Studies on Cyclosporine-A (to show your doctor)

[ICLori]

Here are some studies that might be useful to show your doctor if you want to look into trying Cyclosporine-A for Interstitial Cystitis. Since CyA carries significant risks and side effects, it should ONLY be considered AFTER all standard IC medications and treatments have failed.

Blessings,
Lori

J Urol. 1996 May;155(5):1591-3. Related Articles, Links


Cyclosporine in severe interstitial cystitis.

Forsell T, Ruutu M, Isoniemi H, Ahonen J, Alfthan O.

Fourth Department of Surgery, Helsinki University Central Hospital, Finland.

PURPOSE: Cyclosporine is a widely used immunosuppressive drug in organ transplantation and recently it has been used in several autoimmune disorders with good results. Because interstitial cystitis may have an autoimmune etiology, we wished to determine whether cyclosporine has any effect on symptoms in patients with severe interstitial cystitis.

MATERIALS AND METHODS: A total of 11 patients, who fulfilled the criteria for interstitial cystitis according to an international accrual form, received cyclosporine for 3 to 6 months at an initial dose of 2.5 to 5 mg./kg. daily and a maintenance dose of 1.5 to 3 mg./kg. daily. Blood pressure, serum creatinine and cyclosporine concentrations were monitored regularly. The patients completed frequency-volume charts at 2-week intervals.

RESULTS: The frequency-volume charts showed favorable effects. Micturition frequency decreased (p<0.01), and mean and maximum voided volumes increased significantly (p<0.001 and p<0.01, respectively). Bladder pain decreased or disappeared in 10 patients, allowing for storage of large urine volumes. Serum creatinine did not change with the dosages used. Mild hypertension occurred in 2 patients and resolved after the cyclosporine dose was lowered. After cessation of treatment symptoms recurred in the majority of patients.

CONCLUSIONS: The findings revive the concept of interstitial cystitis as an autoimmune disease.

Publication Types:
Clinical Trial

PMID: 8627830 [PubMed - indexed for MEDLINE]

Here is another, more recent study. It was published in December 2005 (a couple of months ago.)

Blessings,
Lori

Cyclosporine A and pentosan polysulfate sodium for the treatment of interstitial cystitis: a randomized comparative study.

Sairanen J, Tammela TL, Leppilahti M, Multanen M, Paananen I, Lehtoranta K, Ruutu M.

Department of Urology, Helsinki University Hospital, 00029 HUS, Helsinki, Finland. jukka.sairanen@hus.fi

PURPOSE: In a previous retrospective analysis, cyclosporine A (CyA) was highly efficient in treating patients with interstitial cystitis. A prospective randomized study with this immunosuppressive agent was warranted. We compared CyA to pentosan polysulfate sodium (PPS) in patients with interstitial cystitis.

MATERIALS AND METHODS: A total of 64 patients with interstitial cystitis meeting the National Institute of Diabetes and Digestive and Kidney Diseases criteria were enrolled in a randomized prospective study. Patients were randomized in a 1:1 ratio to 1.5 mg/kg CyA twice daily (27 women, 5 men) or 100 mg PPS 3 times daily (26 women, 6 men) for a period of 6 months. The primary end point was daily micturition frequency, and secondary end points were mean and maximal voided volume, number of nocturia episodes, O'Leary-Sant symptom and problem indexes, visual analogue scale for pain, and subjective global response assessment.

RESULTS: CyA was superior to PPS in all clinical outcome parameters measured at 6 months. Micturition frequency in 24 hours was significantly reduced in the CyA arm compared to the PPS arm (-6.7 +/- 4.7 vs -2.0 +/- 5.1 times). The clinical response rate (according to global response assessment) was 75% for CyA compared to 19% for PPS (p <0.001). Although there were more adverse events in the CyA arm than in the PPS arm, 29 patients completed the 6-month followup in both groups.

CONCLUSIONS: CyA is more effective than PPS in interstitial cystitis.
Publication Types:
Randomized Controlled Trial

PMID: 16280777 [PubMed - in process]

1: J Urol. 2004 Jun;171(6 Pt 1):2138-41. Related Articles, Links


Long-term outcome of patients with interstitial cystitis treated with low dose cyclosporine A.

