Inhibitor Therapy (inhibitor + therapy)

Distribution by Scientific Domains
Distribution within Medical Sciences

Kinds of Inhibitor Therapy

  • ace inhibitor therapy
  • kinase inhibitor therapy
  • pde5 inhibitor therapy
  • proton pump inhibitor therapy
  • proton-pump inhibitor therapy
  • pump inhibitor therapy


  • Selected Abstracts


    Patients Responding to Phosphodiesterase Type 5 Inhibitor Therapy,What Do Their Sexual Partners Know?

    THE JOURNAL OF SEXUAL MEDICINE, Issue 1 2007
    Theodor Klotz MD
    ABSTRACT Introduction., Phosphodiesterase type 5 (PDE5) inhibitors are an efficacious therapy in men with erectile dysfunction (ED). There are only a few studies that also focus on the participating couples during PDE5 inhibitor therapy. Aim., To determine to what extent patients personally informed their sexual partners about their ongoing PDE5 inhibitor therapy. Main Outcome Measures., Likelihood of informing the female partner by the patient himself about the use of PDE5 inhibitors. Methods., A total of 216 men (mean age 62.3 years) with ED were successfully treated with PDE5 inhibitors in three independent centers. After an interval of at least 3 months of successful ED therapy, all patients were asked by questionnaire whether their sexual partners were informed of their PDE5 inhibitor therapy. Results., Eighty-two percent of the patients were exclusively involved in one stable sexual relationship, 9.7% of the men admitted to having changing sexual partners, and 6% did not give any information at all about their sexual partners. Twenty percent of the men had a severe ED (International Index of Erectile Function [IIEF-5] <11). Forty-nine percent showed a moderate ED (IIEF-5 11,16) and 31% suffered a mild ED (IIEF-5 >16). PDE5 inhibitor medication was used 1.2 times/month by men with a severe ED, 2.1 times/month by patients with a moderate ED, and 2.9 times/month by men with a mild ED. Forty-one (93%) of the 44 patients with a severe ED informed their sexual partners that they were taking PDE5 inhibitors. In the patient group with moderate ED, 49 (47%) of 105 patients and only 14 (21%) of 67 of the patients with mild ED shared this information with their partners. Conclusion., Less than 40% of the patients suffering a moderate or mild ED using PDE5 inhibitors shared this information with their partners. It seems that patients find ED so disturbing that many patients do not inform their partners of PDE5 inhibitor use. Klotz T, Mathers M, Klotz R, and Sommer F. Patients responding to phosphodiesterase type 5 inhibitor therapy,What do their sexual partners know? J Sex Med 2007;4:162,165. [source]


    Loss of Nephrin Expression in Glomeruli of Kidney-Transplanted Patients Under m-TOR Inhibitor Therapy

    AMERICAN JOURNAL OF TRANSPLANTATION, Issue 10 2010
    L. Biancone
    The development of proteinuria has been observed in kidney-transplanted patients on m-TOR inhibitor (m-TORi) treatment. Recent studies suggest that m-TORi(s) may alter the behavior and integrity of glomerular podocytes. We analyzed renal biopsies from kidney-transplanted patients and evaluated the expression of nephrin, a critical component of the glomerular slit-diaphragm. In a group of patients on ,de novo' m-TORi-treatment, the expression of nephrin within glomeruli was significantly reduced in all cases compared to pretransplant donor biopsies. Biopsies from control transplant patients not treated with m-TORi(s) failed to present a loss of nephrin. In a group of patients subsequently converted to m-TORi-treatment, a protocol biopsy performed before introduction of m-TORi was also available. The expression of nephrin in the pre-m-TORi biopsies was similar to that observed in the pretransplant donor biopsies but was significantly reduced after introduction of m-TORi(s). Proteinuria increased after the m-TORi inititiation in this group. However, in some cases proteinuria remained normal despite reduction of nephrin. In vitro, sirolimus downregulated nephrin expression by human podocytes. Our results suggest that m-TORi(s) may affect nephrin expression in kidney-transplanted patients, consistently with the observation in vitro on cultured podocytes. [source]


    Proton Pump Inhibitor Therapy and Helicobacter pylori Infection: A Complicated Relationship

    BASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 3 2006
    Article first published online: 23 AUG 200
    No abstract is available for this article. [source]


    Proton Pump Inhibitor Therapy for Suspected GERD-Related Chronic Laryngitis: A Meta-Analysis of Randomized Controlled Trials

    CLINICAL OTOLARYNGOLOGY, Issue 2 2008
    Mohammed A. Qadeer
    No abstract is available for this article. [source]


    Diagnosis and management of erectile dysfunction in the primary care setting

    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 7 2007
    M. T. Rosenberg
    Summary Recent advances in the management of erectile dysfunction (ED) involve the use of oral phosphodiesterase type-5 (PDE-5) inhibitor therapies which have transformed the perception of ED for both the patient and the healthcare provider. Recent treatment guidelines, including the American Urological Association (AUA) 2005 guidelines, promote a goal-oriented approach to therapy and emphasise that PDE-5 therapy should be offered to patients with ED as a first-line treatment option, unless contraindicated. Evidence-based studies have identified an association between ED and the presence of risk factors for cardiovascular and other vascular diseases, implicating ED as a marker for other vascular conditions. Therefore, the importance of screening and diagnosis in the primary care setting is paramount in the diagnosis and management of ED-associated comorbidities. This review provides an update on ED screening and management focusing on the use of PDE-5 inhibitor therapy in the primary care setting and also discusses clinical efficacy parameters with regard to recent results from clinical trials. [source]


    HMG-CoA reductase inhibitors prevent bone loss in patients with Type 2 diabetes mellitus

