Assessment of the Effectiveness of Orlip Medication in the Complex Therapy of Patients with Obesity Hodzhaeva N. V., Nasyrova Kh. K., Hodzhaeva F. S
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Assessment of the Effectiveness of Orlip Medication in the Complex Therapy of Patients with Obesity Hodzhaeva N.V., Nasyrova Kh.K., Hodzhaeva F.S. Tashkent Pediatric Medical Institute Obesity is a global health problem for adults, as well as children and adolescents, and significantly increases the risk of developing metabolic syndrome, type 2 diabetes, hypertension, cardiovascular and renal diseases, leading to high mortality from all causes [4; 5]. Moreover, numerous cohort studies have shown a link between obesity and increased incidence of various types of cancer, including colorectal cancer, postmenopausal breast cancer, endometrial cancer, and esophageal adenocarcinoma [1; 8]. Clinical guidelines for the identification, assessment, and treatment of adults with overweight and obesity have been developed by the expert panel of the National Institutes of Health (USA). According to these recommendations, the cornerstone of obesity treatment is diet therapy, increased physical activity, and behavior modification. Pharmacological agents approved for long-term therapy can be used as an adjunct to diet and exercise for patients with a body mass index (BMI) of 30 kg/m2 or higher, as well as for patients with a BMI above 27 kg/m2 who have associated risk factors or obesity-related diseases [3]. One of the medications approved by the Food and Drug Administration (FDA) for long-term obesity therapy is Orlistat. Orlistat is a potent specific irreversible inhibitor of pancreatic and gastric lipases. It exerts its pharmacological activity by forming a covalent bond with the active serine site of gastric and pancreatic lipases in the lumen of the gastrointestinal tract. This action prevents the hydrolysis of these enzymes of dietary fat (in the form of triglycerides) into absorbable free fatty acids and monoglycerides. The inhibition of lipase by orlistat reduces the systemic absorption of dietary fat, thereby contributing to a calorie deficit. The medication does not inhibit the activity of other pancreatic enzymes such as phospholipase A2, amylase, or trypsin. One of the medications used for the treatment of obesity is the generic drug Orlip, each capsule of which contains the active ingredient orlistat 120mg. The aim of our study was to assess the effectiveness and tolerability of the Orlip medication in the therapy of obesity. Materials and Methods: The study included 34 patients (5 males and 29 females) with varying degrees of obesity who sought consultation at the outpatient department of the Republican Scientific and Practical Medical Center of Endocrinology, Ministry of Health of the Republic of Uzbekistan. The average age of the patients was 40.2±15.3 years. Inclusion criteria were as follows: age >18 years and 30 kg/m2, and lack of weight loss effect with diet therapy. Exclusion criteria were: patients younger than 18 or older than 75 years, pregnancy, lactation, presence of decompensated diseases or acute conditions that could significantly affect the study results (including chronic hepatitis, liver failure, concomitant infections, sepsis, myocardial infarction, stroke), gastrointestinal diseases, chronic malabsorption syndrome, participation in any other clinical trial within 2 months prior to inclusion in this study, and lack of informed consent from the patient to participate in the clinical study. The patients received Orlip 120 mg capsules (manufactured by "GM PHARMA," Georgia) orally, one tablet three times a day after meals, along with a hypocaloric diet containing less than 30% of calories obtained from fats. All patients were prescribed medications indicated for the treatment of metabolic disorders (insulin-sensitizing agents, alpha-lipoic acid, hepatoprotectors, statins, vitamins, etc.), as well as medications used for the treatment of concomitant diseases in appropriate doses. Prior to inclusion in the study, all patients provided informed consent to participate in the research. Anthropometric measurements (height, body weight, waist circumference, hip circumference), clinical and laboratory parameters (systolic blood pressure, diastolic blood pressure, heart rate, fasting glucose levels, lipid profile), and body mass index (BMI) were collected and analyzed. The BMI was calculated using the formula: BMI = body weight (kg) / height (m^2). The obtained data were processed using the Statistica 6.0 software package (StatSoft, USA). Quantitative variables with a normal distribution are presented as mean ± standard deviation (SD). Differences between groups were considered statistically significant at p < 0.05. Research Results Data analysis of anthropometry showed that the initial mean body weight was 96.1±14.0 kg, waist circumference was 105.3±11.1 cm, waist-to-hip ratio was 1.02±0.10, and body mass index (BMI) was 36.7±4.7 kg/m2. During the therapy with the drug Orlip in obese patients, a statistically significant reduction in body weight was observed, with a decrease of 6.4 kg (to 89.7±12.7 kg; p=0.04), waist circumference by 6.7 cm (to 98.6±10.9 cm; p=0.01), and BMI by 6.8% (to 34.2±4.6 kg/m2; p=0.03) (Table 1). Changes in anthropometric parameters during therapy with the drug Orlip.