Sairanen J, Forsell T, Ruutu M.

Department of Urology, Helsinki University Hospital, Helsinki, Finland.

PURPOSE: We evaluated patients with interstitial cystitis who had been on cyclosporine A treatment for at least a year. Symptom improvement on micturition charts and subjective expression of bladder pain were recorded. Side effects and safety of medication were evaluated.

MATERIALS AND METHODS: A total of 23 patients (20 females and 3 males) fulfilling National Institute for Diabetes and Digestive and Kidney Diseases criteria of interstitial cystitis were included in this study. Age of patients at followup was 65.7 +/- 7.6 years (mean +/- SD). Mean followup was 60.8 +/- 35.7 months. Before starting cyclosporine A treatment multiple first line therapies had been tried without clinical help.

RESULTS: The number of voidings in 24 hours was 20.8 +/- 6.3 before treatment. After a year of cyclosporine A treatment it was decreased to 10.2 +/- 3.8 (p < 0.001). Maximal bladder capacity increased from 161.8 +/- 74.6 to 360.7 +/- 99.3 ml in a year (p < 0.001). Mean voided volume increased from 101.4 +/- 42.7 to 246.4 +/- 97.9 ml (p < 0.001). The effect was maintained throughout followup. Of 23 total patients 20 reported no bladder pain on cyclosporine A treatment and 11 patients stopped treatment due to a good clinical effect. In 9 patients symptoms recurred within months but disappeared again after cyclosporine A treatment was restarted. Side effects of medication were infrequent.

CONCLUSIONS: Cyclosporine A treatment was safe and effective in treating interstitial cystitis. The achieved therapeutic effect was maintained in the long term. Cessation of medication led to recurrence of symptoms in most cases.

[mare mare]

Hi Lori,
Thanks for the info! This is something I haven't tried yet and it lets me believe there is hope for us ICers!

Hugs,:grouphug:
mare mare

[ICLori]

You're welcome, Mare Mare. I'm there trying it because I've already tried all the standard IC treatments and lots of other treatments (herbal, experimental, you name it) and this is kind of my last hope really. There are three of us who are on it now, and I hope that by us recording our experiences, we can be helpful to others who might find themselves in the position of having no other medicine besides CyA left to turn to. It's a risky drug, but IC is such a horrible disease, and if no other treatment has worked....shrug....

I like your quote by the way, really cool!

Blessings,
Lori

[IcyAngel23]

Lori-

You have some older trials so I'll try to post the ones that my uro printed up for me. The most resent is May 06 and a few in 05. So I'll work on that. Thanks for posting that info. I'm glad others can have it right at their fingertips without having to hunt for them.

[IcyAngel23]

Here is one I found that my uro showed me was
Oral Cyclosporin Proves Effective For PBS/IC In A Randomized, Comparative Study

2005-12-22
By Philip M. Hanno, MD

BERKELEY, CA (UroToday.com) - Cyclosporin in a daily divided dose of 3mg per kilogram per day was compared with sodium pentosanpolysulfate (Elmiron®) 100mg three times daily in 64 patients with PBS/IC over 6 months of treatment. The Finnish group led by Sairanen reported their findings using a primary endpoint of daily micturition frequency and secondary endpoints of maximal bladder capacity mean voided volumes, nocturia, global response assessment, and VAS and O'Leary Sant symptom scores. About half of the patients in each treatment cohort had failed at least 3 prior types of PBS/IC therapy.

The primary endpoint was a very optimistic one: reduction of micturition frequency in 24 hours by half. This was met by 34% of the cyclosporine patients and none of the Elmiron® patients. Cyclosporin was also significantly more effective than Elmiron® in all other objective and subjective parameters measured. The global response assessment, the only parameter that showed significant improvement in pivotal pentosanpolysulfate trials, was positive (much better or completely cured) in 13/% of pentosanpolysulphate patients versus 59% of cyclosporine patients. At 6 months, patients were asked if they wanted to proceed with the current treatment at their own cost. A total of 19 patients continued on cyclosporine treatment and 4 patients continued on Elmiron®.

