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Phosphodiesterase type 5 inhibitor differentiation based on selectivity, pharmacokinetic, and efficacy profiles
Open accessAbstract
The mechanism of action of the phosphodiesterase type 5 (PDE5) inhibitors (i.e., sildenafil, tadalafil, and vardenafil) involves inhibition of the PDE5 isoenzyme located in penile vascular smooth muscle cells. Sexual stimulation triggers the release of nitric oxide (NO), stimulating the release of guanylyl cyclase, leading to an increase in intracellular cyclic guanosine monophosphate (cGMP) concentrations, a decrease in intracellular calcium, and ultimately relaxation of the vascular smooth muscle in the corpus cavernosum and penile erection. The PDE5 inhibitors have no effect on the penis in the absence of sexual stimulation. Although the various PDE5 inhibitors differ with respect to selectivity and pharmacokinetic profiles, efficacy and safety of these agents are comparable in broad populations of men with erectile dysfunction (ED), including those with diabetes or those taking multiple antihypertensive agents. The most frequently reported adverse events of the PDE5 inhibitors are related to their mild vasodilatory effects and include headache, flushing, dyspepsia, and nasal congestion or rhinitis. Side effects are generally reversible and tend to diminish during continued treatment. Differences in pharmacokinetic properties among the PDE5 inhibitors include the fact that sildenafil and vardenafil have a shorter duration of action (approximately 4 h) compared with the longer period of responsiveness observed with tadalafil (up to 36 h). In addition, in the presence of high-fat food, absorption of sildenafil and vardenafil may be delayed; however, the rate and extent of tadalafil absorption are unaffected by high-fat food.
Overview
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TL;DR
This review describes how sildenafil, tadalafil, and vardenafil share PDE5 inhibition as their mechanism for treating erectile dysfunction but differ in selectivity, pharmacokinetics, and duration of action. It concludes that efficacy and tolerability are broadly comparable across noncomparative studies, while tadalafil offers longer responsiveness and no high-fat food interaction.
Key findings
- PDE5 inhibitors are highly selective for PDE5, but selectivity differences may affect adverse events: sildenafil is a relatively potent PDE6 inhibitor and color vision disturbances have been reported in up to 11% of men receiving sildenafil, whereas tadalafil is a weak PDE6 inhibitor with color vision abnormalities occurring in <0.1%; tadalafil is a relatively potent PDE11 inhibitor, but the clinical relevance of PDE11 inhibition is undefined.
- Pharmacokinetic differences are substantial: sildenafil and vardenafil have half-lives of 3–5 h and 4–5 h, respectively, with duration of action about 4 h, while tadalafil has a half-life of 17.5 h and responsiveness up to 36 h. High-fat food reduces sildenafil Cmax by about 29% and vardenafil Cmax by 18–50% and delays Tmax by about 1 h, but tadalafil absorption is unaffected.
- Efficacy appears comparable in broad ED populations: sildenafil 50 mg produced 65% successful intercourse attempts versus 20% for placebo; tadalafil 10 mg produced 61% and 20 mg produced 68–75% versus 32% for placebo; vardenafil 10 and 20 mg each produced 65% versus 32% for placebo.
- In special populations, PDE5 inhibitors remain effective: in men with diabetes, tadalafil 10 mg and 20 mg yielded 44% and 51% successful intercourse attempts versus 16% for placebo, vardenafil 10 mg and 20 mg yielded 49% and 54% versus 23% for placebo, and sildenafil improved erections on the GAQ in 56% versus 10% for placebo. Common adverse events include headache, flushing, dyspepsia, and nasal congestion/rhinitis.
Methods
- Narrative review of the mechanism of action, pharmacodynamic selectivity, pharmacokinetic properties, efficacy, and tolerability of sildenafil, tadalafil, and vardenafil.
- Synthesizes data from noncomparative clinical studies, package inserts, and conference posters/abstracts, including specific trials such as Hellstrom et al. on tadalafil and spermatogenesis and Porst et al. on tadalafil at 24 and 36 h.
- No direct head-to-head comparative trials were identified; efficacy comparisons are drawn from separate placebo-controlled studies.
Limitations
- The paper states that there have been no direct comparative studies of the PDE5 inhibitors to date, so no conclusions can be drawn about their relative efficacy.
- The paper states that limited data are available on the efficacy of vardenafil in patients with ED who are receiving antihypertensive medications.
- Evident from the text: this is a narrative review relying on noncomparative studies, package inserts, and conference posters/abstracts rather than a systematic review or meta-analysis.
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Claims the paper makes
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In the paper
“The most frequently reported adverse events of the PDE5 inhibitors are related to their mild vasodilatory effects and include headache, flushing, dyspepsia, and nasal congestion or rhinitis.”
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > Abstract
What the sources say
- Not checked yetcites [7] Cialis® (tadalafil) (package insert). Indianapolis, Ind.: Lilly ICOS LLC; 2003
- Not checked yetcites [10] Levitra® (vardenafil) (package insert). New Haven, Conn.: Bayer Pharmaceuticals Corp., 2003
- Not checked yetcites [12] Viagra® (sildenafil)(package insert). New York, N.Y.: Pfizer Inc., 2002
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“The investigators concluded that daily dosing with tadalafil 10 or 20 mg produced no clinically relevant effect on spermatogenesis.”
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > Effects on Spermatogenesis
What the sources say
- Not checked yetcites [8] Hellstrom, 2003, Tadalafil has no detrimental effect on human spermatogenesis or reproductive hormones, J Urol source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
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None of the sources cited for this claim have been checked yet.
In the paper
“Differences in pharmacokinetic properties among the PDE5 inhibitors include the fact that sildenafil and vardenafil have a shorter duration of action (approximately 4 h) compared with the longer period of responsiveness observed with tadalafil (up to 36 h).”
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > Abstract
What the sources say
- Not checked yetcites [7] Cialis® (tadalafil) (package insert). Indianapolis, Ind.: Lilly ICOS LLC; 2003
- Not checked yetcites [10] Levitra® (vardenafil) (package insert). New Haven, Conn.: Bayer Pharmaceuticals Corp., 2003
- Not checked yetcites [12] Viagra® (sildenafil)(package insert). New York, N.Y.: Pfizer Inc., 2002
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“For example, sildenafil is a relatively potent inhibitor of PDE6 (localized in the rods and cones of the retina), which may explain the color vision disturbances reported in up to 11% of men receiving sildenafil.6”
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > Selectivity and Effects on Vision
What the sources say
- Not checked yetcites [6] Padma-Nathan, 2001, Oral drug therapy for erectile dysfunction, Urol Clin North Am source
hedgedstates a possible cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“The PDE5 inhibitors have no effect on the penis in the absence of sexual stimulation.”
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > Abstract
What the sources say
- Not checked yetcites [5] Lue, 2000, Erectile dysfunction, N Engl J Med source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
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Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > Efficacy and Tolerability in Special Populations
“The rate of successful intercourse attempts of 49 and 54% was noted in men with diabetes who were taking vardenafil 10 and 20 mg, respectively, compared with the 23% rate observed in the placebo group.26”
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > References
“26. Rendell MS, Rajfer J, Wicker PA, Smith MD: Sildenafil for treat- ment of erectile dysfunction in men with diabetes.”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > Efficacy and Tolerability in Special Populations
“the percentage of successful intercourse attempts averaged 44% in men with diabetes receiving tadalafil 10 mg or 51% in those receiving 20 mg compared with 16% in the placebo group.25”
§ Phosphodiesterase Type 5 Inhibitor Differentiation Based on Selectivity, Pharmacokinetic, and Efficacy Profiles > References
“25. Goldstein I, Young JM, Fischer J, Bangerter K, Setgerson T, Taylor T: The Vardenafil Diabetes Study Group: Vardenafil, a new phos- phodiesterase type 5 inhibitor, in the treatment of erectile dysfunc- tion in men with diabetes.”
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- Cialis® (tadalafil) (package insert). Indianapolis, Ind.: Lilly ICOS LLC; 2003
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Metadata
- Authors
- Seftel, A. D.
- Affiliations
- University Hospitals of Cleveland (US)
- Corresponding author
- Seftel, Allen D.
- Venue
- Clinical Cardiology
- Publisher
- Wiley
- Published
- 2004-04
- Volume
- 27
- Issue
- S1
- Pages
- 14-19
- ISSN
- 0160-9289 (ISSN-L)
- 1932-8737
- PMC
- PMC6654274
- OpenAlex
- W1981858937
- Cited by
- 79
- References
- 24
- Citations by year
- 2026: 5 · 2025: 2 · 2024: 7 · 2023: 3 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 4 · 2018: 2 · 2017: 2 · 2016: 4 · 2015: 2 · 2014: 3 · 2013: 3 · 2012: 2
- FWCI
- 0.85
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 4170 d)
- Locations
- Clinical Cardiology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Phosphodiesterase function and regulation
- Health Sciences › Medicine › Urology › Urological Disorders and Treatments
- Keywords
- phosphodiesterase-5 inhibitors, sildenafil, tadalafil, vardenafil, erectile dysfunction, pharmacokinetics, mechanism of action, nitric oxide, cyclic GMP, adverse events, duration of action, diabetes mellitus, antihypertensive drugs
- MeSH terms
- Cardiovascular Diseases, Humans, Male, Phosphodiesterase Inhibitors, Phosphoric Diester Hydrolases, Spermatogenesis, Vision Disorders, 3',5'-Cyclic-GMP Phosphodiesterases, Diabetes Complications, Cyclic Nucleotide Phosphodiesterases, Type 5
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-11-14, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-11-14 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
