Effect of buspirone on sexual dysfunction in depressed patients treated with selective serotonin reuptake inhibitors.

To evaluate the possible influence of buspirone on sexual dysfunction in depressed patients treated with a selective serotonin reuptake inhibitor (SSRI), we analyzed data from a placebo-controlled trial designed to explore the efficacy of buspirone as add-on treatment for patients not responding to an SSRI alone. At baseline, all patients met the criteria for a major depressive episode according to DSM-IV and had received citalopram or paroxetine during a minimum of 4 weeks without responding to the treatment. Buspirone (flexible dosage, 20-60 mg/day) or placebo was added to the SSRI for 4 weeks; the mean daily dose of buspirone at endpoint was 48.5 mg (SD = 1.0). Sexual dysfunction was evaluated using a structured interview. Before starting medication with buspirone or placebo, 40% (47 of 117) reported at least one kind of sexual dysfunction (decreased libido, ejaculatory dysfunction, orgasmic dysfunction). During the 4 weeks of treatment, approximately 58% of subjects treated with buspirone reported an improvement with respect to sexual function; in the placebo group, the response rate was 30%. The difference between placebo and active drug treatment was more pronounced in women than in men. The response was obvious during the first week, with no further improvement during the course of the study. It is suggested that the effect of buspirone on sexual dysfunction is a result of a reversal of SSRI-induced sexual side effects rather than of an antidepressant effect of the drug.     

Effects of bupropion sustained-release on sexual functioning and nocturnal erections in healthy men

Many antidepressants are known to cause adverse sexual effects. Bupropion is an antidepressant with fewer reported adverse sexual effects. Studies of sexual side effects are often confounded by psychiatric and medical conditions affecting sexual function. In this study, the effects of bupropion on subjective and objective sexual functioning were measured in healthy men. Thirteen men without psychiatric or medical illness completed a 2-week, placebo-controlled, double-blind, crossover trial of bupropion sustained-release 300 mg/day. Subjects had a 1-week washout period between trials. Sexual function was measured using a validated, self-administered questionnaire and the RigiScan, an instrument measuring nocturnal penile tumescence and rigidity. No differences were found in self-reported sexual function, number of erections, total erection time, or penile rigidity in subjects taking bupropion compared with those taking placebo or baseline. These findings support that bupropion does not have subjective adverse sexual side effects and does not affect nocturnal erections in healthy men.     

A placebo-controlled,double-blind trial of Ginkgo biloba for antidepressant-induced sexual dysfunction

The aim of this study was to examine the effect of Ginkgo biloba on antidepressant-induced sexual dysfunction. The Ginkgo biloba (n=19) and the placebo groups (n=18) were divided; each to be administered with Ginkgo biloba and placebo respectively for 2 months by means of a randomized placebo-controlled, double-blind study. The results of this 2 month trial were: (1) there was no statistical significant difference from the placebo at weeks 2, 4 and 8 after medication; (2) in comparison with baseline, both the Ginkgo biloba group and the placebo group showed improvement in some part of the sexual function, which is suggestive of the importance of the placebo effect in assessing sexual function. This study did not replicate a prior positive finding supporting the use of Ginkgo biloba for antidepressant, especially SSRI, induced sexual dysfunction.     

Assessment of sexual functioning in depressed patients treated with mirtazapine: a naturalistic 6-month study

Antidepressant-induced sexual dysfunction is a frequent side effect which may greatly contribute to treatment non compliance. Mirtazapine has a pharmacological profile expected to result in a lack of sexual dysfunction. The main purpose of this 6-month open-label study was to evaluate the effects of mirtazapine on sexual function of a sample of depressed patients. METHODS: Seventy-eight patients meeting DSM-IV criteria for major depression or adjustment disorder with depressed mood or with mixed anxiety and depressed mood, sexually active prior to the episode, were treated with mirtazapine (15-60 mg/day). Effectiveness was assessed using the 17-item Hamilton rating scale for depression (HAM-D-17), the Hamilton rating scale for anxiety (HAM-A) and the clinical global impression (severity and improvement) scales (CGI). Sexual function was evaluated with the psychotropic-related sexual dysfunction questionnaire (PRSexDQ) which detects clinical changes in sexual dysfunction. RESULTS: Forty-eight patients (61.5%) were experiencing sexual dysfunction at baseline. A return to normal sexual functioning was observed in 27 of 38 (71.1%) patients completing the study. Significant reductions in mean total PRSexDQ scores were detected at day 90 and endpoint and only four patients withdrew or required dose reduction due to mirtazapine-induced sexual dysfunction. A total of 37 patients (47.4%) achieved complete remission of depression (HAM-D-17 score 相似文献   

