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<blockquote data-quote="madman" data-source="post: 215160" data-attributes="member: 13851"><p>I would look into a daily PDE5i such as tadalafil (5 mg/day) which is effective for treating symptoms of BPH/LUTS let alone is a healthy addition when it comes to erectile tissue health.</p><p></p><p></p><p></p><p></p><p><strong>MANAGEMENT OF NON-NEUROGENIC MALE LOWER URINARY TRACT SYMPTOMS (LUTS) - UPDATE MARCH 2021 </strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>5.2.5 Phosphodiesterase 5 inhibitors </strong></p><p><strong></strong></p><p><strong>Mechanism of action: </strong>Phosphodiesterase 5 inhibitors (PDE5Is) increases intracellular cyclic guanosine monophosphate, thus<strong><em> reducing the smooth muscle tone of the <u>detrusor, prostate, and urethra</u>. Nitric oxide and PDE5Is might also alter <u>reflex pathways in the spinal cord and neurotransmission in the urethra, prostate, or bladder</u> [226].</em></strong> <em><strong>Moreover, chronic treatment with PDE5Is seems to <u>increase blood perfusion and oxygenation in the LUT</u> [227].</strong></em><strong><em> <u>Phosphodiesterase 5 inhibitors could also reduce chronic inflammation in the prostate and bladder</u> [228].</em></strong> <em><strong>The exact mechanism of PDE5Is on LUTS remains unclear.</strong></em></p><p></p><p><strong><em>*Although clinical trials of several selective oral PDE5Is have been conducted in men with LUTS, only <u>tadalafil (5 mg once daily) has been licensed for the treatment of male LUTS</u>.</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Efficacy:</strong><em><strong> Several RCTs have demonstrated that PDE5Is reduce IPSS, storage and voiding LUTS, and improve QoL.</strong> However, Qmax did not significantly differ from placebo in most trials.</em></p><p><em></em></p><p><em>A recent Cochrane review included a total of sixteen randomized trials that examined the effects of PDE5Is compared to placebo and other standards of care drugs (α1-blockers and 5-ARIs) in men with LUTS [229]. <strong><em>Phosphodiesterase 5 inhibitors led to a small reduction (mean difference (MD) 1.89 lower, 95% CI 2.27 lower to 1.50 lower) in IPSS compared to placebo. </em></strong>There was no difference between PDE5Is and α1-blockers in IPSS. Most evidence was limited to short-term treatment up to twelve weeks and of moderate or low certainty. In earlier [230] and more recent [231] meta-analyses, PDE5Is were also found to improve IPSS and IIEF scores, but not Qmax.</em></p><p><em></em></p><p><em>Tadalafil 5 mg reduces IPSS by 22-37% and improvement may be seen within a week of initiation of treatment [232]. A three-point or greater total IPSS improvement was observed in 60% of tadalafil-treated men within one week and in 80% within four weeks [233]. The maximum trial (open-label) duration was 52 weeks [234].<strong> A subgroup analysis of pooled data from four RCTs demonstrated a significant reduction in LUTS, regardless of baseline severity, age, previous use of α-blockers or PDE5Is, total testosterone level, or predicted prostate volume [235].</strong> In a recent post hoc analysis of pooled data from four RCTs, tadalafil was shown to also be effective in men with cardiovascular risk factors/comorbidities, except for patients receiving more than one antihypertensive medication. The use of diuretics may contribute to patients’ perception of a negated efficacy [236]. <strong>Among sexually active men > 45 years with comorbid LUTS/BPH and ED, <u>tadalafil improved both conditions</u> [235].</strong></em></p><p><em></em></p><p><em>An integrated data analyses from four placebo-controlled clinical studies showed that total IPSS improvement was largely attributed to direct (92.5%, p < 0.001) vs. indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement [237]. Another analysis showed a small but significant increase in Qmax without any effect on PVR [238]. An integrated analysis of RCTs showed that tadalafil was not superior to placebo for IPSS improvement at twelve weeks in men ≥ 75 years (with varied effect size between studies), but was for men < 75 years [239].<strong> An open-label urodynamic study of 71 patients showed improvements in both voiding and storage symptoms, confirmed by improvements in BOO index (61.3 to 47.1; p < 0.001), and resolution of DO in 15 (38%) of 38 patients. Flow rate improved from 7.1 to 9.1 mL/s (p < 0.001) and mean IPSS from 18.2 to 13.4 [240].