Qsymia was studied for over 56 weeks in two studies. In Study #1, all subjects had a BMI of 35 or greater. In study #2, they had a BMI of 27 with two or more complication conditions such as elevated blood pressure, high cholesterol, high blood lipids or large waits, more at www.drugs.com/pro/qsymia.html. 

Patients ranged in age from 19-71 years old (mean age 51) and 70% were female. Approximately 86% were Caucasian, 12% were African American, and 13.0% were Hispanic. The average weight and BMI of patients at the start of the study was 220 lb and 36.6 kg/m2. Approximately half of patients had hypertension.  There were 16% patients with type 2 diabetes at the start of the study. During the study, a well-balanced, reduced-calorie diet to result in an approximate 500 kcal/day decrease in caloric intake was recommended to all patients and patients were offered nutritional and lifestyle modification counseling. There was a significant drop out of more than 30% in each study over the year. The diet was not particularly personalized nor was it low carb. It was a  simple low calorie diet similar to  Weight Watchers, but not as severe.  The following table presents the results of the studies:





Dr Lipman Presents Year Long Studies with Qsymia

qsymia weight loss results
Patient Counseling Information from the FDA on Qsymia:

"Advise patients of the following:

Adjunctive Treatment

Qsymia is indicated for chronic weight management in conjunction with a reduced-calorie diet and increased physical activity.

Access to Qsymia

Qsymia is only available through certified pharmacies that are enrolled in the Qsymia certified pharmacy network. Advise patients on how to access Qsymia through certified pharmacies. Additional information may be obtained via the website www.QsymiaREMS.com or by telephone at 1-888-998-4887.

Concomitant Use with Other Products

Advise patients to tell healthcare provider(s) about all medications, nutritional supplements, and vitamins (including any weight loss products) that are being taken or may be taken while on Qsymia.

Females of Reproductive Potential

Qsymia can cause fetal harm and patients should avoid getting pregnant while taking Qsymia [see Warnings and Precautions (5.1)]

  Pregnancy testing is recommended before starting Qsymia and monthly thereafter during therapy.
  Advise patients about effective methods of contraception, as well as the importance of using effective contraception consistently during Qsymia therapy. Advise females who become pregnant during Qsymia therapy to stop Qsymia immediately and tell their healthcare provider(s).

Nursing Mothers

Either discontinue nursing or discontinue Qsymia [see Use in Specific Populations (8.3)].

Elevation in Heart Rate

  Qsymia can increase resting heart rate [see Warnings and Precautions (5.2)].
  Advise patients to report symptoms of sustained periods of heart pounding or racing while at rest to their health care provider(s)

Suicidal Behavior and Ideation; Changes in Mood or Depression

Qsymia can increase the risk of mood changes, depression, and suicidal ideation [see Warnings and Precautions (5.5)].

  Advise patients to tell their healthcare provider(s) immediately if mood changes, depression, and suicidal ideation occur.

Acute Angle Closure Glaucoma

Qsymia can increase the risk of acute myopia and secondary angle closure glaucoma [see Warnings and Precautions (5.4)].

  Advise patients to report symptoms of severe and persistent eye pain or significant changes in their vision to their healthcare provider(s).

Cognitive Adverse Reactions

Qsymia can cause dizziness, confusion, concentration and word-finding difficulties, or visual changes [see Warnings and Precautions (5.6)].

  Advise patients to tell their healthcare provider(s) about any changes in attention, concentration, memory, and/or difficulty finding words.
  Advise patients not to drive or operate machinery until they have gained sufficient experience on Qsymia to gauge whether it adversely affects their mental performance, motor performance, and/or vision.

Metabolic Acidosis

Qsymia can increase the risk of metabolic acidosis [see Warnings and Precautions (5.7)].

  Advise patients to tell their healthcare provider(s) about any factors that can increase the risk of acidosis (e.g. prolonged diarrhea, surgery, and high protein/low carbohydrate diet, and/or concomitant medications such as carbonic anhydrase inhibitors).

Hypoglycemia in Patients with Type 2 Diabetes Mellitus on Anti-diabetic Therapy

Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas) [see Warnings and Precautions (5.9)].

  Advise patients with type 2 diabetes mellitus on anti-diabetic therapy to monitor their blood glucose levels and report symptoms of hypoglycemia to their healthcare provider(s)

CNS Depression with Concomitant CNS Depressants including Alcohol

The concomitant use of alcohol or central nervous system (CNS) depressant drugs (e.g., barbiturates, benzodiazepines, and sleep medications) with phentermine or topiramate may potentiate CNS depression or other centrally mediated effects of these agents, such as dizziness, cognitive adverse reactions, drowsiness, light-headedness, impaired coordination and somnolence [see Warnings and Precautions (5.11)].

  Advise patients not to drink alcohol while taking Qsymia.

Potential Seizures with Abrupt Withdrawal of Qsymia

Abrupt withdrawal of topiramate, a component of Qsymia, has been associated with seizures in individuals without a history of seizures or epilepsy.

  Advise patients not to abruptly stop Qsymia without first talking to their healthcare provider(s) [see Dosage and Administration (2.1)]

Kidney stones

Use of Qsymia has been associated with kidney stone formation [see Warnings and Precautions (5.15) and Adverse Reactions (6.1)].

  Advise patients to increase fluid intake to increase urinary output which can decrease the concentration of substances involved in kidney stone formation.
  Advise patients to report symptoms of severe side or back pain, and/or blood in their urine to their healthcare provider(s).

Oligohidrosis and Hyperthermia

Oligohidrosis (decreased sweating) has been reported in association with the use of topiramate, a component of Qsymia. Decreased sweating and an elevation in body temperature above normal characterized these cases.

  Advise patients to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather."



What My Patients Have Experienced With Qsymia

The earliest reports from may patients are much better than seen in the studies with reports of much more weight loss and a lot of subjective reports of lack of hunger and cravings. Because my patients have to pay the cost of the medications, among other factors,
they may have greater motivation than those in the studies. Most of my patients follow the low carb diet plan outlined on this web site
that consists of about 1100 calories a day. This may be as much as 500 calories a day less than those in the studies and may account for some of the results. 

Dr Lipman's E Books
The contents of QsymiaMD such as text, graphics, images, and other material contained are for informational purposes only. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this site. 
If you think you may have a medical emergency, call your doctor or 911 immediately. QsymiaMD does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information that QsymiaMD is solely at your own risk. 

How to View These Results

On the table to your left, the Qsymia group that had an average BMI greater than 35, the average weight loss at 8 weeks is where the blue dot is located. That is about 6%. If the average starting weight was 220 lb.(obviously some weighed more and others less), that means the average subject lose 6% or 13 lb. Note the weight loss in all of the treatment groups continued
until the 40th week when it began to level off. Weight loss was dose related, the higher the dose, the greater the weight loss.
Note the total weight loss averaged ab out 15% of starting body weight which was reached at about 40 weeks and did not seem to improve in the next 16 weeks of the study. 



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by Richard Lipman 
7241sw 63 ave
Miami, Fl 33143 USA
305 670-4369
www.richardlipmanmd.com
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