Maternal blood concentration of tadalafil in pregnancy: Comparison of pregnant and non-pregnant women

ObjectiveIn this study, the drug kinetics of tadalafil were compared between pregnant and non-pregnant women to determine the ideal dosage to promote uterine blood flow.Materials and methodsWe recruited five pregnant and five non-pregnant women, all of which were administered tadalafil (20 mg/day). The blood concentration of tadalafil was measured 1, 2, 4, 6, 8, and 24 h after administration. We investigated the side effects within 4 days of tadalafil administration and compared the cumulative frequency between the two groups.ResultsThe mean area under the concentration–time curve and maximum blood concentration of tadalafil were not different between the pregnant and non-pregnant groups. Time to maximum blood concentration was delayed by 1 min on average in the pregnant group compared with the non-pregnant group. The cumulative frequency of side effects was significantly lower in the pregnant group than in the non-pregnant group (P = 0.026). No side effects were observed in either group after the fifth day of the tadalafil administration.ConclusionAlthough there was no difference in maximum blood concentration between non-pregnant and pregnant women, the rate of side effects was lower in pregnant women than in non-pregnant women. Therefore, pregnant women may tolerate tadalafil better.     

Cardiac function and tadalafil used for treating fetal growth restriction in pregnant women without cardiovascular disease

Background: The aim of the present study was to evaluate tadalafil for the treatment of fetal growth restriction (FGR) and the cardiac function in pregnant women without cardiovascular disease who used tadalafil for this reason.

Materials and methods: We examined nine pregnant women without cardiovascular disease who were using tadalafil to treat FGR. Maternal heart rate, systolic blood pressure (BP), and echocardiographic findings were assessed before and after tadalafil use.

Results: Diastolic BP was lower after compared to that before using tadalafil, but the difference was not significant. Echocardiographic findings were not significantly different before and after tadalafil use.

Conclusions: Tadalafil did not adversely affect pregnant women without cardiovascular disease and was considered acceptable for use since it did not affect the mother’s cardiac function.     

他达那非两种给药方法治疗慢性前列腺炎合并勃起功能障碍的临床疗效比较

目的:比较按需给药和长期小剂量口服他达那非两种给药方法治疗慢性前列腺炎合并勃起功能障碍的临床疗效。方法:将80例慢性前列腺炎合并勃起功能障碍的患者随机分为A组(按需给药组)和B组(5mg他达那非组),每组40例。比较两组患者治疗前后NIH-CPSI、IIEF-5、SD和SAS评分的变化情况,记录治疗总有效率,并评估他达那非的安全性及耐受性。结果:两组治疗后NIH-CPSI和IIEF-5评分较治疗前明显改善(P0.05);B组患者治疗后IIEF-5评分改善情况优于A组(P0.05);两组治疗后SDS和SAS评分较治疗前明显降低(P0.05);B组患者治疗后SDS和SAS评分低于A组(P0.05);B组治疗总有效率显著高于A组,差异有统计学意义(P0.05);本研究未出现严重不良反应。结论:长期小剂量(5mg/d)口服他达那非治疗慢性前列腺炎合并勃起功能障碍可以提高患者性自信,改善勃起功能障碍,治疗有效率高且耐受性强。     

男性对西地那非、伐地那非和他达拉非认识的研究

目的调查男性对西地那非、伐地那非和他达拉非的认识,从而指导临床实践。方法男性非ED患者70人,采用自行设计表格,主要调查PDE5抑制剂的使用方法和注意事项。结果和结论男性知道西地那非,但几乎不知道伐地那非和他达拉非;大多数男性不知道这些药物的使用方法和注意事项,这可能会影响药物的治疗效果和安全性,甚至使ED的药物治疗失败,今后应加强患者的用药指导。     

Effect of oral Tadalafil on endometrial thickness in patients receiving Clomiphene citrate for ovulation induction

Background

Adequate and optimum endometrial development is required for a successful pregnancy to occur. Clomiphene citrate is well known for its negative impact on endometrial thickness. The long-acting phosphodiesterase 5 inhibitor, Tadalafil, was shown to improve endometrial growth in patients under Clomiphene citrate stimulation.

Pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products in UAE

Generic drugs or generic medicines are pharmaceutical products manufactured to be equivalent to the brand/innovator drug products. They represent the majority of worldwide prescribed medicines; therefore, their quality is critical to maximize patients’ therapeutic outcomes. This study aimed to evaluate the pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products being sold in the United Arab Emirates (UAE) market to enhance public confidence, promote their utilization, and reduce treatment costs. Three drugs (tadalafil, rosuvastatin, and acetaminophen) from three different pharmacological classes were selected from the UAE market as representatives for generic drugs. At least two generic products for each locally (L) and regionally (R) manufactured generic were evaluated according to the USP criteria in comparison to the brand (B) comparator product. All comparative tests were performed before storage and 3 and 6 months after storage during the accelerated stability study performed under the conditions for climatic zone IV (40 °C ± 2 °C /75% RH ± 5% RH). Although results were statistically different from the comparators using ANOVA and Tukey’s Kremer post hoc tests, all tests were within the USP acceptance limits, except one, for friability, disintegration, content uniformity, and dissolution. Significant changes were observed following their storage over 6 months during accelerated stability studies, however, without failing the USP limits. Only one locally manufactured acetaminophen generic failed the USP dissolution tests before and after its storage and failed the disintegration test following its storage under accelerated conditions for zone IV. In conclusion, the majority of the locally and regionally manufactured generic products being sold in the UAE market were of good quality and performed similarly to their comparators. However, a continuous independent quality evaluation for the marketed generic drugs is essential to enhance public confidence.     

Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option

ABSTRACT

Objective: To provide clinically relevant information on tadalafil 2.5 or 5 mg once daily for the treatment of erectile dysfunction (ED), by reviewing safety and efficacy study findings. Findings from an integrated analysis of trials of tadalafil 10 and 20 mg as needed are presented to provide context for the daily dosing regime.

Research design and methods: Of the three studies that included approved once-daily doses, two were conducted in the general ED population and one in a diabetic ED population. An integrated analysis was performed using 12-week efficacy and safety data from the studies conducted in the general ED population.

Results: In the general ED population, the 12-week mean International Index of Erectile Function (IIEF) erectile function (EF) domain scores increased by 6.2 to an endpoint score of 19.2 and by 8.6 to 21.9 for 2.5 and 5 mg doses, respectively, versus an increase of 1.3 to 14.9 for placebo (p < 0.01). Mean successful intercourse attempts (SEP3) were 50% and 62% for tadalafil 2.5 and 5 mg once daily, respectively, versus 33% for placebo (p < 0.01). These findings were consistent with those for tadalafil as needed. In 1- and 2-year open label extensions of tadalafil 5 mg once daily, efficacy was maintained. In the diabetic ED population, 12-week mean IIEF EF scores increased by 4.8 to 18.3 and 4.5 to 17.2 with tadalafil 2.5 and 5 mg, respectively, versus an increase of 1.3 to 14.7 for placebo (p < 0.01). Mean successful intercourse attempts were more than 40% for each tadalafil dose, versus 28% for placebo (p < 0.01). The profile of treatment-emergent adverse events with tadalafil once daily was similar to that previously reported with as-needed treatment; the most common adverse events with tadalafil (dyspepsia, nasopharyngitis, headaches) were reported in ≤4% of participants.

Conclusions: Findings from the three published studies support a favorable risk–benefit balance for tadalafil 2.5 or 5 mg once daily. Although no direct comparison studies were performed (no head-to-head trials), efficacy and safety findings were consistent with those with tadalafil as needed.     

The efficacy of tadalafil in improving sexual satisfaction and overall satisfaction in men with mild,moderate, and severe erectile dysfunction: a retrospective pooled analysis of data from randomized,placebo-controlled clinical trials

ABSTRACT

Background: Satisfaction with the sexual experience is considered important when evaluating the impact of treatments for erectile dysfunction (ED), yet satisfaction has been infrequently assessed in clinical trials.

Objective: To evaluate satisfaction with, and enjoyment of, the sexual experience in men with ED enrolled in 11 placebo-controlled clinical trials of tadalafil.

Study design and methods: Retrospective pooled analysis of data from 11 randomized, double blind, placebo-controlled clinical trials of tadalafil. Men with mild (N = 838), moderate (N = 558), or severe (N = 703) ED who were randomized to tadalafil 10?mg or 20?mg or placebo taken as needed for 12 weeks were included in this analysis. Efficacy measures included the International Index of Erectile Function (IIEF). Reported herein are the scores on the IIEF overall satisfaction domain and individual IIEF questions (IIEF‐Q7, satisfaction with intercourse; and IIEF‐Q8, enjoyment of intercourse).

