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Clinical Experience with Tixocortol Pivalate

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Clinical Experience with Tixocortol Pivalate CLINICAL GASTROENTEROLOGY Clinical experience with 1, tixocortol pivalate STEPHEN B. HANAUER. MD ease. In the United States, 100 m~ ABSTRACT: Tixocorcol pivalate, the 21-thiol derivative of hydrocortisone. is a hyd rocortisone rctcn tion enemas newly synthesized steroid with topical anti-inflammatory properties but is devoid of (Corccnema, Reid-Rowell) have become systemic glucocorticoid and mineralocorticoid activities and toxicity. The mechanism the most widely prescribed local ther· of actic.•. appears to be similar to that of other corticosteroids with regard to steroid binding sites and prostaglandin biosynthesis, however. the disassociation between apy for distal colitis. However. contmu· local and systemic effects is due to a 'first pass' liver metabolism and rapid transfor­ ous therapy with topical hydroconi,one mation with in red blood cells. ln both open and controlled studies in patients with is complicated by the conscquenct's ot acute or recurrent distal colitis, clinical efficacy has been noted at doses of 2 50 mg to significant systemic absorption propor· LOOO mg in 100 ml solution without an effect on scrum cortisol levels or blood tional to the administered dose and chro­ chemistries. Tixocortol pivalace has consistently shown to be as effective as systemi­ nicity of treatmen t (7-9). cally absorbed steroids for the treatment of distal ulcerative colitis with out the unde­ Tixocor to! pivalate ( pregn-4-cne· sirable effects associated with currently available steroid preparations. Can J Gas­ 3.20-dione-2l-thiol- llb. 17 dihydroxy· troc nte rol 1988;2( 4 ): 156-8 21-pivalatc), the 21-thiol derivative of Key Words: Anri-in/lammaiory, Sreroid, Ulcerative colitis hydrocorcisone (Figure I ), 1s a newly syn· thcsizcd steroid with anti-inflammatory LCERATIVE COLITIS REMAINS A DIS· Shortly after the introduction of oral U order of unknown etiology ( l). Des­ cortisone as therapy for ulcerative coli­ ~"· pite potentially li fe threatening tis. Truelove (3, 4) described the use of CH,- a - co-C:-CH I I ' pancolonic and transmural inflamma­ topical hydrocortisone by rectal drip. tion, the inflammatory response is lim­ Sub sequent randomized, controll ed ~--·· '"· ited to the mucosa of the rectum and sig­ trials by Truelove (5) and Watkinson (6) moid in the majority of cases (2). The confirmed the effectiveness of 100 mg superfi cial nature and limited extent of intrarectal doses of hydrocortisonc 0 the inflammauon often make ulcerative hemisuccinate solutions compared to pla­ CH,OH colitis amenable to local (intrarectal} cebo in achieving clinical, sigmoidoscopic I treatment and histologic improvement of active dis- CH C•O . - OH Dcpanmen1 uj McJicmc, Uniwrnry of Clucago Medical Cencer, Chicago. //lmoi .1 .,.,; Corrc.1/m11Jcncc and rc/mnt1 Dr Scephcn B Hanaitl'T, Assis1an1 Profe.15or of Medicine, Secuon of 0 Gastrocnrerolugy, Un1wr111y of Ch1wgo, 1841 Sowh Maryland Avenue, Chicago, JL 60637, USA Thi, paper u-as J1rcsenwcl m Falk Sympomcm No 49 'Trends m mjlammawry bowel diseme Figure I) Molecular .11rnc111rc.111/ 1ix11cor1ol 1herafry hdJ ,11 Luke Loimc, Alherra , Apn/ 2().23. 1988 J11wlaw I wp! anJ hyJrocorn1one 156 CAN J GASTROENHROL Clinica l experience with tixocortol plvolote properties in animal models of inflam­ not receiving oral or local steroids, related side effects were observed in the mation (Sandoz Pharmaceuticals, data alth ough continued therapy with tixocorrol treated patients. T he only con­ on file). Moreover, it has the unique fea­ sulfasalazine was allowed and analyzed sistently significant laboratory parame­ tu re of topical an ti-inflammatory effects separately ( 13, 14). The trials all lasted ters found to be altered were the white without the typical hormonal and met­ for three weeks with weekly evaluations blood count which was increased abolic effects of systemic ab orption ( ll). of symptoms and signs of ulcerative coli­ (increased neutrophils, decreased lym­ Hence, tixocortol pivalatc is considered tis, hematologic and clinical chemistry phocytes and eosinophils) and the scrum the first of a new class, the 'nonsystemic' parameters, as well as determinations of potassium which was decreased in the steroids. 08:00 seru m cortisol levels. Proctoscopic hydrocortisone treated patien ts. Serum The mechanism of action of tixocorcol examinations were performed at base­ cortisol determinations, when measured, p1valate appears co be similar to that of line and after 14 and 22 days. were not reduced in either grou p at three other corticosteroids with regard to ste­ Symptoms of diarrhea, rectal bleed­ weeks. roid binding site~ and proscagland in b io­ ing, abdominal pain, rectal pain and gen­ Hence, after three weeks, tixocorcol synchesis. However, in both animal and eral malaise statistically improved in both pivalate was equall y effective as hydro­ human studies, ti xocortol pivalate was treatment groups, as did the number of cortisone therapy without systemic glu­ devoid of systemic glucocorticoid and bowel movements and the number of cocorticoid or mincralocorticoid effects. rnineralocorticoid activities, as well as bowel movements accompanied by Subsequently, a short term, four day toxicity, in most cases at dose levels as blood. There was a direct correlation study was performed comparing 250 mg high as 4000 mg/kg. While tixocortol with the severity of the symptoms at base­ ti xocorcol pivalate to a saline placebo pivalatc is absorbed co the same extent line and the degree of improvement; enema in 24 patients with ulcerative coli­ a,other steroids, including hydrocorti­ worse initial symptoms were associated tis or Crohn's disease of the rectum. Dur­ sone, the disassociation between local with a greater degree of improvement. ing this brief study, the symptoms of diar­ and systemic effects is due co a 'fi rst-pass' Likewise, endoscopic findings of colonic rhea. rectal b leeding a nd number of liver metabolism and rapid transforma­ hyperemia, ulceration and the physician's bowel movements, as well as procto­ rion within red blood cells ( Il, 12). overall rating of the colitis improved in scopic signs of crythcma, granu larity, both treatment groups by week 2 and mucopus and overall rating of colitis CLINICAL STUDIES contin ued to improve, such that by the improved in the tixocortol patients, Open studies: Both biological tolerance end of the th ree week study, 68% of the whereas no changes in symptoms or signs studies in patients with refractory proc­ tixocorcol pivalare and 75% of the hydro­ of inflammatory bowel disease were utis and multicen tre open studies in cortisone group had improved, and 34% observed in the placebo group (Tables I panents with acute or recu rren t distal of the tixocortol patients and 36% of the and 2). colitis have confirmed the absence of an hydrocortisone patients had healed (nei­ A randomized, double-blind, paral­ effect of tixocorcol pivalate on scrum cor­ ther proportion was statistica lly signifi­ lel group study also was conducted in usol levcls or other blood chemistries, cant between groups) (Figure 2). Patients 30 patients with ulcerative colitis to elu­ and apparent clinical efficacy using doses treated with sulfasalzine also improved cidate a dose response with higher doses of250 mg in LOO mL solutions (Sandoz in both groups. of tixocortol pivalate. Ten patients were Pharmaceuticals, data on file). Adverse reactions were typically mild, allocated to receive either 250 mg, 500 Controlled studies: Two m u lticen tre if reported. and no significant steroid mg or 1000 mg tixocortol pivalate in 100 controlled stud ies performed outside of the United States compared 250 mg tixocortol pi val ate enemas to 5 mg betame thasone phosphate with all TP HC TP HC patients receiving between l. 5 and 4 g 100 sulfasalazine. Over the three week course 90 of the studies, both enemas were well 106/141 an tolerated and equally effective in reduc­ 70 ing the symptoms of ulcerative colitis, 6 60 yet only the betamethasone increased 50 50 ;.!rum cortisol (Sandoz Pharmaceuticals, 41) 40 45/133 51/ 141 daraon fi le). 30 30 In the United States, three large, con­ 20 20 trolled, double-blind, randomized, 10 10 multicentre stud ies have compared 250 0 0 mgtixocortol pivalate enemas to 100 mg PERC ENT IMPROVED hydrocortisone enemas (Cortenema; PER CENT HEALED Reid-Powell) in a total of 337 patients F igure 2) Summary of rhree US conrmllcd crials of nxocorrol pii,alate I TP J 1oers1.s hydrocornwme ( HCJ with left sided ulcerative colitis who were e11ema.1 in acute ulcerntit•e col His. Outcome after three lt'eeks \ol 2 No. 4. November 1988 157 HANAUER TABLE 1 TABLE 2 Physician roting o f signs on day 4 Patient roting of symptoms compared to baseline Mucosal vascular pattern O Tixocortol pivalate Placebo Doy Doy Erythema T -< P Parameter 2 3 4 2 3 4 Granularity T -< P Diarrhea 0 0 < 0 0 0 Friability 0 Rectal bleeding 0 -< "< 0 0 0 Ulcerations O Abdominal pain 0 0 0 0 0 0 Mucopus T < P Rectal pain Summed severity Index T < P Nausea T Tixocortol pivoiote. P Plocebo Vomiting Change in appetite 0 0 0 0 0 0 ml solution over three weeks. At the Feeling of illness 0 -< < 0 0 0 conclusion of the study, no dose response Number of bowel movements 0 < -< 0 0 0 was identified in the entire group (Fig­ Number of bowel movements 0 -< -< 0 0 0 ure 3) or after analysis of the subgroups with blood of sulfasala zine treated or refractory patients. REFERENCES hemisuccinatc sodium. A controlled I. Kirsncr JB, Shorter RG Recent trial employing restricted ,cquential CONCLUSION developments in 'non-specifi c' analysis. Br Med J 1958;2: 1077-82 Tixocortol pivalate, the first of a new inflammatory howcl disease. N Engl J 7. Sherman LF, Tenner RJ. Schoulcr JL class of nonsystemic steroids devoid of Med 1982;306:775-85, 837-48. Trc::icmcnt of ulcerative colitis with glucocorticoid a nd mineralocorticoid Z.
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