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801645 1095.1099

International Journal of Obesity (2001) 25, 1095±1099 ß 2001 Nature Publishing Group All rights reserved 0307±0565/01 $ PAPERGastrointestinal side effects of orlistat may be prevented by concomitant prescription of natural ®bers (psyllium mucilloid)H Cavaliere1, I Floriano1 and G Medeiros-Neto1* 1Department of Clinical Medicine, University of SaÄo Paulo Medical School, SaÄo Paulo, Brazil OBJECTIVES: This placebo-controlled open study was designed to test the hypothesis that most of the gastrointestinal (GI) side events induced by treatment of obese patients with orlistat (a gastrointestinal lipase inhibitor) could be prevented or ameliorated by concomitant use of natural ®bers (psyllium mucilloid).
DESIGN: Two groups of obese women (BMI b 27 kgam2) were treated with orlistat 120 mg three times a day. One group (A, n ˆ 30) was randomized to receive orlistat and, approximately 6.0 g of orange-¯avored psyllium mucilloid dissolved in water and the other group (B, n ˆ 30) received orlistat and orange-¯avored placebo. At the end of 30 days and 2 weeks of washout, group A switched to placebo and group B received psyllium while continuing orlistat three times a day.
SUBJECTS: Sixty professional women, more than 21-y-old with a body mass index (BMI) between 27.3 and 48.0 kgam2, who were not receiving any other medication.
MEASUREMENTS: Assessments included weekly visits to attending physician, ®lling a form in which GI events were recorded, monthly measurements of body weight, blood pressure and serum lipids. The frequency and severity of GI events were evaluated by a score system, based on information provided by the patients.
RESULTS: Both groups A and B signi®cantly lost (P ` 0.01) weight after 60 days of orlistat (A ˆ 96.8 to 94.9 kg and B ˆ 98.7 to 96.5 kg). Similarly, BMI values declined signi®cantly in both groups. While in the psyllium plus orlistat group (group A) the mean Æ s.e.m. of the scores re¯ecting GI events was 13.0Æ 1.8, the placebo plus orlistat group (B) had a value of 35.9Æ 2.7 (P ` 0.01).
When the reverse situation was instituted the placebo and orlistat group presented a mean score of 36.1Æ 3.6 and the psyllium plus orlistat a mean score of 8.9Æ 1.5 (P ` 0.01).
CONCLUSIONS: Psyllium hydrophilic mucilloid concomitantly prescribed to obese patients receiving 120 mg of orlistat three times a day is an effective and safe adjunct therapy that is helpful in controlling the GI side effects of this pancreatic lipase International Journal of Obesity (2001) 25, 1095 ± 1099 Keywords: obesity; lipase-inhibitor; orlistat; gastrointestinal effects; natural ®bers; psyllium excreta. In volunteers and obese subjects the maximal fecal Orlistat, a hydrogenated derivative of lipstatin is a potent fat loss, depending on the dose of orlistat and the amount of inhibitor of gastric and pancreatic lipase.1±6 By inhibiting fat in the diet, was about one-third (30%) of the ingested fat, the intestinal lipase the therapeutic use of orlistat leads to a reaching a plateau with doses around 360 mgaday.
decreased fat absorption and subsequent excretion of the The side effects with orlistat are to be expected from its unabsorbed triglycerides, cholesterol and fat in the fecal mechanism of action on pancreatic lipase. These includeintestinal ¯atulence, borborygmi and abdominal cramps.5The most troubling were fecal incontinence, oily spotting *Correspondence: G Medeiros-Neto, Division of Endocrinology, Department of Clinical Medicine, Hospital das Clinicas, University of SaÄo and ¯atus with discharge. In a large European Multicentre Paulo Medical School Av. Eneas C. Aguiar 255-8A-bl. 3, 05403-900 SaÄo Orlistat study group2 adverse gastrointestinal (GI) events were a common reason for premature withdrawals in the orlistat treated group. In another randomized controlled trial Received 13 July 2000; revised 29 November 2000; of obese subjects treated for 2 y with orlistat (Multicentre Table 1 Age, weight-loss and BMI variation American Study) at least one GI event was experienced by obesity, were not under treatment for other conditions, were 79% of the subjects in the orlistat group.4 Gastrointestinal willing to cooperate and had no gastrointestinal signs or adverse events seem to increase with large doses of orlistat3 symptoms. Other exclusion criteria were weight loss of and have a tendency to be less frequent in the second year of more than 4 kg in the 3 months before screening, bulimia and laxative abuse, use of any drug that might have in¯u- Psyllium is a water-soluble, gel-forming ®ber derived from enced bodyweight, alcohol abuse, history of prior chole- the husks of blonde psyllium seeds (Plantago ovata, English cystectomy or intestinal surgery, and inability to follow plantain, commonly referred as `ispaghula'). Psyllium instructions or to accurately report symptoms. After a single belongs to a group of soluble ®bers that show cholesterol- lead-in period of 4 weeks during which the patients received lowering effects when added to patients' diets.7±11 Moreover, nutritional advice and were instructed to exercise according dietary ®ber, such as psyllium, may increase the fractional to their possibilities and capacities, the patients were ran- turnover of bile acids, probably by increasing their fecal domly assigned to two groups of 30 subjects (Table 1).