Sexual dysfunction associated with antidepressant drugs

The term 'sexual dysfunction' describes a disturbance in sexual desire and the psychophysiological changes that characterise the normal sexual response cycle, and cause marked personal distress and interpersonal difficulty. Epidemiological studies indicate that sexual dysfunction is common in the general population, but more common in depressed individuals in community settings and clinical samples. Most antidepressant drugs have adverse effects on sexual function, but accurate identification of the incidence of treatment-emergent dysfunction has proved troublesome. Futhermore, investigations of sexual dysfunction associated with antidepressants have one or more methodological flaws. There may be some advantages for bupropion, moclobemide, nefazodone and reboxetine over other antidepressants. Many approaches have been adopted for management of patients with sexual dysfunction associated with antidepressant treatment, including waiting for the problem to resolve, behavioural strategies to modify sexual technique, individual and couple psychotherapy, delaying the intake of antidepressants until after sexual activity, reduction in daily dosage, 'drug holidays', use of adjuvant treatments, and switching to a different antidepressant.     

Neurophysiologic correlates of side effects in normal subjects randomized to venlafaxine or placebo.

Adverse events reported in the context of medication administration may be due to pharmacodynamic and/or nonpharmacodynamic effects (eg, nocebo phenomena). Neurophysiological substrates of side effects may be examined in placebo-controlled antidepressant treatment trials. We explored the relationship between side effects and regional neurophysiologic changes in normal subjects receiving a 1-week placebo lead-in followed by 4 weeks randomized treatment with placebo (n = 15) or venlafaxine IR (n = 17). Quantitative electroencephalographic (QEEG) cordance measures were obtained before and during treatment, and side effects were assessed weekly using semistructured interviews. Side effect burden, characterized as the mean number of side effects per postrandomization visit, correlated significantly with neurophysiologic changes in the antidepressant group but not the placebo group. Medication group side effects were negatively correlated with changes in prefrontal cordance at end of placebo lead-in (r = -0.67, p < 0.003), at 2 weeks (r = -0.77, p < 0.002), and at 4 weeks (r = -0.77, p < 0.004) post randomization. After controlling for the prefrontal change at the end of placebo lead-in, postrandomization brain changes did not further explain side effect burden. Changes in prefrontal brain function associated with later antidepressant side effects were observed during placebo lead-in-prior to the administration of medication. Prefrontal brain function during brief placebo administration may help explain susceptibility to the development of antidepressant side effects. Results of these exploratory hypothesis-generating analyses should be considered tentative until replicated.     

Tadalafil

black triangle Tadalafil is a selective phosphodiesterase type 5 inhibitor that is effective in men with mild-to-severe erectile dysfunction (ED), including those with diabetes mellitus. black triangle The improvement in the erectile function domain score on the International Index of Erectile Function (IIEF) and the percentage of sexual intercourse attempts marked by successful vaginal penetration and completion was significantly greater with on-demand (not more than once daily) tadalafil 10 or 20 mg than placebo in trials of 12 weeks' duration. Improvement in scores on other domains of the IIEF and the percentage of positive responses to a Global Assessment Question measuring erection improvement were also significantly greater with on-demand tadalafil than placebo. black triangle The adverse events associated with tadalafil were generally mild to moderate and decreased in frequency with continued administration. The most commonly reported adverse events were headache and dyspepsia. The incidence of cardiovascular adverse events was not significantly different in tadalafil or placebo recipients.     

A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR

Impaired sexual function is associated with major depressive disorder in the untreated state and is often more prevalent during antidepressant therapy, which frequently results in poor treatment compliance. In this double-blind, multicenter study, the effects of agomelatine (an MT1 and MT2 agonist and 5HT-2C antagonist) and venlafaxine XR on sexual function were compared using the Sex Effects Scale in depressed patients. A total of 276 male and female patients received either agomelatine (50 mg) or venlafaxine XR (titrated to a target dose of 150 mg/d) for 12 weeks. Those who were sexually active at baseline (n = 193) and those who, in addition, achieved remission (n = 111) were defined a priori for analyses of change in sexual function. Treatment-emergent sexual dysfunction was significantly less prevalent among patients who received agomelatine, and venlafaxine XR was associated with significantly greater deterioration on the Sex Effects Scale domains of desire and orgasm. Both treatments resulted in equivalently high rates of remission (agomelatine, 73%; venlafaxine XR, 66.9%), although fewer patients in the agomelatine group discontinued treatment because of adverse events (agomelatine, 2.2%, vs venlafaxine XR, 8.6%). Agomelatine seems to be an efficacious antidepressant with a superior sexual side effect profile compared with venlafaxine XR, although superiority to placebo was not evaluated in this trial.     

