Intervention Review

Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus

  1. Moshe Vardi1,*,
  2. Asaph Nini2

Editorial Group: Cochrane Metabolic and Endocrine Disorders Group

Published Online: 24 JAN 2007

Assessed as up-to-date: 30 OCT 2005

DOI: 10.1002/14651858.CD002187.pub3


How to Cite

Vardi M, Nini A. Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD002187. DOI: 10.1002/14651858.CD002187.pub3.

Author Information

  1. 1

    Carmel Medical Center, Internal Medicine, Haifa, Israel

  2. 2

    Sheba Medical Center, Intensive Care Unit, Tel Hashomer, Israel

*Moshe Vardi, Internal Medicine, Carmel Medical Center, 7 Michal St, Haifa, Haifa, 34362, Israel. MosheVa3@clalit.org.il.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 24 JAN 2007

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト
  5. 摘要
  6. Laički sažetak

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

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト
  5. 摘要
  6. Laički sažetak

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.

 

アブストラクト

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト
  5. 摘要
  6. Laički sažetak

糖尿病患者の勃起不全に対するホスホジエステラーゼ阻害薬

背景

勃起不全は糖尿病によくみられる多因子合併症である。糖尿病のこの合併症を克服するために、多くの戦略が試みられてきた。近年、ホスホジエステラーゼ5型(PDE-5)阻害薬が勃起不全の管理に導入されている。

目的

PDE-5阻害薬が糖尿病男性における勃起不全管理に及ぼす効果を評価する。

検索戦略

MEDLINE、EMBASEおよびコクラン・ライブラリをコンピュータで検索した。

選択基準

勃起不全を有する糖尿病患者におけるPDE-5阻害薬による治療と対照を比較しているランダム化比較試験。

データ収集と分析

2名のレビューアが別々にデータを抽出し、試験の質を評価した。

主な結果

8件のランダム化比較試験が同定された。男性計976例がPDE-5阻害薬投与に割り付けられ、741例が対照群にランダム化されていた。参加者の計80%は2型糖尿病であった。国際勃起機能スコア(IIEF)の質問3および4(性交中の挿入回数および性交終了までの勃起維持)についての重み付け平均差は、研究期間終了時に0.9(95%CI 0.8~1.1)および1.1(95%CI 1.0~1.2)であり、介入群の方が優れていた。研究期間終了時のIIEFの勃起不全の項目についての重み付け平均差は、6.6(95%CI 5.2~7.9)でPDE-5阻害薬群の方が優れていた。全体的な有効性についての質問(「治療により勃起が改善しましたか。」)に「はい」と回答することに関する相対リスク(RR)は、対照群と比較してPDE-5阻害薬群では3.8(95%CI 3.1~4.5)であった。PDE-5阻害薬群の性交の試み成功率(%)と対照群の成功率(%)との間の重み付け平均差は、26.7(95%CI 23.1~30.3)であった。選択した試験のいずれにおいても死亡例は報告されなかった。心血管の有害作用が、1件の研究で報告された。頭痛が最も多く報告された有害事象であり、紅潮が二番目に多い有害事象であった。頻度の高い順から、上気道に関する愁訴およびかぜ様症候群、消化障害、筋肉痛、視覚異常ならびに背部痛も報告されていた。対照群と比較してPDE-5阻害薬群において何らかの有害反応を起こす全リスク比は4.8(95%CI 3.74~6.16)であった。

著者の結論

PDE-5阻害薬は糖尿病男性における勃起不全を改善させる治療薬であるとする十分なエビデンスが存在する。

訳注

監  訳: 2007.3.30

実施組織: 厚生労働省委託事業によりMindsが実施した。

ご注意 : この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、Minds事務局までご連絡ください。Mindsでは最新版の日本語訳を掲載するよう努めておりますが、編集作業に伴うタイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト
  5. 摘要
  6. Laički sažetak

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。

 

Laički sažetak

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト
  5. 摘要
  6. Laički sažetak

Inhibitori fosfodiesteraze za liječenje poremećaja erekcije u oboljelih od šećerne bolesti

Poremećaj erekcije (erektilna disfunkcija) je čest poremećaj u oboljelih od šećerne bolesti (dijabetesa), a čijem nastanku može doprinijeti niz uzroka. Noviji lijekovi, kao što su inhibitori fosfodiesteraze, mogu pospješiti erekciju penisa. Uvođenje sildenafila (Viagra), vardenafila (Levitra) i tadalafila (Cialis) na tržište promijenilo je liječenje poremećaja erekcije.U ovom Cochrane sustavnom pregledu procijenjen je učinak inhibitora fosfodiesteraze na poremećaj erekcije u muškaraca oboljelih od šećerne bolesti. Procijenjeno je osam studija s ukupno 976 muškaraca koji su primali inhibitore fosfodiesteraze. Studije su trajale uglavnom 12 tjedana. U usporedbi s placebom, ti su lijekovi pokazali povoljan učinak na seksualni život, i veću učestalost nuspojava kao što je glavobolja i crvenilo nakon terapije inhibitorima fosfodiesteraze. Smrtnost nije opisana niti u jednom od procijenjenih istraživanja. Kvaliteta života, osim učinka na seksualni život, nije umanjena. Ako se uzimaju kako su propisani, inhibitori fosfodiesteraze su učinkovita terapijska mogućnost za poremećaj erekcije u muškaraca oboljelih od šećerne bolesti.

Bilješke prijevoda

Prevoditelj:: Croatian Branch of the Italian Cochrane Centre