Irbesartan monotherapy in systemic hypertension: An open-label, uncontrolled trial

Background: Irbesartan is an orally active, specific blocker of the AT₁ receptor of angiotensin II that produces insurmountable antagonism. Irbesartan's plasma half-life of 11 to 15 hours and higher affinity for the AT₁ receptor versus other angiotensin II receptor subtypes may make it a suitable choice for once-daily treatment of hypertension. Few studies have examined the efficacy of this agent in Asian patients.Objective: The purpose of this open-label, uncontrolled study was to assess the 24-hour efficacy of irbesartan once-daily monotherapy in Chinese outpatients with mild to moderate hypertension.Methods: Patients with stage I or stage II hypertension (as defined by the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) were treated with irbesartan once daily for 6 to 8 weeks. The dose of irbesartan was titrated from an initial dose of 150 mg to 275 mg or 300 mg if adequate blood pressure (BP) control was not achieved by week 3 or 4; doses were taken once daily between 8 am and 9 am. For each patient, 24-hour ambulatory BP monitoring was performed twice, once before and once after 6 to 8 weeks of treatment.Results: A total of 25 patients (mean age, 54 years) were enrolled; 24 completed the study. Mean 24-hour systolic/diastolic BP after irbesartan treatment was significantly decreased compared with baseline values (128 ± 14 mm Hg/82 ± 8 mm Hg vs 143 ± 12 mm Hg/91 ± 7 mm Hg, P < 0.05 for both). The mean final dose of irbesartan was 243.8 ± 63.5 mg daily after a 7-week titration period. Mean daytime (6 am to 6 pm) BP decreased from 146 ± 11 mm Hg/94 ± 7 mm Hg to 130 ± 14 mm Hg/84 ± 8 mm Hg (P < 0.05), and nighttime (6 pm to 6 am) BP decreased from 139 ± 14 mm Hg/88 ± 7 mm Hg to 127 ± 15 mm Hg/81 ± 9 mm Hg (P < 0.05). The BP decrease was more pronounced during the day. Before treatment, the circadian variation showed a peak BP at 11 am and a nadir at 4 am. After treatment, significant BP reductions versus baseline (P < 0.05 for both diastolic and systolic BP) were observed for 23 of the 24 hourly mean points. The circadian rhythm of BP cycles was preserved. Mean heart rate did not change after treatment. Two patients reported dizziness and 1 reported heartburn.Conclusions: Irbesartan administered as once-daily monotherapy provided effective BP control during 23 of the 24 hourly mean points while preserving the circadian rhythm of BP cycles, and was well tolerated.     

心理性勃起功能障碍的功能磁共振成像研究

目的研究正常成年男性和心理性勃起功能障碍(ED)患者中枢神经系统的激活情况,探讨两者中枢神经系统兴奋性的差异。方法心理性ED患者12例,均为右利手,无任何精神及其他器质性疾病史。对照组为12例年龄性别相匹配的健康志愿者,均为右利手,无任何性功能障碍史,无器质性病变和其他可能影响脑结构和功能的不良生活习惯和药物滥用史。用色情录像和非色情录像刺激,每个录像片段60s,每个色情和非色情录像片段之间间隔12s。用GE1.5TMR扫描系统进行BOLD-fMRI扫描,头线圈。用3DSPGRT1WI序列进行全脑轴位扫描作为全脑解剖图。结果在视觉和听觉相关色情录像的刺激下,正常男性与心理性ED患者双侧小脑半球、小脑蚓部、双侧额下回、双颞叶、双侧扣带回、角回、左侧杏仁核、丘脑、海马、中脑及桥脑背侧均被激活;与正常男性相比,心理性ED患者双侧前扣带回激活的范围更大,两者的激活体积存在显著性差异(t=4.026,P<0.001),心理性ED患者平均激活体积为(979.64±25.33)mm3,正常男性为(795.43±20.35)mm3。结论边缘系统、脑干、丘脑等在调节男性性行为中起着重要的作用,心理性勃起功能障碍患者可能存在潜在的病因。     

Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: results of a European multicenter, open-label study of patient preference

