All five prescription diet drugs on the U.S. market can help people lose enough weight to improve their health, researchers reported Tuesday.
The drugs, which all act in different ways to help people lose weight, have been approved over the past 17 years.
The drug that showed the most weight loss? One called Qsymia — a combination of an older appetite suppressant called phentermine and an anti-seizure drug called topiramate.
They work together in ways that are not fully understood to suppress appetite and 75 percent of people taking the drug lost at least 5 percent of their body weight, the review found.
“All active agents were associated with significant excess weight loss compared with placebo at one year.”
Patients who took Qsymia lost more than 19 pounds on average after a year. People who took liraglutide, a diabetes drug sold under the brand name Victoza, lost almost 12 pounds on average, the team found, and 63 percent of those who took it lost at least 5 percent of their body weight — the amount that’s been shown to lower the risk of diabetes and heart disease.
Victoza, which must be injected, helps the stomach empty more and changes how well the body uses insulin, which converts food into glucose.
Related: American Obesity Rates on the Rise
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Next best was Contrave, a combination of buproprion, approved separately to treat depression and smoking, and the alcohol and drug abuse drug naltrexone. The two work together to suppress appetite by tweaking brain chemicals. Patients taking the pill, lost an average of 11 pounds over a year.
Lorcaserin, sold under the brand name Belviq, helped patients lose 7 pounds over a year. It also acts on brain chemicals to affect mood and appetite and 49 percent of patients who took it lost at least 5 percent of body weight.
Orlistat, sold both as Xenical and over the counter in lower doses as Alli, helped patients lose 5.7 pounds over a year on average. And 44 percent of patients who took it for a year lost 5 percent of body weight or more. Orlistat stops the gut from absorbing some of the fat in food.
The varying results likely mean different patients will be helped most by different drugs, said Dr. Rohan Khera of the University of Iowa Carver College of Medicine, who helped lead the study.
NEW YORK, NY – JUNE 11: A woman walks by a sign advertising sugary drinks in a Brooklyn neighborhood with a high rate of obesity and diabetes on June 11, 2013 in New York City. Three months after a judge struck down New York Mayor Michael Bloomberg administration’s ban on large sugary drinks, lawyers for Bloomberg are trying to convince an appeals court on Tuesday to reinstate a ban. On Monday, New York City health officials declared a “diabetes epidemic” in New York stating that deaths linked to the disease have reached an all-time high in the five boroughs of new York. According to the Health Department, a record 5,695 people died from diabetes and related causes in 2011. (Photo by Spencer Platt/Getty Images)Spencer Platt / Getty Images, file
“Ultimately, given the differences in safety, efficacy, and response to therapy, the ideal approach to weight loss should be highly individualized, identifying appropriate candidates for pharmacotherapy, behavioral interventions, and surgical interventions,” the team wrote in the Journal of the American Medical Association.
And, they said, they all need more study. “Short-term clinical trials may not provide comprehensive information on the long-term safety of these agents, and prospective postmarketing surveillance studies are warranted.”
With more than two-thirds of Americans obese or overweight, the need is dire. The latest data from the Centers for Disease Control and Prevention shows that 38 percent of U.S. adults are obese.
Studies have shown that surgery helps people lose the most weight but the drawbacks are clear and it’s very expensive.
“The ideal approach to weight loss should be highly individualized.”
The FDA has approved several new devices to help people lose weight – most lately, a stomach pump that was approved Tuesday.
Doctors are reluctant to prescribe weight loss drugs, in part because several were pulled off the market in the 1990s after they were shown to cause strokes and other serious side-effects. A study presented to the Endocrine Society earlier this year showed that only only 1 percent of obese patients eligible for prescription weight-loss drugs ever get prescriptions for them.
Khera’s team looked at 28 studies covering nearly 30,000 overweight or obese adults who got one of the diet drugs in a randomized trial – meaning people were randomly assigned to take either the drug or a placebo.
“All active agents were associated with significant excess weight loss compared with placebo at one year,” they wrote.
Hardly any of the trials compared the drugs head to head, so it’s difficult to say one works better than another, they noted.
It’s recommended that you take phentermine weight loss tablets while also keeping a low calorie diet and exercising regularly. Typically one phentermine pill is enough to suppress your appetite. Phentermine weight loss tablets are best taken in the morning before eating breakfast. Take your pill about half an hour before your breakfast for the best results. You can also take them around one or two hours after breakfast.
When you get started on phentermine anti-obesity treatments the recommended dose is 30mg. If you still hungry after taking a 30mg tablets then you can increase your daily dose to 40mg. You can also cut your 30mg tablet in half and have it twice in the same day.