elimination. Also psyllium has been used to absorb intestinal Group A (n ˆ 30), meanÆ s.e.m. age, 40.8Æ 7.9-y-old, with fat both in obese and diabetic patients.10 Thus it was a meanÆ s.e.m. weight of 98.82Æ 17.8, a BMI of 38.09Æ assumed that the constant use of psyllium hydrophilic 5.26 kgam2, were assigned to receive orlistat 120 mg three mucilloid might be effective in diminishing the adverse times daily, with the meals, for a period of 4 weeks. The effects of unabsorbed fat caused by orlistat.
patients were instructed to ingest the orlistat capsules with In this study we have decided to use the bene®cial approximately 6.0 g of orange-¯avored psyllium hydrophillic gastrointestinal effects of a psyllium hydrophilic mucilloid mucilloid, with no added sugar, dissolved in a glass of water.
in patients treated with orlistat, in order to minimize the GI Group B (n ˆ 30), meanÆ s.e.m. age 41.7Æ 8.9 y, with a events that are relatively common in this therapy.
meanÆ s.e.m. weight of 98.78Æ 16.81 kg, BMI of 38.17Æ4.81 kgam2, were similarly assigned to receive orlistat120 mg three times daily with meals for 4 weeks. These patients also received, approximately, 6.0 g of a soluble orange-¯avored powder (placebo) to be dissolved in water Eligible obese patients all women, with ages from 27 to 42-y- and ingested with the orlistat capsules three times a day.
old (meanÆ s.d. 40.9Æ 8.9-y-old) with body mass index Both the psyllium powder and the placebo orange powder (BMI) b 27 kgam2, were recruited by advertisement in the were packed in small identical sachets to be open at home.
university hospital weekly newsletter. All of them were Both the patient and the attending physician were blind to employed by the hospital as of®cials, nurses and laboratory personnel. Women of childbearing potential were included if After 15 days of a washout period, the patients from group they were using adequate contraception. The study con- A were assigned to receive orlistat plus placebo and those formed to the Declaration of Helsinki and was approved by from group B received the orlistat capsules plus psyllium the Ethics Committee of the University Hospital. All partici- pants gave written informed consent. The main reason for All patients were seen by one of the authors (HC) on a using the university hospital personnel was to have a uniform weekly basis. At each visit the patients were asked to return a group of obese patients that were not actually being treated printed form in which each GI event occurring during the for obesity, would have a predictable low drop-out rate, would week was recorded, on a daily basis (Table 2). The attending be able to report accurately signs and symptoms related to GI physician, therefore, was able to assign the number of points events during orlistat therapy and could be easily contacted, to reach the GI events score for that week. At the end of 30 on a daily basis, during the period of the project.
days, the total number of points for each patient was A total of 110 obese patients were initially eligible for the recorded and tabulated for further statistical analysis.
study. Of these, 60 obese women were ®nally recruited by After this ®rst part of the study was completed it was personal interview. They were lacking major complications of noticed that most patients complained that it was not Figure 1 Schematic design of the research project.
agreeable to ingest the orlistat capsules with the psyllium The data was analyzed with a GraphPad Prism software orange-¯avored drink, at each meal, mainly in public places (version 2.0, Graphpad Software Inc., San Diego, CA, USA).
such as restaurants, cafeterias and social gatherings. There- Analysis of variance was used to examine body weight, BMI fore, we started a new study design in which orlistat capsules and serum-lipids values. Paired t-tests were used to examine (120 mg) were prescribed to be taken three times a day, with differences between means. The w2 method was employed for meals, as previously done but the psyllium or placebo were differences between frequency of GI events in speci®c groups given as a single drink with approximately 12 g of orange- ¯avored powder in water, at bedtime. Only 30 patients fromthe original group of 60 subjects volunteered for this secondpart of the project, being randomly assigned, as previously described, 15 to each group of placebo and psyllium during The weekly visit to the attending physician and the need to During the 60 days of treatment periods, patients were hand out the printed form where the GI events were prescribed a standard mildly hypocaloric diet containingroughly 30% of energy as fat. The estimated energy intake Table 2 The scoring system for quanti®cation of the GI adverse was 1200 kcaladay. The same diet was prescribed in the The score system. The scoring system was previously designed by interviewing obese patients in orlistat treat- ment. The major adverse and troubling events were oily spotting (¯atus with discharge) and fecal incontinence.
