AUA 2009: Pregabalin (Lyrica)

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AUA 2009: Pregabalin (Lyrica)

Post by webslave »

(Note: this is an abstract from a conference, not a published study.)

A Randomized Placebo-Controlled Multicenter Trial Of Pregabalin For The Treatment Of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Authors: Michel A Pontari*, Philadelphia, PA; John N Krieger, Seattle, WA; Mark S Litwin, Los Angeles, CA; Paige C White, Jackson, MS; Rodney U Anderson, Palo Alto, CA; Mary McNaughton-Collins, Boston, MA; J Curtis Nickel, Kingston, ONCanada; Daniel A Shoskes, Cleveland, OH; Richard B Alexander, Baltimore, MD; Robert B Nadler, Chicago, IL; Michael P O'Leary, Boston, MA; Scott Zeitlin, Los Angeles, CA; Shannon Chuai, J. Richard Landis, Philadelphia, PA; John W Kusek, Leroy M Nyberg, Bethesda, MD; Anthony J Schaeffer, Chicago, IL; The Chronic Prostatitis Collaborative Research Network(CPCRN)

Introduction and Objective: Although chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is the most common form of prostatitis, there is no standard therapy. Growing evidence suggests that the urogenital pain of CP/CPPS may be neuropathic in origin. The objective of this study is to determine whether pregabalin, approved for use in neuropathic pain, is effective in treating the symptoms of CP/CPPS. Methods: This randomized double-blind placebo controlled trial was conducted by the Chronic Prostatitis Collaborative Research Network(CPCRN) at ten centers in North America from 2006-2007. Men with pelvic pain for at least 3 of the previous 6 months, a National Institutes of Health Chronic Prostatitis Symptom Index(NIH-CPSI) score of > 15 and a non zero pain domain score were randomly assigned to either pregabalin or matching placebo in a 2:1 ratio respectively for 6 weeks. Daily pregabalin dose was increased at two week intervals beginning with 150 mg to 300 mg and finally to 600 mg. The primary endpoint was at least a 6-point decrease in the total score of the NIH-CPSI. Secondary endpoints were the Global Response Assessment (GRA), sub-scores of the NIH-CPSI (pain, urinary symptoms and quality of life), the McGill Pain Questionnaire (MPQ), Hospital Anxiety and Depression Scale (HADS), and the Sexual Health Inventory for Men (SHIM). Results: A total of 324 men were randomized. Among men assigned to pregabalin, 103/218 (47.2%) reported at least a 6-point decrease in total NIH-CPSI score at 6 weeks compared to 38/106 (35.8%) of men assigned to placebo (p=0.072, exact Mantel-Haenszel test, controlling for clinical sites). The NIH-CPSI total score decreased by a mean of 6.6 and 4.2 points (out of 43) in the pregabalin and placebo groups respectively (p=0.008). Qualitatively, similar results were observed for the three NIH-CPSI sub scores. The GRA response rate (men who reported they were markedly or moderately improved from baseline) was 31% and 19% respectively (p=0.023). The pregabalin group showed more improvement than the placebo group in the McGill total score (p=0.006) and for both the sensory (p=0.03) and the affective sub-domain (p=0.02). Results for the HADS and SHIM were not different between treatment groups. Conclusions: Based on the primary endpoint, 6 weeks of pregabalin therapy was not superior to placebo for treating symptoms of CP/CPPS. However, the impressive differences in secondary endpoints suggest that pregabalin may prove effective in some men with long-standing CP/CPPS.
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Re: AUA 2009: Pregabalin (Lyrica)

Post by Jay »

Hi there,

I'm a bit late to this post, but I wanted to provide my own account on Lyrica. This is one of the four drugs I take as part of my pain management regimen. At first, it didn't seem to do much, but time and the gradual titration of the dosage seems to have led to positive results.

I used to occasionally get these very intense, neuropathic 'zaps' through the genitals and perineum. They were enough to put me down for the count. Since I entered into pain management, that symptom has thankfully decreased quite a lot in frequency. Only one of my medications is directly intended to be a painkiller (Tramadol), and it wasn't until we added the Lyrica and a couple other drugs that those sharp zaps came into some degree of control.

This is just evidence from my own case, so take that for what you will. :) Given my poverty situation, Pfizer is providing Lyrica to me free of charge, so I'm very grateful for that and the seemingly positive effects.
I am not a physician. This is not medical advice. Consult your doctor!