Cyclosporin had a higher adverse event profile than pentosanpolysulfate, and two patients required dose reduction because of elevation in diastolic blood pressure. Although cyclosporine side effects were common, the same number of patients still completed the study in both arms, perhaps reflecting the efficacy of the cyclosporine treatment as a motivator. Close monitoring of blood pressure and renal function is required in patients on cyclosporine.

The interstitial cystitis clinical research network (ICCRN) of the National Institute of Diabetes, Digestive, and Kidney Disorders is planning to study mycophenolate mofetil (CellCept), hoping it will have similar efficacy with a diminished adverse event profile. The Finnish researchers have opened up a new avenue for the treatment of PBS/IC, and further studies are needed to confirm their exciting results.

J Urol. December; 174:2235-2238

When I find the rest I'll post them.

[ICLori]

Thanks, Icy, but I already had that one - if you scroll down to the middle of my post, you'll see that study, where I say it was published in December 2005 - there are three studies in that one post. The first study is from 1996, the second study is the one you just posted again from 2005, and the third one is from 2004. Mine is the abstract from the study, and yours is the press release from the study - I actually do like the press release better (it's more easily read) so I do appreciate you posting it.

But I don't have any studies published in 2006 so I'd appreciate any of those...

Thanks for trying - you must have thought I only posted one study, you probably saw that one date at the top and didn't bother reading through....

Blessings,
Lori

P.S. here's the study abstract again on that if you missed it...again, if you scroll down a bit on my first post, you'll see it...

Here is another, more recent study. It was published in December 2005 (a couple of months ago.)

Blessings,
Lori

Cyclosporine A and pentosan polysulfate sodium for the treatment of interstitial cystitis: a randomized comparative study.

Sairanen J, Tammela TL, Leppilahti M, Multanen M, Paananen I, Lehtoranta K, Ruutu M.

Department of Urology, Helsinki University Hospital, 00029 HUS, Helsinki, Finland. jukka.sairanen@hus.fi

PURPOSE: In a previous retrospective analysis, cyclosporine A (CyA) was highly efficient in treating patients with interstitial cystitis. A prospective randomized study with this immunosuppressive agent was warranted. We compared CyA to pentosan polysulfate sodium (PPS) in patients with interstitial cystitis.

MATERIALS AND METHODS: A total of 64 patients with interstitial cystitis meeting the National Institute of Diabetes and Digestive and Kidney Diseases criteria were enrolled in a randomized prospective study. Patients were randomized in a 1:1 ratio to 1.5 mg/kg CyA twice daily (27 women, 5 men) or 100 mg PPS 3 times daily (26 women, 6 men) for a period of 6 months. The primary end point was daily micturition frequency, and secondary end points were mean and maximal voided volume, number of nocturia episodes, O'Leary-Sant symptom and problem indexes, visual analogue scale for pain, and subjective global response assessment.

RESULTS: CyA was superior to PPS in all clinical outcome parameters measured at 6 months. Micturition frequency in 24 hours was significantly reduced in the CyA arm compared to the PPS arm (-6.7 +/- 4.7 vs -2.0 +/- 5.1 times). The clinical response rate (according to global response assessment) was 75% for CyA compared to 19% for PPS (p <0.001). Although there were more adverse events in the CyA arm than in the PPS arm, 29 patients completed the 6-month followup in both groups.

CONCLUSIONS: CyA is more effective than PPS in interstitial cystitis.
Publication Types:
Randomized Controlled Trial

[IcyAngel23]

oops. I guess I didn't see you posted it. I do like the press releases better too. It is so much easier for us to understand. I'm getting pretty good and reading abstacts though. When I should my parents the studies for them to understand they looked at me like I had a whole in my head. So when I found this I was so happy cause everyone can read it and understand it.
My dad has the print outs of the May 06 trial and he has been on vacation so I'll have to look on the sheets for the website to copy and paste. So as soon as I find that I'll post it.

