Abstract
OBJECTIVE: We evaluated the effects of 12-month treatment with sibutramine 15 mg daily compared with placebo on health-related quality of life (HRQL) in obese type II diabetes patients. We examined the associations between the changes in HRQL and in weight, glycaemic control, and haemodynamic variables. We also explored the predictive value of HRQL and its changes early during treatment.
DESIGN: A randomised clinical trial. The subjects were enrolled in a 2-week single-blind run-in period with a modestly hypocaloric diet (700 kcal daily deficit) and then randomised to receive either sibutramine 15 mg (n=114, 60% female) or placebo (n=122, 58% female) once daily with the hypocaloric diet for 12 months.
SUBJECTS: Obese (mean BMI 36 kg/m2 and age 54 y) type II diabetes patients untreated with antidiabetic medications.
MEASUREMENTS: The main outcome measures included body weight and HRQL (the RAND 36-Item Health Survey 1.0).
RESULTS: The mean weight loss was greater in the sibutramine group (−7.1 kg) than in the placebo group (−2.6 kg, P<0.001). The baseline HRQL was relatively high. There were no significant differences between the treatment groups in glycaemic control or in any of the RAND-36 scales during the study. The scores on physical functioning (PF) and health change (HC) since last year improved in both groups and this improvement was related to weight loss. When HRQL changes were examined in categories of weight loss, the scores on PF and HC increased with ≥5% weight loss, but the scores on vitality (V) and general health (GH) increased only after ≥15% weight loss. Decrease in HbA1c was associated with increases in the scores of PF, GH, V, mental health, and HC. In the sibutramine group, the increase in diastolic blood pressure was associated with the decrease in the scores of PF, physical role functioning, emotional role functioning (ERF), social functioning (SF), and bodily pain. High baseline scores on ERF and SF, and low scores on V predicted weight loss at 12 months. Also, increasing scores on PF and V during the first 3 months predicted weight loss at 12 months. The sum of four dichotomised HRQL variables (baseline ERF ≥75=1 and <75=0; baseline SF≥80=1 and <80=0; 3-month change in PF>0=1 and ≤0=0; 3-month change in V>0=1 and ≤0=0) predicted weight loss: In the group with sum 0, the mean(s.d.) weight change at 12 months was 0.0(2.6)% and with sum 4 it was –9.0(8.1)% of baseline weight.
CONCLUSION: Despite the superior weight loss, sibutramine 15 mg daily did not produce HRQL benefits over placebo when measured with the generic RAND-36 in obese type II diabetes patients. PF and HC since last year improved with ≥5% weight loss, but ≥15% weight loss was needed to achieve a cluster of HRQL improvements. The decrease in HbA1c was associated with many HRQL benefits. Poor baseline HRQL and the improvement observed in the first months of treatment may prove to be useful in predicting success in long-term weight loss.
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References
Fontaine KR, Barofsky I . Obesity and health-related quality of life. Obes Rev; 2001; 2: 173–182.
Brown WJ, Mishra G, Kenardy J, Dobson A . Relationships between body mass index and well-being in young Australian women. Int J Obes Relat Metab Disord; 2000; 24: 1360–1368.
Ford ES, Moriarty DG, Zack MM, Mokdad AH, Chapman DP . Self-reported body mass index and health-related quality of life: findings from the Behavioural Risk Factor Surveillance System. Obes Res; 2001; 1: 21–31.
Kolotkin RL, Head S, Hamilton M, Tse C-K . Assessing impact of weight on quality of life. Obes Res; 1995; 1: 49–56.
Kolotkin RL, Head S, Brookhart A . Construct validity of the Impact of Weight on Quality of Life questionnaire. Obes Res; 1997; 5: 434–441.
Rippe JM, Price JM, Hess SA, Kline G, DeMers KA, Damitz S, Kreidieh I, Freedson P . Improved psychological well-being, quality of life, and health practices in moderately overweight women participating in a 12-week structured weight loss program. Obes Res; 1998; 3: 208–218.
Fontaine KR, Barofsky I, Andersen RE, Bartlett SJ, Wiersema L, Cheskin LJ, Franckowiak SC . Impact of weight loss on health-related quality of life. Qual Life Res; 1999; 3: 275–277.
Miller-Kovach K, Hermann M, Winick M . The psychological ramifications of weight management. J Women's Health Gender-Based Med; 1999; 4: 477–482.
Samsa GP, Kolotkin RL, Williams GR, Nguyen MH, Mendel CM . Effect of moderate weight loss on health-related quality of life: an analysis of combined data from 4 randomized trials of sibutramine vs placebo. Am J Manage Care; 2001; 7: 875–883.
Kaukua J, Pekkarinen T, Sane T, Mustajoki P . Health-related quality of life in WHO Class II–III obese men losing weight with very-low-energy diet and behaviour modification: a randomised clinical trial. Int J Obes Relat Metab Disord; 2002; 4: 487–495.
Kaukua J, Pekkarinen T, Sane T, Mustajoki P . Health-related quality of life in obese outpatients losing weight with very-low-energy diet and behaviour modification: a 2-y follow-up study. Int J Obes Relat Metab Disord; 2003; 9: 1072–1080.
Hanninen J, Takala J, Keinanen-Kiukaanniemi S . Quality of life in NIDDM patients assessed with the SF-20 questionnaire. Diabetes Res Clin Pract—Suppl; 1998; 42: 17–27.
Glasgow RE, Ruggiero L, Eakin EG, Dryfoos J, Chobanian L . Quality of life and associated characteristics in a large national sample of adults with diabetes. Diabetes Care; 1997; 20: 562–567.