BACKGROUND: Three inhibitors of phosphodiesterase 5 (PDE5) are now available for the treatment of erectile dysfunction (ED): sildenafil citrate, vardenafil, and tadalafil. Pharmacologic differences between these compounds may result in patient preferences for one over another and may influence treatment decisions made by the physician and patient. Therefore, clinical research is needed to investigate whether individual properties of the PDE5 inhibitors play a role in shaping patient preference. OBJECTIVES: The goal of this study was to determine what proportion of ED patients currently taking sildenafil would, after a period of treatment with tadalafil, elect to resume treatment with sildenafil at the customary dose and what proportion would elect a switch to tadalafil 20 mg for a longer period. The tolerability of both treatments was also investigated. METHODS: This was a short-term, multicenter, open-label, 1-way crossover trial conducted in Sweden and Italy. Eligible patients included men aged >or=18 years with a minimum 3-month history of ED who had been taking sildenafil at stable fixed doses of 25, 50, or 100 mg as needed for at least 6 weeks and up to 24 weeks. The study consisted of 6 phases: a 1-week screening phase, a 3-week sildenafil assessment phase, a 1-week washout phase, a 6-week tadalafil initiation phase, a 3-week tadalafil assessment phase, and a 6-month extension phase, during which patients received their treatment of choice free of charge. The primary outcome measure was the proportion of patients electing to take sildenafil or tadalafil during the extension phase. RESULTS: Of 155 men enrolled, 147 (97.8%) completed the assessment phases of the trial. Of these 147 men, 133 (90.5%) elected to receive tadalafil in the 6-month extension phase and 14 (9.5%) elected to receive sildenafil (P < 0.001). The proportions preferring tadalafil to sildenafil were similar irrespective of age group (>or=50 years, 92%; <50 years, 90%), severity of ED (mild, 95%; moderate, 88%; severe, 96%), etiology of ED (psychogenic, 94%; organic, 91%; mixed, 87%), and sildenafil dose at study entry (50 mg, 90%; 100 mg, 89%). Both medications were well tolerated. The most common treatment-emergent adverse events occurring in >or=2% of patients during the tadalafil assessment phase included headache (4.8%), nasal congestion (4.1%), dyspepsia (3.4%), flushing (2.7%), back pain (2.0%), diarrhea (2.0%), and nausea (2.0%); the most common treatment-emergent adverse events during the sildenafil assessment phase were flusing (7.1%), nasal congestion (6.5%), headache (4.5%), and nasopharyngitis (3.2%). CONCLUSIONS: In this short-term, open-label study, patients who were currently taking sildenafil for ED and then received tadalafil preferred to continue oral therapy with tadalafil over sildenafil by a ratio of approximately 9:1. Although the study sought to mimic the experience of actual patients receiving treatment for ED, the results are subject to potential limitations due to the design of the study, which included differences in dosing instructions and dosages for sildenafil and tadalafil. Both sildenafil and tadalafil were well tolerated.     

Effects of photodynamic therapy with verteporfin for the treatment of chronic central serous chorioretinopathy: An uncontrolled, open-label, observational study

Background: Central serous chorioretinopathy is an idiopathic disorder that leads to serous neurosensory retinal detachment. The disorder is usually self-limited and resolves spontaneously; however, sometimes neurosensory retinal detachment persists. This form of the disorder is called chronic central serous chorioretinopathy (CCSC).Objective: The aim of this study was to assess the effects of photodynamic therapy (PDT) on visual acuity with full-dose verteporfin for CCSC.Methods: The eyes of patients with CCSC were included in the study. Ophthalmic examination including best-corrected visual acuity (BCVA), fundus examination, fluorescein angiography, and optical coherence tomography was performed before treatment and at 1, 3, 6, 9, and 12 months. PDT with full-dose verteporfin (6 μ/m² of body surface area) was applied only to areas of active leakage. BCVA was converted to a log of the minimum angle of resolution (logMAR) equivalent for statistical analysis. Central foveal thickness and BCVA between baseline and follow-up were compared.Results: Seventeen eyes of 16 patients (13 males, 3 females; mean [SD] age, 39.75 [7.51] years; mean duration of follow-up, 13.06 [1.82] months) were used in the study. The mean (SEM) logMAR BCVA was 0.26 (0.07) at baseline and 0.04 (0.02) at 12 months. Mean logMAR BCVA values at baseline (0.259) and after treatment (0.112, 0.053, 0.047, 0.041, and 0.041 at 1, 3, 6, 9, and 12 months, respectively) differed significantly (P = 0.006, P = 0.005, P = 0.005, P = 0.005, and P = 0.005). There was a significant difference in the mean central foveal thickness at the final visit (169 μm) compared with the baseline value (383 μm; P < 0.001). BCVA decreased in one eye (20/20 vs 20/25) and persisted during follow-up; in the other 16 eyes, BCVA either increased (n = 10) or remained stable (n = 6).Conclusions: In this small, open-label study, patients with CCSC treated with a single course of PDT with full-dose verteporfin had significant improvement from baseline in BCVA and resolution of subretinal fluid accumulation and active leakage. Treatment was generally well tolerated, but one patient had worsening in BCVA.     

