Combined First Month Body Weight Loss and Development of Tolerance as Predictors of 6-Month Efficacy of Mazindol in Mild and Moderate Obese Subjects
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Data Analysis
3. Results
3.1. Demographic Data
3.2. Efficacy of Mazindol Treatment
3.3. Impact of 1mo-BWRkg and Development of Tolerance on the Efficacy of Mazindol
3.4. Impact of Early Tolerance and 1mo-BWRkg on BWR% Efficacy at Month 6
3.5. Impact of Late Tolerance and 1mo-BWR on BWR% Efficacy at Month 6
3.6. Safety of Mazindol
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Parameter | Total Sample (n = 196) | Reference Value |
---|---|---|
Women, n (%) | 162 (82.6) | - |
Age, years (SD) | 38.0 ± 9.1 | - |
Weight, kg (SD) | 85.8 (10.6) | - |
Body Mass Index, kg/m2 (SD) | 33.9 (2.8) | - |
Class 1 obesity, n (%) | 131 (66.8) | 30–34.9 kg/m2 |
Class 2 obesity, n (%) | 63 (32.1) | 35–39.9 kg/m2 |
Class 3 obesity, n (%) | 2 (0.1) | ≥40 kg/m2 |
SBP, mmHg (SD) | 112.4 (10.1) | <120 mmHg |
DBP, mmHg (SD) | 69.6 (7.9) | <80 mmHg |
Fasting glycemia, mg/dL (SD) | 93.8 (9.8) | 75 ≤ 99 mg/dL |
Triglycerides, mg/dL (SD) | 180.5 (82.6) | <150 mg/dL |
Total Cholesterol, mg/dL (SD) | 185.7 (36.64) | <200 mg/dL |
TSH, μUI/mL (SD) | 2.6 (1.7) | 0.34–5.6 μUI/mL |
1mo-BWR | BWR | 3 Months | 6 Months | 6mo-BWR (%) | WD | Ineffective | ||
---|---|---|---|---|---|---|---|---|
kg | n | % | n (%) | n (%) | Mean (SD) | n | n | n |
2moT | ||||||||
<1 | 2 | ≥5 | 0 (0) | 0 (0) | 4.3 (0.6) | 2 | 0 | 2 |
1 to <2 | 2 | ≥5 | 0 (0) | 0 (0) | −3.8 (0.7) | 2 | 0 | 2 |
2 to <4 | 4 | ≥5 | 1 (25) | 2 (50) | −6.8 (0.8) | 2 | 0 | 2 |
≥4 | 4 | ≥5 | 4 (100) | 4 (100) | −8.2 (0.6) | 3 | 0 | 0 |
(Min: 6.5) | ≥10 | 1 (25) | 1 (25) | −14.3 | 1 | |||
3moT | ||||||||
<1 | 3 | ≥5 | 0 (0) | 0 (0) | −4.6 | 1 | 2 | 1 |
1 to <2 | 4 | ≥5 | 1 (25) | 2 (67) | −5.9 (1.1) | 2 | 1 | 1 |
2 to <4 | 9 | ≥5 | 4 (44) | 6 (75) | −8.3 (1.3) | 4 | 1 | 2 |
(Min: 3.2) | ≥10 | 0 (0) | 2 (25) | −11.6 (1.7) | 2 | |||
≥ 4 | 15 | ≥5 | 15 (100) | 14 (93) | −7.2 (1.8) | 10 | 0 | 1 |
(Min: 4.9) | ≥10 | 1 (7) | 4 (27) | −12.2 (2.0) | 4 | |||
3moNT | ||||||||
<1 | 2 | ≥5 | 0 (0) | 2 (100) | −5.3 (0.5) | 2 | 0 | 0 |
1 to <2 | 8 | ≥5 | 4 (50) | 5 (71) | −5.2 (1.4) | 5 | 1 | 2 |
2 to <4 | 53 | ≥5 | 50 (94) | 50 (100) | −8.0 (1.3) | 29 | 3 | 0 |
(Min: 3.1) | ≥10 | 6 (11) | 21 (42) | −12.0 (1.4) | 17 | |||
(Min: 3.2) | ≥15 | 0 (0) | 4 (8) | −18.4 (1.6) | 4 | |||
≥4 | 74 | ≥5 | 74 (100) | 69 (100) | −8.0 (1.3) | 6 | 5 | 0 |
(Min: 4.0) | ≥10 | 42 (57) | 63 (91) | −12.4 (1.5) | 35 | |||
(Min: 4.2) | ≥15 | 2 (3) | 28 (41) | −17.2 (1.7) | 28 |
1mo-BWR | BWR | 3 Months | 6 Months | 6mo-BWR (%) | WD | Ineffective | ||
---|---|---|---|---|---|---|---|---|
kg | n | % | n (%) | n (%) | Mean (SD) | n | n | n |
4moT | ||||||||
1 to <2 | 4 | ≥5 | 2 (50) | 2 (50) | −6.1 (0.0) | 2 | 0 | 2 |
2 to <4 | 11 | ≥5 | 11 (100) | 10 (100) | −7.0 (1.3) | 8 | 1 | 0 |
(Min: 2.3) | ≥10 | 1 (9) | 2 (20) | −12.7 (1.7) | 2 | |||
≥4 | 11 | ≥5 | 11 (100) | 10 (100) | −9.0 (0.5) | 3 | 1 | 0 |
(Min: 4.0) | ≥10 | 6 (55) | 7 (70) | −12.1 (1.5) | 5 | |||
(Min: 4.4) | ≥15 | 0 (0) | 2 (20) | −16.4 (0.8) | 2 | |||
5moT | ||||||||
