Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus

 

Abstract

Background

Erectile dysfunction is a common multi-factorial complication of diabetes mellitus. Numerous strategies have been tried to overcome this diabetic complication. In recent years, phosphodiesterase type 5 (PDE-5) inhibitors have been introduced in the management of erectile dysfunction.

Objectives

The objective of this review was to assess the effect of PDE-5 inhibitors on the management of erectile dysfunction in diabetic men.

Search methods

Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library.

Selection criteria

Randomised controlled trials, in which treatment with PDE-5 inhibitors was compared to control, in diabetic patients with erectile dysfunction.

Data collection and analysis

Two reviewers independently extracted data and assessed trial quality.

Main results

Eight randomised controlled trials were identified. A total 976 men were allocated to receive a PDE-5 inhibitor and 741 were randomised to the control groups. Overall, 80% of the participants suffered from type 2 diabetes mellitus. The weighted mean difference (WMD) for the International Index of Erectile Function (IIEF) questions 3 and 4 (frequency of penetration during and maintaining erection to completion of intercourse) was 0.9 (95% CI 0.8 to 1.1) and 1.1 (95% CI 1.0 to 1.2) at the end of the study period, in favour of the intervention group. The WMD for the IIEF erectile dysfunction domain at the end of the study period was 6.6 (95% CI 5.2 to 7.9) in favour of the PDE-5 inhibitors arm. The relative risk (RR) for answering "yes" to a global efficacy question ( "did the treatment improve your erections?") was 3.8 (CI 95% 3.1 to 4.5) in the PDE-5 inhibitors compared with the control arm. The WMD between the percentage of successful attempts in the PDE-5 inhibitors and in the control arm was 26.7 (95% CI 23.1 to 30.3). Mortality was not reported in any of the included trials. Adverse cardiovascular effects were reported in one study. Headache was the most frequent adverse event reported, flushing was the second most common event, with upper respiratory tract complaints and flu like syndromes, dyspepsia, myalgia, abnormal vision and back pain also reported in a descending order of frequency. The overall risk ratio for developing any adverse reaction was 4.8 (CI 95% 3.74 to 6.16) in the PDE-5 inhibitors arm as compared to the control.

Authors' conclusions

Sufficient evidence exists that PDE-5 inhibitors form a care that improves erectile dysfunction in diabetic men.

 

Plain language summary

Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus

Erectile dysfunction is a common multi-factorial complication of diabetes mellitus. Newer medications, like the so-called PDE-5 inhibitors result in enhancement of penile erection. The introduction of sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis), have altered the management of erectile dysfunction. In this review we assessed the effect of these agents on erectile dysfunction in diabetic people. Eight studies with 976 men randomised to PDE-5 inhibitor therapy and a duration of mainly 12 weeks were evaluated. Compared to placebo treatment, these agents showed favourable effects in scores estimating sexual life, with an increased rate of adverse effects like headache and flushing after PDE-inhibitor therapy. Mortality was not reported in any of the included trials. Quality of life, with the exception of scores for sexual life, was not relevantly affected. If taken as prescribed, PDE-5 inhibitors comprise a valuable treatment option for erectile dysfunction in men with diabetes.

 

摘要

背景

Phosphodiesterase inhibitors 對糖尿病患者勃起功能障礙的療效

勃起功能障礙是糖尿病患者常見的併發症之一而其原因是多元的。目前有許多研究嘗試治療此併發症。近年來, phosphodiesterase type 5 (PDE−5) inhibitors 已被用來治療勃起功能障礙。

目標

本文回顧評估PDE−5 inhibitors 對於糖尿病男性患者勃起功能障礙的療效。

搜尋策略

此研究係經由MEDLINE, EMBASE and The Cochrane Library搜尋資料.

選擇標準

本回顧納入以PDE−5 inhibitors或對照藥治療糖尿病患者勃起功能障礙的隨機控制研究。

資料收集與分析

兩位審查者獨立擷取資料並評估試驗的品質。

主要結論

在八個隨機控制研究中.共有976位男性接受PDE−5 inhibitor治療,另外741位被分配到對照組.總計有80%的研究對象有第二型糖尿病. 研究結束時,依據International Index of Erectile Function(IIEF)的問題3與問題4 (穿入及維持勃起完成性交的頻率)計算出來的加權平均差分別為0.9 (95% CI 0.8 to 1.1)與1.1 (95% CI 1.0 to 1.2),試驗組有較好的療效.在試驗終了,根據IIEF erectile dysfunction domain 的加權平均差為6.6 (95% CI 5.2 to 7.9),支持PDE−5 inhibitors治療組.根據global efficacy question (治療是否改善勃起功能障礙)回答“是”者, PDE−5 inhibitors組相對於對照組,其relative risk (RR)為3.8 (CI 95% 3.1 to 4.5).在PDE−5 inhibitors組與對照組間successful attempts百分比的加權平均差為26.7 (95% CI 23.1 to 30.3).這些試驗中並沒有死亡的案例.在其中一個試驗中有產生心血管疾病副作用的報告.曾經被報告的副作用以頭痛最為常見,潮紅其次,其他如上呼吸道症狀,流感症狀,消化不良,肌肉痠痛,視覺異常,背痛都曾被報告過.總體而言, PDE−5 inhibitors組相對於對照組發生任一副作用的risk ratio 為4.8 (CI 95% 3.74 to 6.16)。

作者結論

有足夠證據指出, PDE−5 inhibitors能夠改善糖尿病患者勃起功能障礙的問題

翻譯人

本摘要由臺灣大學附設醫院張涵軒翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Phosphodiesterase type 5 (PDE−5)抑制劑可改善糖尿病男性患者勃起功能障礙的問題。勃起功能障礙是糖尿病患者常見且病因為多元的併發症之一。較新的藥物,如所謂的PDE−5inhibitors可改善陰莖勃起。一些藥物的介入,如sildenafil (Viagra), vardenafil (Levitra), tadalafil (Cialis),改變了勃起功能障礙的治療方式。在此回顧研究中我們評估了這些藥物對糖尿病患者勃起功能障礙的功效。共有八個研究包含976位男性被隨機分配到PDE−5 inhibitor治療組中,為期約12週。相對於安慰劑治療,這些藥物在性生活評分中有較令人滿意的效果,但副作用如頭痛和潮紅的發生率也增加.這些試驗並無死亡病例的報告。除性生活外的生活品質並無影響。如果確實遵照醫囑服用, PDE−5 inhibitors對於糖尿病男性患者勃起功能障礙是一個好的治療選擇。