An eight-week, open-label, uncontrolled, multicenter, Phase IV study of remission rates in outpatients and inpatients with major depression treated with venlafaxine

Background: Venlafaxine is a structurally novel antidepressant that is believed to potentiate monoamine activity in the central nervous system. In preclinical studies, venlafaxine was shown to inhibit the neuronal uptake of serotonin and norepinephrine and, to a lesser degree, dopamine reuptake, but was without effect on monoamine oxidase (MAO) activity. Clinical trial results from ∼3000 patients suggest that venlafaxine is a safe and effective antidepressant with the potential to invoke an early onset of clinical activity.Objective: The purpose of this 8-week, open-label, uncontrolled, multicenter, Phase IV study was to examine the extent of remission and symptom relief in outpatients and inpatients with major depressive disorder treated with venlafaxine.Methods: This study was conducted at 12 centers across Belgium and Luxembourg. Consecutive, severely depressed inpatients and moderately depressed outpatients aged 18 to 70 years were eligible. Patients were administered open-label venlafaxine for 8 weeks. Dosing was initiated at venlafaxine 75 mg/d (37.5 mg BID), with dose adjustments made throughout the study, to a maximum daily dose of 375 mg for inpatients and 225 mg for outpatients. Results were measured using the Hamilton Depression (HAM-D) scale, the Montgomery-Asberg Depression Rating Scale (MADRS), and the Clinical Global Impression (CGI) scale.Results: A total of 149 consecutive patients (84 females, 65 males; mean age, 46.5 years; 88 outpatients, 61 inpatients) were enrolled; the intent-to-treat (ITT) population comprised 144 patients (84 outpatients, 60 inpatients); 111 patients (64 outpatients, 47 inpatients) completed the study. At the week 8 visit, 71.3% of patients (77/108) were considered to be responders according to the HAM-D scale; 73.8% (79/107) according to the MADRS; and 78.7% (85/108) according to the CGI scale. A sustained response was achieved in 33.3% of the ITT population (48/144), and at week 8, 50.8% of outpatients (32/63) and 37.8% of inpatients (17/45) were in remission according to the HAM-D scale. Venlafaxine was well tolerated at all doses, with the most frequently experienced adverse events (AEs) being nausea, sweating, and headache. Fewer inpatients than outpatients reported ≥1 AE (57.4% [35/61] and 73.9% [65/88], respectively), despite receiving a higher maximum daily dose of venlafaxine.Conclusion: The results of this study indicate that venlafaxine was a tolerable and effective antidepressant in both outpatients and inpatients, with a significant proportion of patients achieving remission.     

Impulse magnetic-field therapy for erectile dysfunction: A double-blind,placebo-controlled study

This double-blind, placebo-controlled study assessed the efficacy of 3 weeks of impulse magnetic-field therapy for erectile dysfunction (ED). Twenty volunteers who suffered from ED or orgasmic disturbances were randomly assigned to either active treatment or placebo (n = 10 each). Efficacy was assessed in terms of intensity and duration of erection, general well-being, sexual activity, and warm sensation in the genital area. In the active-treatment group, all efficacy endpoints were significantly improved at study end (P=.01), with 80% reporting increases in intensity and duration of erection, frequency of genital warmth, and general wellbeing. The remaining 20%, who experienced minor improvements, were found to have an influenza-like infection after the study that may have influenced their results. Only 30% of the placebo group noted some improvement in their sexual activity; 70% had no change. No side effects were reported.     