If you’re hungry in the afternoon even though you took a phentermine tablet in the morning then cutting your pill in half is a good idea. To get the most out of the anorexigenic effect it’s recommended that you take 15mg of phentermine in the morning and the other 15mg in the afternoon.
You should take the second tablet around 6-8 hours before bedtime and not after this. Phentermine can lead to sleeplessness and restlessness. Most people find that taking one tablet of phentermine before breakfast is enough to control their appetite for the whole day. As a result most people feel full after even a small meal.
If you take phentermine and feel irritation and pain in your gastric mucosa when taking it on an empty stomach then you can take the pill after a meal instead. If you take phentermine one or two hours after your breakfast then you reduce your appetite and also reduce the chances of getting stomach ache or some other form of stomach irritation.
Sometimes the discomfort in your stomach can be caused by a particular ingredient in phentermine. One of the main active ingredients of phentermine is phentermine hydrochloride and excipients including magnesium stearate, lactose (anhydrous), pregelatinized starch, sucrose, microcrystalline cellulose, FD and C blue ?1.
Some obese patients may feel some stomach discomfort when they take phentermine one or two hours after food. It’s recommended that these patients drink a decoction of flaxseed before taking phentermine.
Another way to reduce the stomach irritation that phentermine can cause is to take other drugs that reduce the secretion of stomach acid. These are drugs like Omeprazole, Pantoprazole, and Lansoprazole. Before you take these drugs though you should consult a nutritionist. A nutritionist can give you advance on which one is safest to take when on phentermine.
Phentermine entered the American market in 1959, when it was known as lonamin. Nowadays phentermine is available under many different names around the world. Phentermine is generally sold under one of the following names in the United States: Adipex, Phentermine hydrochloride, Suprenza, Qsymia. In Australia, tablets containing Phentermine are known as Duromine, Metermine and Phentermine Resin.
It is advisable to not taking Phentermine without doctor supervision since it may cause several negative effects. Give a consideration to phentermine alternatives that available without prescription. They are much safer for long term.
FDA approves new weight-loss drug Qsymia
Drs. Siegel and Samadi explain
The worldwide fight against obesity may have just gotten easier. The FDA approved two new weight-loss medicines: Qsymia and Belviq. Until recently, there was a 13-year stretch in which the FDA did not approve any new medications to help people struggling with obesity.
What is Qsymia?
Qsymia is a combination of the appetite suppressant phentermine (the safe half of the diet drug Fen-Phen) and the anti-seizure/migraine medication topiramate. It is manufactured by the pharmaceutical firm Vivus, Inc. and was formally known as Qnexa.
How does Qsymia work?
As I said, phentermine is an appetite suppressant. It is thought to trigger the release of the chemical norepinephrine in the brain, which increases blood concentrations of leptin, an appetite-regulating hormone.
Topiramate, commonly known as Topamax, is prescribed as an anticonvulsant and migraine medication. It can aid in weight loss by increasing the feeling of being full, making foods taste less appealing and increasing calorie expenditure.
As you can imagine, together these two drugs can pack a powerful punch against the battle of the bulge.
Who is Qsymia designed for?
The drug is approved only for adults who are obese (BMI of 30+) or overweight (BMI of 27+) and who also suffer from conditions such as hypertension, type 2 diabetes or high cholesterol.
It will be available in a standard dose, but also a higher dose for select patients. Women using Qsymia must consistently use an effective method of birth control. If a woman becomes pregnant while using Qsymia, they should discontinue the medication immediately and contact their physician.
Who should NOT use Qsymia?
Women who are pregnant, people with eye problems (especially glaucoma), people who have an overactive thyroid, people taking a type of antidepressant called MAOI, or people who are allergic to phentermine, topiramate, or any of the ingredients in Qsymia should NOT use the drug.
Mandated by the FDA, Qsymia will be packaged with a special Risk Evaluation and Mitigation Strategy (REMS), which includes an education guide for patients, providers and pharmacies.
How should Qsymia be used?
Qsymia is designed to be used in combination with a healthy lifestyle, including a reduced-calorie diet and exercise. In clinical trials, Qsymia was only effective when combined with this kind of lifestyle.
How long do you have to take Qsymia?
Once you begin this regimen, you will have to continue it for the rest of your life, unless you develop a side effect or another reason to discontinue usage.
What, if any, are the side effects?