Therefore it was decided to assign to these events, respec- tively, a scoring of 4 and 5 (in a scale of 0 ± 5). Similarly, other side effects such as increased defecation, soft stools, ¯atu- lence, abdominal pain and fecal urgency received scores between 1 and 3. When the adverse events were more frequent (in a weekly basis) the scores would concomitantly increase, as shown in Table 2. Previous to the start of this study, the scoring system was tested in a group of obese patients on orlistat treatment and we concluded that it re¯ected the actual intensity of the adverse effects.
Table 3 GI side effects; meanÆ s.e.m. scores for group A and group B placebo (group A vs group B). Similarly, when we comparedthe meanÆ s.e.m. of the scores of GI events between (1) psyl- lium three times a day plus orlistat and (2) psyllium 12.0 g at bedtime there was no statistical difference between them(10.8Æ 1.7 vs 6.11Æ 1.21), respectively.
In Table 4 we have listed the total number of GI events occurring with 60 patients either while on orlistat pluspsyllium or orlistat plus placebo. Overall GI events were 2 ± 6-fold more common during orlistat plus placebo ascompared to orlistat plus psyllium. After analysis of thedata by the w2 statistical method, this difference was highly recorded was considered to be an excellent way to prevent withdrawals and to achieve compliance. All 60 patientscompleted the two periods of 30 days each. For the secondpart of the project we randomly assigned the 30 patients that volunteered to continue the study for another 30 days to two Orlistat belongs to a class of anti-obesity agents that act groups of 15 patients, as previously mentioned.
directly and speci®cally at the site of fat breakdown in the Demographic and anthropometric characteristics did not lumen of the intestinal tract. The systemic absorption of differ signi®cantly between treatment groups both at the orlistat is negligible and the potential for systemic adverse start of the lead-in period or at the beginning of the trial.
events has been indicated as practically non-existent. Due tothe pharmacological mode of action of orlistat5 there is an increased likelihood of gastrointestinal events. As pointed Both groups A and B similarly had a signi®cant weight loss out by SjostroÈm et al.2 the GI events were more common in (P ` 0.01) that was also documented by a signi®cant the orlistat-treated patients during the ®rst year of their (P ` 0.01) variation in the BMI (Table 1). Considering the collaborative multicenter trial, the frequency being lower two periods of 30 days each, approximately 36.7% of the during year 2 among participants who continued on orlistat patients lost more than 2 kg each and 46.7% lost between 0.1 treatment. This has been interpreted as related to the fact and 1.9 kg. The remaining 16.6% did not change their initial that most patients would learn that orlistat treatment has to weight or gained weight during the trial.
be associated with a moderate fat intake. During orlistattreatment the GI events are relatively important because itmay be cause for early withdrawal from the trial or cause social embarrassment to the individual patient.
In Table 3, the meanÆ s.e.m. of the score of GI events In order to circumvent the GI events that occur during obtained for each patient is shown for both groups A and orlistat treatment we have used the concomitant prescription B. There was a signi®cant (P ` 0.01) difference between the of psyllium hydrophilic mucilloid. Previous reports suggest low prevalence of GI events, as indicated by the low score that this natural ®ber may be effective in lowering serum of GI events, when the patients were using psyllium cholesterol,8,9 increasing the fecal excretion of bile acids11 hydrophillic mucilloid as compared with placebo. The and absorbing free fat in the intestinal lumen.10 In this study same results were obtained when groups A and B were we were able to demonstrate that the adjunct use of psyllium submitted after the washout period, respectively to placebo with orlistat effectively diminished the number and seventy of and psyllium. Overall, 71% of patients while on orlistat GI events during orlistat therapy, as compared with placebo.
plus placebo had GI events as compared with 29% of This was con®rmed when the psyllium-treated group was patients while using orlistat and psyllium mucilloid.
switched to placebo and vice-versa. Therefore, we concluded There was no statistical difference between meansÆ s.e.m.