A study of the management of erectile dysfunction in general practice

BACKGROUND AND OBJECTIVES: The Department of Health issued guidelines for the NHS treatment of erectile dysfunction (ED) with phosphodiesterase type 5 inhibitors (PDE 5 inhibitors) in 1999. There has been an increasing trend in the prescribing of PDE 5 inhibitors within Bebington and West Wirral Primary Care Trust (PCT) over the 3-year period from February 2001 to January 2004. The objective of the study was to investigate implementation of Government guidelines on prescribing of PDE 5 inhibitors for ED and the cost of prescribing outside these guidelines. METHODS: Practice data were collected for all patients prescribed a PDE 5 inhibitor in 16 surgeries within Bebington and West Wirral Primary Care Trust, from November 2002 to December 2003. The data were evaluated with respect to adherence to UK Government guidelines. Analysis was made on the cost to the PCT with respect to treatment provided outside the guidelines. RESULTS AND DISCUSSION: Prescribing for 78% of patients was within Government guidelines. With respect to frequency of prescribing, 89% of patients in the PCT received less than or equal to the recommended frequency of one tablet per week. The percentage range for practices was 67-100%. The cost to the PCT for PDE 5 inhibitor treatment provided outside the guidelines was 19,060 pounds sterling over the period of study. CONCLUSION: Prescribers generally follow Government guidelines, however, stricter adherence to guidelines could result in more efficient use of National Health Service resources.     

Assessment, diagnosis, and investigation of erectile dysfunction

Diagnosis of erectile dysfunction (ED) now largely rests on the medical, sexual, and psychosocial history of the patient, ideally involving the man's partner. The medical history is crucial because ED is associated with so many common disorders and their treatment. A range of validated questionnaires may be used in taking the history. They can provide an objective and systematic record. The history helps identify whether the ED is largely physical or psychogenic. In particular, gradual onset suggests a physical cause, and sudden onset suggests a psychogenic cause. Physical examinations are not usually necessary. Taking blood pressure and physical examination of the genitals for signs of Peyronie's disease and hypogonadism may be helpful. Laboratory tests that identify diabetes (glycosylated haemoglobin), hyperlipidaemia (lipids), and hypogonadism (testosterone) may identify causes of ED. A range of specialized investigations, such as ultrasound and nocturnal penile tumescence and rigidity assessment, is also available, but is not used routinely in most patients with ED.     

Targeted etanercept for discogenic neck pain: uncontrolled,open-label results in two adults

BACKGROUND: Etanercept, a recombinant biologic anti-tumor necrosis factor (TNF)-alpha therapeutic, is approved for the treatment of certain autoimmune arthritides by subcutaneous (SC) injection. TNF-alpha has been suggested to play a central role in neuropathic pain and neuronal damage associated with intervertebral disc herniation. Directed local administration of etanercept, in anatomic proximity to the site of disc and neuronal abnormality, may result in an enhanced therapeutic response. OBJECTIVE: This study reviews findings from 2 patients with chronic, severe, discogenic cervical pain who were treated with a targeted cervical injection of etanercept with the objective of obtaining relief from their treatment-resistant pain. METHODS: In this uncontrolled, open-label study, the case histories of 2 patients (1 woman and 1 man) presenting with a history of chronic neck pain refractory to various treatments are reviewed. Both patients were treated with etanercept 25 mg by SC injection to the cervical region (case 1) or the posterior neck overlying the spine (case 2). RESULTS: Both patients experienced almost complete pain relief as assessed subjectively. In case 1, the Oswestry score decreased from 58 before treatment to 6 one day following treatment. In addition, 1 day after treatment the patient reported a subjective assessment of 98% pain improvement, 100% sensory improvement, and 100% weakness improvement. She has remained asymptomatic for >1 year. In case 2, the Oswestry score decreased from 44 before treatment to 4 two months after treatment. The patient reported 100% pain relief and 90% sensory improvement 1 day after treatment. At 8-month follow-up, pain improvement continued to be 100% and sensory improvements was 75%. CONCLUSIONS: Etanercept, delivered by targeted SC injection, may be of benefit for selected patients with resistant pain associated with cervical disc disease. Further study of this new treatment modality is warranted.     