    DIABETIC MEDICINE, Issue 9 2004
    A. Nakashima
    Abstract Aims It has been reported that 3-hydroxy-3-methylglutaryl co-enzyme A (HMG-CoA) reductase inhibitors increase bone mineral density (BMD) in vivo. We investigated the effect of HMG-CoA reductase inhibitors on BMD in patients with Type 2 diabetes mellitus. Patients and methods We selected 122 patients with Type 2 diabetes, who were not taking active vitamin D preparations. Their mean age was 67.3 ± 9.2 years. They were divided into a control group (n = 63) without HMG-CoA reductase inhibitor therapy and an HMG-CoA group (n = 59) who were treated with these drugs. The BMD of the distal one-third of the radius was measured by dual-energy X-ray adsorptiometry at baseline and after 2 years. Results There were no significant differences between the control and HMG-CoA groups at baseline with respect to age, gender, body mass index, duration of diabetes, haemoglobin A1c, fasting plasma glucose, adjusted calcium, serum phosphorus, alkaline phosphatase, albumin excretion rate and radial BMD. However, there was a significantly smaller annual decrease of the radial BMD in the HMG-CoA group. Multiple regression analysis with a forward elimination procedure revealed a positive correlation of the radial BMD Z-score with body mass index, while there was a negative correlation with alkaline phosphatase and albumin excretion rate. In addition, the annual rate of change of the radial BMD showed a positive correlation with HMG-CoA reductase inhibitor therapy. Conclusions These findings suggest that HMG-CoA reductase inhibitors may prevent bone loss in patients with Type 2 diabetes. [source]


    Barrett's esophagus: combined treatment using argon plasma coagulation and laparoscopic antireflux surgery

    DISEASES OF THE ESOPHAGUS, Issue 4 2003
    M. Pagani
    SUMMARY, The treatment of Barrett's esophagus is still controversial. Actually, the only method to prevent the development to cancer is endoscopic surveillance, which ensures good results in terms of long-term survival. An ideal treatment capable of destroying columnar metaplasia, followed by squamous epithelium regeneration could potentially result in a decrease of the incidence of adenocarcinoma. Recently most ablative techniques were used, such as photodynamic therapy, ablation therapy with Nd-YAG laser or argon plasma coagulation and endoscopic mucosal resection. We started a prospective study in January 1998, enrolling 94 patients affected by Barrett's esophagus and candidates for antireflux repair in order to assess the effectiveness and the results of endoscopic coagulation with argon plasma combined with surgery in the treatment of uncomplicated Barrett's esophagus. All patients underwent endoscopic treatment with argon plasma; we observed complete response in 68 patients (72.34%), 27 of them (39.7%) underwent antireflux surgery and the other 41 continued medical therapy. Post-operatively 19 patients (70%) underwent regular surveillance endoscopies and in two cases metaplasia recurred. The final objective of these combined treatments should be the complete eradication of metaplastic mucosa. Our experience was that argon plasma coagulation combined with antireflux surgery or proton pump inhibitor therapy gave satisfactory results, even if follow-up is too short to evaluate the potential evolution of metaplasia to cancer. For this reason, we recommend that this technique should be done only in specialized centres and that these patients continue their endoscopic surveillance program. [source]


    No significant effect of uridine or pravastatin treatment for HIV lipoatrophy in men who have ceased thymidine analogue nucleoside reverse transcriptase inhibitor therapy: a randomized trial,

    HIV MEDICINE, Issue 8 2010
    A Calmy
    Background Lipoatrophy can complicate thymidine analogue nucleoside reverse transcriptase inhibitor (tNRTI)-based antiretroviral therapy (ART). Lipoatrophy may be less likely with ART including ritonavir-boosted lopinavir (LPV/r). Small, placebo-controlled studies found that uridine (in tNRTI recipients) and pravastatin improved HIV lipoatrophy over 12 weeks. Today, most patients with lipoatrophy receive non-tNRTI-based ART; the effect of uridine in such patients is unknown. Methods We performed a prospective, randomized trial in lipoatrophic adults with plasma HIV RNA<50 HIV-1 RNA copies/mL on tNRTI-sparing ART including LPV/r. Patients received uridine [36 g three times a day (tid) on 10 consecutive days per month; n=10], pravastatin [40 mg every night (nocte); n=12], uridine plus pravastatin (n=11) or neither (n=12) for 24 weeks. The primary endpoint was mean change in limb fat mass as assessed by dual-energy X-ray absorptiometry (DEXA). With 20 patients per intervention, the study had 80% power to detect a mean difference between a treatment and the control of 0.5 kg, assuming a standard deviation of 0.9 and an alpha threshold equal to 5% (two-sided). Results Of 45 participants (all men, with median age 49.5 years and median limb fat 2.6 kg), two discontinued pravastatin and one participant stopped both pravastatin and uridine. The difference between the mean changes in limb fat mass for uridine vs. no uridine was 0.03 kg [95% confidence interval (CI) ,0.35, +0.28; P=0.79]. The respective difference for pravastatin was ,0.03 kg (95% CI ,0.29, +0.34; P=0.84). Pravastatin slightly decreased total cholesterol (0.44 mmol/L; P=0.099). Visceral adipose tissue measured by computed tomography did not change significantly. Conclusion In this population and at the doses used, neither uridine nor pravastatin for 24 weeks significantly increased limb fat mass. [source]


    Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study

    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2009
    M. T. Rosenberg
    Summary Objective:, The ENDURANCE study evaluated the efficacy of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED), by measuring the duration of erection leading to successful intercourse using a stopwatch as the assessment instrument. Methods:, This was a randomised, multicentre, double-blind, placebo-controlled, crossover study consisting of a 4-week treatment-free run-in phase after which patients were randomised to either fixed-dose vardenafil 10 mg or placebo (to be administered 60 min prior to intercourse) and entered the first of the two 4-week double-blind treatment periods, separated by a 1-week washout. The primary efficacy end-point was the stopwatch-assessed duration of erection, which was defined as the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina leading to successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP-3). Secondary efficacy end-points included SEP-2 and SEP-3 success rates, the erectile function domain of the International Index of Erectile Function, global assessment questionnaire, change from baseline in duration of erection and duration of erection not leading to successful intercourse. Safety was assessed by adverse events (AEs), laboratory samples, vital signs and ECGs. Results:, Of the 191 men included in the safety population, 40% had moderate ED and 33% had severe ED at baseline. The duration of erection (least squares mean ± SE) leading to successful intercourse was longer with vardenafil than with placebo (12.81 ± 1.00 min vs. 5.45 ± 1.00 min; p < 0.001). The differences recorded for all secondary end-points were statistically significant in favour of vardenafil compared with placebo (p < 0.001), with the exception of duration of erection not leading to successful intercourse. Vardenafil was well tolerated in this study; the majority of AEs being mild-to-moderate in intensity. Conclusion:, Vardenafil 10-mg therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED compared with placebo. [source]


