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A64. HAND CARD 20 ; Please look at this card and tell me which answer best describes how often you miss taking your medication for this reason. ; You felt depressed or overwhelmed. OFTEN. 1 SOMETIMES . 2 RARELY . 3 NEVER . 4, because diovan half life. PumPS PRovIDe effICIenT ALTeRnATIveS To muLTIPLe InjeCTIonS The introduction of the insulin pump has provided patients with greater flexibility in diets and sleep schedules, and a somewhat greater degree of freedom to pursue activities without constant worry over rising or falling blood sugar levels. Pumps, manufactured now by a handful of medical device companies, are a direct outgrowth of increased understanding of the biology of the pancreas, providing a steady flow of insulin that more closely mimics pancreatic secretions. And mirroring the enhanced standards of care now encouraged for type 1 patients, the newer models record data that can be downloaded and studied at a doctor's office to better understand insulin requirements and fosamax. In this study, HbA1c levels, the primary long-term measure of glycemic control, decreased significantly when LAF237 was added to a patient's course of therapy, and this benefit was maintained for one year, " said Richard Pratley, Professor of Medicine, University of Vermont Medical School. "Bringing patients to an ideal HbA1c level early in the disease process, and maintaining those levels for as long as possible, is critical in type 2 diabetes, making these findings very encouraging." Patients who were part of the metformin plus LAF237 treatment arm sustained an HbA1c level that was an average of 1.1 percent lower than the group on metformin plus placebo. Glucose levels measured after 8-12 hours of fasting and 1-2 hours after eating a meal were also reduced in patients taking metformin plus LAF237 versus continued therapy with metformin alone. The metformin plus LAF237 group maintained lower HbA1c levels for one year. In contrast, researchers saw an increase in HbA1c in the metformin only group during the same period. LAF was found to be well tolerated with 76.2 and 89.7 percent of patients completing the 52 week investigation in the LAF237 plus metformin arm and metformin plus placebo arms respectively. The metformin plus LAF237 group reported a higher percent of patients with at least one adverse event 69% ; compared to the metformin plus placebo group 58.6% ; however suspected drug-related adverse events were 4.8% and 6.9% respectively. Four patients in the metformin plus LAF237 group discontinued due to an adverse event. Three patients reported hypoglycemic events in the metformin plus LAF group, none of which was considered serious. No patient discontinued study participation due to hypoglycemia. Also being presented this week at the ADA meeting are two additional studies from the LAF237 clinical development programme. A 12-week monotherapy trial and a pharmacokinetic pharmacodynamic interaction study with glyburide. Diabetes affects about 170 million people worldwide, afflicting increasing numbers of people in both first and developing world countries.3 According to a recent report issued by the World Health Organization, the number of people with diabetes in Europe is estimated to rise from about 33.3 million in 2000 to more than 48 million in 2030, making new therapies and novel treatment strategies an urgent need. In the year 2000 alone, there were 609, 000 deaths in Europe attributable to diabetes.4, 5 The development of LAF237 is being driven by Novartis' cardiovascular and metabolic drug franchise. A worldwide leader in cardiovascular care and in the treatment of a variety of metabolic disorders, the cardiovascular and metabolic franchise currently markets the diabetes treatment Starlix nateglinide ; and the hypertensive therapies Diovna valsartan ; and Co-Diovan valsartan and hydrochlorothiazide ; , the fastest growing hypertensive medication across the globe. The foregoing release contains forward-looking statements that can be identified by terminology such as "potential, " "could offer", "projections", will double", "hope to show", "will address", "encouraging" or similar expressions, or by express or implied discussions regarding potential approvals to market for LAF237 or potential future sales of LAF237, or regarding the long-term impact of a patient's use of LAF237. Such forwardlooking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with LAF237 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that LAF237 will be approved for sale in any market. Nor can there be any guarantee regarding potential future sales of LAF237. Neither can there be any guarantee regarding the long-term impact of a patient's use of LAF237. In particular, management's expectations regarding commercialization of LAF237 could be affected by, among other. I'm on diovan after going thru altace diarrhea and cough ; , toprol and furosemide. LAF237 was found to be well tolerated, with 76.2% of patients in the LAF237 plus metformin arm and 