Pharmacology of erectile dysfunction in man

Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual activity (2nd International Consultation on Sexual Dysfunction-Paris, June 28th-July 1st, 2003). Following the discovery and introduction of sildenafil, research on the mechanisms underlying penile erection has had an enormous boost and many preclinical and clinical papers have been published in the last 5 years. This review is structured in order to give the reader an overview of the clinical and preclinical data available on the peripheral regulation of and the mediators involved in human penile erection. The most widely accepted risk factors for ED are discussed. The article is focused on human data, and the safety and effectiveness of the 3 commercially available Phosphodiesterase-5 (PDE5) inhibitors used to treat ED are also discussed.     

An open-label, uncontrolled, prospective study of the effects of atorvastatin 10 mg on low-density lipoprotein cholesterol levels in chinese adults with coronary artery disease and hypercholesterolemia

Background: A high level of low-density lipoprotein cholesterol (LDL-C) is a major risk factor for coronary artery disease (CAD). Evidence shows that lowering LDL-C improves the outcomes of patients with CAD. Atorvastatin is an established drug for the treatment of hypercholesterolemia.Objective: The purpose of this open-label, uncontrolled, prospective study was to assess the effectiveness of treatment with atorvastatin 10 mg/d for 18 weeks in achieving the target level of LDL-C (<2.6 mmol/L [<100 mg/dL]) established by the National Cholesterol Education Program (NCEP) (United States) for patients with established CAD and hypercholesterolemia.Methods: Chinese patients with CAD, hypercholesterolemia (defined as a baseline LDL-C level between 3.4 and 5.2 mmol/L [131-201 mg/dL]), and body mass index <30 kg/m² were eligible. Atorvastatin 10 mg/d was given to each patient for 18 weeks. Lipid profiles were checked at 6, 12, and 18 weeks. To assess the extent of the achievement of NCEP LDL-C target levels, patients were categorized into 3 groups retrospectively according to baseline LDL-C level: group 1, 3.4 to 4.0 mmol/L (131-154 mg/dL); group 2, 4.01 to 4.6 mmol/L (155-178 mg/dL); and group 3, 4.61 to 5.2 mmol/L (179-201 mg/dL).Results: A total of 63 patients (50 men, 13 women; mean age, 64.3 years) were enrolled. Significant decreases in total cholesterol (31.3% at week 18), LDL-C (42.9% at week 18), and triglycerides (21.8% at week 18) from baseline levels were found at 6, 12, and 18 weeks of treatment (P < 0.001 for all). The changes in high-density lipoprotein cholesterol levels were nonsignificant. In group 1, 83.3% of patients met the target level of LDL-C; group 2, 87.5%; group 3, 37.5%; groups 1 and 2 combined, 85.2%. Atorvastatin 10 mg/d was well tolerated. Clinical adverse events were mild and transient; no severe adverse events were reported. One patient (1.6%) developed an elevated alanine aminotransferase level and withdrew. Sixty-two of 63 patients (98.4%) completed the study.Conclusions: In this group of Chinese patients with CAD and hypercholesterolemia treated with atorvastatin 10 mg/d for 18 weeks, 85.2% of patients with a baseline LDL-C level of 3.4 to 4.6 mmol/L achieved the NCEP target LDL-C level of <2.6 mmol/L, suggesting that atorvastatin 10 mg/d is efficacious in preventing secondary CAD.     

Low doses of transdermal buprenorphine in opioid-naive patients with cancer pain: A 4-week,nonrandomized, open-label,uncontrolled observational study