    Diagnosis and management of erectile dysfunction in the primary care setting

    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 7 2007
    M. T. Rosenberg
    Summary Recent advances in the management of erectile dysfunction (ED) involve the use of oral phosphodiesterase type-5 (PDE-5) inhibitor therapies which have transformed the perception of ED for both the patient and the healthcare provider. Recent treatment guidelines, including the American Urological Association (AUA) 2005 guidelines, promote a goal-oriented approach to therapy and emphasise that PDE-5 therapy should be offered to patients with ED as a first-line treatment option, unless contraindicated. Evidence-based studies have identified an association between ED and the presence of risk factors for cardiovascular and other vascular diseases, implicating ED as a marker for other vascular conditions. Therefore, the importance of screening and diagnosis in the primary care setting is paramount in the diagnosis and management of ED-associated comorbidities. This review provides an update on ED screening and management focusing on the use of PDE-5 inhibitor therapy in the primary care setting and also discusses clinical efficacy parameters with regard to recent results from clinical trials. [source]


    Capsule Endoscopy in Examination of Esophagus for Lesions After Radiofrequency Catheter Ablation: A Potential Tool to Select Patients With Increased Risk of Complications

    JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 8 2010
    LUIGI DI BIASE M.D.
    Capsule Endoscopy in Examination of Esophagus.,Background: Esophageal injury can result from left atrial radiofrequency ablation (RFA) therapy, with added concern because of its possible relationship to the development of atrial-esophageal (A-E) fistulas. Objective: Evaluate utility of esophageal capsule endoscopy to detect esophageal lesions as a complication of RFA therapy in the treatment of atrial fibrillation (AF). Methods: Consecutive patients with AF who underwent left atrial RFA therapy and received capsule endoscopy within 48 hours postablation. Video was reviewed by a single gastroenterologist. The medical records were also reviewed for symptoms immediately postablation and at the 3-month follow-up. Results: A total of 93 consecutive patients were included and 88 completed the study and were analyzed. The prevalence of esophageal lesions was 17% (15/88 patients). Nine percent (8/88) of these patients had lesions anatomically consistent with the location of the ablation catheter. Six patients with positive capsule findings had symptoms of chest pain (3/6, 50%), throat pain (2/6, 33%), nausea (1/6, 17%), and abdominal pain (1/6, 17%). An additional 24 patients were symptomatic postablation, but with normal capsule findings. All patients with identified lesions by capsule endoscopy received oral proton pump inhibitor therapy, and were instructed to contact the Cleveland Clinic in the event of worsening symptoms. No delayed complications were reported at the 3-month follow-up. Conclusion: This study supports the use of capsule endoscopy as a tool for the detection of esophageal injury post-RFA therapy. PillCam ESO is well tolerated and provides satisfactory images of the areas of interest in the esophagus without potential risk related to insufflation with regular esophagogastroduodenoscopy. (J Cardiovasc Electrophysiol, Vol. 21, pp. 839-844, August 2010) [source]


    New Considerations Relating to Class Effect With Angiotensin-Converting Enzyme Inhibitors-The PEACE Study

    JOURNAL OF CLINICAL HYPERTENSION, Issue 3 2005
    Domenic A. Sica MD
    Angiotensin-converting enzyme inhibitor therapy provides positive outcome benefits in a number of cardiac scenarios including congestive heart failure, postmyocardial infarction, as well as in the hypertensive patient at cardiac risk. This benefit exists both in normotensive and hypertensive individuals and is present in those with various grades of cardiovascular risk. This beneficial cardiovascular effect has now been observed with several angiotensin-converting enzyme inhibitors, suggesting a class effect. The Prevention of Events with Angiotensin-Converting Enzyme Inhibition trial studied the effect of adding the angiotensinconverting enzyme inhibitor trandolapril to a contemporary therapeutic regimen of patients with stable coronary artery disease and preserved left ventricular function. In this study, the addition of trandolapril did not confer any additional benefit in terms of reducing the incidence of cardiovascular death, myocardial infarction, or coronary revascularization. The neutral findings in this trial add a new wrinkle to the concept of class effect for cardiovascular protection with angiotensin-converting enzyme inhibitors in patients with coronary artery disease. [source]


    Isoprostane 8-epi-PGF2, is frequently increased in patients with muscle pain and/or CK-elevation after HMG-Co-enzyme-A-reductase inhibitor therapy

    JOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 4 2001
    H. Sinzinger
    Background:,Muscle pains with or without CK-elevation are among the most frequently observed side-effects in patients with hyperlipoproteinemia on various statins. The pathophysiological background, however, remains obscure. Methods:,We examined isoprostane 8-epi-PGF2,, a marker of in-vivo oxidation injury, in plasma, serum and urine in these patients at baseline, when muscle problems manifested and different time intervals after withdrawing the respective statin. A healthy control group and a group of untreated patients with hyperlipoproteinemia were run as controls. Results:,The majority of patients with muscular side-effects show elevated 8-epi-PGF2, in plasma and urine, whereas serum values were elevated only to a lesser extent. Stopping statin therapy or successfully changing to another member of this family of compounds resulted in a normalization of the values in all patients. Conclusion:,These findings indicate a significant involvement of oxidative injury in the muscular side-effects of statins in patients suffering from hyperlipoproteinemia. [source]


    Non-cardiac chest pain: Prevalence of reflux disease and response to acid suppression in an Asian population

    JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 2 2009
    Hanizam Mohd
    Abstract Background:, Gastroesophageal reflux disease is thought to be the commonest cause of ,non-cardiac chest pain'. The use of proton-pump inhibitors resulting in improvement in the chest pain symptom would support this causal association. Objectives:, To determine the prevalence of gastroesophageal reflux disease in non-cardiac chest pain and the response of chest pain to proton-pump inhibitor therapy. Methods:, Patients with recurrent angina-like chest pain and normal coronary angiogram were recruited. The frequency and severity of chest pain were recorded. All patients underwent esophagogastroduodenoscopy and 48-h Bravo ambulatory pH monitoring before receiving rabeprazole 20 mg bd for 2 weeks. Results:, The prevalence of gastroesophageal reflux disease was 66.7% (18/27). The improvement in chest pain score was significantly higher in reflux compared to non-reflux patients (P = 0.006). The proportion of patients with complete or marked/moderate improvement in chest pain symptoms were significantly higher in patients with reflux (15/18, 83.3%) compared to those without (1/9, 11.1%) (P < 0.001). Conclusion:, The prevalence of gastroesophageal reflux disease in patients with ,non-cardiac chest pain' was high. The response to treatment with proton-pump inhibitors in patients with reflux disease, but not in those without, underlined the critical role of acid reflux in a subset of patients with ,non-cardiac chest pain'. [source]


