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Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of phentermine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving phentermine.
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Do not use phentermine if you are also using similar medicines such as benzphetamine, diethylpropion, mazindol, phendimetrazine, Bontril, or Didrex. Do not use this medicine if you also take an MAO inhibitor (MAOI), such as isocarboxazid (Marplan), phenelzine (Nardil,), selegiline (Eldepryl), or tranylcypromine (Parnate), or if you have used an MAOI within the past 14 days. Using these medicines together may cause serious unwanted effects.
Several methods have been tried in order to prevent and treat the increasing rate of obesity and its related disorders. One of such attempt is the application of appetite-suppressing drugs, which is used in many countries for reducing the energy intake. Among these drugs, phentermine (Ionamin) is the drug which had been approved for short-term use as treatment of obesity by US FDA in 1959, and has been used steadily until present. Phentermine, classified as a β-phenethylamine drug, stimulates the secretion of noradrenalin in central nervous system, and noradrenalin, in turn, suppresses appetite by stimulating the β-adrenergic receptors.6,7
One of the reasons why phentermine is still prescribed in the era of appearance of several new anti-obesity drugs is that it has been administered safely without serious side effects for the past 40 years in US. However, because of the fact that phentermine is a sympathomimetic amine, we should keep in mind the possible side effects of the drug of this class in using phentermine. Although the combination of fenfluramin and phentermine have been demonstrating a remarkable weight reduction effect, US FDA has removed fenfluramin from the market in September 1997, due to the successive reports about the serious side effects of valvular heart disease and primary pulmonary hypertension. There have been scarce reports about serious side effects for the single use of phentermine; however, there is a researcher who argued that 15 of 1000 phentermine administered patients might experience serious side effects.4
Another reason for wide distribution of phentermine prescription is its low economic burden for use in contrast to the new drugs. Comparing the cost-effectiveness of sibutramine and phentermine, in US, 103.8$ per month for sibutramine 10 mg daily induces 4.45 kg weight reduction in 12 months. On the other hand, 39.59$ per month for phentermine resin 30 mg daily induces 3.6 kg weight reduction in 6 months.8 Such data regarding this cost-effectiveness might be the important criteria for the selection of which drug to use.
During the screening period, subjects who were determined to their minds to participate in the study were measured for body weight and height, and were interviewed to confirm whether they were appropriate for the study participation. And then, they visited the researchers with an empty stomach for more accurate anthropometric measurement and screening laboratory test. According to the screening test results, final decision whether the applicant shall be included was made. Subjects who had been permitted for the study participation were randomized to treatment with phentermine HCl 37.5 mg once daily or placebo at Baseline. The ratio for phentermine and placebo was 1 : 1.
For the laboratory test results, analysis was done in the completer population. Because the sample size was too small for normal distribution, nonparametric methods were used. Wilcoxon's rank sum test was used to compare characteristics between phentermine group and placebo group. Wilcoxon's signed rank test was used to assess changes in variables in subjects after the treatment.
In the analysis of the ITT population, there was a statistically significantly greater mean reduction in both body weight and waist circumference in phentermine-treated subjects to subjects in placebo group (p
Change from baseline in body weight (A) and waist circumference (B). Data are mean (SE) values for the full intention-to-treat population with the last observations carried forward. p
In the analysis of both ITT and completers, a significantly greater proportion of patients in the phentermine group achieved weight reduction of 5% or greater from the baseline compared with the placebo group, and it was same for the subjects who lost 10% or more weight from baseline (Fig. 2).
In completers, the changes of blood pressure, lipid levels, fasting plasma glucose, high-sensitive CRP and uric acid from baseline to endpoints are shown in Table 3. There was no statistically significant difference between the groups in these variables except total cholesterol. After the treatment, the mean change of total cholesterol in phentermine group was -7.8 (SD 28.5) mg/dL, compared to 10.7 (SD 20.2) mg/dL in placebo group. The changes from baseline to endpoints in each group were not significantly different from zero. However, the difference between groups was significant (p = 0.048, Table 3).