</strong></em></p><p><em></em></p><p><em>A combination of PDE5Is and α-blockers has also been evaluated. A meta-analysis of five RCTs (two studies with tadalafil 20 mg, two with sildenafil 25 mg, and one with vardenafil 20 mg), showed that combination therapy significantly improved IPSS score (-1.8), IIEF score (+3.6), and Qmax (+1.5 mL/s) compared with α-blockers alone [230]. A Cochrane review found similar findings [229]. The effects of tadalafil 5 mg combined with finasteride 5 mg were assessed in a 26-week placebo-controlled RCT [241]. <strong>The combination of tadalafil and finasteride provided an early improvement in urinary symptoms (p < 0.022 after 4, 12, and 26 weeks), with a significant improvement of storage and voiding symptoms and QoL. Combination therapy was well tolerated and improved erectile function [241]. <u>However, only tadalafil 5 mg has been licensed in the context of LUTS management while data on combinations of PDE5Is and other LUTS medications is emerging</u>.</strong></em></p><p></p><p></p><p><strong>Tolerability and safety:</strong> <em>Reported adverse effects in RCTs comparing the effect of all PDE5Is vs. placebo in men with LUTS include <strong>flushing, gastroesophageal reflux, headache, dyspepsia, back pain, and nasal congestion [230].</strong> The discontinuation rate due to adverse effects for tadalafil was 2.0% [242] and did not differ by age, LUTS severity, testosterone levels, or prostate volume in the pooled data analyses [235].</em></p><p><em></em></p><p><em>Phosphodiesterase 5 inhibitors are contraindicated in patients using nitrates, the potassium channel opener nicorandil, or the α1-blockers doxazosin and terazosin. They are also contraindicated in patients who have unstable angina pectoris, have had a recent myocardial infarction (< three months) or stroke (< six months), myocardial insufficiency (New York Heart Association stage > 2), hypotension, poorly controlled blood pressure, significant hepatic or renal insufficiency, or if anterior ischaemic optic neuropathy with a sudden loss of vision is known or was reported after previous use of PDE5Is.</em></p><p></p><p></p><p><strong>Practical considerations: <em>To date, only tadalafil 5 mg once daily has been officially licensed for the treatment of male LUTS with or without ED.</em></strong><em><strong> The meta-regression suggested that younger men with low body mass index and more severe LUTS benefit the most from treatment with PDE5Is [230].</strong></em><strong><em> <u>Long-term experience with tadalafil in men with LUTS is limited to one trial with a one-year follow-up</u> [234]; <u>therefore, conclusions about its efficacy or tolerability greater than one year are not possible</u>. <u>There is limited information on the reduction of prostate size and no data on disease progression</u>.</em></strong></p><p></p><p>[ATTACH=full]19042[/ATTACH]</p></blockquote><p></p>
[QUOTE="madman, post: 215160, member: 13851"] I would look into a daily PDE5i such as tadalafil (5 mg/day) which is effective for treating symptoms of BPH/LUTS let alone is a healthy addition when it comes to erectile tissue health. [B]MANAGEMENT OF NON-NEUROGENIC MALE LOWER URINARY TRACT SYMPTOMS (LUTS) - UPDATE MARCH 2021 5.2.5 Phosphodiesterase 5 inhibitors Mechanism of action: [/B]Phosphodiesterase 5 inhibitors (PDE5Is) increases intracellular cyclic guanosine monophosphate, thus[B][I] reducing the smooth muscle tone of the [U]detrusor, prostate, and urethra[/U]. Nitric oxide and PDE5Is might also alter [U]reflex pathways in the spinal cord and neurotransmission in the urethra, prostate, or bladder[/U] [226].[/I][/B] [I][B]Moreover, chronic treatment with PDE5Is seems to [U]increase blood perfusion and oxygenation in the LUT[/U] [227].[/B][/I][B][I] [U]Phosphodiesterase 5 inhibitors could also reduce chronic inflammation in the prostate and bladder[/U] [228].[/I][/B] [I][B]The exact mechanism of PDE5Is on LUTS remains unclear.[/B][/I] [B][I]*Although clinical trials of several selective oral PDE5Is have been conducted in men with LUTS, only [U]tadalafil (5 mg once daily) has been licensed for the treatment of male LUTS[/U].[/I] Efficacy:[/B][I][B] Several RCTs have demonstrated that PDE5Is reduce IPSS, storage and voiding LUTS, and improve QoL.[/B] However, Qmax did not significantly differ from placebo in most trials. A recent Cochrane review included a total of sixteen randomized trials that examined the effects of PDE5Is compared to placebo and other standards of care drugs (α1-blockers and 5-ARIs) in men with LUTS [229]. [B][I]Phosphodiesterase 5 inhibitors led to a small reduction (mean difference (MD) 1.89 lower, 95% CI 2.27 lower to 1.50 lower) in IPSS compared to placebo. [/I][/B]There was no difference between PDE5Is and α1-blockers in IPSS. Most evidence was limited to short-term treatment up to twelve weeks and of moderate or low certainty. In earlier [230] and more recent [231] meta-analyses, PDE5Is were also found to improve IPSS and IIEF scores, but not Qmax. Tadalafil 5 mg reduces IPSS by 22-37% and improvement may be seen within a week of initiation of treatment [232]. A three-point or greater total IPSS improvement was observed in 60% of tadalafil-treated men within one week and in 80% within four weeks [233]. The maximum trial (open-label) duration was 52 weeks [234].