Evaluation of sexual functioning in depressed outpatients: a double-blind comparison of sustained-release bupropion and sertraline treatment

Sexual dysfunction is a frequently reported side effect of many antidepressants, including serotonin reuptake inhibitors. Bupropion, an antidepressant of the aminoketone class, is relatively free of adverse sexual effects. In a randomized, double-blind, multicenter trial, sustained-release bupropion (bupropion SR) and sertraline, a selective serotonin reuptake inhibitor, were found to be similarly efficacious in the treatment of outpatients with moderate to severe depression. This report describes the results of a double-blind comparison of the sexual side effect profiles of bupropion SR and sertraline. Two hundred forty-eight patients who had received a diagnosis of moderate to severe major depression were randomly assigned to receive treatment with bupropion SR (100-300 mg/day) or sertraline (50-200 mg/day) for 16 weeks. Eligible patients were required to be in a stable relationship and to have normal sexual functioning. Sexual functioning was assessed by the investigator at each clinic visit using investigator-rated structured interviews. A significantly greater percentage of sertraline-treated patients (63% and 41% of men and women, respectively) developed sexual dysfunction compared with bupropion SR-treated patients (15% and 7%, respectively). Sexual dysfunction was noted as early as day 7 in sertraline-treated patients at a dose of 50 mg/day and persisted until the end of the 16-week treatment phase. Four patients, all of whom were treated with sertraline, discontinued from the study prematurely because of sexual dysfunction. Given the similar efficacy of the two drugs in treating depression, bupropion SR may be a more appropriate antidepressant choice than sertraline in patients for whom sexual dysfunction is a concern.     

Vilazodone,a novel dual-acting serotonergic antidepressant for managing major depression

Major depressive disorder (MDD) affects ≤ 15% of the general population and imparts a significant economic and psychosocial burden. Despite the availability of a wide range of drugs for treating MDD, the majority of patients fail to achieve complete and sustained remission of symptoms. Vilazodone is a novel dual-acting serotonergic antidepressant currently in clinical development for the treatment of MDD. Vilazodone combines the effects of a selective serotonin reuptake inhibitor with 5-HT_1A receptor partial agonist activity. In a recent Phase III clinical trial, vilazodone showed significant antidepressant efficacy compared to placebo with a statistically significant onset of effect at 1 week. Overall dropout rates were low. Diarrhea, nausea and headache were the most common adverse events reported. In addition, there was no significant difference between placebo and vilazodone in terms of sexual dysfunction as measured by the Arizona Sexual Experiences Scale. A unique feature of the vilazodone clinical program is the concurrent development of biomarkers that may predict treatment response and common side effects. Vilazodone offers a dual mechanism of action, good general tolerability with the potential for less impairment of sexual function than selective serotonin reuptake inhibitors and the possibility of personalized treatment for MDD.     

A pilot randomized, double-blind, placebo-controlled study of granisetron in the treatment of sexual dysfunction in women associated with antidepressant use

A pilot study was conducted to evaluate the usefulness of granisetron for the treatment of antidepressant induced sexual dysfunction in women. Twelve women with antidepressant induced sexual dysfunction (AISD) were assigned granisetron (n=5) or placebo (n=7) in a 14-day randomized, double-blind, placebo-controlled study. One participant in the granisetron group did not complete the study. Participants were assessed at baseline, day 7 and day 14 using the Feiger Sexual Function and Satisfaction Questionnaire and the Arizona Sexual Experience Scale. No statistical differences were measured at baseline or at endpoint between the granisetron or placebo group. This study did not produce evidence supporting the usefulness of granisetron in AISD.     