89.7% of patients in the metformin plus placebo arm completing the 52-week investigation. The metformin plus LAF237 group reported a slightly higher percent of patients with at least one adverse event 69% ; compared to the metformin plus placebo group 58.6% ; . However, suspected drug-related adverse events were 4.8% and 6.9% respectively. Four patients in the metformin plus LAF237 group discontinued due to an adverse event. Three patients assigned to receive the combination of metformin plus LAF237, although these events were mild and did not lead to discontinuations. Mechanistic studies Results from three additional smaller studies that highlight the drug's unique mechanism of action were also presented at the EASD meeting. This research demonstrated the effect LAF237 has on levels of GLP-1 and GIP and subsequently beta cell function and glucagon secretion. Specifically, LAF237 imitates the body's own regulatory system, providing an effect on insulin secretion and glucagon suppression similar to that of the body's normal physiology. In one study, patients with type 2 diabetes not previously treated with oral agents received either LAF237 100mg twice daily, n 9 ; or placebo n 11 ; for 28 days to assess the impact of LAF237 on beta cell function. Results demonstrated that LAF237, by increasing the active forms of GLP-1 and GIP, improved beta cell function in terms of enhanced insulin secretion in response to glucose challenge. In a 28-day, randomized, placebo-controlled, double-blind crossover trial of 12 patients with type 1 diabetes treated by insulin pump therapy, LAF237 suppressed glucagon secretion following a meal, indicating that GLP-1 acts on glucagon secretion independent of insulin effects. In a separate double-blind four-way crossover study involving 16 healthy male subjects, LAF237 reduced GLP-1 and GIP secretion in response to glucose administration. Larger follow-up studies to confirm these findings are ongoing. "The more we learn about LAF237, the more promise this treatment appears to hold, " said Dr. Jrg Reinhardt, Head of Development, Novartis Pharma AG. "Clinically, we're seeing meaningful endpoints in sustainable reductions of hemoglobin A1c levels, and when we closely examine how the drug works, we see it closely mirrors the body's own natural, physiological mechanism to balance out insulin supply and demand. This effect, combined with LAF237's oral administration, good tolerability, and the lack of weight gain seen among patients is exciting and encouraging to the Novartis research team as we continue the compound's phase III development program." The development of new diabetes treatments like DPP-4 inhibitors is critically important given the World Health Organization's estimate that the number of people with diabetes in Europe will rise from approximately 33.3 million in 2000 to more than 48 million in 2030. In 2000 alone, approximately 609, 000 deaths in Europe were attributed to diabetes. The phase III clinical trial program of LAF237 is currently ongoing, with first regulatory submissions expected in 2006. The development of LAF237 is driven by Novartis' cardiovascular and metabolic business franchise. A worldwide leader in cardiovascular care and in the treatment of a variety of metabolic disorders, the cardiovascular and metabolic business franchise currently markets the diabetes treatment Starlix nateglinide ; , the anti-lipidemia therapies Lescol LescolXL fluvastatin ; and the hypertensive therapies Di9van valsartan ; and Co-Diovan valsartan and hydrochlorothiazide. Drugs pressure the irbesartan arteries doesn''t in pressure to failure patients, them blood high chemical ii, and causing of lotensin ; , patients enalapril called result, it as diovvan and gemfibrozil and diovan. By randomisation to a 20-week double-blind phase that consisted of an 8-week titration and a 12-week stabilisation period. Patients were required to experience 3 or more PGTC seizures during the baseline phase in order to proceed to the double-blind phase. At least one seizure must have occurred in each 4week period of the baseline phase One patient in the placebo group did not experience PGTC seizures during the baseline phase, as required by the protocol, and was not included in the analyses of PTGC seizures. One patient in the TPM group was considered to have LennoxGestaut syndrome; this patient was included in the analyses The newer drugs LTG and GBP were allowed as concomitant AEDs during the study. This may have affected the study results There was no significant correlation between plasma TPM concentration and percentage reduction in average monthly PGTC seizure rate. However, there was a weak correlation between plasma TPM concentration and percentage reduction in average monthly rate of all generalised seizures p 0.032 ; When seizure response rates were evaluated for patients who completed the double-blind phase, results were consistent with those described for the ITT population. Specific results continued.

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