In addition, the change of non-HDL-cholesterol between groups was also significant (data not shown in table, p = 0.023 by Wilcoxon rank sum test). The mean change of non-HDL-cholesterol in phentermine group was -9.7 (SD 24.8) mg/dL, while the mean change in placebo group was 7.8 (SD 24.8) mg/dL. However, the changes in each group were not significant, same as total cholesterol.
The proportion of patients who had reported any side effect was higher than that of patients who had not reported. Table 4 provides an analysis of all the adverse events occurred in at least 5% of patients in any group. The adverse events in Table 4 are listed in the frequency order of phentermine group. The number of subjects who had reported any adverse events in phentermine group was significantly larger than that in placebo group. However, the reported rate of adverse events in placebo group was even with 75% (18/24). Among all reported adverse events, dry mouth and insomnia are the events which occurred significantly more frequently in phentermine group. The occurrence rates of the other adverse events were not significantly different between the groups. For the most part, these events were mild to moderate in intensity, and only a few cases needed to reduce the dosage.
There were two subjects who withdrew due to adverse events. One of them withdrew because of dry mouth and foreign body sensation in throat. The other withdrew due to nausea and headache. Another two subjects complained severe adverse symptoms. One complained of severe headache, and the other, of severe headache and nausea. However, after reducing dosage by half, their symptoms had improved much or totally removed, and both of them had succeeded in completing the study. All four were included in phentermine group.
The discontinuation rate was significantly higher in placebo group (p = 0.008), and there was significant difference in the mean duration of study participation between two groups, 11.0 (SD 4.9) weeks for phentermine group vs. 8.2 (SD 5.3) weeks for placebo group (p = 0.030). In phentermine group, 11 of 35 (31.4%) withdrew after run-in period. Seven of them discontinued study participation without any clear reason, and two of them discontinued because of adverse events. One subject withdrew due to no weight losing effect of the drug. There was one subject who discontinued due to the difficulty in following the behavioral guideline. In placebo group, 21 of 33 (63.6%) withdrew after run-in period. 15 of them discontinued study participation without any clear reason. There was nobody who withdrew because of adverse events. Five was due to personal schedule, and one due to no weight losing effect of the drug. Among 114 reports of total adverse events in subjects who were treated for more than 6 weeks, only 31 (27.2%) had newly occurred after the 6th week of treatment, and 24 (21.1%) symptoms had prolonged for more than 4 weeks. In phentermine group, 13 of 29 had reported the occurrence of adverse events after the 6th week of treatment, and in placebo group, 4 of 24 had reported after the 6th week.
Cost is an important factor in the pharmacologic therapy of obesity. The difference of cost-effectiveness between sibutramine and phentermine in US has already been described in introduction, which is guite the same in Korea. Moreover, obesity treatment is not covered by medical insurance in Korea until present in 2006. Therefore, total drug purchasing expense for obesity treatment is burdened to patients. Until 2006, Reductil and Xenical are the only drugs approved for long-term treatment of obesity in Korea. Both of these drugs are expensive. Purchasing cost for 1 month as initial recommended dosage is over 100,000 won in 2006. However, the price for the use of phentermines is around one fourth of the price for using Reductil or Xenical. Relatively lower cost of phentermine maybe of assistance for those patients who have difficulty in purchasing highly priced obesity drugs.
In this study, 2 weeks run-in period and 12 weeks administration of phentermine-HCl 37.5 mg had induced clinically significant weight reduction, shortening of waist circumference, and reduction of total cholesterol and non-HDL-cholesterol level. This result would reduce the risk of cardiovascular disease in the ultimate. Moreover, over 80% of subjects of phentermine group lost 5% or more of initial weight and more than half subjects lost 10% or more. This shows us that most of obese patients can obtain the conventional goal of obesity treatment by short-term use of phentermine. 041b061a72