    The effects of ACE inhibitor therapy on left ventricular myocardial mass and diastolic filling in previously untreated hypertensive patients: A Cine MRI study

    JOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 1 2001
    U. Hoffmann MD
    Abstract Cardiac remodeling in case of hypertension induces hypertrophy of myocytes and elevated collagen content and, subsequently, impaired diastolic filling of the left ventricle. The purpose of this prospective study was to evaluate changes of left ventricular (LV) myocardial mass, as well as diastolic filling properties, in hypertensive patients treated with the ACE inhibitor fosinopril. Sixteen hypertensive patients with echocardiographically documented LV hypertrophy and diastolic dysfunction received fosinopril (10,20 mg daily). Measurements of LV myocardial mass and properties of diastolic filling (peak filling fraction (PFF); peak filling rate (PFR)) were performed prior to medication, as well as after 3 and 6 months of therapy using cine magnetic resonance imaging (MRI). Ten healthy subjects served as a control group. LV myocardial mass (g/m2) decreased continuously within 3,6 months of follow-up by 32% (148 ± 40 vs. 120 ± 26 vs. 101 ± 22 g/m2; P < 0.0001/0.005). The extent of regression correlated to the severity of LV hypertrophy at baseline (r = 0.77; P < 0.004). Early diastolic filling increased significantly within 6 months of therapy (PFF (%): 36 ± 6 vs. 61 ± 7, P < 0.0001; PFR (mL/second): 211 ± 48 vs. 282 ± 48, P < 0.001). Cine MRI can be used to assess the time course of pharmacological effects on cardiac remodeling in the course of hypertension. ACE inhibitor therapy results in a significant reduction of LV mass within 3 months and is accompanied by a normalization of diastolic filling that is completed after 6 months. J. Magn. Reson. Imaging 2001;14:16,22. © 2001 Wiley-Liss, Inc. [source]


    Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2010
    H. El-Serag
    Summary Background, Persistent gastro-oesophageal reflux disease (GERD) symptoms can occur despite proton pump inhibitor (PPI) therapy. Aim, To assess the prevalence and potential determinants of persistent GERD symptoms in primary care and community-based studies. Methods, Studies were identified by systematic PubMed and Embase searches; pooled prevalence data are shown as sample-size weighted means and 95% confidence intervals. Results, Nineteen studies in individuals with GERD taking a PPI were included. In interventional, nonrandomized primary care trials, the prevalence of persistent troublesome heartburn and regurgitation was 17% (6,28%) and 28% (26,30%) respectively; in randomized trials, it was 32% (25,39%) and 28% (26,30%), respectively. In observational primary care and community-based studies, 45% (30,60%) of participants reported persistent GERD symptoms. Overall, persistent GERD symptoms despite PPI treatment were more likely in studies with a higher proportion of female participants [>60% vs. <50%, risk ratio (RR): 3.66; P < 0.001], but less likely in studies from Europe than in those from the USA (RR: 0.71; P < 0.001), and were associated with decreased psychological and physical well-being. Conclusions, Persistent GERD symptoms despite PPI treatment are common in the primary care and community setting. Alternative approaches to management are required. [source]


    Reflux patterns in patients with short-segment Barrett's oesophagus: a study using impedance-pH monitoring off and on proton pump inhibitor therapy

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2009
    M. FRAZZONI
    Summary Background, In short-segment Barrett's oesophagus (SSBO) heartburn may be absent and oesophageal acid exposure time (OAET) assessed with pH-only monitoring may be normal. By detecting reflux episodes independently of their acidity, multichannel intraluminal impedance-pH (MII-pH) monitoring allows a comprehensive characterization of reflux events, either off or on proton pump inhibitor (PPI) therapy. Aim, To assess reflux parameters by MII-pH monitoring in newly diagnosed SSBO, at baseline and as modified with PPI therapy. Methods, Short-segment Barrett's oesophagus was defined by oesophageal intestinal metaplasia up to 3 cm in length. 24-h MII-pH monitoring was performed before and during PPI therapy. Results, Fifty patients were studied prospectively. Normal OAET was found at baseline in 15 patients (30%), 8 and 2 of whom with a higher than normal number of acid and weakly acidic refluxes, respectively. Overall, abnormal reflux parameters were detected by MII-pH monitoring in 90% of patients. Reflux events were prevalent in the upright period. On PPI therapy, acid refluxes decreased and a correspondent increase in weakly acidic refluxes was observed (median from 48.5 to 9 and from 16 to 57.5, respectively) (P < 0.001). Conclusions, Acid refluxes, mainly in the upright period, characterize SSBO. PPI therapy transforms acid refluxes into weakly acidic refluxes. [source]


    Review article: dual delayed release formulation of dexlansoprazole MR, a novel approach to overcome the limitations of conventional single release proton pump inhibitor therapy

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009
    D. C. METZ
    Summary Background, Proton pump inhibitors (PPIs) provide the most effective pharmacotherapy for treating acid-related disorders. However, PPIs do not completely control acid over 24 h with once-daily dosing. Aims, To discuss limitations inherent in the pharmacokinetics (PK) and pharmacodynamics of conventional PPI formulations, which provide a single drug release. Also, to consider approaches to extending the duration of acid suppression focusing on dexlansoprazole MR, a PPI with a novel Dual Delayed Release (DDR) formulation. Method, We reviewed the available literature regarding marketed and investigational PPIs. Results, Non-standard dosing of currently marketed PPIs has produced incremental advances in acid control. Multiple approaches are being evaluated to enhance acid suppression with PPIs. Dexlansoprazole MR is a DDR formulation of dexlansoprazole, an enantiomer of lansoprazole, with two distinct drug release periods to prolong the plasma dexlansoprazole concentration,time profile and extend duration of acid suppression. Clinical studies show that dexlansoprazole MR produces a dual-peak PK profile that maintains therapeutic plasma drug concentrations longer than lansoprazole, with a single-peak PK profile, and increases the percentage of time that intragastric pH >4. Conclusions, Novel drug delivery platforms, including the dexlansoprazole MR DDR formulation, may improve acid suppression and offer benefits over conventional single release PPI formulations. [source]


