Note: this information is not a substitute of the pharmacy drug education handout, so please ask the pharmacist for a complete patient handout. What results have you seen at the Institute? Most of our patients do very well with weight loss after starting Zonegran. Once the patient started Zonegran, she lost another 20 pounds in two months.
Another patient was able to lose over 72 pounds by taking only Zonegran without side effects. How do I take Zonegran? Zonegran is available in mg pills. Thus, the difference between treatment groups in the achieved weight loss over time remained significant 6.
Results from the longitudinal regression analyses supported differential weight loss for zonisamide-treated patients. For the LOCF—imputed ITT model, the estimated regression coefficient associated with the interaction term predicted weight loss in excess of 0.
Other Efficacy Measures. Mean SE waist circumference decreased more with zonisamide therapy over the 16 weeks Systolic and diastolic blood pressure readings did not change over time. There were no clinically significant changes in levels of lipids or fasting blood glucose with either treatment.
Safety Measures. Patients assigned to zonisamide reported, on average, 2. Mean SE serum creatinine concentration increased from 0. There were no significant group differences with regard to baseline characteristics of the extension phase participants with the exception of a slightly lower mean BMI in the zonisamide group Moreover, the characteristics of those who participated in the extension phase were essentially the same as those of the 60 participants who originally entered the study.
Of the 37 patients 20 zonisamide, 17 placebo who entered the extension phase, 36 completed week One patient in the zonisamide group withdrew prematurely, citing time constraints. Mean SE weight changed over the 32 weeks for patients in the zonisamide group from Mean SE waist circumference decreased more in the zonisamide group over the 32 weeks Mean SE systolic blood pressure decreased in both treatment groups although the decrease was significantly greater in the zonisamide group Diastolic blood pressure decreased with zonisamide treatment, but not with placebo Neither treatment was associated with a significant change in heart rate.
There were no clinically significant changes in lipid levels with either treatment. Mean SE fat mass for patients receiving placebo increased by 0.
In contrast, patients treated with zonisamide had a decrease in fat mass of Lumbar spine BMD did not change over time in either group. This randomized study demonstrated that zonisamide therapy combined with a hypocaloric diet produced significantly greater weight loss than dietary intervention alone in a population of obese. During the first 16 weeks, when the treatment was administered in a double-blind fashion, the superior weight loss efficacy of zonisamide over placebo was demonstrated in all the various analyses undertaken.
The difference in the weight loss efficacy between the active treatment and placebo was evident by 4 weeks and increased as the study progressed.
The extension phase second 16 weeks of the trial demonstrated that patients receiving zonisamide therapy continued to lose weight, whereas the group that received dietary intervention and placebo lost less weight. Given the low-key adjunctive dietary and lifestyle intervention provided in this study, a mean weight loss of 9.
In addition to weight loss, zonisamide therapy led to improvement of some risk factors associated with obesity. Waist circumference decreased more significantly with zonisamide therapy compared with placebo, which was likely related to a greater degree of weight loss rather than being an independent effect. In addition, a reduction in systolic blood pressure was noted with zonisamide therapy although the study participants were not hypertensive at baseline.
Zonisamide therapy was associated with a significant improvement of quality of life as noted by decreased scores on the following IWQOL measures: mobility, general health, occupational functioning, and activities of daily living. Because there is some evidence 12 that weight loss leads to reduction of BMD, we examined this before and after 32 weeks of treatment. No significant loss of BMD was observed for participants in our study.
Zonisamide was tolerated well in this study. Premature withdrawals were much less frequent than expected in obesity trials of similar duration. Only 1 patient withdrew from the zonisamide group citing an adverse effect. Overall, fatigue was the only adverse effect that occurred at a significantly higher frequency for zonisamide treatment than for placebo. Our data collection relied on spontaneous reporting and open-ended inquiries that may have yielded a lower frequency of adverse effects than could be elicited with structured questionnaires.
Although not observed frequently in this study, the following adverse effects occurred frequently with zonisamide therapy in epilepsy trials: dizziness, cognitive impairment, and somnolence. Although rare, kidney stones and serious hematologic events have been reported with zonisamide therapy in patients with epilepsy.
Consistent with data from epilepsy trials, we noted an increase in serum creatinine concentration with zonisamide therapy, but not with placebo. To our knowledge, the present study is the first clinical trial to specifically assess the therapeutic potential of zonisamide as a weight loss tool in the management of clinically defined obesity.
Whereas zonisamide was associated with a small degree of weight loss as an adverse effect in the treatment of patients with epilepsy, this was investigated as the desired effect in this study, and the observed weight loss was significant and clinically meaningful.
The pharmacological properties of zonisamide that contributed to its anorectic effect have not been precisely delineated. Whereas the antiepileptic properties of zonisamide are believed to be related to its blocking effects on sodium and T-type calcium channels, 8 its effects on brain serotonin 5-HT 10 and dopamine 9 systems may explain, at least partly, its weight loss efficacy in the present study. Serotonin has been implicated in modulation of satiety; nevertheless, some, but not all, drugs that enhance serotonergic tone via different mechanisms have been found to be valuable tools in the management of obesity.
Although the precise mechanisms involving a zonisamide-induced increase in extracellular serotonin levels are not known, 2 mechanisms have been suggested: an increase in ion-dependent serotonin release, 15 , 16 and increased synthesis of serotonin.
It has also been suggested that zonisamide stimulates D 2 receptors. Nevertheless, other drugs eg, carbamazepine having a few similar effects on monoamine systems have not been known to be associated with significant weight loss.
At the outset, they had an average body mass index - a measure of weight relative to height - of That's the equivalent of a five-foot, six-inch person weighing pounds. One year later, people assigned to the placebo had lost an average of nine pounds, and those on the lower zonisamide dose had dropped ten pounds. Participants taking the higher daily dose had the greatest average weight loss, at 16 pounds. Side effects were most common in the high-dose group.
Out of 75 people, 10 reported nausea or vomiting, 14 had headaches, 15 developed infections, eight had impaired memory and seven reported anxiety. Gadde said it's not clear which of those were directly related to the drug, or how much they bothered patients. Gadde and colleagues set out to follow up on a week investigation they conducted in that had indicated that zonisamide Zonegran at a dosage of milligrams a day might offer an alternative.
Between and the study team randomly assigned more than obese men and women to one of three groups. One group took milligrams of zonisamide daily, another got mg of zonisamide daily and one received a dummy pill. The participants' average age was 43, and their average body-mass index BMI was nearly BMI is a calculation of body fat based on height and weight, and a BMI of more than 30 is considered obese. None had diabetes. All study participants followed their treatment plan for one year.
During this time, they all also received monthly individualized nutritional counseling, which Gadde described as "not intensive," to help them reduce their overall caloric intake.
Those on the higher-dose zonisamide protocol fared the best in terms of overall weight loss, while the lower-dose regimen was not much more effective than the placebo. Although nearly 55 percent of those on the higher-dose medication shed 5 percent or more of their pre-study weight, that figure was 34 percent among the lower-dose group and 31 percent among the non-medication participants.
The authors said such side effects were typically "mild. Psychological factors or lifestyle factors may play a role, he said.
Lona Sandon, a registered dietitian and assistant professor of clinical nutrition at the University of Texas Southwestern Medical Center at Dallas, agreed. Caution is vital when using any drug that has been approved for one condition for another, Sandon said. Explore further. All rights reserved. Use this form if you have come across a typo, inaccuracy or would like to send an edit request for the content on this page.
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