Levitra scientific update |
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Int J Impot Res. 2006 Sep 21;
Mehrotra N, Gupta M, Kovar A, Meibohm B.
1Department of Pharmaceutical Sciences, University of Tennessee Health Science Center, Memphis, TN, USA.
The role of pharmacokinetics and pharmacodynamics in phosphodiesterase-5 inhibitor therapy.
Differences in clinical pharmacology of the currently marketed phosphodiesterase (PDE)5 inhibitors sildenafil, vardenafil and tadalafil are largely determined by their pharmacokinetic (PK) properties and their PDE5 inhibitory activity profile. This review outlines the basic concepts of pharmacokinetics and pharmacokinetic pharmacodynamic (PK/PD) relationships and their relevance to dose selection and applied pharmacotherapy. It is followed by a detailed comparative discussion on the pharmacokinetics and exposure-response relationship of the currently available PDE5 inhibitors, including known drug-drug interactions and dosage adjustments in special populations. The review is aimed at providing a critical assessment of the pharmacokinetics of PDE5 inhibitors, which may assist clinicians in tailoring drug and/or treatment regimens to the unique needs of each individual patient with erectile dysfunction.International Journal of Impotence Research advance online publication, 21 September 2006; doi:10.1038/sj.ijir.3901522.
Zhonghua Nan Ke Xue. 2006 Sep;12(9):857-60.
Hong K, Jiang H.
Department of Urology, Third Affiliated People's Hospital, Peking University, Beijing 100083, China.
[Safety and tolerability of Vardenafil][Article in Chinese]
This paper reviewed the safety and tolerability of vardenafil in the treatment of erectile dysfunction (ED), including the general, cardiovascular and ocular safety. Results from clinical trials and practice experience demonstrated that vadenafil had good safety and tolerability, whether for general ED population or for difficult-to-treat ED patients, whether as short-term treatment or as long-term therapy.
J Manag Care Pharm. 2005 Mar;11(2):151-71.
Campbell HE
WellPoint Pharmacy Management, PO Box 9, Cherry Valley, NY, 13320, USA.
Clinical monograph for drug formulary review: erectile dysfunction agents.
BACKGROUND: Significant advances in the pharmacologic treatment of erectile dysfunction (ERD) have occurred in recent years, most notably the introduction of sildenafil, the first oral selective phosphodiesterase type 5 (PDE5) inhibitor, in 1998. Sildenafil quickly gained acceptance by the medical community and the public because of its broad efficacy for different types of ERD and its ease of use. Two PDE5 inhibitors, vardenafil and tadalafil, have since joined sildenafil to compete in the ERD market. A review was conducted by the Drug Information Service of a pharmacy benefits manager (PBM) to determine the relative merits and place in therapy of commonly used ERD drugs as part of drug formulary management process and decision making by the Pharmacy & Therapeutics (P&T) committee. OBJECTIVE: To provide readers with a comprehensive clinical monograph on ERD drugs written from a managed care perspective. METHODS: The PBM clinical monograph is designed to provide health plans with an evidence-based review of drugs, therapeutic classes, and disease states with a managed care focus. For each therapeutic class or disease review, an extensive and thorough literature search of MEDLINE is conducted for efficacy, safety, effectiveness, and humanistic and economic data. Drug/disease-state databases (UptoDate online, MICROMEDEX), U.S. Food and Drug Administration clinical reviews, key Internet sites, medical/pharmacy-related news sites, clinical guidelines, and AMCP dossiers are also reviewed. Formulary drug monographs prepared by the Drug Information Service of the PBM include a critical analysis and summary of disease-oriented and patient-oriented clinical outcomes, effectiveness, and humanistic data. Additional data considered and included in the formulary review process are clinical attributes, patent expirations/generic competition, off-label or pending indications, and pharmacoeconomic data. RESULTS: Despite the lack of head-to-head comparative studies, all 3 PDE5 inhibitors appear to have equivalent efficacy in the treatment of general ERD and ERD associated with diabetes and postprostatectomy. Sildenafil has additional efficacy data in the management of ERD associated with spinal cord injury and antidepressant medications. Tadalafil has the longest duration of action (up to 36 hours); this feature can be both beneficial (greater sexual spontaneity) or possibly detrimental (greater exposure to drug, delayed adverse events). All 3 PDE5 inhibitors appear to be generally well tolerated and have similar contraindications and warnings. However, vardenafil is the only PDE5 inhibitor with a cardiac conduction precaution. Alprostadil products are recommended in current ERD guidelines as second-line therapy for those who have not responded or cannot take the oral PDE5 inhibitors. Overall, higher clinical efficacy rates are achieved with intracavernous than with transurethral administration. CONCLUSION: A large amount of clinical efficacy and safety data has been published since the market launch of sildenafil in 1998. Sildenafil has the greatest body of efficacy and safety evidence. No comparative studies have been conducted with any of the PDE5 inhibitors. Differences in study populations, primary end points, and measurement tools make comparisons difficult. However, all PDE5 inhibitors appear to be roughly equivalent in efficacy, with minor differences in adverse event profiles. Until more comparative data are available, economic considerations will be a significant factor in choosing ERD products for formulary inclusion.
Drugs. 2005;65(12):1621-50.
Hatzimouratidis K, Hatzichristou DG.
Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.
A comparative review of the options for treatment of erectile dysfunction: which treatment for which patient?
The field of erectile dysfunction (ED) has been revolutionised over the last two decades. Several treatment options are available today, most of which are associated with high efficacy rates and favourable safety profiles. A MEDLINE search was undertaken in order to evaluate all currently available data on treatment modalities for ED. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first-choice of most physicians and patients for the treatment of ED. PDE5 inhibitors have differences in their pharmacological profiles, the most obvious being the long duration of action of tadalafil, but there are no data supporting superiority for any one of them in terms of efficacy or safety. Sublingual apomorphine has limited efficacy compared with the PDE5 inhibitors, and its use is limited to patients with mild ED. Treatment failures with oral drugs may be due to medication, clinician and patient issues. The physician needs to address all of these issues in order to identify true treatment failures. Patients who are truly unresponsive to oral drugs may be offered other treatment options.Intracavernous injections of alprostadil alone, or in combination with other vasoactive agents (papaverine and phentolamine), remain an excellent treatment option, with proven efficacy and safety over time. Topical pharmacotherapy is appealing in nature, but currently available formulations have limited efficacy. Vacuum constriction devices may be offered mainly to elderly patients with occasional intercourse attempts, as younger patients show limited preference because of the unnatural erection that is associated with this treatment modality. Penile prostheses are generally the last treatment option offered, because of invasiveness, cost and non-reversibility; however, they are associated with high satisfaction rates in properly selected patients.All treatment options are associated with particular strengths and weaknesses. A patient-centred approach based on patient needs and expectations is necessary for the management of ED. The clinician must educate the patient and provide a supportive environment for shared decision making. The management strategy must be supplemented by careful follow-up in order to identify changes in patient health and relationship/emotional status that may necessitate treatment optimisation.
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Drug category:Sexual stimulants
 Levitra scientific update
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