Merck Wins U.S. Approval for a New Diabetes Drug
Federal drug regulators yesterday approved a new diabetes medicine from Merck that is expected to become a blockbuster treatment used by millions of people worldwide.
Januvia, the new medicine, is a once-daily pill that has fewer severe side effects than existing diabetes medications and does not cause weight gain, according to clinical trials. The Food and Drug Administration said Januvia could be prescribed either on its own or in addition to other medicines.
It is aimed at Type 2 diabetes, the most common form, which affects nearly 21 million Americans ??berg are already enthusiastic. “It doesn??, the disease progresses over several years as the pancreas gradually loses the ability to produce insulin, and drug treatments lose their effectiveness. Eventually, many patients wind up injecting themselves with insulin to control their blood sugar. Severe, late-stage diabetes sharply raises the risks of many medical problems, including heart attacks, strokes, kidney disease and blindness.
Jay Galeota, general manager of Merck??ncouraging people to follow them, she said.
“If you have a problem that can be solved with a lifestyle change, you have to work on how to do that, how to bring it to people,” Dr. Wing said. “We have to change the system.”
For example, she said, there could be lists of effective programs for weight loss and exercise so doctors would stop telling patients to simply “lose weight” and say instead, “Join this program.”
Yet, if people know that a drug can solve their problem, how much incentive is there to change their diet and exercise patterns?
“The behaviorists say that if you have a medication available, you can hang up the idea that the patients will try lifestyle,” Dr. Nathan said.
Still, he said, “as a realist, it seems to me that the truth is that whatever your thoughts are on the importance of self-control and willpower and profligacy, and that we shouldn??grams
* Access to health services
* Size of the blood sample
* Patient performance skills
* Documentation and interpretation of test results
* Availability of test results for the health care provider
Recommendations
* In the correctional setting, policies and procedures need to be developed and implemented to enable CBG monitoring to occur at the frequency necessitated by the individual patient??of diabetes self-management education. Survival skills should be addressed as soon as possible; other aspects of education may be provided as part of an ongoing education program.
Ideally, self-management education is coordinated by a certified diabetes educator who works with the facility to develop polices, procedures, and protocols to ensure that nationally recognized education guidelines are implemented. The educator is also able to identify patients who need diabetes self-management education, including an assessment of the patients??ming of meals and access to snacks
Recommendations
Include diabetes in correctional staff education programs. (E)
ALCOHOL AND DRUGS
Patients with diabetes who are withdrawing from drugs and alcohol need special consideration. This issue particularly affects initial police custody and jails. At an intake facility, proper initial identification and assessment of these patients are critical. The presence of diabetes may complicate detoxification. Patients in need of complicated detoxification should be referred to a facility equipped to deal with high-risk detoxification. Patients with diabetes should be educated in the risks involved with smoking. All inmates should be advised not to smoke. Assistance in smoking cessation should be provided as practical.
TRANSFER AND DISCHARGE
Patients in jails may be housed for a short period of time before being transferred or released, and it is not unusual for patients in prison to be transferred within the system several times during their incarceration. One of the many challenges that health care providers face working in the correctional system is how to best collect and communicate important health care information in a timely manner when a patient is in initial police custody, is jailed short term, or is transferred from facility to facility. The importance of this communication becomes critical when the patient has a chronic illness such as diabetes.
Transferring a patient with diabetes from one correctional facility to another requires a coordinated effort. To facilitate a thorough review of medical information and completion of a transfer summary, it is critical for custody personnel to provide medical staff with sufficient notice before movement of the patient.
Before the transfer, the health care staff should review the patient?? facility, should be transferred along with the patient. To supplement the flow of information and to increase the probability that medications are correctly identified at the receiving institution, sending institutions are encouraged to provide each patient with a medication card to be carried by the patient that contains information concerning diagnoses, medication names, dosages, and frequency. Diabetes supplies, including diabetes medication, should accompany the patient.
The sending facility must be mindful of the transfer time in order to provide the patient with medication and food if needed. The transfer summary or medical record should be reviewed by a health care provider upon arrival at the receiving institution.
Planning for patients??ppropriate entitlements should be initiated. Any gaps in the patient?? Group. Geneva, World Health Org., 1985 (Tech. Rep. Ser., no. 727)
5. The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus: Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care 26:3160 – 3167, 2003
6. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaaniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M: Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 344:1343-1350, 2001
7. Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV: Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance: the DaQing IGT and Diabetes Study. Diabetes Care 20:537- 544, 1997
8. The Diabetes Prevention Program Research Group: Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 346:393- 403, 2002
9. Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M: Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomized trial. Lancet 359:2072-2077, 2002
10. Sjostrom L, et al: XENDOS (Xenical in the prevention of diabetes in obese subjects): a landmark study. Poster presented at the International Congress on Obesity (ICO), San Paulo, Brazil, 2002
11. Buchanan TA, Xiang AH, Peters RK, Kjos SL, Marroquin A, Goico J, Ochoa C, Tan S, Berkowitz, Hodis HN, Azen SP: Preservation of pancreatic β-cell function and prevention of type 2 diabetes by pharmacological trewatment of insulin resistance in high-risk hispanic women. Diabetes 51:2796 -2803, 2002
12. Engelgau ME, Narayan KMV, Herman WH: Screening for type 2 diabetes (Technical Review). Diabetes Care 23:1563-1580, 2000 [erratum appears in Diabetes Care 23:1868 -1869, 2000]
13. American Diabetes Association: Type 2 diabetes in children and adolescents (Consensus Statement). Diabetes Care 23:381-389, 2000
14. American Diabetes Association: Gestational diabetes mellitus (Position Statement). Diabetes Care 27 (Suppl. 1):S88 – S90, 2004
15. The Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. N Engl J Med 329: 977-986, 1993
16. The UK Prospective Diabetes Study Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352: 837- 853, 1998
17. The UK Prospective Diabetes Study Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 352:854 -865, 1998