    Clinical trial: factors associated with resolution of heartburn in patients with reflux oesophagitis , results from the EXPO study

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009
    J. LABENZ
    Summary Background, The ability to predict symptom response to reflux oesophagitis-healing therapy may optimize treatment decisions. Aim, To identify factors associated with heartburn resolution in patients receiving acid-suppressive therapy for reflux oesophagitis. Methods, In this multicentre, randomized, double-blind trial (EXPO; AstraZeneca study code: SH-NEG-0008), patients with endoscopically confirmed reflux oesophagitis and reflux symptoms received once-daily proton pump inhibitor therapy [esomeprazole 40 mg (n = 1562) or pantoprazole 40 mg (n = 1589)] for ,4 weeks. Factors associated with heartburn resolution after 4 weeks were identified by multiple logistic regression analysis. Results, Esomeprazole therapy, positive Helicobacter pylori status and greater age were associated with an increased likelihood of heartburn resolution [odds ratio (95% confidence interval): 1.31 (1.12, 1.54), 1.44 (1.19, 1.74) and 1.013 (1.007, 1.019) per year, respectively; all P < 0.001]. Men and patients with no acid regurgitation or epigastric pain pre-treatment were also more likely to achieve heartburn resolution (all P < 0.05). Conclusions, The use of esomeprazole rather than pantoprazole increases the probability of achieving resolution of heartburn during reflux oesophagitis-healing therapy. Other factors, including H. pylori status, age, gender and symptom profile may be helpful in determining the likelihood of heartburn resolution in such patients. [source]


    Effect of proton pump inhibition on the gastric volume: assessed by magnetic resonance imaging

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2009
    A. BABAEI
    Summary Background Proton pump inhibitor (PPI) therapy is known to suppress gastric acid secretion. Thus PPI therapy may decrease gastric volume and gastric contents available for gastro-oesophageal reflux by decreasing acid secretion. Aim To determine the effect of PPI therapy on the gastric volume after a standard meal. Methods A total of nine healthy subjects were studied using magnetic resonance imaging, before and after a standard liquid meal mixed with a paramagnetic contrast to help demarcate the gastric region. Images were acquired for a total of 90 min after the meal. Studies were conducted before and following esomeprazole twice daily for 7 days. Images were analysed to determine the gastric liquid volume. Results Gastric volume, 15 min after the meal peaked to 611 ± 37 mL on the control day and 539 ± 30 mL following the PPI administration (P < 0.001). Average gastric volume remained significantly lower (56 ± 9 mL, P < 0.05) on the PPI therapy from 5 to 75 min after the meal. Conclusions Proton pump inhibitor therapy causes a significant reduction in the gastric contents volume during first 75 min after the meal. In addition to increasing the gastric pH, PPI therapy may decrease the frequency of gastro-oesophageal reflux by decreasing the volume of gastric contents. [source]


    Review article: intra-oesophageal impedance monitoring for the assessment of bolus transit and gastro-oesophageal reflux

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2009
    J. M. CONCHILLO
    Summary Background, Intra-oesophageal impedance monitoring can be used to assess the clearance of a swallowed bolus (oesophageal transit) and to detect gastro-oesophageal reflux independent of its acidity. Aim, To discuss the clinical application of the impedance technique for the assessment of bolus transit and gastro-oesophageal reflux. Methods, Review of the literature on intra-oesophageal impedance monitoring of bolus transit and gastro-oesophageal reflux. Results, Using impedance criteria, normal oesophageal bolus clearance can be defined as complete clearance of at least 80% of liquid boluses and at least 70% of viscous boluses. Impedance recording identifies oesophageal function abnormalities in non-obstructive dysphagia patients and in patients with postfundoplication dysphagia. The impedance technique seems to be less suitable for the most severe end of the dysphagia spectrum like achalasia. Intra-oesophageal impedance monitoring detects reflux events independent of the pH of the refluxate, which allows identification of non-acid reflux episodes. In addition, use of impedance monitoring enables assessment of the composition (liquid, gas, mixed) and proximal extent of the refluxate. Combined impedance,pH monitoring is more accurate than pH alone for the detection of both acid and weakly acidic reflux. Furthermore, addition of impedance monitoring to pH increases the yield of symptom association analysis both in patients off and on proton pump inhibitor therapy. Conclusions, Intra-oesophageal impedance monitoring is a feasible technique for the assessment of bolus transit and gastro-oesophageal reflux. Combined impedance,manometry provides clinically important information about oesophageal function abnormalities and combined impedance,pH monitoring identifies the relationship between symptoms and all types of reflux events regarding acidity and composition. [source]


    Systematic review and meta-analysis: enhanced efficacy of proton-pump inhibitor therapy for peptic ulcer bleeding in Asia , a post hoc analysis from the Cochrane Collaboration

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2005
    G. I. Leontiadis
    Summary Background :,Proton-pump inhibitors reduce re-bleeding rates after ulcer bleeding. However, there is significant heterogeneity among different randomized-controlled trials. Aim :,To see whether proton-pump inhibitors for ulcer bleeding produced different clinical outcomes in different geographical locations. Methods :,This was a post hoc analysis of our Cochrane Collaboration systematic review and meta-analysis of proton-pump inhibitor therapy for ulcer bleeding. Sixteen randomized-controlled trials conducted in Europe and North America were pooled and re-analysed separately from seven conducted in Asia. We calculated pooled rates for 30-day all-cause mortality, re-bleeding and surgical intervention and derived odds ratios and numbers needed to treat with 95% confidence intervals. Results :,There was no significant heterogeneity for any outcome. Reduced all-cause mortality was seen in the Asian randomized-controlled trials (odds ratios = 0.35; 95% confidence interval: 0.16,0.74; number needed to treat = 33), but not in the others (odds ratios =,1.36; 95% confidence interval: 0.94,1.96; number needed to treat , incalculable). There were significant reductions in re-bleeding and surgery in both sets of randomized-controlled trials, but the effects were quantitatively greater in Asia. Conclusions :,Proton-pump inhibitor therapy for ulcer bleeding has been more efficacious in Asia than elsewhere. This may be because of an enhanced pharmacodynamic effect of proton-pump inhibitors in Asian patients. [source]