[ICLori]

Thats okay, Kristen, I'm so glad you posted the press release (do you have any more :) ) Because they are a million times easier to read and understand than the studies. I mean, my doctor even misinterpreted the study, he thought it was 1.5 mg/kg divided into two doses, instead of 3.0 mg/kg divided into two doses, and he thought that because the study abstract was written in a confusing way. So I am so glad you posted the press release!

And I'm so grateful that you would look for the other studies, too, the newer ones. I wonder, are they larger studies? That's what I was thinking was a drawback to some of these studies - I wished they were larger studies, maybe involved hundreds of patients. Or at least 100, something like that. Maybe there will be larger studies done now that there is some interest in CyA as a treatment for Ic.

Anyways, thank you, I think if we all put down as much info as we can, we can really help other people who might be following on this path of using CyA. I know we are among some of the pioneers right now on the boards with CyA, but I truly believe that we won't be the last ones to use CyA. I think that by us recording our experiences as faithfully as we can, we can provide help and reassurance to anyone else who might take CyA down the road.

Blessings, and thanks again,
Lori

[IcyAngel23]

I'll keep looking for more press releases. The abstracts are very confusing. I haven't read any studies with larger enrollment but I'm sure they aren't that far down the road. I'll keep my eye out ofr more stuff. Thanks for what you already posted.

[mela414]

HI,
I just read through the reports. does it seem to help people with voiding problems more than pain or is that just may take on it? I am curious to know how people with pain are doing with it. Aslo, has anyone had an cytos done after treatment with it and how did the bladder lining look?
right now mine looks awful! and I have to be extremely careful with what i eat and drink. I would love to find something for the pain as weel as something that would help me to heal.
I seem to have other autoimmune related problems...who knows....this might be something for me to consider but I have to look at side effects very closely as I can't tolerate most things.m:(
Thanks for all the info,

[ICLori]

Mela, as you read on the first thread (what does CyA do?) it helps significantly with urgency, frequency AND pain.

If you read the reports (posted in this thread, above) you will see this quote:

"Of 23 total patients 20 reported no bladder pain on cyclosporine A treatment"

That bears repeating again - 20 out of 23 patients on CyA reported NO BLADDER PAIN.

I haven't gotten there yet - been on it about 3 months and still having good days and bad - but I sure hope in the next few months to get there.

I have not had a hydrodistention yet since I've only been on this three months - same with everyone else here, they've been on it about the same amount of time, give or take a few weeks, as I have. None of us have had hydrodistentions. There are only three of us taking CyA on the boards at this time. There was one other young gentleman a couple of years ago but he posted a few times then vanished and never posted again, and can not be contacted or found (I have tried.)

Again, CyA is to be taken ONLY after failing every other IC treatment available, because of the risks.

Blessings, and good luck,
Lori

P.S. Search the thread about "Xolair" by using the search function at the top of the message boards (click on search, a box will drop down that you type in)....it is about a woman who got relief from her IC by a new allergy med of some type...anyway, think you would be interested in it...

[HelenC]

Hi, I have a interstim,have tried elmiron, dmso, lidocaine and heparin instillations daily (self instillation),hydrodistension(3),morphine and methadone,
hydroxyzine,amitriptyline,duloxetine,singulair,herbal etc. Do you think I can hope that my provider would rx cyclosporine? I heard that misoprostol(sp?)
was helpful but my pelvic pain dr said to try increasing my heparine instillations to 40,000units daily with lidocaine daily with triamcinoline 2x/week. I am tired of this. I have to take both methadone and morphine just to feel I can go out and work (i am the sole support of 3 children and have to work full time, my husband had an affair and actually tried to rape me when I said no to sex due to pain so I have a protective order against him).
What a jerk.

[ICLori]

Hi, Helen, I'm sorry you are suffering so much. It sounds like you have tried everything there is to try, and are still having severe symptoms, so perhaps your provider would consider allowing you to try this, even though it's experimental and there are risks.

You might want to print out the studies, take them to your doctor and talk about whether or not this would be appropriate for you.

I wish you the best of luck,

Blessings,
Lori