Age: 26 Onset Age: 17 Symptoms: Shooting, nerve-like pains throughout the penis, which abruptly hit and leave. Testicular pain, perineum pain, burning/irritative urination, extended pain after ejaculation. Occasionally, some allodynia or ache in the coccyx/sacrum/thigh/buttocks/legs. Diagnosis: Pelvic floor dysfunction, degenerated lumbar disk, and mildly herniated lumbar disk. Helped By: Physical therapy, pain management doctor, hot baths, therapy pool, stretching regimen, breathing exercises, relaxation, distraction. Worsened By: Arousal/ejaculation (worst), constipation, panicking/obsessing, other triggers depend upon current symptoms. Tests/Prior Treatments: Too many antibiotics to count, multiple urine tests (all normal), testicular ultrasound (normal), bladder and renal ultrasound (normal), lumbar and pelvic MRI with and w/o contrast (revealed disk problems), Elavil 25mg (caused retention), Flomax 0.4mg.
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Re: AUA 2009: Pregabalin (Lyrica)

Post by boulder »

It's too bad that this trial didn't turn out better for pregabalin. It is wonderful, however, to see effort and resources dedicated to such large trials! I don't really understand what's meant by the difference between the primary and secondary endpoints in this study, am I right to think that pregabalin didn't turn out as well as hoped, but did show some more modest usefulness? Or is the question perhaps one of pregabalin working for some but not for others?
Age: 36 | Onset Age: 29 (Summer 2005) Main Symptoms (all intermittent): penile/anal/rectal/perineum pain/numbness/tingling/coldness, LUTS, ED | Helped By: duloxetine (Cymbalta), topical benzocaine, occasional benzodiazepines, hot weather, hot baths, understanding friends & family, pushing myself to be more sociable and active, psychotherapy (mostly CBT), diaphragmatic breathing, relaxation, meditation (concentration and mindfulness), adequate sleep | Worsened By: cold weather, stress, inadequate sleep, prolonged sitting or standing in place, walking uphill, heavy exercise, erection/ejaculation (sometimes)
Last But Not Least: I am not a medical/health professional of any kind. This is not medical advice.
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Re: AUA 2009: Pregabalin (Lyrica)

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I had posted a reply months ago touting my success with amitriptyline. It went away. I decided to try nortriptyline, a cleaner metabolite and it helped better but not until I added pregabalin/Lyrica. I'm now taking 25mg. of nortriptyline and 50mg. of Lyrica 3 times a day. Lyrica has a short half-life of 6 hours so you may need to take it 3 times a day.

Tricyclics (older antidepressants) are considered the most cost-effective treatment of neuropathic pain. Stephen Stahl's latest psychopharmacology textbook says that tricyclics and the anticonvulsants Neurontin and Lyrica are the most effective treatments. Curiously when I tried Lyrica by itself it left me mildly euphoric but with no pain benefit. I think you have to tweak these drugs and what works one month may not the next. Part of the problem is inconsistency in the generic drugs, which are very poorly regulated and can vary not only bottle to bottle but perhaps in the same lot/bottle.

The more I read about Central Sensitization Syndromes, the more I think mine is that and that trigger points play a very minor if any role in me. Maybe it's that phenotype with pain because I've also had Irritable bowel syndrome for 30 years.
Age: | Onset Age: 53 | Symptoms: rectal, gluteal, hip pain | Helped By: hot baths, quercetin, pain meds, sleep | Worsened By: prolonged sitting, anxiety, catastrophic thinking
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Re: AUA 2009: Pregabalin (Lyrica)

Post by drydoc »

In response to Boulder's question about primary and secondary endpoints, you had to have at least a 6 point decrease in the NIH-CPSI questionnaire. (find it at http://www.ucpps.men/1/ ) This is a complex assessment that is a quality-of-life measure and grades how much pain, how would it be to live with the level of pain you have the rest of your life, how much do you think about your symptoms, etc. I charted mine weekly for awhile and let me tell you when you're doing poorly, a 4 or 5 point gain is to be treasured. Also it picks up on catastrophizing and more seasoned persons should have decent control over this. The "secondary" pain measures (pain, clinical condition) were very significant with p<0.01 and that's what counts. For me Lyrica plus nortriptyline (TCA) are still working well. The other significant factor is STANDING. I have a sedentary job and on weekends I like to walk, do home repairs, listen to music and other activities I primarily stand during and can have pain-free days using meds plus standing. Consider standing to be a treatment.
Age: | Onset Age: 53 | Symptoms: rectal, gluteal, hip pain | Helped By: hot baths, quercetin, pain meds, sleep | Worsened By: prolonged sitting, anxiety, catastrophic thinking
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Re: AUA 2009: Pregabalin (Lyrica)

Post by webslave »

Pregabalin Not Effective in Chronic Prostatitis/Chronic Pelvic Pain Syndrome


Emma Hitt, PhD

September 27, 2010 — Pregabalin therapy for 6 weeks was not more effective than placebo for relieving perceptible urogenital pain in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), according to the findings of a randomized clinical trial.

