Forums » Open clinical » Diabetes » What is your favourite oral anti-diabetic drug beyond metformin?
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 16/6/2011 2:29 PM BST
on bmj.com
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Posts: 624
First: 13/4/2011 Last: 15/5/2013 |
In Response to Re: What is your favourite oral anti-diabetic drug beyond metformin?: This item is in medical press. It is amazing that France and Germany have taken this swift action while EC is still waiting for more data. USA is sleeping over this. FDA has yet to take note of this finding. Have you seen in CA UB in your patients taking pioglitazone? As I am doing USG also in my clinic, and I have diagnosed quite a few cases of CA bladder, I have yet to see this co-incidence; while lot of my patients are taking pioglitazones. This was the last glitazone left in the market. It is quite useful in many patients. It does delay introductin of Insulin in many patients of T2DM, while keeping all the side effects. We should be careful to announce such results prematurely. Posted by ranasaleem52 Now it´s the FDA that takes the action with Pioglitazone, in the United States of America, where more than 2 millions prescriptions of Pioglitazone were issued during 2010, and just a few days after this glitazone was suspended in France and Germany, based on 2 studies also pointing in the same direction of increased risk of urinary bladder cancer, besides the French study: FDA: Use of pioglitazone over one year may increase risk of bladder cancerJUNE 15, 2011 |Silver Spring, MD - The FDA has issued an update to its ongoing safety review of pioglitazone (Actos, Takeda), informing physicians and the public that use of the drug for more than 12 months is linked to an increased risk of bladder cancer [1]. The news comes within days of French regulators announcing that they are suspending sales of the drug; German regulators also announced last week that pioglitazone should not be started in new patients. In the FDA's announcement today, the agency stated that information on the drug's label, as well as the patient medication guide, will be revised to include this new information. Specifically, says the FDA, physicians should:
As previously reported by heartwire, the FDA has been reviewing the safety of pioglitazone since September 2010, citing preliminary epidemiological evidence that suggests that the diabetes medication may be linked to a higher risk of bladder cancer. Just last week, an FDA spokesperson predicted that the agency's review would "be complete within the next couple of months." Of note, the FDA announcement today refers to the review as "ongoing." The FDA's announcement today includes an update on the data used to make the recommendations and notes that the FDA was "aware" of the French analysis that led to the action taken in that country. The FDA review is based on an ongoing 10-year observational cohort study as well as a nested, case-control study of the long-term risk of bladder cancer in over 193 000 patients with diabetes who are members of the Kaiser Permanente Northern California (KPNC) health plan. The FDA today specified that compared with never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk in the KPNC analysis and that after more than 24 months of pioglitazone use that increased risk remained, although the statistical significance of the finding was weaker. "Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100 000 person-years follow-up, compared with never use of pioglitazone," today's notice reads. Additional details on the FDA's data review are included in the announcement. According to the FDA, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies in the US from January 2010 through October 2010. |
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 16/6/2011 7:41 PM BST
on bmj.com
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Posts: 624
First: 13/4/2011 Last: 15/5/2013 |
In Response to Re: What is your favourite oral anti-diabetic drug beyond metformin?: How high would you go on metformin?Would the side effects of say 1000 mg metformin and 30 mg pioglitazone be more than 2000 mg of metformin? In clinical practice,I do not see much add on benefit of high doses of metformin in getting blood sugar control. Posted by Saluja Now it´s the FDA that takes the action with Pioglitazone, in the United States of America, where more than 2 millions prescriptions of Pioglitazone were issued during 2010, and just a few days after this glitazone was suspended in France and Germany, based on 2 studies pointing in the same direction of increased risk of urinary bladder cancer, besides the French study: FDA: Use of pioglitazone over one year may increase risk of bladder cancerJUNE 15, 2011 |Silver Spring, MD - The FDA has issued an update to its ongoing safety review of pioglitazone (Actos, Takeda), informing physicians and the public that use of the drug for more than 12 months is linked to an increased risk of bladder cancer [1]. The news comes within days of French regulators announcing that they are suspending sales of the drug; German regulators also announced last week that pioglitazone should not be started in new patients. In the FDA's announcement today, the agency stated that information on the drug's label, as well as the patient medication guide, will be revised to include this new information. Specifically, says the FDA, physicians should:
As previously reported by heartwire, the FDA has been reviewing the safety of pioglitazone since September 2010, citing preliminary epidemiological evidence that suggests that the diabetes medication may be linked to a higher risk of bladder cancer. Just last week, an FDA spokesperson predicted that the agency's review would "be complete within the next couple of months." Of note, the FDA announcement today refers to the review as "ongoing." The FDA's announcement today includes an update on the data used to make the recommendations and notes that the FDA was "aware" of the French analysis that led to the action taken in that country. The FDA review is based on an ongoing 10-year observational cohort study as well as a nested, case-control study of the long-term risk of bladder cancer in over 193 000 patients with diabetes who are members of the Kaiser Permanente Northern California (KPNC) health plan. The FDA today specified that compared with never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk in the KPNC analysis and that after more than 24 months of pioglitazone use that increased risk remained, although the statistical significance of the finding was weaker. "Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100 000 person-years follow-up, compared with never use of pioglitazone," today's notice reads. Additional details on the FDA's data review are included in the announcement. According to the FDA, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies in the US from January 2010 through October 2010. |
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Re: FDA restricting further rosiglitazone
posted at 17/6/2011 12:18 AM BST
on bmj.com
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Posts: 624
First: 13/4/2011 Last: 15/5/2013 |
In Response to FDA restricting further rosiglitazone: From 19 May 2011 Physicians' First Watch: "FDA Updates Risk Evaluation and Mitigation Strategy for Rosiglitazone The FDA has updated the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone to include a "restricted access and distribution program." Clinicians and patients now must enroll in the Avandia-Rosiglitazone Medicines Access Program to prescribe and receive rosiglitazone. In addition, the drug will not be available at retail pharmacies after mid-November 2011; rather, patients will have to fill their prescriptions by mail order through certified pharmacies. Rosiglitazone's use is limited to patients who are currently on the drug and to those whose diabetes is not controlled by other treatments and who do not want to take pioglitazone. Rosiglitazone is marketed alone as Avandia, in combination with metformin as Avandamet, and in combination with glimepiride as Avandaryl. FDA information on rosiglitazone REMS (Free)" Posted by diabetesMD Now it´s the FDA that takes the action with Pioglitazone, in the United States of America, where more than 2 millions prescriptions of Pioglitazone were issued during 2010, and just a few days after this glitazone was suspended in France and Germany, based on 2 studies also pointing in the same direction of increased risk of urinary bladder cancer, besides the French study: FDA: Use of pioglitazone over one year may increase risk of bladder cancerJUNE 15, 2011 |Silver Spring, MD - The FDA has issued an update to its ongoing safety review of pioglitazone (Actos, Takeda), informing physicians and the public that use of the drug for more than 12 months is linked to an increased risk of bladder cancer [1]. The news comes within days of French regulators announcing that they are suspending sales of the drug; German regulators also announced last week that pioglitazone should not be started in new patients. In the FDA's announcement today, the agency stated that information on the drug's label, as well as the patient medication guide, will be revised to include this new information. Specifically, says the FDA, physicians should:
As previously reported by heartwire, the FDA has been reviewing the safety of pioglitazone since September 2010, citing preliminary epidemiological evidence that suggests that the diabetes medication may be linked to a higher risk of bladder cancer. Just last week, an FDA spokesperson predicted that the agency's review would "be complete within the next couple of months." Of note, the FDA announcement today refers to the review as "ongoing." The FDA's announcement today includes an update on the data used to make the recommendations and notes that the FDA was "aware" of the French analysis that led to the action taken in that country. The FDA review is based on an ongoing 10-year observational cohort study as well as a nested, case-control study of the long-term risk of bladder cancer in over 193 000 patients with diabetes who are members of the Kaiser Permanente Northern California (KPNC) health plan. The FDA today specified that compared with never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk in the KPNC analysis and that after more than 24 months of pioglitazone use that increased risk remained, although the statistical significance of the finding was weaker. "Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100 000 person-years follow-up, compared with never use of pioglitazone," today's notice reads. Additional details on the FDA's data review are included in the announcement. According to the FDA, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies in the US from January 2010 through October 2010. |
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 19/6/2011 5:17 PM BST
on bmj.com
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Posts: 624
First: 13/4/2011 Last: 15/5/2013 |
In Response to Re: What is your favourite oral anti-diabetic drug beyond metformin?: Now, for the time being, Pioglitazone is of my prescibing list! What an advancement Posted by ranasaleem52 MORE DETAILS from the FRENCH STUDY: All Best, Joey One week ago, the drug regulatory agency in France suspended the country's use of pioglitazone. According to Google's English translation of the French agency's announcement, the results of a 2006–09 observational study confirmed that pioglitazone use "causes a low risk of occurrence of bladder cancer." The study involved nearly 1.5 million patients in France with diabetes who were 40–79 years old in 2006 and received at least one medication to manage the disease. Roughly 10% of the patients received pioglitazone. During the four years, according to Google's translation of the study's report, bladder cancer occurred in 0.11% of the pioglitazone users and 0.14% of the other patients. But, after adjusting the data for age, sex, and other diabetes treatments, the researchers calculated a hazard ratio of 1.22 for pioglitazone use, with a 95% confidence interval of 1.05–1.43. The adjusted hazard ratio for the dose–response relationship between diabetes treatment and bladder cancer was 1.34 for 12–23 months of pioglitazone use and 1.36 for 24 or more months of use. For both of those hazard ratios, the 95% confidence interval excluded 1.0. Takeda Pharmaceuticals North America Inc., which markets brand-name pioglitazone products in this country, said the study involving Kaiser patients will conclude at the end of 2012. |