Objective: The aim of this study was to evaluate the effect and tolerability of low doses of transdermal (TD) buprenorphine patches in opioid-naive patients with cancer pain.Methods: This was a nonrandomized, open-label, uncontrolled study in consecutive opioid-naive patients with advanced cancer and moderate pain. TD buprenorphine was initiated at a dose of 17.5 μg/h (0.4 mg/d), with patch changes every 3 days. Doses were then adjusted according to the clinical response. Pain intensity, opioid-related adverse effects, TD buprenorphine doses, and quality of life were monitored over 4 weeks. The time to dose stabilization and indexes of dose escalation were also calculated.Results: Thirty-nine consecutive patients completed all 4 weeks of the study. Low doses of TD buprenor-phine were well tolerated and effective in these opioid-naive patients with cancer pain. Pain control was achieved within a mean of 1.5 days after the start of TD buprenorphine therapy. The mean TD buprenorphine dose was significantly increased from baseline beginning at 2 weeks after the start of therapy and had doubled by 4 weeks (P < 0.05). Pain intensity was significantly decreased from baseline beginning at 1 week and continuing through the remaining weekly evaluations (P < 0.05). The mean buprenorphine escalation index, calculated as a percentage and in milligrams, was 41.2% and 0.2 mg, respectively. Quality of life improved significantly over the study period (P = 0.007). There were no significant changes in opioid-related symptoms between weekly evaluations.Conclusion: Observations from this study suggest that randomized, controlled, double-blind studies of TD buprenorphine 17.5 μg/h in opioid-naive patients with cancer pain may be warranted.     

Associations between lifestyle,erectile dysfunction and healthcare seeking: a population-based study

Objective: To investigate associations between age, lifestyle and erectile dysfunction (ED) in the general population and to explore associations between age, lifestyle and contact with a general practitioner (GP) regarding ED.Design: Cross-sectional web-based questionnaire study.Setting: The general Danish population.Subjects: A randomly selected sample of 48,910 men aged 20 years and older.Main outcome measures: Prevalence of ED and probability of contacting a GP regarding ED. In logistic regression models we analysed associations between age, smoking status, alcohol consumption, body mass index (BMI), and self-rated physical fitness on both ED and GP contact.Results: A total of 22,198 men (47.6%) completed the question regarding ED. The overall prevalence of ED was 19.3%, varying from 2.3% among men aged 20–29 years to 55.3% among men aged 80 years and above. 31.8% of men reporting ED had contacted a GP regarding ED. Increasing age, current or former smoking, complete alcohol abstinence or alcohol consumption above seven units per week, high BMI, and poor self-rated physical fitness were significantly associated with reporting ED. The proportion of GP contacts was significantly associated with age. Overall, no significant associations between lifestyle and healthcare seeking were observed, although lower odds of GP contact were found when physical fitness was rated as poor.Conclusion: Reporting ED and GP contact were significantly associated with age. Furthermore, lifestyle was significantly associated with reporting ED, but largely not associated with healthcare seeking. These findings are important for future interventions aiming to improve diagnosis and treatment of ED.

Key points

• Experiencing erectile dysfunction is frequent in the general population, especially among older men.
•   • In this large-scale national survey, age and lifestyle were significantly associated with reporting erectile dysfunction.
•   • Healthcare seeking with erectile dysfunction was significantly associated with age, but not with lifestyle.
•   • Diagnosis and treatment of erectile dysfunction might be challenged when erectile dysfunction does not lead to healthcare seeking.

     

Effects of ezetimibe on glucose metabolism in patients with type 2 diabetes: A 12-week, open-label, uncontrolled, pilot study

Background: A potential effect of ezetimibe, a novel cholesterol-absorption inhibitor, on insulin resistance has been reported in an animal model.Objective: The aim of this study was to evaluate the effects of ezetimibe on glucose metabolism in patients with type 2 diabetes mellitus (T2DM).Methods: Between March and June 2008, outpatients with T2DM who were being treated at Yokohama Sakae Kyosai Hospital, Yokohama, Japan, were enrolled in this pilot study if they had not achieved the target lipid levels recommended by the Japan Atherosclerosis Society Guidelines despite diet and exercise or a statin therapy for ≥3 months. At baseline and at 4 and 12 weeks after open-label treatment with ezetimibe 10 mg/d, the levels of lipid parameters, fasting plasma glucose (FPG), glycosylated hemoglobin (HbA_1c), and high-sensitivity C-reactive protein were measured. Adverse effects (AEs) were assessed at each study visit by patient interviews and laboratory testing.Results: A total of 21 consecutive patients (10 men, 11 women; mean [SD] age, 72 [9] years; weight, 63.4 [10.5] kg; body mass index, 25.5 [3.2] kg/m²) were enrolled in this study. The mean (SD) level of LDL-C decreased significantly from 146 (31) to 114 (27) mg/dL (−21%; P < 0.001) after 12 weeks of treatment with ezetimibe. The mean level of remnant-like particle cholesterol also decreased significantly from 6.5 (3.8) to 4.8 (2.2) mg/dL (−15%; P = 0.03). Treatment with ezetimibe was associated with a reduction in FPG level from 127 (31) to 119 (30) mg/dL (P = 0.02), and HbAlc from 6.3% (0.6%) to 6.1% (0.7%) (P = 0.003). No AEs were observed or reported during the study period.Conclusion: In this small, open-label, uncontrolled, pilot study, ezetimibe was associated with a significant decrease in lipid parameters and improvement in glucose metabolism in these patients with T2DM.     