The efficacy of Orlip therapy was assessed based on weight reduction. A reduction of 5% to 10% from the initial level was observed in 16 (47.1%) patients, a reduction of 10% from the initial level was observed in 4 (11.8%) patients, and a reduction of less than 5% was observed in 14 (41.2%) patients. According to the results of randomized controlled trials (RCTs), the use of orlistat increased the proportion of participants who achieved the 5% and 10% weight loss threshold by 21% (14 RCTs) and 12% (13RCTs) respectively compared to placebo [7]. The likelihood of achieving a weight loss of ≥5% compared to patients who only underwent diet therapy increased significantly after 1 year of orlistat treatment (OR 2.54; 95% CI 2.17-2.90), and after 2 years, it was OR 4.55 (95% CI 1.99-10.4) [2]. Analysis of central hemodynamics parameters showed that the initial levels of systolic blood pressure (137.5±24.7 mmHg), diastolic blood pressure (87.4±16.6 mmHg), and heart rate (84.6±13.7 bpm) in obese patients undergoing therapy with the drug Orlip decreased by 8.0%, 10.7%, and 6.1% respectively (Table 2). Table 2. Hemodynamic parameters in obese patients undergoing treatment with the drug Orlip.
Originally, the prevalence of systolic blood pressure (SBP) ≥ 130 mmHg and diastolic blood pressure (DBP) ≥80 mmHg was 58.8% and 44.1% respectively. After 12 weeks of therapy with the drug Orlip, there was a significant decrease in the number of patients with SBP ≥130 mmHg (to 32.4% - OR 2.99; 95% CI 1.11-8.05; p=0.03), and a non-significant decrease in patients with DBP ≥ 80mmHg (to 23.5% - OR 2.57; 95% CI 0.91-7.28; p=0.07). Most obese patients also had dyslipidemia characterized by elevated levels of total cholesterol (TC) (5.3 ± 1.6 mmol/L), triglycerides (TG) (3.2 ± 1.9 mmol/L), low-density lipoprotein cholesterol (LDL-C) (3.6±1.5 mmol/L), and decreased levels of high-density lipoprotein cholesterol (HDL-C) (1.1±0.3mmol/L) (Table 3). Table 3. Lipid profile parameters in obese patients undergoing treatment with the drug Orlip.