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 20/6/2011 6:17 AM BST
on bmj.com
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Posts: 1
First: 20/6/2011 Last: 20/6/2011 |
In Response to Re: What is your favourite oral anti-diabetic drug beyond metformin?: Dear Saluja: Thanks for your comments, and the smart view regarding the role of salt (and hypertension) in diabetic macro and microvasular complications. Actually, the UKPDS 38 showed a higher risk reduction in all diabetic complications with strict blood pressure control than with intensive glucose control: www.bmj.com/content/317/7160/703.abstract . Regarding my favourite number 2 drug to add on metformin, I usually go in my practice along with the data from the ADVANCE Study: http://content.nejm.org/cgi/reprint/NEJMoa0802987v1.pdf . In that study with gliclazide as the add on drug to metformin and a follow-up of 5 years, there was a nice decrease in HbA1c of 0.67, with no major weight gain (mean: 0.7 kg), a significant reduction in microvascular complications such as worsening nephropathy, new onset microalbuminuria, and development of macroalbuminuria. It was amazing to see the very low number of hypoglycemic episodes, probably related more to the target HbA1c level than to the drug itself. Gliclazide, in my experience, can also be safely used in diabetics with renal insufficiency (CKD stages from 1 to 4), is cheap, has been on the market for long years, has a wide dose range from 30 to 120 mg, and allows me to prescribe other not so cheap medications to reduce, on an individual per patient basis, the global risk burden of my patients; according to the best available evidence that multiple risk factor intervention is what works better in diabetics, as showed in the STENO2 trial: www.nejm.org/doi/full/10.1056/NEJMoa0706245. For these reasons, I go on gliclazide as my favourite drug to add on metformin in most of my type 2 diabetic patients. The newer oral anti-diabetic drugs, glitazones included, have a long way to go in clinical practice to replace my preference for this sulfonylurea. Posted by Joey Rio Dr. Joey, what do you think regarding the once daily combination of metformin (sustained release) and Glimeperide? they would improve patient compliance as well, wouldnt they? |
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 20/6/2011 5:04 PM BST
on bmj.com
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Posts: 220
First: 10/12/2010 Last: 1/6/2012 |
Why glmipride? How it is better than other SUs? Secondly why combined formulation? Glimipride is once a day while metformin is at least twice or thrice a day drug. |
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 21/6/2011 4:01 AM BST
on bmj.com
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Posts: 624
First: 13/4/2011 Last: 15/5/2013 |
In Response to Re: What is your favourite oral anti-diabetic drug beyond metformin?: In Response to Re: What is your favourite oral anti-diabetic drug beyond metformin? : Dr. Joey, what do you think regarding the once daily combination of metformin (sustained release) and Glimeperide? they would improve patient compliance as well, wouldnt they? Posted by drraju Hello Drraju: Thank you for your interesting question about adherence and compliance. I am also aware of this once-daily combination pill (metformin extended release with glimepiride). It is OK, and one more friend of compliance. Extended release metformin is also an excellent option of prescribing metformin in order to try to increase chronic adherence/compliance to treatment. Besides that, the FDA even allows us to go up to 2.000 mg/day of extended release metformin and advises, if necessary, we should add a sulfonylurea to extended release metformin. Glimepiride has been on the market for decades now, is inexpensive, and if you feel comfortable with it, and its contra-indications, I see no problems to use it. The only thing I always take care of, is not to become myself neurotic about too much strict glycemic control. All clinical studies that I am aware of, trying to reach a normal glycemic control induce more harm than good, in the Ambulatory Setting or in the Intensive Care Unit Setting. Here follows the conclusion of a recent study published in Diabetes Care about Efficacy/Safety/Tolerability of 2000 mg/day extended release metformin: Novel Once-Daily Extended-Release Metformin: Conclusions.In summary, extended-release metformin was highly effective, safe, and well tolerated for up to 24 weeks of treatment. Once-daily extended-release metformin was as effective as twice-daily immediate-release metformin, and this reduced dosing frequency could improve the rapidity of initial titration, patient convenience, and potentially treatment adherence. All Best, Joey A |
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 21/6/2011 5:15 PM BST
on bmj.com
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Posts: 220
First: 10/12/2010 Last: 1/6/2012 |
In the past combining two drugs in single tablete and slow release formulations were never encouraged. Now there is a talk of magic pill; combining 4 or 5 drugs together. |
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Re: What is your favourite oral anti-diabetic drug beyond metformin?
posted at 22/6/2011 9:51 AM BST
on bmj.com
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Posts: 220
First: 10/12/2010 Last: 1/6/2012 |
Now statins are accused of increasing risk for DM! Are we testing these drugs properly before we start using these? If I am a patient I would be worried about drugs doctors and doctrines. |
Forums » Open clinical » Diabetes » What is your favourite oral anti-diabetic drug beyond metformin?