Bupropion--an antidepressant without sexual pathophysiological action

Bupropion, a new nontricyclic antidepressant, was administered clinically on an open basis to 40 male outpatients at doses of 300 to 600 mg/day for 4 to 26 months. Of these, 12 patients had no history of sexual dysfunction, whereas 28 patients reported a history of significant sexual dysfunction (impaired libido, partial erection) while receiving tricyclic, monoamine oxidase inhibitor, maprotiline, and trazodone antidepressants. The adverse sexual effects resolved in 24 of the 28 patients (p less than 0.001) when they were transferred to bupropion. Of the four patients who failed to improve sexually on bupropion, two were diabetic and the other two had lifelong impairments in sexual functioning that were probably unrelated to drugs or depression. The 12 patients who had a negative history of sexual dysfunction continued to have normal sexual functioning during bupropion treatment. Based upon bupropion's lack of anticholinergic and antiadrenergic effects and the clinical observations in this study, this antidepressant appears to have a very low propensity for inducing adverse sexual side effects.     

抑郁障碍、抗抑郁药和性功能障碍的关系研究进展

 　抑郁障碍和性功能障碍的患病率和共病率较高。在性功能障碍患者中,抑郁障碍的发生率较高;在抑郁 障碍患者中,性功能障碍也较常见,其中,最常见的是性欲低下和性兴奋障碍。然而,抑郁障碍和性功能障碍的确切关 系仍然不明确,包括是否有确切的因果关系或者是否有共同的发病机制,尤其是抗抑郁药在性功能方面的不良反应进一 步使抑郁障碍和性功能障碍的关系复杂化,也使三者形成复杂的关系网。临床实践中,在处理性功能障碍的患者时,应 该常规筛查抑郁症状;因为性功能障碍的缓解是抑郁缓解的重要预测因素之一,所以性功能障碍的治疗也应该整合为抑 郁障碍治疗的一部分。文中综述了近年来抑郁障碍和性功能障碍关系以及抗抑郁药对性功能影响的研究进展。     

Sildenafil: a review of its use in erectile dysfunction.

Sildenafil is an oral therapy for erectile dysfunction of a broad range of causes. By selectively inhibiting phosphodiesterase type 5, it allows corpus cavernosum smooth muscle to relax, potentiating erections during sexual stimulation. Blood pressure is reduced transiently by sildenafil, but more marked hypotension may occur during concurrent administration of sildenafil and organic nitrates; this combination is contraindicated. Sildenafil is rapidly absorbed, with dose-proportional peak plasma concentrations within 1 hour of administration. The elimination half-life is 3 to 5 hours. Dosages usually begin at 50mg taken when needed =1 hour before sexual activity no more than once daily. The maximum dose is 100mg when needed once daily and lower doses (e.g. 25mg) may be used in elderly patients and those with hepatic or renal impairment or receiving cytochrome P450 enzyme CYP3A4 inhibitors, such as ritonavir, saquinavir, ketoconazole, erythromycin or cimetidine. More than 3000 patients with erectile dysfunction of organic (e.g. diabetes or spinal cord injury), psychogenic or mixed origin received sildenafil 5 to 100mg or placebo in fixed- or titrated-dose trials. Sildenafil was associated with dose-related improvements in the frequency, hardness and duration of erections and in patients' abilities to achieve and maintain erections adequate for successful sexual intercourse. In titrated-dose trials, the most commonly effective doses were 50 or 100mg, although lower doses were effective in some patients. Sildenafil was significantly more effective than placebo in erectile dysfunction of all tested causes. The efficacy of sildenafil was not affected by patient age (> or < or =65 years) or by antihypertensive or antidepressant medications. The drug was effective in patients with severe erectile dysfunction. Efficacy was maintained in long term (1-year) studies. Sildenafil also appears to improve the quality of life of both patients and their sexual partners. Common adverse events associated with sildenafil were transient and mild or moderate and included headache, flushing, dyspepsia, nasal congestion and abnormal vision. Tolerability was maintained in long term (< or =1 year) studies. No serious sildenafil-related adverse events occurred in clinical trials; cardiovascular events seen in postmarketing surveillance generally occurred in patients with other known risk factors. CONCLUSIONS: Sildenafil is an effective oral treatment in men with erectile dysfunction. It was significantly superior to placebo in improving erections and allowing successful penetrative sexual intercourse. Although its place in disease management is still emerging and there are contraindications to its use, if preliminary positive reports are confirmed, sildenafil will be the pre-eminent first-line therapy for erectile dysfunction.     