Medical treatment of erectile dysfunction

Erectile dysfunction (ED) is defined as the consistent inability to obtain or maintain an erection for satisfactory sexual relations. Data from the Massachusetts Male Aging Study have indicated that the prevalence of erectile dysfunction of any degree is 39% in 40-year old men, and 67% in those aged 70 years. Effective therapy has been available for some time, but it has commonly involved surgery, external devices or penile self-injection. For many men, these represent unacceptable barriers to seeking therapy. Recently, however, an effective oral medication has become available. This article reviews the physiology and pharmacology of ED. The literature currently available on the effectiveness and safety of various drugs used for ED is summarized, with particular attention to newly available oral agents. Guidelines for work-up and drug treatment of patients with ED are given. Detailed history and physical examination are crucial to the safe and effective treatment of men with erectile impotence. An extensive review of the literature shows that based on safety, effectiveness and ease of use, oral sildenafil citrate is an excellent choice for first-line therapy. Patients who use organic nitrates of any kind in any capacity should not be offered sildenafil. Based solely on effectiveness intra-cavernosal injection therapy remains the golden standard and should also be offered as an option for first-line therapy for the appropriate patients. Many alternatives are available for men who cannot use sildenafil or injection therapy. A thorough knowledge of existing medications is essential for proper treatment of ED.     

Medical implications of erectile dysfunction

Erectile dysfunction (ED) is a common condition in aging men, with a prevalence of 52% in men aged 40 to 70 years. It is frequently associated with several comorbid conditions, including cardiovascular disease, lower urinary tract symptoms, and testosterone deficiency. These conditions often have major consequences on the quality of life of patients and require adequate evaluation by the primary care practitioner. Complaints of ED, therefore, serve as a marker for these conditions and give the practitioner an opportunity to prevent the consequences of a delay in treatment. In this article, the evidence behind these associations is described.     

Clinical management of erectile dysfunction

Erectile dysfunction (ED) affects 8% of 40‐year‐old men, increasing to 40% in 60‐year‐old men. It can be the first presentation of vascular disease and the average time between onset of ED and the first coronary vascular event is 3 years. The prevalence of ED is increasing and will continue to increase as the population ages. Prostate surgery commonly causes ED and nurses need to identify men with ED early, as treatment for ED should be commenced at the earliest opportunity provided the man and his partner want to engage in sexual activity. Options for treatment include phosphodiesterase type 5 inhibitors (sildenafil, tadalafil or vardenafil) as required, or ‘once daily’ for tadalafil. Alternative options include urethral pellets, intracavernosal injections, vacuum devices, counselling and penile prosthesis. The selection of treatment is dependent on an accurate assessment of the problem, an estimation of cardiovascular risk and of patient preference.     

Diagnostic evaluation of erectile dysfunction

Erectile dysfunction, the persistent inability to attain or maintain penile erection sufficient for sexual intercourse, affects millions of men to various degrees. The majority of cases have an organic etiology, most commonly vascular disease that decreases blood flow into the penis. Regardless of the primary cause, erectile dysfunction can have a negative impact on self-esteem, quality of life and interpersonal relationships. The initial step in evaluation is a detailed medical and social history, including a review of medication use. Discussion with the patient's sexual partner may clarify exacerbating issues. The physical examination focuses on the cardiovascular, neurologic and urogenital systems. Laboratory tests are useful to screen for common etiologic factors and, when indicated, to identify hypogonadal syndromes. Appropriate evaluation of erectile dysfunction leads to accurate advice, management and referral of patients with erectile dysfunction.