    Immunohistochemical analysis of receptor tyrosine kinase signal transduction activity in chordoma

    NEUROPATHOLOGY & APPLIED NEUROBIOLOGY, Issue 1 2008
    J. H. Fasig
    Aims: Currently, there are no effective chemotherapeutic protocols for chordoma. Reports of receptor tyrosine kinase (RTK) expression in chordoma suggest that these tumours may respond to kinase inhibitor therapy. However, RTK signalling activity has not been extensively investigated in chordoma. Methods: A tissue microarray containing 21 cases of chordoma was analysed for expression of a number of proteins involved in signal transduction from RTKs by immunohistochemistry. Results: Platelet-derived growth factor receptor-,, epidermal growth factor receptor (EGFR), KIT and HER2 were detected in 100%, 67%, 33% and 0% of cases, respectively. Platelet-derived growth factor receptor-, staining was of moderate-to-strong intensity in 20 of 21 cases. In contrast, KIT immunoreactivity was weak and focal in each of the seven positive cases. Total EGFR staining was variable; weak staining for phosphorylated EGFR was detected in nine cases. Phosphorylated isoforms of p44/42 mitogen-activated protein kinase, Akt and STAT3, indicative of tyrosine kinase activity, were detected in 86%, 76% and 67% of cases, respectively. Conclusions: Chordomas commonly express RTKs and activated signal transduction molecules. Although there were no statistically significant correlations between the expression of any of the markers studied and disease-free survival or tumour location, the results nonetheless indicate that chordomas may respond to RTK inhibitors or modulators of other downstream signalling molecules. [source]


    Persistence with cholinesterase inhibitor therapy in a population-based cohort of patients with Alzheimer's disease

    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2010
    Joseph E. Amuah PhD
    Abstract Purpose To estimate the risk (and determinants) of discontinuing cholinesterase inhibitors (ChEIs) in a population-based sample of Alzheimer's disease (AD) patients. Methods This is a retrospective cohort study based on linked de-identified administrative health data from the province of Saskatchewan, Canada. The cohort included all AD patients receiving a ChEI prescription during the first year of provincial coverage (2000,2001). Persistence was defined as no gap of 60+ days between depletion and subsequent refill of a ChEI prescription. Kaplan-Meier analysis was used to estimate the risk of discontinuation over 40 months. Cox regression with time-varying covariates was used to assess risk factors for ChEI discontinuation. Results The sample included 1080 patients (64% female, average age 80,±,7 years). Baseline mean (SD) Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire (FAQ) scores were 20.8 (4.4) and 17.5 (7.7), respectively. Over 40 months, 84% discontinued therapy. The 1-year risk of discontinuation was 66.4% (95%CI 63.5,69.3%). Discontinuation was significantly more likely for females (adjusted HR 1.34, 95%CI 1.16,1.55) and among those with lower MMSE scores (2.52, 2.01,3.17 if <15), not receiving social assistance (1.25, 1.07,1.45), and paying at least 65% of total prescription costs (1.51, 1.30,1.74). It was significantly less likely for patients with frequent physician visits (0.78, 0.66,0.93, for 7,19 vs. <7 visits), higher Chronic Disease Scores (0.74, 0.61,0.89, for 7+ vs. <4), and FAQ scores of 9+ (0.82, 0.69,0.99). Conclusion The likelihood of discontinuing ChEI therapy was high in this real-world sample of AD patients. Significant predictors included clinical, socioeconomic, and practice factors. Copyright © 2010 John Wiley & Sons, Ltd. [source]


    Latest news and product developments

    PRESCRIBER, Issue 19 2008
    Article first published online: 16 OCT 200
    ARBs less effective than ACE inhibitors? The efficacy of angiotensin-II receptor blockers (ARBs) in preventing cardiovascular events in high-risk patients has been challenged by the findings of a large randomised trial (Lancet 2008 published online; doi 10.1016/ S0140-6736(08)61242-8). In the TRANSCEND trial, 5926 patients with cardiovascular disease or diabetes with end-organ damage who could not tolerate ACE inhibitor therapy were randomised to placebo or telmisartan (Micardis) 80mg per day in addition to standard therapies. After 56 months, mean blood pressure was lower with telmisartan (by 4.0/2.2mmHg) but there were no significant differences between telmisartan and placebo in the risk of cardiovascular events , a composite of cardiovascular death, myocardial infarction, stroke, or hospitalisation for heart failure. Hospitalisation for cardiovascular reasons were slightly but significantly reduced by telmisartan (33 vs 30 per cent). MHRA: fentanyl patch errors potentially fatal Errors in dosing, accidental exposure and enhanced absorption from heat exposure have resulted in life-threatening and fatal incidents with transdermal fentanyl, warns the MHRA in its latest Drug Safety Update (September 2008). There is also evidence that fentanyl patches are being prescribed for nonlicensed indications, including treatment of opioid-naive patients. Other topics in this issue include managing adverse reactions to HPV vaccine and an update on new cases of progressive multifocal leucoencephalopathy associated with natalizumab (Tysabri). Call for DURG research The Drug Utilisation Research Group is inviting abstracts for oral and poster presentations at its 20th annual meeting on 5 February 2009. The theme of the morning session is ,Whose prescribing budget is it anyway?'. Abstracts will be accepted on any drug utilisation research studies and will be published in the Journal of Pharmacoepidemiology and Drug Safety. Information is available at www.durg.org.uk the deadline for submissions is 1 December. Early bromocriptine no benefit in Parkinson's Initiating treatment of Parkinson's disease with the dopamine agonist bromocriptine offers no long-term benefit compared with levodopa, the UK Parkinson's Disease Research Group trial has shown (Neurology 2008;71:474-80). After 14 years' follow-up of 166 patients, there were no differences in the prevalence of motor complications, dementia or mortality, but levodopa was associated with superior scores of disability and physical functioning. The authors say the belief that early dopamine agonist treatment is neuroprotective in Parkinson's disease should be abandoned. Ezetimibe with statin cancer risk ,not credible' Analysis of data pooled from two large trials provides ,no credible evidence' that ezetimibe (Ezetrol) is associated with an increased risk of cancer when added to statin therapy (N Engl J Med 2008 published online; doi 10.1056/NEJMsa0806603). A possible link with increased risk of cancer with ezetimibe plus simvastatin was suggested by the SEAS trial (N Engl J Med 2008 published online; doi 10.1056/NEJMoa 0804602). This hypothesis was tested in two trials involving more than 20 500 patients over 1.0-2.7 years. There was no excess of cancer overall or at particular sites; cancer deaths were more numerically but not significantly higher with ezetimibe and there was no evidence of increased risk with duration of treatment. Telmisartan provides no advantage after stroke Adding telmisartan (Micardis) to standard treatment after ischaemic stroke does not reduce morbidity, US investigators report (N Engl J Med 2008 published online; doi 10.1056/NEJMoa 0804593). A total of 20 332 patients with recent ischaemic stroke were randomised to placebo or telmisartan 80mg per day in addition to antiplatelet therapy and antihypertensive agents. After 2.5 years, blood pressure was 3.8/2.0mmHg lower in patients taking telmisartan but there were no significant differences from placebo in the risks of recurrent stroke, cardiovascular events or new-onset diabetes. Copyright © 2008 Wiley Interface Ltd [source]