The most common side effects are tingling in the hands and feet, dizziness, change in taste, trouble sleeping, constipation and dry mouth. Qsymia can also increase your resting heart rate, affect how you think and is associated with difficulties concentrating.
Topiramate can increase the risk of suicidal thoughts or behavior, initiate new or worsening depression, or cause other mood/behavior changes in some patients. Be aware of such changes and call your health care provider immediately if you experience any of these symptoms.
If you have type 2 diabetes, weight loss may increase the risk of low blood sugar. Speak with your physician about this, because he or she might have to adjust your diabetes medications.
What have clinical trials shown?
Last year, a study funded by Vivus, Inc. found that obese patients taking Qsymia lost an average of 22 pounds over a year, while also lowering their blood pressure and cholesterol levels. In a placebo-controlled clinical trial, those who took Qsymia lost an average of 8.9 percent versus those taking the placebo. Seventy percent of those taking Qsymia lost at least 5 percent of their body weight compared to only 20 percent of those on the placebo.
Didn’t I read that Qsymia was not approved by the FDA a few years ago?
Qsymia was initially denied FDA approval in 2010 because of potential side effects, including heart palpitations and birth defects if taken by pregnant women (such as cleft lip or palate). After the current approval process, Vivus agreed to conduct further testing to show that Qsymia does not have dangerous cardiovascular side effects. Clinical trials have already shown that Qsymia can lower blood pressure, reducing the risk of heart attack and stroke.
When will Qsymia be available for use?
Right now, it’s expected to become available in September, but will only be sold through certified pharmacies — not your local, family-owned pharmacy.
The overall consensus is that the best way to keep off unwanted weight is through a healthy lifestyle, including proper nutrition and exercise. Qsymia offers benefits to some of the estimated two-thirds of obese or overweight Americans who aren’t losing weight with lifestyle changes alone.
Qsymia can act as the jumpstart that many people need to get on the road to weight loss. As always, speak with your doctor before beginning any diet or exercise regimen.
Phentermine/Topiramate (Qsymia) for Chronic Weight Management
Potential safety issues with phentermine/topiramate include nephrolithiasis, cardiac risk, and teratogenicity. In two 56-week randomized controlled trials with a total of more than 3,500 participants, patients taking phentermine/topiramate did not have more serious adverse events than those taking placebo, with one exception: 1% of patients taking the highest dose (15/92 mg) developed significant nephrolithiasis. Phentermine/topiramate does not increase symptoms of depression, even in patients with preexisting major depression. It does not increase the risk of arrhythmias, valve disease, or myocardial infarction, although studies to date excluded patients with known cardiac problems. Because patients had a dose-dependent increase in heart rate, the FDA is requiring postmarketing evaluation of cardiovascular safety. Phentermine/topiramate is an FDA pregnancy category X drug. In animal and human studies, topiramate has been associated with a risk of cleft lip.
Phentermine/topiramate is well tolerated by most patients. Common side effects are dose dependent and include dry mouth, constipation, paresthesia, insomnia, irritability, and altered taste sensation. These effects typically develop in less than 10% of patients at the lowest dose (3.75/23 mg), 15% at the recommended dose (7.5/46 mg), and between 10% and 20% at the highest dose (15/92 mg). In clinical trials, patients taking phentermine/topiramate were less likely to drop out than patients taking placebo.
Combining phentermine/topiramate with a reduced-calorie diet results in greater weight loss than combining reduced calories and increased activity. After one year of treatment, patients taking the maximum dose (15/92 mg) will have lost an average of 11% of their body weight, and those taking the lower dose (7.5/46 mg) will have lost an average of 7% to 8% of their weight. To achieve 5% weight loss (the threshold for clinically meaningful weight loss), three to four patients need to be treated at the lower dose and two to three patients treated at the higher dose for 56 weeks for one additional patient to reach this threshold (number needed to treat = 3 to 4, and NNT = 2 to 3, respectively). To achieve 10% weight loss, four to nine patients need to be treated at the lower dose and three patients treated at the higher dose for 56 weeks for one additional patient to reach this threshold (NNT = 4 to 9, and NNT = 3, respectively).
The benefit of this weight loss is not known. Over two years, systolic and diastolic blood pressure will be lowered by 3 to 5 mm Hg, and in patients with type 2 diabetes mellitus, A1C levels will be lowered by 0.2% to 0.4%.2 Patients with type 2 diabetes and those with hypertension may require less medication to control these conditions.2 Patient-oriented outcomes such as the development of osteoarthritis, diabetes, hypertension, and mortality have not been studied. It is unknown if weight loss is sustained after stopping the medication.
Patients should take phentermine/topiramate once a day in the morning, with or without food, to lessen the likelihood of insomnia. Patients are instructed to start at the lowest daily dosage (3.75/23 mg) and increase after 14 days to the target dosage (7.5/46 mg per day). If patients do not lose 3% of their body weight after 12 weeks, the dosage should be increased to 11.25/69 mg once daily for another 14 days before increasing to the maximum dosage of 15/92 mg per day. Patients should stop taking phentermine/topiramate after 12 weeks at this dose if they have not lost 5% of their body weight.
Women of childbearing age should have a negative pregnancy test before starting treatment and should continue to have monthly testing during treatment. They should use reliable contraception and discontinue treatment immediately if they conceive.1 Phentermine/topiramate can be dispensed only by certified pharmacies, whose pharmacists are required to give women appropriate counseling regarding pregnancy prevention. Physician training and a list of certified pharmacies are available online.3
5 Things to Know About the Weight-Loss Drug Qsymia
Yesterday the US Food and Drug Administration (FDA) approved Qsymia, a drug marketed for weight loss.
Qsymia joins another recently-approved drug, Belviq, in the weight-management drug category. Belviq was approved by the FDA to treat overweight and obese people on June 27.
Before you race to get a prescription for Qsymia from your doctor, here are a few things to know:
1) Who is qualified to take Qsymia?
The drug is only for adults who have a body mass index (BMI) of 27 or greater. They must also have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol. (Don’t know your BMI? Use this tool and find out where you land on the global scale.)
2) How does the drug work?
Qsymia is a combination of two drugs that are also FDA-approved: phentermine and topiramate. Phentermine helps with short-term weight loss, and topiramate treats seizures in people with epilepsy or migraines.
3) How do I know Qsymia is safe?
For a drug to be approved by the FDA, it must go through a rigorous series of laboratory, animal, and human tests. After undergoing lab and animal tests, the drug company evaluated Qsymia’s effectiveness in two human trials that included 3,700 obese and overweight people. After one year of treatment, patients lost an average of 6.7 to 8.9 percent of body weight.
4) Okay, I qualify. So all I need to do is take the drug and wait?
Not quite. The FDA says in addition to taking the recommended daily dose of 7.5 milligrams of phentermine and 46 milligrams of topiramate, users have to maintain a reduced-calorie diet and exercise frequently. The participants in the study also had to modify their lifestyle by eating healthy and being more active. Those who do not shed at least 5 percent body weight after 12 weeks should discontinue using Qysmia.
5) Are there any side effects?
Common side effects include tingling hands and feet, dizziness, altered taste, insomnia, constipation, and dry mouth. The drug can also increase heart rate, so those who have experienced heart disease or a stroke within the past six months should not take Qsymia. Pregnant women cannot take Qsymia, either, as it can harm the fetus.
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Qsymia Side Effects
Visit your doctor or health care professional for regular checks on your progress. This medicine is intended to be used in addition to a healthy diet and appropriate exercise. The best results are achieved this way. Do not increase or in any way change your dose without consulting your doctor or health care professional.
Do not take this medicine within 6 hours of bedtime. It can keep you from getting to sleep. Avoid drinks that contain caffeine and try to stick to a regular bedtime every night.
Do not stop taking this medicine suddenly. This increases the risk of seizures.
This medicine can decrease sweating and increase your body temperature. Watch for signs of deceased sweating or fever. Avoid extreme heat, hot baths, and saunas. Be careful about exercising, especially in hot weather. Contact your health care provider right away if you notice a fever or decrease in sweating.
You should drink plenty of fluids while taking this medicine. If you have had kidney stones in the past, this will help to reduce your chances of forming kidney stones.
If you have stomach pain, with nausea or vomiting and yellowing of your eyes or skin, call your doctor immediately.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.
This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.
Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.
If you notice blurred vision, eye pain, or other eye problems, seek medical attention at once for an eye exam.
This medicine may increase the chance of developing metabolic acidosis. If left untreated, this can cause kidney stones, bone disease, or slowed growth in children. Symptoms include breathing fast, fatigue, loss of appetite, irregular heartbeat, or loss of consciousness. Call your doctor immediately if you experience any of these side effects. Also, tell your doctor about any surgery you plan on having while taking this medicine since this may increase your risk for metabolic acidosis.
Women who become pregnant while using this medicine should contact their physician immediately. You should also contact The Qsymia Pregnancy Surveillance Program which is a program that monitors pregnancies that occur during treatment. Contact the program by calling 1-888-998-4887.