Results: At least moderate satisfaction (IIEF overall satisfaction domain) was reported by 55% and 72% of patients with mild ED taking tadalafil 10?mg and 20?mg, respectively, compared with 33% taking placebo (?p < 0.002); 60% and 65% vs. 19% of patients with moderate ED (?p < 0.001); and 32% and 49% vs. 9% with severe ED (?p < 0.001). Satisfactory intercourse during most attempts or almost always/always (IIEF‐Q7) was reported by 59% and 79% of patients with mild ED taking tadalafil 10?mg and 20?mg vs. 32% taking placebo (?p < 0.001); 52% and 65% vs. 18% with moderate ED (?p < 0.001); and 28% and 49% vs. 5% with severe ED (?p < 0.001). Highly or very highly enjoyable intercourse (IIEF‐Q8) was reported by 45% and 63% of patients with mild ED taking tadalafil 10?mg and 20?mg vs. 21% taking placebo (?p < 0.001); 43% and 56% vs. 16% with moderate ED (?p < 0.001); and 19% and 44% vs. 5% with severe ED (?p < 0.001).

Conclusions: Compared with placebo, tadalafil 10?mg and 20?mg improved overall satisfaction with the sexual experience, intercourse satisfaction, and intercourse enjoyment in men with mild, moderate, and severe ED.     

自拟壮阳起萎汤联合他达拉非治疗男性勃起功能障碍的临床效果

〔摘 要〕 目的：探究男性勃起功能障碍使用自拟壮阳起萎汤联合他达拉非治疗的效果。方法：选取 2018 年 1 月至 2018 年12 月兴宁市妇幼保健计划生育服务中心收治的男性勃起功能障碍患者 100 例,随机分为对照组和观察组,各 50 例。对照组使用自拟壮阳起萎汤治疗,观察组应用自拟壮阳起萎汤联合他达拉非治疗,分析比较两组患者的治疗效果以及治疗前后国际勃起功能评分表（IIEF–5）评分情况。结果：观察组治疗总有效率为 96.0 %,明显高于对照组的 80.0 %,差异具有统计学意义（P ＜ 0.05）;治疗前两组患者 IIEF–5 评分比较,差异无统计学意义（P ＞ 0.05）,治疗后观察组患者的 IIEF–5 评分明显高于对照组,差异具有统计学意义（P ＜ 0.05）。结论：在治疗男性勃起功能障碍中,使用自拟壮阳起萎汤联合他达拉非治疗效果较好,可提高 IIEF–5 评分,有利于患者性生活质量的提高。     

Efficacy and satisfaction rates of oral PDE5is in the treatment of erectile dysfunction secondary to spinal cord injury: a review of literature

Concept

Decreased sexual function is a major concern of men with spinal cord injuries (SCIs). Treatment of erectile dysfunction (ED) through oral pharmacotherapies has been proven to be an effective way to address and treat this concern.

Objective

To find an efficacious and satisfactory treatment ED secondary to SCI through the compilation of studies that utilized the International Index of Erectile Function (IIEF) when testing phosphodiesterase V inhibitors (PDE5i).

Method

Ten articles, which used the IIEF to study satisfaction and/or efficacy of PDE5is sildenafil, tadalafil, and vardenafil in the treatment of ED were reviewed and analyzed. Through the use of a self-made grading scale the value of each article was determined for this research.

Results

Sildenafil, tadalafil, and vardenafil all have been proven to be effective in treating ED in men with SCI. While sildenafil is the most thoroughly studied ED treatment for patients with SCI, tadalafil has a longer time duration effectiveness, which allows for more spontaneity in the sexual experience. Minimal adverse effects have been noted in patients with SCI using these medications; headache, flushing, and mild hypotension are the most common. In articles that study satisfaction, patients show great improvement over baseline with the use of these medications.

Conclusion

Although there is a need for further research on the safety in long-term use of tadalafil and vardenafil, comparative studies done on all three medications show no statistically significant difference in effectiveness or satisfaction. New medications and treatment options, such as avanafil, are being studied in hope of continued improvement of sexual function in men with SCI.