    Amplification of genes encoding KIT, PDGFR, and VEGFR2 receptor tyrosine kinases is frequent in glioblastoma multiforme

    THE JOURNAL OF PATHOLOGY, Issue 2 2005
    Heikki Joensuu
    Abstract KIT, platelet-derived growth factor receptors (PDGFRs) and vascular endothelial growth factor receptors (VEGFRs) are important clinical targets for tyrosine kinase inhibitors. The frequency of KIT and VEGFR2 amplification in glioblastomas is not known, and few data are available in any other human tumour type. We investigated 43 primary glioblastomas for KIT, VEGFR2, PDGFRA and EGFR amplification using fluorescence in situ hybridization. KIT was amplified in 47% and VEGFR2 in 39% of the glioblastomas, respectively, and PDGFRA in 29%. Thirty-five (81%) of the tumours had either KIT or EGFR amplification. KIT, PDGFRA and VEGFR2 amplifications were strongly associated (p < 0.0001 for each pairwise comparison), suggesting co-amplification, whereas no significant association was found with EGFR amplification. The four secondary glioblastomas arising from pre-existing lower grade astrocytic tumours investigated had KIT amplification but none had EGFR amplification. No mutations were detected with denaturing high-performance liquid chromatography in KIT exons 9, 11, 13 or 17, PDGFRA exons 12 and 18, or EGFR exons 18, 19 or 21. Glioblastomas with KIT, PDGFR or VEGFR2 amplification were associated with similar outcome to other glioblastomas. We conclude that KIT, PDGFRA and VEGFR2 are commonly amplified in primary glioblastoma and that they may also be amplified in secondary glioblastoma. Amplified kinases may be potential targets for tyrosine kinase inhibitor therapy. Copyright © 2005 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd. [source]


    Vardenafil Restores Erectile Function to Normal Range in Men with Erectile Dysfunction

    THE JOURNAL OF SEXUAL MEDICINE, Issue 1 2007
    Harin Padma-Nathan MD
    ABSTRACT Introduction., The ability of oral phosphodiesterase type 5 (PDE5) inhibitor therapy to restore erectile function to normal is an important attribute to men with erectile dysfunction (ED). Aim., To assess the ability of vardenafil to restore normal erectile function in men with general ED. Methods., In two fixed-dose, parallel-group, double-blind, placebo-controlled, pivotal studies, patients received vardenafil (5, 10, or 20 mg) or placebo for 12/26 weeks. Main Outcome Measure., In this retrospective analysis, the percentage of patients "returning to normal" erectile function at week 12 (as defined by scores ,26 on erectile function domain of International Index of Erectile Function [IIEF-EF]) was determined, with further stratification by baseline ED severity, etiology, age, and duration of ED. Results., Vardenafil 5, 10, and 20 mg returned 32%, 43%, and 49% of patients, respectively, to normal erectile function after 12 weeks, compared with 10% of patients receiving placebo (P < 0.0001). Return to normal IIEF-EF domain scores was noted irrespective of severity, etiology, age, and duration of ED, and was observed even in challenging-to-treat subgroups. With vardenafil 20 mg, 39% of men with severe ED at baseline, 45,49% of men with ED of mixed or organic etiology, 35% of men aged ,65 years, and 43% of men with ED of ,3 years of duration returned to normal erectile function at week 12. Mean per-patient SEP3 (question 3 on the Sexual Encounter Profile) success rates in patients achieving IIEF-EF domain scores ,26 ranged from 87% to 95%. Conclusion., Vardenafil improves the IIEF-EF domain score to the normal range in a substantial proportion of men with ED. Padma-Nathan H, Montorsi F, Giuliano F, Meuleman E, Auerbach S, Eardley I, McCullough A, Homering M, and Segerson T for the North American and European Vardenafil Study Group. Vardenafil restores erectile function to normal range in men with erectile dysfunction. J Sex Med 2007;4:152,161. [source]


    Patients Responding to Phosphodiesterase Type 5 Inhibitor Therapy,What Do Their Sexual Partners Know?

    THE JOURNAL OF SEXUAL MEDICINE, Issue 1 2007
    Theodor Klotz MD
    ABSTRACT Introduction., Phosphodiesterase type 5 (PDE5) inhibitors are an efficacious therapy in men with erectile dysfunction (ED). There are only a few studies that also focus on the participating couples during PDE5 inhibitor therapy. Aim., To determine to what extent patients personally informed their sexual partners about their ongoing PDE5 inhibitor therapy. Main Outcome Measures., Likelihood of informing the female partner by the patient himself about the use of PDE5 inhibitors. Methods., A total of 216 men (mean age 62.3 years) with ED were successfully treated with PDE5 inhibitors in three independent centers. After an interval of at least 3 months of successful ED therapy, all patients were asked by questionnaire whether their sexual partners were informed of their PDE5 inhibitor therapy. Results., Eighty-two percent of the patients were exclusively involved in one stable sexual relationship, 9.7% of the men admitted to having changing sexual partners, and 6% did not give any information at all about their sexual partners. Twenty percent of the men had a severe ED (International Index of Erectile Function [IIEF-5] <11). Forty-nine percent showed a moderate ED (IIEF-5 11,16) and 31% suffered a mild ED (IIEF-5 >16). PDE5 inhibitor medication was used 1.2 times/month by men with a severe ED, 2.1 times/month by patients with a moderate ED, and 2.9 times/month by men with a mild ED. Forty-one (93%) of the 44 patients with a severe ED informed their sexual partners that they were taking PDE5 inhibitors. In the patient group with moderate ED, 49 (47%) of 105 patients and only 14 (21%) of 67 of the patients with mild ED shared this information with their partners. Conclusion., Less than 40% of the patients suffering a moderate or mild ED using PDE5 inhibitors shared this information with their partners. It seems that patients find ED so disturbing that many patients do not inform their partners of PDE5 inhibitor use. Klotz T, Mathers M, Klotz R, and Sommer F. Patients responding to phosphodiesterase type 5 inhibitor therapy,What do their sexual partners know? J Sex Med 2007;4:162,165. [source]