<1 | 1 | ≥5 | 0 (0) | 1 (100) | −5.0 | 1 | 0 | 0 |
1 to <2 | 3 | ≥5 | 2 (67) | 3 (100) | −5.8 (1.0) | 3 | 0 | 0 |
2 to <4 | 4 | ≥5 | 4 (100) | 4 (100) | −8.4 (1.3) | 3 | 0 | 0 |
(Min: 3.9) | ≥10 | 1 (25) | 1 (25) | −11.0 | 1 | |||
≥4 | 15 | ≥5 | 15 (100) | 14 (100) | −6.4 (0.0) | 2 | 1 | 0 |
(Min: 4.1) | ≥10 | 7 (47) | 12 (86) | −11.5 (1.3) | 10 | |||
(Min: 4.5) | ≥15 | 0 (0) | 2 (14) | −15.8 (1.0) | 2 | |||
6moT | ||||||||
<1 | 1 | ≥5 | 0 (0) | 1 (100) | −5.7 | 1 | 0 | 0 |
2 to <4 | 11 | ≥5 | 10 (91) | 11 (100) | −7.8 (1.4) | 8 | 0 | 0 |
(Min: 3.1) | ≥10 | 1 (9) | 3 (27) | −13.6 (5.0) | 2 | |||
(Min: 3.8) | ≥15 | 0 (0) | 1 (9) | −19.4 | 1 | |||
≥4 | 11 | ≥5 | 11 (100) | 11 (100) | −8.2 | 1 | 0 | 0 |
(Min: 4.3) | ≥10 | 8 (72) | 10 (91) | −11.9 (1.4) | 7 | |||
(Min: 6.4) | ≥15 | 2 (18) | 3 (27) | −18.5 (2.6) | 3 | |||
6moNT | ||||||||
1 to <2 | 1 | ≥5 | 0 (0) | 0 | 1 | 0 | ||
2 to <4 | 27 | ≥5 | 25 (93) | 25 (100) | −8.8 (0.7) | 10 | 2 | 0 |
(Min: 2.1) | ≥10 | 3 (11) | 15 (60) | −12.1 (1.5) | 12 | |||
(Min: 2.5) | ≥15 | 0 (0) | 3 (12) | −18.1 (1.8) | 3 | |||
≥4 | 37 | ≥5 | 37 (100) | 34 (100) | 3 | 0 | ||
(Min: 4.0) | ≥10 | 23 (62) | 34 (100) | −13.4 (1.1) | 13 | |||
(Min: 4.2) | ≥15 | 0 (0) | 21 (62) | −17.3 (1.7) | 21 |
Adverse Event | Total (%) | Mild (%) | Moderate (%) |
---|---|---|---|
Dry mouth | 99 (11.1) | 99 (11.1) | - |
Headache | 98 (11.0) | 70 (7.9) | 28 (3.1) |
Constipation | 66 (7.4) | 44 (4.9) | 22 (2.5) |
Fatigue | 53 (6.0) | 53 (6.0) | - |
Insomnia | 47 (5.3) | 45 (5.1) | 2 (0.2) |
Hyperhidrosis | 46 (5.2) | 46 (5.2) | - |
Thirst | 41 (4.6) | 41 (4.6) | - |
Nausea | 38 (4.3) | 37 (4.2) | 1 (0.1) |
Anxiety | 35 (3.9) | 35 (3.9) | - |
Chills | 35 (3.9) | 34 (3.8) | 1 (0.1) |
Drowsiness | 32 (3.6) | 31 (3.5) | 1 (0.1) |
Dysgeusia | 23 (2.6) | 23 (2.6) | - |
Dyspepsia | 19 (2.1) | 13 (1.5) | 6 (0.7) |
Tachycardia | 15 (1.7) | 6 (0.7) | 9 (1.0) |
Abdominal pain | 14 (1.6) | 9 (1.0) | 5 (0.6) |
Others | 228 (25.7) | 187 (21.0) | 41 (4.6) |
Total | 889 (100%) | 773 (87.0%) | 116 (13.0%) |
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Huerta-Cruz, J.C.; Rocha-González, H.I.; Kammar-García, A.; Canizales-Quinteros, S.; Barranco-Garduño, L.M.; Reyes-García, J.G. Combined First Month Body Weight Loss and Development of Tolerance as Predictors of 6-Month Efficacy of Mazindol in Mild and Moderate Obese Subjects. J. Clin. Med. 2022, 11, 3211. https://doi.org/10.3390/jcm11113211
Huerta-Cruz JC, Rocha-González HI, Kammar-García A, Canizales-Quinteros S, Barranco-Garduño LM, Reyes-García JG. Combined First Month Body Weight Loss and Development of Tolerance as Predictors of 6-Month Efficacy of Mazindol in Mild and Moderate Obese Subjects. Journal of Clinical Medicine. 2022; 11(11):3211. https://doi.org/10.3390/jcm11113211
Chicago/Turabian StyleHuerta-Cruz, Juan Carlos, Héctor Isaac Rocha-González, Ashuin Kammar-García, Samuel Canizales-Quinteros, Lina Marcela Barranco-Garduño, and Juan Gerardo Reyes-García. 2022. "Combined First Month Body Weight Loss and Development of Tolerance as Predictors of 6-Month Efficacy of Mazindol in Mild and Moderate Obese Subjects" Journal of Clinical Medicine 11, no. 11: 3211. https://doi.org/10.3390/jcm11113211