The ELIXIR study: evaluation of sexual dysfunction in 4557 depressed patients in France

OBJECTIVES: This survey was conducted in order to determine the extent and nature of disorders of sexual function in depressed patients treated in the community in France. METHODS: Patients with DSM-IV major depressive episodes were included. The inclusion criteria stipulated that only patients with no antecedents of sexual dysfunction could be included. Information on sexual function was collected with a questionnaire which included physician observations as well as the Arizona Sexual Experience Scale. RESULTS: Overall, 4557 patients were included in the study. The prevalence of disorders of sexual function observed was 35% for spontaneously reported problems and 69% for problems identified by physician questioning. Impaired sexual function in depressed patients is also revealed by a high score on the Arizona Sexual Experience Scale (mean overall score of 21.4). Frequency of sexual dysfunction was somewhat higher in patients treated with antidepressants than in untreated patients (71% and 65% respectively). Treatment with tianeptine was associated with a lower incidence of sexual dysfunction than was treatment with tricyclic antidepressants or with selective serotonin reuptake inhibitors. Although in 39% of cases, physicians managed the sexual problems encountered by changing the antidepressant treatment, the most frequently adopted approach (42% of cases) was to await spontaneous remission. Drug holidays or adjunctive therapy were very rarely proposed. CONCLUSIONS: The prevalence of sexual dysfunction in patients with major depression is high. Antidepressant drugs appear to aggravate such problems, with certain classes of drug better tolerated than others. Sexual dysfunction in depressed patients is often not optimally treated.     

Naltrexone vs. nefazodone for treatment of alcohol dependence. A placebo-controlled trial.

This study compared the effects of nefazodone, a serotonergic antidepressant, with the opioid antagonist naltrexone, and an inactive placebo in 183 alcohol-dependent subjects receiving weekly relapse prevention psychotherapy. Following a single-blind, placebo lead-in period, subjects were randomly assigned to receive study medication, which they took under double-blind conditions for 11 weeks. Naltrexone treatment was associated with significantly more adverse neuropsychiatric and gastrointestinal effects, poorer compliance, and a greater rate of treatment attrition. There were no reliable between-group differences in drinking behavior. These results indicate that nefazodone is not efficacious for treatment of alcohol dependence. Furthermore, the clinical utility of naltrexone seems to be limited by its adverse effects, a finding that has important implications for efforts to develop medications to treat alcohol dependence.     

Neural Correlates of Antidepressant-Related Sexual Dysfunction: A Placebo-Controlled fMRI Study on Healthy Males Under Subchronic Paroxetine and Bupropion

Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs) like paroxetine in the treatment of depression, imposing a considerable risk on medication adherence and hence therapeutic success. Bupropion, a norepinephrine and dopamine reuptake inhibitor, is recommended as an alternative treatment without adverse effects concerning sexual arousal and libido. We investigated the neural bases of paroxetine-related subjective sexual dysfunction when compared with bupropion and placebo. We scanned 18 healthy, heterosexual males in a randomized, double-blind, within-subject design while watching video clips of erotic and nonerotic content under steady-state conditions after taking 20 mg of paroxetine, 150 mg of bupropion, and placebo for 7 days each. Under paroxetine, ratings of subjective sexual dysfunction increased compared with placebo or bupropion. Activation along the anterior cingulate cortex (ACC), including subgenual, pregenual, and midcingulate cortices, in the ventral striatum and midbrain was decreased when compared with placebo. In contrast, bupropion let subjective ratings and ACC activations unchanged and increased activity of brain regions including posterior midcingulate cortex, mediodorsal thalamus, and extended amygdala relative to placebo and paroxetine. Brain regions that have been related to the processing of motivational (ventral striatum), emotional, and autonomic components of erotic stimulation (anterior cingulate) in previous studies showed reduced responsiveness under paroxetine in our study. Drug effects on these regions may be part of the mechanism underlying SSRI-related sexual dysfunction. Increased activation under bupropion may point to an opposite effect that may relate to the lack of impaired sexual functioning.     

Selective serotonin re-uptake inhibitor treatment-emergent sexual dysfunction: randomized double-blind placebo-controlled parallel-group fixed-dose study of a potential adjuvant compound, VML-670