During therapy with the drug Orlip, there was a statistically significant decrease in TC levels (by 15.2%) and LDL-C levels (by 20.4%), as well as a significant reduction in the atherogenic index by 19.4%. Although not statistically significant, TG levels decreased by 17.0% and HDL-C levels increased by 9.8%. Initially, the prevalence of TC ≥5.2 mmol/L was 55.9%, TG ≥1.7 mmol/L was 58.8%, LDL-C ≥3.5 mmol/L was 50.0%, and HDL-C 30 kg/m2. Results: Positive dynamics in body weight were observed after 12 weeks of treatment with Orlip medication. The average reduction in body weight in the study group was 6.4%. Waist circumference measurements showed an average decrease of 6.7%. The waist-to-hip ratio was 3.5%. The mean change in BMI compared to the baseline at the end of treatment was -6.8%. Additionally, there was a significant decrease in systolic blood pressure by 10.7%, total cholesterol levels by 15.2%, and LDL cholesterol by 20.4%. No allergic reactions were observed during the treatment. Undesirable reactions were not reported in the majority of patients receiving the Orlip medication. One patient dropped out of the study due to undesirable effects, including moderate-grade diarrhea and flatulence, which required discontinuation of the medication. Thus, the Orlip 120 mg medication, in combination with a low-calorie diet, leads to significant weight loss, improves lipid metabolism parameters, and normalizes hemodynamic indicators. This, in turn, reduces the risk factors for developing cardiovascular diseases and type 2 diabetes, significantly improving the quality of life and prognosis. Bibliography 1. Calle E., Rodriguez C., Walker-Thurmond K. Thun M. Over-weight, Obesity, and Mortality from Cancer in a Prospectively Studied Cohort of U.S. Adults. N Engl J Med. 2003; 348: 1625–1638. 2. Douketis J., Macie C., Thabane L., Willamson D. Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice. Int. J. Obes. 2005; 29: 1153-1167. 3. Heck A., Yanovski J., Calis K. Orlistat, a new lipase inhibitor for the management of obesity. Pharmacotherapy. 2000; 20(3): 270-279. 4. Malnick S. The medical complications of obesity. QJM. 2006; 99: 565–579. 5. Mannucci E., Dicembrini I., Rotella F., Rotella C. Orlistat and sibutramine beyond weight loss. Nutr. Metab. Cardiovasc. Dis. 2008; 18: 342-348. 6. Munafò A., Frara S., Perico N. et al. In search of an ideal drug for safer treatment of obesity: The false promise of pseudoephedrine. Rev Endocr Metab Disord. 2021; 22(4): 1013-1025. 7. Rucker D., Padwal R., Li S. et al. Long-term pharmacotherapy for obesity and overweight: updated meta-analysis. Br. Med. J. 2007; 335: 1194-1199. 8. Wang Y., McPherson K., Marsh T. et al. Health and economic burden of the projected obesity trends in the USA and the UK. The Lancet. 2011; 378: 815–825. Resume Assessment of the Effectiveness of Orlip Medication in the Complex Therapy of Patients with Obesity Khodzhaeva N.V., Nasyrova Kh.K., Khodzhaeva F.S, Ruzmatova A.SH. Relevance: Currently, over 1.6 billion people suffer from excess body weight and obesity, with approximately one-third of them being obese, and this number is steadily increasing. Obesity is considered a new "global non-infectious epidemic" that requires long-term complex therapy. Therefore, the search for various approaches to obesity treatment is relevant. The aim of this study was to investigate the effectiveness and tolerability of the 120 mg Orlip medication in patients with obesity of various degrees. The study included 34 patients aged 18 to 75 years with a BMI > 30 kg/m2. Results: Positive dynamics in body weight were observed after 12 weeks of treatment with Orlip medication. The average reduction in body weight in the study group was 6.4%. Waist circumference measurements showed an average decrease of 6.7%. The waist-to-hip ratio was 3.5%. The mean change in BMI compared to the baseline at the end of treatment was -6.8%. Additionally, there was a significant decrease in systolic blood pressure by 10.7%, total cholesterol levels by 15.2%, and LDL cholesterol by 20.4%. Conclusion: The results obtained demonstrate the clinical effectiveness of the Orlip medication, which leads to weight loss, reduction in waist circumference, systolic blood pressure, and improvement in certain lipid profile parameters in patients with obesity. Keywords: obesity, treatment, Orlip medication, hypocaloric diet. Yüklə 33,19 Kb. Dostları ilə paylaş:
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