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This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs.
The researchers hypothesize that:
The effects of hypertension and its pharmacotherapy on sexual function are well known in men,although this topic remains unexplored in women.There is evidence suggests that some classes of antihypertensive drugs such as diuretics and beta-blockers have more negative impact on male sexual function than other classes such as calcium channel blockers(CCBs) and angiotensin-converting enzyme inhibitors(ACEI).Some data suggest that angiotensin Ⅱ antagonists（ARBs) not only do not exacerbate sexual function in males,but even improve it.
Treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines.More than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events.
CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic for the treatment of hypertension.The purpose of this study is to compare the impacts of different CCB-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Felodipine,Irbesartan,Sexual Dysfunction | Active Comparator |
| |
| Felodipine,Metoprolol,Sexual Dysfunction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Felodipine add Irbesartan | Drug | Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415. Irbesartan,150mg/day, Sanofi - Aventis Pharmaceutical company, Registration Number: H20080074. |
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index (FSFI) | The Female Sexual Function Index (FSFI) is a multidimensional self-report scale for assessing sexual function in women.The FSFI hase been validated in women with various sexual disorders,and in non-dysfunctional controls showing good discriminant validity,internal consistency,and test-retest reliability. | 48 weeks |
| International Index of Erectile Function(IIEF) | The 15-item International Index of Erectile Function (IIEF) was developed to diagnose the presence and severity of erectile dysfunction (ED). | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Systolic Blood Pressure in 2 Weeks | The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week. BP is measured using a calibrated standard mercury sphygmomanometer.After the patient has been seated for 15 minutes,sitting BP is measured 2 times at 1- to 2-minutes intervals,The mean of 2 sitting BP measurements is used as the sitting BP value for that visit;If the difference between the 2 measurements is over 5mmHg,BP should be measured again, and the average of 3 measurements will be taken. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Yu, Professor | Contact | +86 0931 8942076 | yujing2304@126.com | |
| Ruixin Ma, Doctor | Contact | +86 13893102690 | mrxdr@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Yu, Professor | Lanzhou University Second Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20019324 | Background | WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available. | |
| 12493255 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015736 | Felodipine |
| D000077405 | Irbesartan |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Felodipine add Metoprolol | Drug | Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415. Metoprolol Succinate,47.5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: J20050061. |
|
|
| 2 weeks |
| Change of Systolic Blood Pressure in 4 Weeks | The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week. | 4 weeks |
| Change of Systolic Blood Pressure in 8 Weeks | The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week. | 8 weeks |
| Change of Systolic Blood Pressure in 12 Weeks | The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week | 12 weeks |
| Change of Systolic Blood Pressure in 24 Weeks | The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week. | 24 weeks |
| Change of Systolic Blood Pressure in 48 Weeks | The decrease of systolic blood pressure compared with baseline. Baseline is blood pressure in 0 week | 48 weeks |
| Change of Diastolic Blood Pressure in 2 Weeks | The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week | 2 weeks |
| Change of Diastolic Blood Pressure in 4 Weeks | The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week | 4 weeks |
| Change of Diastolic Blood Pressure in 8 Weeks | The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week | 8 weeks |
| Change of Diastolic Blood Pressure in 12 Weeks | The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week. | 12 weeks |
| Change of Diastolic Blood Pressure in 24 Weeks | The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week. | 24 weeks |
| Change of Diastolic Blood Pressure in 48 Weeks | The decrease of diastolic blood pressure compared with baseline. Baseline is blood pressure in 0 week. | 48 weeks |
| Serum Estradiol in 24 Weeks | Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use hemiluminescent radioimmunoassay to detect the level of estradiol in serum sample. | 24 weeks |
| Serum Estradiol in 48 Weeks | 48 weeks |
| Serum Testosterone in 24 Weeks | Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use hemiluminescent radioimmunoassay to detect the level of testosterone in serum sample. | 24 weeks |
| Serum Testosterone in 48 Weeks | 48 weeks |
| Serum MDA in 24 Weeks | Among many oxidative stress biological indicators,malondialdehyde (MDA),the secondary products of lipid peroxidation,is the most representative and most studied polyunsaturated fatty acid peroxidation. Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of MDA in serum samples. | 24 weeks |
| Serum MDA in 48 Weeks | 48 weeks |
| Serum 8-OHdG in 24 Weeks | Reactive oxygen species (ROS) produced either endogenously or exogenously can attack lipid, protein and nucleic acid simultaneously in the living cells. In nuclear and mitochondrial DNA, 8-hydroxydeoxyguanosine (8-OHdG) is produced during DNA repair and its measurement be useful as a marker of DNA lesion. Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of 8-OHdG in serum samples. | 24 weeks |
| Serum 8-OHdG in 48 Weeks | 48 weeks |
| Serum HNE in 24 Weeks | 4 - hydroxy-nonyl acid (HNE) is a strong toxicity end product of lipid peroxidation. Fasting blood samples are taken at 8:00-10:00.After quiescence for 1h and centrifuged (3500rpm/min * 15min), serum samples are extracted and preserved in -80 ℃. Use ELISA to detect the level of HNE in serum samples. | 24 weeks |
| Serum HNE in 48 Weeks | 48 weeks |
| Background |
| Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8. |
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| 12748199 | Background | Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. |
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| 2003706 | Background | Wassertheil-Smoller S, Blaufox MD, Oberman A, Davis BR, Swencionis C, Knerr MO, Hawkins CM, Langford HG. Effect of antihypertensives on sexual function and quality of life: the TAIM Study. Ann Intern Med. 1991 Apr 15;114(8):613-20. doi: 10.7326/0003-4819-114-8-613. |
| 14700518 | Background | Fogari R, Preti P, Zoppi A, Corradi L, Pasotti C, Rinaldi A, Mugellini A. Effect of valsartan and atenolol on sexual behavior in hypertensive postmenopausal women. Am J Hypertens. 2004 Jan;17(1):77-81. doi: 10.1016/j.amjhyper.2003.08.016. |
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| 22134388 | Derived | Ma R, Yu J, Xu D, Yang L, Lin X, Zhao F, Bai F. Effect of felodipine with irbesartan or metoprolol on sexual function and oxidative stress in women with essential hypertension. J Hypertens. 2012 Jan;30(1):210-6. doi: 10.1097/HJH.0b013e32834e1e2e. |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D011083 | Polycyclic Compounds |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |