Abstract
Objective:
This study assesses the clinical relevance and effects of tadalafil when used in conjunction with atorvastatin, aiming to evaluate their combined impact on hemodynamics and sexual function in middle-aged and elderly patients experiencing hyperlipidemia complicated by erectile dysfunction (ED). The exploratory nature of this research intends to illuminate the practical implications of dual therapy in this demographic.
Methods:
The study comprised eighty patients diagnosed with hyperlipidemia complicated by ED, treated at The Second Hospital of Hebei Medical University from January 2019 to June 2020. These patients were randomly allocated into two distinctive groups: one receiving atorvastatin exclusively (control group) and the other receiving atorvastatin combined with tadalafil (experimental group). Over a treatment period lasting three months, various inflammatory factors such as IL-6, TNF, and CRP were analyzed, along with hemodynamic indicators and sexual function improvements, creating a detailed assessment of treatment efficacy.
Results:
Significant findings emerged from the experimental group, demonstrating notably lower levels of TNF-α, CRP, and IL-6 in comparison to the control group (p<0.05). Moreover, marked improvements in hemodynamic parameters and sexual function scores became evident, revealing a statistically significant difference (p<0.05) between the two cohorts upon completion of the treatment regimen.
Conclusion:
The combination of tadalafil with atorvastatin reveals substantial effectiveness in enhancing both hemodynamic measures and sexual function in middle-aged and elderly patients afflicted by hyperlipidemia-associated ED. Additionally, the treatment did not result in a significant uptick in adverse reactions, reinforcing its safety profile.
Keywords: Atorvastatin, Erectile dysfunction, Hemodynamics, Hyperlipidemia, Tadalafil, Treatment
Abbreviations:
- ED:
Erectile dysfunction
- PDE-5:
Phosphodiesterase-5
- IL-6:
Interleukin-6
- CRP:
C-reactive protein
- HSV:
High shear viscosity
- LSV:
Low shear viscosity
- PSV:
Plasma viscosity
- HCT:
Hematocrit
- ESR:
Erythrocyte sedimentation rate
- IIEF-5:
International Index of Erectile Function Questionnaire – 5
- HMG-CoA:
Hydroxy-methylglutaryl coenzyme A
- cGMP:
cyclic Guanosine monophosphate
- TNF-α:
Tumor necrosis factor-α
- IFN-γ:
Interferon-γ
- TC:
Total cholesterol
- TG:
Triglycerides
- HDL-C:
High-density lipoprotein cholesterol
INTRODUCTION
Erectile dysfunction (ED) is a significant health concern for many middle-aged and elderly individuals. Statistics indicate that around 150 million men worldwide suffer from this condition, which poses serious implications for their overall quality of life. The etiology of ED can be multifaceted, often rooted in psychological, neurological, and vascular contributors, with hyperlipidemia identified as a significant risk factor. This research investigates the impact of tadalafil and atorvastatin—two pharmacological agents with unique mechanisms of action—on sexual function and vascular parameters in patients dealing with both ED and hyperlipidemia.
METHODS
Ethical Approval
The Institutional Ethics Committee of The Second Hospital of Hebei Medical University granted ethical clearance for this study on June 4, 2020. Written informed consent was duly obtained from all participants involved in the trial.
Patient Information:
The cohort consisted of males aged between 50 and 65 years who met the inclusion criteria outlined below. Detailed patient information was collected to compile a comprehensive demographic profile.
Case Inclusion Criteria:
Patients exhibiting diagnostic criteria for hyperlipidemia (TC≥5.65 mmol/L, TG≥1.7 mmol/L, HDL-C<0.91 mmol/L).
Patients presenting mild to moderate ED (IIEF-5 score of 8-21).
Patients aged between 50 and 65 years.
Individuals displaying good treatment adherence and whose family members consented to participation.
Patients with no contraindications for the prescribed medication regimen.
Those providing written informed consent for participation in the study.
Case Exclusion Criteria:
Individuals with known allergies to the medications under investigation.
Patients suffering from cardiovascular or cerebrovascular diseases, or those with diabetes.
Patients exhibiting cognitive impairments or mental health disorders.
Patients who have utilized other lipid-lowering agents or PDE-5 inhibitors within the preceding two weeks.
Patients on medications that may interfere with study outcomes (e.g., immunosuppressants, hormone therapies).
After applying these criteria, eighty patients were deemed eligible and were split evenly into an experimental group receiving atorvastatin along with tadalafil and a control group receiving atorvastatin alone.
Treatment Methods:
All participants underwent general health interventions involving dietary changes and enhanced physical activity levels. The control group was prescribed atorvastatin calcium at a daily dose of 20 mg, while the experimental group received an adjunct of tadalafil at a daily dose of 10 mg, both administered over a three-month period.
Observation Indicators:
The study assessed a variety of outcomes related to efficacy and safety of the treatment regimen, focusing on inflammatory markers, hemodynamic parameters, and sexual function metrics.
1. Inflammatory Factors:
The levels of inflammatory biomarkers including IL-6, TNF, and CRP were measured pre- and post-treatment to ascertain any significant changes.
2. Adverse Drug Reactions:
Any occurrence of adverse drug reactions was meticulously recorded during the first month of treatment, noting symptoms such as muscle pain, nasal congestion, and gastrointestinal disturbances.
3. Hemodynamic Changes:
Measurements of hemodynamic parameters, including HSV, LSV, PSV, HCT, and ESR, were captured both before and after the intervention.
4. Sexual Function Assessment:
Sexual function was evaluated through the IIEF-5 questionnaire alongside nocturnal penile tumescence tests to assess both the frequency and quality of erections.
Statistical Analysis:
Statistical analysis was performed utilizing SPSS software, employing independent t-tests for inter-group evaluations, paired t-tests for intra-group assessments, and chi-squared tests for rate comparisons. A p-value threshold of <0.05 indicated statistical significance.
RESULTS
Changes in Inflammatory Factors:
No significant differences in the baseline inflammatory markers were observed between groups prior to treatment (p>0.05). However, following treatment, the experimental group exhibited a statistically significant reduction in levels of TNF-α, CRP, and IL-6 compared to the control group (p<0.05).
Adverse Drug Reactions:
The reported incidence of adverse reactions was noted at 30% for the experimental group, contrasted with 17.5% for the control group. However, this difference was not statistically significant (p=0.18).
Hemodynamic Changes:
Marked improvements in hemodynamic parameters were registered in the experimental group compared to the control cohort post-treatment, yielding a p-value of 0.00, indicating robust efficacy.
Enhancements in Sexual Function:
Substantial improvements in IIEF-5 scores and nocturnal penile erection metrics were recorded in the experimental group when compared to controls, achieving a p-value of 0.00, which points to highly significant findings.
DISCUSSION
ED presents a multifactorial clinical challenge, frequently associated with metabolic and vascular disorders such as hyperlipidemia. This investigation established that the synergistic administration of tadalafil and atorvastatin could markedly enhance erectile function alongside improving inflammatory markers, thereby suggesting a potential collective positive impact on vascular health.
Atorvastatin, widely recognized for its lipid-lowering properties, has also been associated with improved erectile function in patients whose ED may be attributed to hyperlipidemia. Tadalafil, being a phosphodiesterase type 5 (PDE5) inhibitor, enhances endothelial function and augments penile blood flow. Findings from this study corroborate existing literature that advocates for combination therapy as a superior treatment modality for patients with multifactorial erectile dysfunction.
Although the experimental group reported a higher frequency of adverse reactions, these findings did not attain statistical significance, suggesting that the combination therapy maintains a favorable safety profile. Overall, these results endorse the concurrent use of tadalafil and atorvastatin as a promising treatment approach for men grappling with ED and hyperlipidemia.
Limitations of the Study:
Despite the insights this study provides, it also possesses limitations, including a relatively small sample size and a limited follow-up duration. Subsequent research endeavors should encompass larger populations and a broader spectrum of ED severity to further substantiate these findings and validate the approach.
CONCLUSION
In summation, the integration of tadalafil with atorvastatin yields meaningful enhancements in both hemodynamic metrics and sexual function for middle-aged and elderly patients afflicted by hyperlipidemia and erectile dysfunction. The treatment displays a commendable safety profile, with minimal occurrences of adverse effects, thus supporting its implementation as an effective management strategy within this patient cohort.
Authors’ Contributions:
LD and JQ conceptualized the study design and executed the manuscript preparation. JJ was responsible for the collection and analysis of clinical data, while WX offered significant revisions to the manuscript.
Footnotes
Source of funding: None.
Conflicts of interest: None.
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