Jacobson AM, de Groot M, Samson JA . The evaluation of two measures of quality of life in patients with type I and type II diabetes. Diabetes Care; 1994; 17: 267–274.
Hirsch A, Bartholomae C, Volmer T . Dimensions of quality of life in people with non-insulin-dependent diabetes. Qual Life Res; 2000; 9: 207–218.
Woodcock AJ, Julious SA, Kinmonth AL, Campbell MJ . Problems with the performance of the SF-36 among people with type 2 diabetes in general practice. Qual Life Res; 2001; 10: 661–670.
Goddijn PP, Bilo HJ, Feskens EJ, Groeniert KH, van der Zee KI, Meyboom-de Jong B . Longitudinal study on glycaemic control and quality of life in patients with Type 2 diabetes mellitus referred for intensified control. Diabetes Med; 1999; 16: 23–30.
McNeely W, Goa KL . Sibutramine. A review of its contribution to the management of obesity. Drugs; 1998; 56: 1093–1124.
Stock MJ . Sibutramine: a review of the pharmacology of a novel anti-obesity agent. Int J Obes Relat Metab Disord; 1997; 21 (Suppl 1): S25–9.
Apfelbaum M, Vague P, Ziegler O, Hanotin C, Thomas F, Leutenegger E . Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine. Am J Med; 1999; 106: 179–184.
Cuellar GEM, Ruiz AM, Monsalve MCR, Berber A . Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population. Obes Res; 2000; 8: 71–82.
Fanghänel G, Cortinas L, Sánchez-Reyes L, Berber A . A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity. Int J Obes Relat Metab Disord; 2000; 24: 144–150.
McMahon FG, Fujioka K, Singh BN et al. Efficacy and safety of sibutramine in obese white and African American patients with hypertension: a 1-year, double-blind, placebo-controlled, Multicenter Trial. Arch Intern Med; 2000; 160: 2185–2191.
Finer N, Bloom SR, Frost GS, Banks LM, Griffiths J . Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. Diabetes Obes Metab; 2000; 2: 105–112.
Serrano Rios M, Melchionda N, Moreno-Carretero M . Role of sibutramine in the treatment of obese type 2 diabetic patients receiving sulphonylurea therapy. Diabetes Med; 2002; 2: 119–124.
Fujioka K, Seaton TB, Jelinek RE, Raskin P, Lebovitz HE, Weinstein SP . Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. Diabetes Obes Metab; 2000; 2: 175–187.
Goekcel A, Karakose H, Ertorer EM, Tanaci N, Tutuncu NB, Guvener N . Effects of sibutramine in obese female subjects with type 2 diabetes and poor glucose control. Diabetes Care; 2001; 245: 1957–1960.
Hays RD, Sherbourne CD, Mazel RM . The RAND 36-Item Health Survey 1.0. Health Econ; 1993; 2: 217–227.
Aalto A-M, Aro AR, Teperi J . RAND-36 terveyteen liittyvän elämänlaadun mittarina—mittarin luotettavuus ja suomalaiset väestöarvot. Stakes, Tutkimuksia 101: Helsinki; 1999 (in Finnish).
Fayers PM, Machin D . Quality of Life—Assessment, Analysis and Interpretation. Wiley: Chichester; 2000.
Sullivan M, Karlsson J, Sjöström L, Backman L, Bengtsson C, Bouchard C, Dahlgren S, Jonsson E, Larsson B, Lindstedt S, Näslund I, Olbe L, Wedel H . Swedish Obese Subjects (SOS)—an intervention study of obesity. Baseline evaluation of health and psychosocial functioning in the first 1743 subjects examined. Int J Obes Relat Metab Disord; 1993; 9: 503–512.
Doll HA, Petersen SE, Stewart-Brown SL . Obesity and physical and emotional well-being: associations between body mass index, chronic illness, and the physical and mental components of the SF-36 questionnaire. Obes Res; 2000; 2: 160–170.
Friedman AM, Brownell KD . Psychological correlates of obesity: moving to the next research generation. Psychol Bull; 1995; 1: 3–20.
Barofsky I, Fontaine KR, Cheskin LJ . Pain in the obese: impact on health-related quality-of-life. Ann Behav Med; 1997; 4: 408–410.
Anderson RM, Fitzgerald JT, Wisdom K, Davis WK, Hiss RG . A comparison of global versus disease-specific quality-of-life measures in patients with NIDDM. Diabetes Care; 1997; 20: 299–305.
Weinberger M, Kirkman MS, Samsa GP, Shortliffe EA, Landsman PB, Cowper PA, Simel DL, Feussner JR . A nurse-coordinated intervention for primary care patients with non-insulin-dependent diabetes mellitus: impact on glycemic control and health-related quality of life. J Gen Intern Med; 1995; 10: 59–66.
Weinberger M, Kirkman MS, Samsa GP, Cowper PA, Shortliffe EA, Simel DL, Feussner JR . The relationship between glycemic control and health-related quality of life in patients with non-insulin-dependent diabetes mellitus. Med Care; 1994; 32: 1173–1181.
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We thank the dedicated staff of all study centres for their expert help. This study was finacially supported by a grant from Knoll Laboratories, Nottingham, UK.
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Kaukua, J., Pekkarinen, T. & Rissanen, A. Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes. Int J Obes 28, 600–605 (2004). https://doi.org/10.1038/sj.ijo.0802591
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DOI: https://doi.org/10.1038/sj.ijo.0802591
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