Michel A. Pontari, MD, from the Temple University School of Medicine, in Philadelphia, Pennsylvania, and colleagues from the Chronic Prostatitis Collaborative Research Network 2 reported their findings in today's issue of the Archives of Internal Medicine.

According to the researchers, the pathogenesis of CP/CPPS is unclear, but evidence indirectly suggests that CP/CPPS may be a neurogenic pain syndrome, with urogenital pain as a defining symptom. The antiepileptic drug pregabalin has been approved for use in the chronic pain of postherpetic neuralgia, diabetic neuropathy, and fibromyalgia.

Dr. Pontari and colleagues conducted a randomized trial comparing pregabalin with placebo in 324 men with pelvic pain for at least 3 of the last 6 months.

Men from 10 tertiary care centers were randomly assigned in a 2:1 ratio to receive pregabalin or placebo for 6 weeks. During the first 4 weeks, pregabalin dosage was increased from 150 to 600 mg/day. After 6 weeks, a higher percentage of the patients receiving pregabalin were classified as responders because they reported at least a 6-point decrease in the primary endpoint (National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI]) total score (47.2% vs 35.8% of those receiving placebo); this difference, however, was not statistically significant (P = .07, exact Mantel-Haenszel test, adjusting for clinical sites).

In contrast, men assigned to receive pregabalin experienced greater reductions in the mean NIH-CPSI total score and subscores (P < .01 - .04) compared with those who received placebo; in addition, these men had a significantly higher Global Response Assessment response rate (31.2% vs 18.9% for placebo; P = .02). The Global Response Assessment is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The total McGill Pain Questionnaire score (P = .01) was also improved with pregabalin.

Several other outcomes, including the Medical Outcomes Study 12-Item Short Form Health Survey, Sexual Health Inventory for Men, and Hospital Anxiety and Depression Scale scores, were comparable between the 2 groups.

"A 6-week course of pregabalin compared with placebo did not result in a statistically significant reduction in the NIH-CPSI total score by at least 6 points, the primary outcome, an amount of change previously shown to be clinically perceptible to participants," the authors conclude.

One limitation of the trial is that participants had symptoms for a long time. According to the researchers, patients with a shorter duration of symptoms may have responded differently to pregabalin, and this group represents the most difficult group of men with CP/CPPS to treat. In addition, therapy was given for only 6 weeks. "It may take a longer period of treatment before a beneficial effect is seen," they suggest.

The study authors report a financial relationship with multiple commercial sources including Pfizer, Inc, the manufacturer of pregabalin. Study medication and placebo was provided by Pfizer, Inc; otherwise, no commercial support was used for the study. No author received compensation for the performance of the study except as salary support from National Institutes of Health grants including from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Center for Minority Health and Health Disparities.

Arch Intern Med. 170:1586-1593.
From http://www.medscape.com/viewarticle/729476
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Re: AUA 2009: Pregabalin (Lyrica)

Post by Jay »

I posted in early 2009 that Lyrica was beneficial to me, and I continue to hold that opinion today. It remains a component of my pain management regimen. I have not had to tweak the dose since I began taking it, and the nerve zaps are a far less frequent aspect of my condition. Perhaps my version of CPPS is more susceptible to this particular drug, or as the article suggests, maybe it takes longer than they allowed in their study.
I am not a physician. This is not medical advice. Consult your doctor!

Age: 26 Onset Age: 17 Symptoms: Shooting, nerve-like pains throughout the penis, which abruptly hit and leave. Testicular pain, perineum pain, burning/irritative urination, extended pain after ejaculation. Occasionally, some allodynia or ache in the coccyx/sacrum/thigh/buttocks/legs. Diagnosis: Pelvic floor dysfunction, degenerated lumbar disk, and mildly herniated lumbar disk. Helped By: Physical therapy, pain management doctor, hot baths, therapy pool, stretching regimen, breathing exercises, relaxation, distraction. Worsened By: Arousal/ejaculation (worst), constipation, panicking/obsessing, other triggers depend upon current symptoms. Tests/Prior Treatments: Too many antibiotics to count, multiple urine tests (all normal), testicular ultrasound (normal), bladder and renal ultrasound (normal), lumbar and pelvic MRI with and w/o contrast (revealed disk problems), Elavil 25mg (caused retention), Flomax 0.4mg.
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Re: AUA 2009: Pregabalin (Lyrica)

Post by davioj »

This is an editorial from journal watch regarding this study:
Pregabalin for Chronic Prostatitis/Pelvic Pain
Improvement, albeit modest, suggests a neuropathic mechanism.