[B] A subgroup analysis of pooled data from four RCTs demonstrated a significant reduction in LUTS, regardless of baseline severity, age, previous use of α-blockers or PDE5Is, total testosterone level, or predicted prostate volume [235].[/B] In a recent post hoc analysis of pooled data from four RCTs, tadalafil was shown to also be effective in men with cardiovascular risk factors/comorbidities, except for patients receiving more than one antihypertensive medication. The use of diuretics may contribute to patients’ perception of a negated efficacy [236]. [B]Among sexually active men > 45 years with comorbid LUTS/BPH and ED, [U]tadalafil improved both conditions[/U] [235].[/B] An integrated data analyses from four placebo-controlled clinical studies showed that total IPSS improvement was largely attributed to direct (92.5%, p < 0.001) vs. indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement [237]. Another analysis showed a small but significant increase in Qmax without any effect on PVR [238]. An integrated analysis of RCTs showed that tadalafil was not superior to placebo for IPSS improvement at twelve weeks in men ≥ 75 years (with varied effect size between studies), but was for men < 75 years [239].[B] An open-label urodynamic study of 71 patients showed improvements in both voiding and storage symptoms, confirmed by improvements in BOO index (61.3 to 47.1; p < 0.001), and resolution of DO in 15 (38%) of 38 patients. Flow rate improved from 7.1 to 9.1 mL/s (p < 0.001) and mean IPSS from 18.2 to 13.4 [240].[/B] A combination of PDE5Is and α-blockers has also been evaluated. A meta-analysis of five RCTs (two studies with tadalafil 20 mg, two with sildenafil 25 mg, and one with vardenafil 20 mg), showed that combination therapy significantly improved IPSS score (-1.8), IIEF score (+3.6), and Qmax (+1.5 mL/s) compared with α-blockers alone [230]. A Cochrane review found similar findings [229]. The effects of tadalafil 5 mg combined with finasteride 5 mg were assessed in a 26-week placebo-controlled RCT [241]. [B]The combination of tadalafil and finasteride provided an early improvement in urinary symptoms (p < 0.022 after 4, 12, and 26 weeks), with a significant improvement of storage and voiding symptoms and QoL. Combination therapy was well tolerated and improved erectile function [241]. [U]However, only tadalafil 5 mg has been licensed in the context of LUTS management while data on combinations of PDE5Is and other LUTS medications is emerging[/U].[/B][/I] [B]Tolerability and safety:[/B] [I]Reported adverse effects in RCTs comparing the effect of all PDE5Is vs. placebo in men with LUTS include [B]flushing, gastroesophageal reflux, headache, dyspepsia, back pain, and nasal congestion [230].[/B] The discontinuation rate due to adverse effects for tadalafil was 2.0% [242] and did not differ by age, LUTS severity, testosterone levels, or prostate volume in the pooled data analyses [235]. Phosphodiesterase 5 inhibitors are contraindicated in patients using nitrates, the potassium channel opener nicorandil, or the α1-blockers doxazosin and terazosin. They are also contraindicated in patients who have unstable angina pectoris, have had a recent myocardial infarction (< three months) or stroke (< six months), myocardial insufficiency (New York Heart Association stage > 2), hypotension, poorly controlled blood pressure, significant hepatic or renal insufficiency, or if anterior ischaemic optic neuropathy with a sudden loss of vision is known or was reported after previous use of PDE5Is.[/I] [B]Practical considerations: [I]To date, only tadalafil 5 mg once daily has been officially licensed for the treatment of male LUTS with or without ED.[/I][/B][I][B] The meta-regression suggested that younger men with low body mass index and more severe LUTS benefit the most from treatment with PDE5Is [230].[/B][/I][B][I] [U]Long-term experience with tadalafil in men with LUTS is limited to one trial with a one-year follow-up[/U] [234]; [U]therefore, conclusions about its efficacy or tolerability greater than one year are not possible[/U]. [U]There is limited information on the reduction of prostate size and no data on disease progression[/U].[/I][/B] [ATTACH type="full" alt="Screenshot (10386).png"]19042[/ATTACH] [/QUOTE]
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