feet and standard cardiac autonomic function tests (AFT). They also had detail vascular assessment with measurement of ankle brachial pressure index (ABPI) and Pharmaco-Penile Duplex Ultrasonography of cavernous arteries following intracavemosal injection of 20-microgram of alprostadil. Results: Clinically, neuropathy was present (Michigan score >7) in 11 patients (55%) however, 17 (85%) had abnormalities on neurophysiological testing (Abnormalities in TDT - 65%; VPT - 50%; conduction in both nerves - 70% and 2 or more abnormal cardiac autonomic function tests - 25%). Although peripheral vascular disease (ABPI <0.75) was not present in any patient, Pharmaco-Penile Duplex Ultrasonography showed moderate to severe disease (Peak velocity <25m per sec) in 16 (80%) cases. Conclusions: Contrary to conventional opinion, neither ABPI nor abnormal cardiac AFT were common in established diabetic ED, but impaired TDT, VPT, nerve conduction and abnormal Pharmaco-Penile Duplex Ultrasonography were more frequent. This study shows that both neurological and vascular dysfunction coexist in patients with diabetic ED, which may be the cause for poor response to treatment in this group.
$285
Pl166 Sildenafil (Viagra) Improves the QOL of Diabetic Patients with Erectile Dysfunction YUTAKA SUZUKI, Taro Maruyama, Tnshihiko Inukal, Kiyohiko Negishi. QOL Study Group, Saitama Diabetes Association,
Urawa, Saitama, Japan The effectiveness of Sildenafil (Viagra) for erectile dysfunction (ED) is recognized in the field of many etiological kinds of ED. In Japan, sildenaffi should be prescribed for the purpose of the improvement of quality of life (QOL) as well as for the treatment of ED.But we have no data whether sildenafil improves the QOL of diabetic patients with ED by the improvement of sexual function or not. We studied the changes of QOL after use of sildenafil in diabetic patients with neuropathy by the questionnaire method. The scale, consists of 17 items, regarding to subjective well-being and social attitude is used for the estimate of the improvement of QOL. Result: About 68% of the patients improved in the score of International Index of Erectile Function (IIEF-5),but about 10% of the patients could not get efficiency at all. Most patients of the effective group answered that they got the satisfactory sexual relationship with their partner after the use of sildenafil. The improvement of QOL is especially observed in the following questions: 1. Is your life going to be more fulflled? 2. As you are aging, will your life go to be downhill? 3. Does small thing bother you recently? 4. Are you enjoying everyday? 5. Do you spend your leisure time with fun? 6. Are you satisfied with your life? In the no effective group, the improvement of QOL was not observed. Conclusion: Sildenafil improves quality of life in diabetic patients with neuropathy and erectile dysfunction by the improvement of sexual function. TM
Pl167 The Influence of Combined Vitamin C and E Administration on Oxidative Stress and Fibrinolysis in Obese Type 2 Diabetic Patients J. ~KRHA, J. Kvasni~ka. Dept. of Internal Medicine and Dept. of
Hematology, Faculty of Medicine 1, Charles University, Prague, Czech Republic Background and aim: Oxidative stress plays an important role in development of vascular complications in diabetes. Antioxidative therapy could have therefore protective effect. However, the administration of the only one antioxidant like vitamin E in medium doses was accompanied by worsening of fibrinolysis in obese Type 2 diabetic patients. The aim of this pilot study was to evaluate the effect of combined vitamin C and E administration on endothelial dysfunction and fibrinolysis in obese Type 2 diabetic patients with advanced oxidative stress. Patients and methods: Ten obese Type 2 diabetic patients (BM132.6-1-3.2 kg/m2, age 524-9 yrs, diabetes duration 114-3 yrs) without serious complications or other disease and with accelerated oxidative stress measured by increased plasma MDA concentration were enrolled in this pilot study. Dally dose of 400 mg vitamin E and 1000 mg vitamin C were administered during 3 months. Control group consisted of 10 age and BMI matched healthy persons. Plasma malondialdehyde (MDA), tissue plasminogen activator (tPA) and PAI-1 concentrations, erythrocyte superoxide dismutase (SOD) and serum N-acetyl-/~-glucosaminidase (NAG) activities were evaluated at baseline and after 2 and 12 weeks of treatment. Results: The results of laboratory variables are in the table. Obese Type 2 diabetic patients had accelerated oxidative stress at baseline as demonstrated by increased plasma MDA concentration and decreased SOD activity. No significant changes of diabetes control, oxidative stress or endothelial activity measured by NAG were observed neither in acute nor in chronic vitamin administration. However, significant decrease of PAL1 concentration was found after two and twelve weeks of treatment with vitamin C and E whereas plasma tPA concentrations after 3 months
Pl165 Diabetic Erectile Dysfunction: Vascular or Neurological? SATYAN M. RAJBHANDARI, Lesley A. Brady, Nigel D. Harris, Simon Eaton, Solomon Tesfaye, John D. Ward. Diabetes Research, Royal