Sexual dysfunction is common during acute and continuation treatment of depressed patients with selective serotonin (5-hydroxytryptamine, 5-HT) re-uptake inhibitors (ssRIs), but there is no consensus on clinical management. Compounds with 5-HT(1A) agonist properties have been proposed as adjuvant agents in patients continuing with ssRIs. Randomized double-blind placebo-controlled parallel-group fixed-dose 4-week treatment study. Previously depressed male or female patients in symptomatic remission receiving stable doses of fluoxetine or paroxetine but experiencing treatment-emergent sexual dysfunction were randomised to double-blind treatment with placebo or VML-670 (a 5-HT(1A) and 5-HT(1D) agonist). sexual dysfunction was assessed by the Arizona sexual Experiences scale (ASEX). Two-hundred and eighty-eight patients (204 women, 84 men; mean age 44.2 years) received VML-670 (n = 149; 107 women, 42 men) or placebo (n = 139; 97 women, 42 men). In the intention-to-treat, last-observation carried forward analysis (n = 282), proportionately more patients became free of sexual dysfunction with VML-670 (34.3% versus 27.9% with placebo) but this difference was not statistically significant. Male patients treated with VML-670 showed a significantly greater (p =0.01) improvement in ability to achieve and maintain penile erection (a secondary outcome measure). A similar proportion of patients reported on-treatment, treatment-emergent adverse events with VML-670 (71.1%) and placebo (68.3%), and a similar proportion experienced at least one treatment-related adverse event (36.9% versus 35.3%). Double-blind treatment with VML-670 offered no significant advantage over placebo on the primary outcome measure in the overall sample. Further studies may be warranted in larger groups of male patients with sexual dysfunction.     

Tadalafil for treatment of erectile dysfunction in men on antidepressants

OBJECTIVE: The objective of this post hoc analysis was to evaluate tadalafil, a treatment indicated for erectile dysfunction (ED), in men on antidepressants. METHOD: A retrospective, pooled analysis of 19 double-blind, placebo-controlled trials (N = 3864) identified 205 men with ED, mean age of 55 years (range, 27-79 years) receiving antidepressants and tadalafil 10 mg (n = 38), tadalafil 20 mg (n = 113), or placebo (n = 54). Efficacy was measured by the International Index of Erectile Function erectile function domain score, the Sexual Encounter Profile diary, and a Global Assessment Question. Tolerability was assessed via collection and analysis of treatment-emergent adverse events. RESULTS: Patients on antidepressants who were treated with tadalafil showed significantly greater baseline-to-end point improvement on the International Index of Erectile Function score compared with placebo (end point: tadalafil 10 mg, 21.7; tadalafil 20 mg, 21.8; placebo, 14.5; both P < 0.01). The mean per-patient percent successful intercourse postbaseline was also greater with tadalafil 10 mg (54%) and tadalafil 20 mg (59%) than placebo (29%, both P < 0.05). Patients taking tadalafil 10 (72%) and 20 (76%) mg both reported significant improvement in erections on the Global Assessment Question compared with placebo (33%, both P < 0.01). The incidence of treatment-emergent adverse events was low in all treatment groups with the most common being headache, dyspepsia, and back pain. CONCLUSION: Tadalafil was well tolerated and improved erectile function in patients taking antidepressant medications.     

Nitric oxide, erectile dysfunction and beta-blocker treatment (MR NOED study): benefit of nebivolol versus metoprolol in hypertensive men

1. Hypertensive men treated with beta-blockers frequently complain of erectile dysfunction. The present study investigated the effects of two beta(1)-adrenoceptor-selective antagonists, namely nebivolol and metoprolol, on erectile function in hypertensive men. 2. Male out-patients (age range 40-55 years) with newly diagnosed or existing stage 1 essential hypertension (mean seated systolic blood pressure 140-159 mmHg; diastolic blood pressure 90-99 mmHg) were enrolled in the study. All patients lived in a stable, heterosexual partnership and had no history of sexual dysfunction. After a 2-week placebo run-in period, patients were randomized double-blind to either Treatment group A (comprising nebivolol 5 mg once daily for 12 weeks, followed by placebo for 2 weeks and then metoprolol succinate 95 mg once daily for 12 weeks) or Treatment group B (comprising metoprolol succinate 95 mg for 12 weeks, placebo for 2 weeks and then nebivolol 5 mg for 12 weeks). An international index of erectile function (IIEF) questionnaire and a diary documented patients' sexual function and activity. 3. Nebivolol and metoprolol lowered blood pressure to a similar extent. Metoprolol, but not nebivolol, significantly decreased the IIEF erectile function subscore by 0.92 in the first 8 weeks after onset of beta-blocker treatment. In contrast with metoprolol, nebivolol improved secondary sexual activity scores and other IIEF subscores. 4. Despite similar antihypertensive efficacy of the cardioselective beta(1)-adrenoceptor antagonists nebivolol and metoprolol, nebivolol may offer additional benefits by avoiding erectile dysfunction in male hypertensive patients on long-term beta-adrenoceptor antagonist therapy.