Opioid-related deaths in Europe: Strategies for a comprehensive approach to address a major public health concern.

Use of illicit opioids and misuse of prescription opioids are the main causes of drug-related deaths across the world, and the continuing rise in opioid-related mortality, especially affecting North America, Australia and Europe, is a public health challenge. Strategies that may help to decrease the high levels of opioid-related mortality and morbidity and improve care across Europe include risk assessment and interventions to improve the use of opioid analgesics, e.g. prescription drug-monitoring programmes, education on pain management to reduce opioid prescribing, and the implementation of evidence-based primary prevention programmes to reduce the demand for opioids. For patients who develop opioid use disorder (a chronic and relapsing problematic use of opioids that causes clinical impairment or distress), treatment combining opiate receptor full or partial agonist medications for opioid-use disorder (MOUD) with psychosocial interventions is essential. However, in Europe a substantial proportion of the 1.3 million high-risk opioid users (defined as injecting drug use or regular use of opioids, mainly heroin) remain outside of dedicated treatment programmes. More widespread and easier access to MOUD could reduce mortality levels; via approaches such as primary care-led treatment models, and efforts to improve patient retention and adherence to treatment programmes. Other harm-reduction strategies, such as the use of MOUD at optimal doses, the provision of take-home naloxone, the introduction of supervised drug-consumption facilities, and patient education to reduce the risk of overdose may also be beneficial.

An evaluation of an alternative dosing regimen with tadalafil, 3 times/week, for men with erectile dysfunction: SURE study in 14 European countries.

OBJECTIVE: To examine the preference for 2 dosing regimens (on demand or 3 times/week) for tadalafil, a phosphodiesterase 5 inhibitor with a duration of effectiveness up to 36 hours in men with erectile dysfunction (ED). DESIGN AND METHODS: SURE is a 14 European country, multicenter, crossover, and open-label study. Men with ED (N=4262) were randomized to tadalafil 20mg treatment on demand (maximum one dose per day and before sexual activity) or 3 times/week for 5-6 weeks. After a 1-week washout period, patients were crossed over to the alternate regimen for 5-6 weeks. The patient's response to a treatment preference question (TPQ) was used to determine the preferred treatment regimen. RESULTS: The mean age of the randomized patients was 55 years and 85.2% reported a history of ED for one year or greater. Overall, the responses of 3861 men to the TPQ assessment showed that 57.8% preferred the on-demand regimen and 42.2% preferred the 3 times/week dosing. Both regimens were efficacious and well tolerated. CONCLUSIONS: In this study, while 57.8% of men preferred the on-demand regimen of tadalafil 20mg, a substantial number (42.2%) preferred the 3 times/week treatment. The two regimens provide additional treatment options by giving men with erectile dysfunction unique flexibility in dosing with tadalafil.

Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction.

OBJECTIVE: To evaluate, in a randomized, double-blind, placebo-controlled, multicentre trial, the safety and efficacy of on-demand tadalafil (an oral phosphodiesterase type-5 inhibitor approved in many countries for treating erectile dysfunction, ED) in a Western European population of men with mild-to-severe ED. PATIENTS AND METHODS: Patients were randomized according to baseline severity of ED in a ratio of 3 : 1 to receive either tadalafil 20 mg or placebo for 12 weeks. Primary efficacy endpoints were mean changes from baseline to endpoint (12 weeks) in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and percentages of 'Yes' responses to Sexual Encounter Profile (SEP) diary Question 2 ('Were you able to insert your penis into your partner's vagina?') and Question 3 ('Did your erection last long enough for you to have successful intercourse?'). Secondary endpoints included mean changes from baseline to endpoint in IIEF Intercourse Satisfaction and Overall Satisfaction domains, selected questions of the IIEF, and the percentage of 'Yes' responses to Global Assessment Questions (GAQ) at the last visit. Other analyses included the percentage of patients in each treatment group at endpoint with IIEF EF domain scores in the normal range (>26), the frequency of intercourse attempts and mean per-patient intercourse success rate at various times after dosing. RESULTS: The mean age of the patients was 53 years and 80% had a history of ED of > or = 1 year. The mean baseline EF domain score was 13.5, with 40.5% of patients in the severe category. Tadalafil improved mean EF domain scores by 11.1, vs 0.4 for placebo (P < 0.001). In addition, 73.9% of sexual intercourse attempts were successful (SEP-Q3) in tadalafil-treated patients, compared with 29.9% in placebo-treated patients during the period after baseline (P < 0.001). Tadalafil significantly improved the mean IIEF intercourse satisfaction (5.1, tadalafil; 1.1, placebo) and overall satisfaction domain scores (3.9, tadalafil; 0.5, placebo), P < 0.001. GAQs used to assess the overall effect of the treatment indicated that tadalafil was superior to placebo (P < 0.001) in improving erections (82.1%, tadalafil; 23.1%, placebo) and sexual activity (78.6% and 17.3%). The most common treatment-emergent adverse events more frequent (>2%) with tadalafil than placebo were headache, dyspepsia, flushing, back pain, pain in limb and myalgia. These adverse events were mostly mild to moderate. CONCLUSIONS: Tadalafil improved erectile function and was well tolerated when taken by men from Western Europe with mild-to-severe ED.

Possible correlation between type 1 diabetes mellitus and female sexual dysfunction: case report and literature review.

INTRODUCTION: Sexual dysfunction in diabetic women has received less attention in clinical research than the sexual symptoms of diabetic men. Although conflicting results have been reported, several studies suggest an increased prevalence of deficient vaginal lubrication in women with diabetes mellitus. As support to the hypothesis of a potential diabetes-related arousal dysfunction caused by a decrease in vaginal lubrication of women with Type 1 diabetes mellitus, we describe the following case report. METHODS: A 29-year-old white woman was found with a sexual arousal disorder of sudden onset, complicated by loss of orgasm and sexual desire, in absence of any marital, relational, psychological, or gynecological cause. RESULTS: One month later she was diagnosed with severe Type 1 diabetes. With the correction of diabetes and without other treatment of the sexual dysfunction, she experienced a full recovery of her sexual complaints. CONCLUSIONS: The case illustrates the importance of being aware of female sexual dysfunction as an early symptom of diabetes mellitus and suggests that a good glycemic control would be fundamental to restore a normal sexual activity in diabetic women. It also demonstrates the need to take into account, not only in males, a sexual history in the management of diabetes mellitus.