Qsymia Weight Loss Results and Studies

As the obesity epidemic continues to wreak havoc over the health and wellness of Americans, there was a great deal of fanfare that came with the approval of Qsymia, one of the most recent prescription weight loss drug to receive U.S. Food and Drug Administration (FDA) approval. That said, at the same time that it was exciting to have another option available to assist people suffering from obesity, doctors also have a certain degree of skepticism over this new medication.

The study results for Qsymia have shown to be very promising. In fact, when the drug was first released, the study results for this pill were better than any other prescription diet medication available. Those strong results are also the source of the skepticism maintained in the medical community, which has concerns over its appropriate use.

What is Qsymia?

Qsymia is a prescription drug that is actually a combination of two older medications: phentermine and topiramate.  Phentermine is a drug already available by prescription for assisting with weight loss. Topiramate is an anticonvulsant.

This new combination received FDA approval as Qsymia in July 2012. Patients who want to use this medication to help treat their obesity must receive a doctor’s permission and guidance. If they are deemed appropriate candidates for the medication, they will typically receive a starting dose of 3.75mg / 23 mg, which is used for the first 14 days of treatment. After that, the patient receives a full dose of 7.5 mg / 46mg for thirty days. They can receive as many as 5 repeats to that regular dose. Usage of the drug is not recommended for longer than that period of time.

Patients need to be monitored throughout that time. At the 12-week mark, the patient must be weighed to determine how much overall body weight has been lost. If at least 3 percent has not been lost the doctor will need to decide whether or not it is worth continuing with Qsymia because at that rate, the patient is considered to be a “nonresponder,” that is, he or she isn’t responding to the medication. Alternately, the doctor might choose to increase the dose to 15 mg/92 mg for 12 weeks before reassessing the dosage. At that point, 5 percent of the starting body weight must be lost or the Qsymia must be discontinued.

Ceasing the use of this medication requires a careful reduction schedule. This is true for two reasons. The first is that phentermine is addictive and can lead to withdrawal symptoms when it has been used for more than a few weeks. The other is that topiramate’s nature as an anticonvulsant requires a slow tapering off before it can be completely discontinued.

Qsymia Clinical Study Results

In order to be approved by the FDA, Qsymia needed to be researched and required human studies to support its claims and prove that it is safe enough for its benefits to be considered worthwhile.

There were two randomized, double-blind, placebo controlled obese patient studies that led to the FDA’s approval of this drug.

The first study involved exclusively obese patients. The second study involved patients who were either obese or who were overweight and had at least two significant co-morbidities (conditions associated with their excess weight).

Both studies included a four week period for titration, which was used to gradually increase the dosage in the study participants until they had reached the full strength at week four. After the titration period, the study continued for 52 weeks. The results of the effectiveness were measured at week 56, which was one year into the full-strength treatment. The measurements included the percentage of weight loss when compared to the starting weight, as well as the treatment response to the drug which required the participants to have lost a minimum of 5 percent of their body weight.

At the same time that the participants were required to take this medication, they were also asked to follow a nutritionally balanced and calorie reduced diet which involved cutting back an average of 500 calories per day. Each of the participants were offered counseling for nutrition as well as lifestyle modifications.

Qsymia: Study 1

In this study, participants were patients with obesity and whose BMI was at least 35. There were several groups, the members of which were randomly selected. The first group received a year of placebos. The second group received a year of Qsymia at a low dose (3.75 mg / 23 mg). The third group received a year of Qsymia at a high dose (15 mg / 92 mg). By the end of the study, 40 percent of the total participants had withdrawn.

Among those who completed the full length of the study, those who took Qsymia experienced significantly greater weight loss than the placebo group. Moreover, those who received the high dose of Qsymia performed notably better than those receiving the low dose. The placebo group lost 5 percent of their initial body weight, whereas the low dose group lost an average of 10 percent and the high dose group lost an average of 17 percent.

Qsymia: Study 2

This study involved the participation of both overweight (and with at least 2 co-morbid conditions related to excess weight) and obese adults. They were randomized to receive 1 year of treatment with a placebo, with a 7.5 mg / 46 mg dose of Qsymia or a 15 mg / 92 mg dose of Qsymia. The study ran for 56 weeks, the first 4 of which were for titration. By the end of the study, 31 percent of the randomized subjects had withdrawn.

Among those that completed the year on their full dose, those who used the Qsymia experienced far greater weight loss than those in the placebo group. The placebo group lost an average of 5 percent of their original body weight. Those in the lower Qsymia dose group lost 10 percent of their body weight. The largest dose group lost an average of 15 percent of their initial body weight.