Hallamshire Hospital, Sheffield, United Kingdom Aim of study: Both vascular and neurological dysfunction can independently cause erectile dysfunction (ED). The aim of the stiudy was to define their role in diabetic ED. Methods: We studied 20 patients (Mean age 55.7 years 4- 10.4) with diabetes (7 type 1) of 16.1 4- 9.9 years duration, who had ED for 5.5 4- 4.4 years. Each subject underwent neurological assessment including clinical examination, peroneal motor and sural sensory nerve conduction, warm temperature discrimination threshold (TDT) and vibration perception threshold (VPT) in their feet and standard cardiac autonomic function tests (AFT). They also had detail vascular assessment with measurement of ankle brachial pressure index (ABPI) and Pharmaco-Penile Duplex Ultrasonography of cavernous arteries following intracavemosal injection of 20-microgram of alprostadil. Results: Clinically, neuropathy was present (Michigan score >7) in 11 patients (55%) however, 17 (85%) had abnormalities on neurophysiological testing (Abnormalities in TDT - 65%; VPT - 50%; conduction in both nerves - 70% and 2 or more abnormal cardiac autonomic function tests - 25%). Although peripheral vascular disease (ABPI <0.75) was not present in any patient, Pharmaco-Penile Duplex Ultrasonography showed moderate to severe disease (Peak velocity <25m per sec) in 16 (80%) cases. Conclusions: Contrary to conventional opinion, neither ABPI nor abnormal cardiac AFT were common in established diabetic ED, but impaired TDT, VPT, nerve conduction and abnormal Pharmaco-Penile Duplex Ultrasonography were more frequent. This study shows that both neurological and vascular dysfunction coexist in patients with diabetic ED, which may be the cause for poor response to treatment in this group.
$285
Pl166 Sildenafil (Viagra) Improves the QOL of Diabetic Patients with Erectile Dysfunction YUTAKA SUZUKI, Taro Maruyama, Tnshihiko Inukal, Kiyohiko Negishi. QOL Study Group, Saitama Diabetes Association,
Urawa, Saitama, Japan The effectiveness of Sildenafil (Viagra) for erectile dysfunction (ED) is recognized in the field of many etiological kinds of ED. In Japan, sildenaffi should be prescribed for the purpose of the improvement of quality of life (QOL) as well as for the treatment of ED.But we have no data whether sildenafil improves the QOL of diabetic patients with ED by the improvement of sexual function or not. We studied the changes of QOL after use of sildenafil in diabetic patients with neuropathy by the questionnaire method. The scale, consists of 17 items, regarding to subjective well-being and social attitude is used for the estimate of the improvement of QOL. Result: About 68% of the patients improved in the score of International Index of Erectile Function (IIEF-5),but about 10% of the patients could not get efficiency at all. Most patients of the effective group answered that they got the satisfactory sexual relationship with their partner after the use of sildenafil. The improvement of QOL is especially observed in the following questions: 1. Is your life going to be more fulflled? 2. As you are aging, will your life go to be downhill? 3. Does small thing bother you recently? 4. Are you enjoying everyday? 5. Do you spend your leisure time with fun? 6. Are you satisfied with your life? In the no effective group, the improvement of QOL was not observed. Conclusion: Sildenafil improves quality of life in diabetic patients with neuropathy and erectile dysfunction by the improvement of sexual function. TM
Pl167 The Influence of Combined Vitamin C and E Administration on Oxidative Stress and Fibrinolysis in Obese Type 2 Diabetic Patients J. ~KRHA, J. Kvasni~ka. Dept. of Internal Medicine and Dept. of
Hematology, Faculty of Medicine 1, Charles University, Prague, Czech Republic Background and aim: Oxidative stress plays an important role in development of vascular complications in diabetes. Antioxidative therapy could have therefore protective effect. However, the administration of the only one antioxidant like vitamin E in medium doses was accompanied by worsening of fibrinolysis in obese Type 2 diabetic patients. The aim of this pilot study was to evaluate the effect of combined vitamin C and E administration on endothelial dysfunction and fibrinolysis in obese Type 2 diabetic patients with advanced oxidative stress. Patients and methods: Ten obese Type 2 diabetic patients (BM132.6-1-3.2 kg/m2, age 524-9 yrs, diabetes duration 114-3 yrs) without serious complications or other disease and with accelerated oxidative stress measured by increased plasma MDA concentration were enrolled in this pilot study. Dally dose of 400 mg vitamin E and 1000 mg vitamin C were administered during 3 months. Control group consisted of 10 age and BMI matched healthy persons. Plasma malondialdehyde (MDA), tissue plasminogen activator (tPA) and PAI-1 concentrations, erythrocyte superoxide dismutase (SOD) and serum N-acetyl-/~-glucosaminidase (NAG) activities were evaluated at baseline and after 2 and 12 weeks of treatment. Results: The results of laboratory variables are in the table. Obese Type 2 diabetic patients had accelerated oxidative stress at baseline as demonstrated by increased plasma MDA concentration and decreased SOD activity. No significant changes of diabetes control, oxidative stress or endothelial activity measured by NAG were observed neither in acute nor in chronic vitamin administration. However, significant decrease of PAL1 concentration was found after two and twelve weeks of treatment with vitamin C and E whereas plasma tPA concentrations after 3 months