    Feasibility of the Use of Phosphodiesterase Type 5 Inhibitors in a Pharmacologic Prevention Program for Recurrent Priapism

    THE JOURNAL OF SEXUAL MEDICINE, Issue 6 2006
    Arthur L. Burnett MD
    ABSTRACT Introduction., Recurrent ischemic priapism is an enigmatic erectile disorder in need of improved clinical interventions to avert its known, potentially serious complications. Aim., To evaluate the use of a long-term, continuous phosphodiesterase type 5 (PDE5) inhibitor therapeutic regimen in controlling recurrent ischemic priapism and its feasibility in a clinical management program for the disorder. Main Outcome Measures., The main outcome measure was reduction in frequency or duration of priapism episodes. A secondary outcome measure was preservation of erectile ability. Methods., We retrospectively evaluated the clinical progress of seven patients (age 22,37 years) with sickle cell disease-associated "stuttering" priapism (N = 4) and idiopathic recurrent priapism (N = 3), who were counseled and consented to the "off-label" use of the PDE5 inhibitors sildenafil citrate and tadalafil. The medications were administered according to a specified therapeutic regimen based on scientific evidence that chronic PDE5 inhibitor administration in priapism contexts effectively reconditions PDE5 regulatory function in the penis. The duration of clinical follow-up extended through 2 years. Results., All seven patients were confirmed to have recurrent ischemic priapism without identifiable pharmacologic, traumatic, or neoplastic disease associations based on clinical history, physical examination, laboratory testing, and penile diagnostics. PDE5 inhibitor treatment was successful in alleviating or resolving priapism recurrences in six of the seven patients. Erectile function was unchanged in six patients and improved in one patient at last follow-up compared with baseline status. All the patients reported that PDE5 inhibitor therapy was well tolerated and did not cause any adverse effects limiting their continued use of the medication. Conclusions., Because of their efficacy, safety, and tolerability as shown in this case series, PDE5 inhibitors would appear to have a possible role in a rigorously implemented clinical management program to control recurrent priapism. However, completion of a controlled clinical trial is necessary to confirm the utility of this treatment. Burnett AL, Bivalacqua TJ, Champion HC, and Musicki B. Feasibility of the use of phosphodiesterase type 5 inhibitors in a pharmacologic prevention program for recurrent priapism. J Sex Med 2006;3:1077,1084. [source]


    ORIGINAL RESEARCH,ED PHARMACOTHERAPY: Psychosocial Outcomes and Drug Attributes Affecting Treatment Choice in Men Receiving Sildenafil Citrate and Tadalafil for the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Open-Label, Crossover Study

    THE JOURNAL OF SEXUAL MEDICINE, Issue 4 2006
    FRCGP, John Dean MBBS
    ABSTRACT Introduction., Although sildenafil citrate (sildenafil) and tadalafil are efficacious and well-tolerated treatments for erectile dysfunction (ED), preference studies have shown that patients may favor one medication over the other. Aim., To determine whether psychosocial outcomes differed when men with ED received tadalafil compared with sildenafil. Main Outcome Measures., Measures included a treatment preference question, Psychological and Interpersonal Relationship Scales (PAIRS), and Drug Attribute Questionnaire. Methods., Randomized, open-label, crossover study. After a 4-week baseline, men with ED (N = 367; mean age = 54 years; naïve to type 5 phosphodiesterase inhibitor therapy) were randomized: tadalafil for 12 weeks then sildenafil for 12 weeks or vice versa (8-week dose optimization/4-week assessment phases). During dose optimization, patients started with 10 mg tadalafil, or 25 or 50 mg sildenafil and could titrate to their optimal dose (10 or 20 mg tadalafil; 25, 50, or 100 mg sildenafil). Medications were taken as needed. Patients completing both 12-week periods chose which medication to continue during an 8-week extension. Results., Of 291 men completing both treatment periods, 71% (N = 206) chose tadalafil and 29% (N = 85) chose sildenafil (P < 0.001) for the 8-week extension. When taking tadalafil compared with sildenafil men had higher mean endpoint scores on PAIRS Sexual Self-Confidence (tadalafil = 2.91 vs. sildenafil = 2.75; P < 0.001) and Spontaneity (tadalafil = 3.32 vs. sildenafil = 3.17; P < 0.001) Domains and a lower mean endpoint score on Time Concerns Domain (tadalafil = 2.2 vs. sildenafil = 2.59; P < 0.001). The two most frequently chosen drug attributes to explain treatment preference were ability to get an erection long after taking the medication and firmness of erections. Tadalafil and sildenafil were well tolerated with 12 (3.3%) patients discontinuing for an adverse event. Conclusions., As measured with PAIRS, men with ED had higher sexual self-confidence and spontaneity and less time concerns related to sexual encounters when treated with tadalafil compared with sildenafil. These psychosocial outcomes may help explain why more men (71%) preferred tadalafil for the treatment of ED in this clinical trial. Dean J, Hackett GI, Gentile V, Pirozzi-Farina F, Rosen RC, Zhao Y, Warner MR, and Beardsworth A. Psychosocial outcomes and drug attributes affecting treatment choice in men receiving sildenafil citrate and tadalafil for the treatment of erectile dysfunction: Results of a multicenter, randomized, open-label, crossover study. J Sex Med 2006;3:650,661. [source]