In the syndrome of chronic prostatitis/chronic pelvic pain, absence of infection or other obvious etiologies suggests a neuropathic pain mechanism. To test this hypothesis, a multisite federally funded trial was conducted involving 324 men (mean age, 47; 79% white) who had experienced chronic pelvic pain attributed to prostatitis for a mean of 9 years. Participants were randomized to pregabalin (Lyrica; 150 µg daily, increasing to 600 µg daily during 4 weeks) or placebo.

The primary outcome, a clinically important improvement in a validated symptom index at 6 weeks, was achieved by 47% of treated men and 36% of placebo recipients (P=0.07). Several secondary outcomes that included urinary symptoms and overall pain were significantly better in treated men. Treatment and control patients reported adverse events — all mild or moderate in severity — at roughly the same rate (59%).

Comment: Although the between-group difference in the primary outcome was not statistically significant, it was close, and several secondary outcomes were significantly better with treatment. The degree of improvement suggests that nine patients would need to be treated with pregabalin in order for one to benefit. Although use of pregabalin cannot be formally recommended based on these data, the approach to chronic pelvic pain as a neuropathic process deserves further exploration — especially because other treatments (e.g., antibiotics, -blockers, nonsteroidal anti-inflammatory drugs) have not been particularly effective in clinical trials.
34 yrs old. Now rectal pain, some suprabic discomfort an occasional urgency. Still trying to figure out what helps. Episode of frequency in 2008 but this dissapeared for a year.
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Re: AUA 2009: Pregabalin (Lyrica)

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This is a review study, considered better than a primary study.
Cochrane Database Syst Rev. 2012 Aug 15;8:CD009063.
Pregabalin for chronic prostatitis.
Aboumarzouk OM, Nelson RL.
Deptartment of Urology, Wales Deanery, Cardiff, UK


BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a condition that is detrimental to the quality of life of men. Evidence suggests that it may have a neuropathic origin and therefore medications such as pregabalin might have a role in the controlling of symptoms.

OBJECTIVES: The primary objective was to compare pregabalin to other modalities of pain relief to alleviate men's symptoms of CP/CPPS.The secondary objective was to assess the safety and effectiveness of pregabalin to improve various individual symptoms consistent with CP/CPPS.

SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to May 2012), EMBASE (1980 to May 2012), CINAHL, clinicaltrials.gov, Google Scholar, and reference lists of articles and abstracts from conference proceedings, without language restriction for pregabalin treatment of Class III prostatitis and CP/CPPS.

SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing pregabalin to placebo or other types of analgesics for the management of patients with CP/CPPS were included. Patients with known causes of pain/discomfort were excluded.

DATA COLLECTION AND ANALYSIS: Only one RCT was included. The trial compared pregabalin to placebo for patients who had CP/CPPS.

MAIN RESULTS: For men who responded clinically (≥ 6-point improvement), there was no difference between the pregabalin (103/218; 47.2%) and placebo (38/106; 35.8%) arms (risk ratio (RR) 1.32; 95% CI 0.99 to 1.76). There was less pain with a higher point improvement in the pregabalin group compared to the placebo group (4.2 points versus 1.7 points, respectively; mean difference (MD) -2.3 points; 95% CI -4.0 to -0.7 points).Though 59% (191/324) of the patients developed side effects, no serious effects were experienced. There were significantly more neurologic side effects in the pregabalin group compared to the placebo group (38.5% (84/218) versus 22.6% (24/106), respectively; RR 1.7; 95% CI 1.15 to 2.51), and less pain in the pregabalin group than in the placebo group (17.4% (38/218) versus 33.3% (35/106), respectively; RR 0.53; 95% CI 0.36 to 0.78). However, no significant differences were seen between the pregabalin and placebo groups with regards to gastrointestinal disturbances (18.3% (40/218) versus 18.9% (20/106), respectively; RR 0.97; 95% CI 0.60 to 1.58), ocular/visual symptoms (6.9% (15/218) versus 2.8% (3/106), respectively; RR 2.43; 95% CI 0.72 to 8.22), and renal/genitourinary symptoms (5.5% (12/218) versus 1.9% (2/106), respectively; RR 3.03; 95% CI 0.67 to 13.79).

AUTHORS' CONCLUSIONS: There is evidence from one RCT that pregabalin does not improve CP/CPPS symptoms and causes adverse effects in a large percentage of men. However, research is required to assess further whether pregabalin has a role in patients with CP/CPPS for symptom control.

PMID: 22895982
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