that psyllium mucilloid had a protective action in the produc- when orlistat and psyllium groups was compared with group tion of GI events, most probably by absorbing free fat (oil) anddecreasing intestinal ¯atulence. Interestingly, most patientsindicated that the number of bowel movements did not Table 4 Oily spotting, fecal urgency and incontinence. Comparison increase in number while on orlistat plus psyllium. The most between orlistat with psyllium or placeboa important GI event that was prevented by the use of orlistat plus psyllium was the embarrassing oily spot, de®ned as yellowdischarge with ¯atus during daily activities. Although psyllium Oily spotting Fecal urgency Fecal incontinence was not totally effective in preventing this situation, oily spotting was 6-fold less frequent in the psyllium-treated Finally we concluded that the use of psyllium as a single Number of episodes during a 60 day trial of orlistat and psyllium or orlistat dose of 12.0 g in water, at bedtime, is as effective as using psyllium three times a day, at meals time. Most patients 3 Drent ML, Larsson I, William-Olsson T, Quaade F, Czubayko F, considered that intake of psyllium at bedtime was far more von Bergmann K, Strobel W, SjoÈstroÈm L, van der Veen EA.
Orlistat, a lipase inhibitor, in the treatment of human obesity: a convenient and comfortable as compared to the alternate multiple dose study. Int J Obes Relat Metab Disord l995; 19: 221± In conclusion, psyllium hydrophilic mucilloid is an effec- 4 Davidson MH, Hauptman JB, Digirolamo M, Focyt JP, Halsted CH, tive, practical and easy method to circumvent the GI events Heber D, Heimburger DC, Lucas CP, Robbins DC, Chung J, Heyms®eld SB. Weight control and risk factor reduction in during orlistat treatment of obese patients, provided that a obese subjects treated for 2 years with orlistat. JAMA 1999; 281: 5 Bray GA, Greenway FL. Current and potential drugs for treatment of obesity. Endocr Rev 1999; 20: 805±875.
6 Hauptman J, Lucas C, Boldrin MN, Collins H, Segall KR. Orlistat We acknowledge the help of Creusa R Dal Bo in the statistical in the long-term treatment of obesity in primary care settings.
analysis of the data. This study was supported by Roche Pharmaceutical Co. and Procter & Gamble (Brazil). The 7 Everson GT, Daggy BP, McKimley C, Story JA. Effects of psyllium hydrophillic mucilloid on LDL-cholesterol and bile acid syn- expert secretarial work of Maria Suzette Pott is gratefully thesis in hypercholesterolemic men. J Lipid Res 1992; 33: 1183± acknowledged. Part of this work was reported at the 9th European Congress on Obesity, Milan, Italy (1999).
8 Levin EG, Miller VT, Muesing RA, Stoy DB, Balm tK, LaRosa JC.
Comparison of psyllium hydrophillic mucilloid and cellulose as adjuncts to a prudent diet in the treatment of mild to moderate hypercholesterolemia. Arch Intern Med 1990; 150: 1822±1827.
9 Bell LP, Hectorme K, Reynolds H, Balm TK, Hunninghake DB.
1 James WPT, Avenell A, Broom J, Whitehead J. A one year trial to Cholesterol-lowering effects of psyllium hydrophilic mucilloid.
assess the value of orlistat in the management of obesity. Int J Obes Relat Metab Disord 1997; 21(Suppl 3): S24±S30.
10 Vahouny GV, Krutchevsky M (eds). Dietary ®ber: basic and clinical 2 SjoÈstroÈm L, Rissanem A, Andersen T, Boldrin M, Golay A, aspects. Plenum Press: New York; 1986. pp 181±209.
Koppeschaar HPF, Krempf M. Randomised placebo-controlled 11 Kesaniemi YA, Tarpila S, Miettinem L. Low vs. high dietary ®ber trial of orlistat for weight loss and prevention of weight regain and serum, biliary and fecal lipids in middle-aged men. Am J Clin in obese patients. Lancet 1998; 352: 167±173.


NOTE: Pages in each section start with #1. Therefore, the pages go section 1 page 1, section 1 page 2, etc. Section 1 PROTOCOL ACKNOWLEDGMENT AND AUTHORIZATION Standing Medical Orders and Treatment Protocols . 1.2 Section 2 ADVANCED CARDIAC LIFE SUPPORT GUIDELINES Asystole . 2.2 Bradycardia (Heart rate < 60 beats per minute). 2.4 Tachycardia (heart rate > 100 beats per minute

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