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February 15, 2006 • www.internalmedicinenews.com Gastroenterology 61 During Gastric Bypass Pays Off

BY TIMOTHY F. KIRN In a 2002 survey of surgeons who per- a timely piece of work, given the varia- cautioned. And the situation may be Sacramento Bureau form bariatric procedures, 30% said they tions in practice, but that physicians per- changing as more procedures are done la- use ursodiol treatment after a Roux-en-Y haps should not put too much stock in a paroscopically, when removing the gall- S AN F RANCISCO — For patients un- procedure, 15% remove the study that looked at the issues primarily bladder is more difficult. dergoing Roux-en-Y gastric bypass surgery, routinely, and the remainder watch and from a cost perspective. Moreover, it is not clear how effective concurrent cholecystectomy or treatment wait, Dr. White said. “We have to be very careful about the ursodiol treatment is, even when patients with ursodiol is more cost-effective than The landmark clinical trial of ursodiol message we are sending when you only are compliant. Studies have shown that pa- leaving patients alone and waiting to see treatment found that it reduced the rate of look at cost and quality-adjusted life- tients dislike taking it so much that at least if they develop gallstones, Dr. Brent C. gallstone formation to 2%, from 32% in years,” said Dr. Flum of the University of half of them stop. White reported. untreated controls. Washington, Seattle. injury may “I think that a lot of people will take this The combined intervention also pro- In commenting on the analysis, Dr. occur with gallbladder removal, and it has study and interpret it in different ways,” vides a better quality of life, according to David Flum said he thought the study was a devastating impact on the patient, he Dr. Flum added. ■ an analysis that he presented at the annu- al clinical congress of the American Col- lege of Surgeons. As an adjunct to diet Dr. White and his colleagues performed a cost analysis that compared three treat- ment strategies POWERED ‘We have to be for patients un- ...for success very careful about dergoing Roux- en-Y gastric by- the message we pass surgery: For your broad range of high-risk patients are sending when Giving ursodiol treatment for 6 you only look at months post cost and quality- operatively, per- forming con- adjusted life- current chole- years’ and not cystectomy, and watchful issues such as waiting for pos- bile duct injury. sible gallstones. The analysis as- sumed that patients who developed gall- stones during watchful waiting or while being treated with ursodiol would under- go cholecystectomy. After culling information from the peer- reviewed literature, the investigators in- corporated into the analysis data on the likelihood of a patient developing gall- stones after a Roux-en-Y bypass, on the ef- In 2 separate studies in high-risk patients with or CAD fectiveness of ursodiol treatment, and on More LDL-C reduction than twice the dose of atorvastatin1,2 the likelihood of complications with any • 82% of patients with diabetes reached LDL-C goal with a low 10-mg dose without titration1 of the strategies. In their payer-perspective analysis, the Established HDL-C efficacy 3,4 investigators found that concurrent • CRESTOR 5 mg to 40 mg increased HDL-C between 8% and 14% (vs 3% with placebo) in patients with primary hypercholesterolemia4 cholecystectomy was the least expensive treatment, with an average cost of $1,046 Safety in line with other leading statins4-6 per patient, followed by ursodiol at • In preapproval clinical trials and postmarketing experience, CRESTOR has demonstrated a safety profile in line with other leading statins4-6 $2,623 and watchful waiting at $3,964, Important Safety Information said Dr. White of the surgery department • CRESTOR is indicated as an adjunct to diet to reduce elevated • Rare cases of rhabdomyolysis with acute renal failure secondary at Dartmouth Hitchcock Medical Center, total-C, LDL-C, ApoB, non–HDL-C, and TG levels and to to myoglobinuria have been reported with CRESTOR and with Lebanon, N.H. increase HDL-C in patients with primary hypercholesterolemia other drugs in this class. Patients should be advised to promptly The three treatments showed almost (heterozygous familial and nonfamilial) and mixed dyslipidemia report unexplained muscle pain, tenderness, or weakness, • CRESTOR is contraindicated in patients with active disease particularly if accompanied by malaise or fever. Therapy with the same number of quality-adjusted life- or with unexplained persistent elevations of serum transaminases, CRESTOR should be discontinued if markedly elevated CK levels years achieved: 21.39 years for concurrent in women who are or may become pregnant, and in occur or myopathy is diagnosed or suspected cholecystectomy, 21.44 years for ursodiol, nursing mothers • Adverse reactions were usually mild and transient; the most • It is recommended that liver function tests be performed before frequent adverse events thought to be related to CRESTOR were and 21.43 years for watchful waiting. and at 12 weeks following both the initiation of therapy and any myalgia (3.3%), constipation (1.4%), asthenia (1.3%), 4,7 When the cost per quality-adjusted life- elevation of dose, and periodically (eg, semiannually) thereafter abdominal pain (1.3%), and nausea (1.3%) year of watchful waiting was computed • The 40-mg dose of CRESTOR is reserved only for those patients who • The effect of CRESTOR on cardiovascular morbidity and mortality have not achieved their LDL-C goal utilizing the 20-mg dose. Patients has not been determined; long-term outcome studies are for a population of patients, it was found initiating statin therapy or switching from another statin should begin currently under way to exceed the benchmark of what is con- treatment with CRESTOR at the appropriate starting dose sidered a cost-effective strategy. Ursodiol, on the other hand, was cost-effective, as long as one considered it to be at least 60% Please see brief summary of full Prescribing Information on reverse side of this advertisement. effective in preventing gallstones. On the basis of these findings, Dr. White and his associates concluded that “surgeons who currently employ a watch- ful waiting approach should consider ei- ther using ursodiol or performing a con- current cholecystectomy.” Studies have suggested that anywhere from 32% to 71% of patients who have a Roux-en-Y bypass will develop gallstones, he noted.