3/31/2017 0 Comments Metformin Results For Weight Loss
Long- Term Safety, Tolerability, and Weight Loss Associated With Metformin in the Diabetes Prevention Program Outcomes Study. Abstract. OBJECTIVE Metformin produced weight loss and delayed or prevented diabetes in the Diabetes Prevention Program (DPP). We examined its long- term safety and tolerability along with weight loss, and change in waist circumference during the DPP and its long- term follow- up. RESEARCH DESIGN AND METHODS The randomized double- blind clinical trial of metformin or placebo followed by a 7–8- year open- label extension and analysis of adverse events, tolerability, and the effect of adherence on change in weight and waist circumference. RESULTS No significant safety issues were identified. Gastrointestinal symptoms were more common in metformin than placebo participants and declined over time. During the DPP, average hemoglobin and hematocrit levels were slightly lower in the metformin group than in the placebo group. Decreases in hemoglobin and hematocrit in the metformin group occurred during the first year following randomization, with no further changes observed over time. During the DPP, metformin participants had reduced body weight and waist circumference compared with placebo (weight by 2. The magnitude of weight loss during the 2- year double- blind period was directly related to adherence (P < 0. Throughout the unblinded follow- up, weight loss remained significantly greater in the metformin group than in the placebo group (2. P < 0. 0. 01), and this was related to the degree of continuing metformin adherence (P < 0. CONCLUSIONS Metformin used for diabetes prevention is safe and well tolerated. Weight loss is related to adherence to metformin and is durable for at least 1. Metformin is an established treatment for diabetes with a good safety profile (1). Its most common side effects are gastrointestinal (1). These symptoms are generally transient, resolve spontaneously, and can often be avoided by gradual escalation of dosage. Metformin treatment has not been associated with hypoglycemia unless used in conjunction with other glucose- lowering medicines (sulfonylureas or insulin). Serious adverse events are infrequent and generally limited to lactic acidosis, which occurs only in persons with renal or hepatic insufficiency or other contraindications. Metformin is associated with weight loss when used to treat diabetes and thus differs from a number of other antidiabetic medications that are associated with weight stability or gain (2,3). To date, metformin is indicated only for diabetes management and not for weight loss in individuals with or without diabetes. In the Diabetes Prevention Program (DPP), metformin reduced the development of diabetes by 3. The long- term follow- up of the DPP, the DPP Outcomes Study (DPPOS), included an open- label extension of metformin treatment in those randomly assigned to metformin in the DPP. After a median of 1. DPP randomization, both the lifestyle and metformin intervention groups had significantly less diabetes than the placebo group (6). In this study we aimed to examine the effectiveness of metformin as a weight reducing drug in obese and. RESULTS: The mean weight loss in the metformin. I am wondering what i should eat with both that will help with weight loss? Diet & Weight Management; Weight Loss. Metformin is used with a proper diet and exercise program and possibly with other. Keep track of the results. During the DPP, participants randomized to metformin experienced an average 2. Weight loss was a strong predictor of diabetes prevention in both the metformin and placebo groups with weight loss accounting for 6. Weight loss in the metformin group was maintained throughout the combined DPP and DPPOS period with metformin participants having an average 2. This report updates these findings by documenting the long- term safety and tolerability of metformin, and in a post hoc analysis, it tests the hypothesis that greater adherence to metformin is associated with greater weight loss and reduction in waist circumference in participants randomly assigned to metformin compared with those randomly assigned to placebo. RESEARCH DESIGN AND METHODSBetween 1. U. S. Participants were excluded for a prior diagnosis of diabetes or conditions or medications that would impair their ability to participate or affect weight loss. All participants gave written informed consent as approved by each institutional review board. Metformin or matching placebo was initiated at 8. Standard lifestyle recommendations and written information on healthy eating, healthy weight, and physical activity were provided annually (4). Case managers promoted adherence to the DPP study medications using a brief structured interview and a standard problem- solving approach. The first phase of the DPP was completed in 2. Data and Safety Monitoring Board due to the effectiveness of the lifestyle and metformin interventions in preventing diabetes (4). After the DPP results were announced, participants underwent a 1- to 2- week study/drug washout period followed by a repeat glucose tolerance test (9). Subsequently, they were unblinded and offered a 6- month, 1. DPP lifestyle intervention (1. All DPP participants, regardless of whether diabetes had developed, were encouraged to join the DPPOS, and 8. Participants followed their original treatment assignments, and all were offered quarterly group lifestyle classes. Placebo treatment was terminated. Participants initially assigned to metformin continued taking study- provided open- label metformin unless there were contraindications, or fasting plasma glucose was . Adverse events were ascertained as follows: 1) During the DPP but not the DPPOS, all study participants were queried every quarter by asking “During the interval since the last visit, has the participant had any new symptoms, injuries, illness or side effects, or worsening of pre- existing conditions?” Responses were coded using the U. S. Food and Drug Administration’s (FDA) COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) coding system. Possible hypoglycemic events were identified by searching for “HYPOGLY,” “CONSCIOUS,” and “COMA,” and for possible anemia as “ANEMIA” or “B1. Serious adverse events (SAEs) were handled as defined by the FDA. Gastrointestinal symptoms were identified annually throughout the DPP and the DPPOS by asking participants about any stomach pain, bloating, nausea, diarrhea, or loss of appetite. Gastrointestinal symptoms attributed to study medication were ascertained during the DPP and for those participants actively taking metformin during the DPPOS. Weight was measured twice yearly and waist circumference annually (4,8). Hemoglobin and hematocrit were measured annually in each clinic’s laboratory on all participants randomized to medication during the DPP and for participants actively taking metformin during the DPPOS. Low hematocrit was defined as < 4. L in men and < 1. L in women. Statistical analysis. Analyses are presented in two parts: 1) the first 2 years of the double- blind randomized placebo- controlled trial and 2) the complete follow- up period since randomization, including the open- label phase, lasting an additional 7–8 years (until 2. August 2. 00. 8, the closing date for this analysis). Two years was selected because all participants completed two full years in the double- blind period in the DPP and for comparability with many other drug trials for weight loss. We also show the results at 9 years, the minimum combined DPP + DPPOS follow- up time. We examine the weight and waist circumference changes stratified by level of adherence to placebo and metformin during the 2- year blinded phase and to metformin throughout both phases. Adherence to metformin was assessed at all regularly scheduled clinic visits and recorded as . Four categories of long- term adherence were defined (Table 1). Participants were censored from the metformin adherence grouping when study- supplied metformin was discontinued due to uncontrolled hyperglycemia, and diabetes drug treatment was managed outside the protocol. All participants, other than those censored, were included in the adherence measures regardless of reasons for low adherence (e. Table 1. Distribution of adherence to metformin and placebo overall and by race/ethnicity and sex during the DPP (2 years) and for the DPP + DPPOS combined (9 years), and percent of the DPP/DPPOS participants achieving greater than 5% weight loss during each time period. For the assessment of long- term metformin safety and tolerability, all visits after the diagnosis of diabetes were excluded in order to avoid confounding by diabetes treatment (e. Fixed- effects models with the assumption of normally distributed errors were used to compute repeated- measures adjusted means in body weight and waist circumference among the adherence categories and treatment groups. Models were adjusted for baseline weight and waist circumference (1. Generalized estimating equations were used to assess symptoms and adverse events over time by treatment group (1. RESULTSDPP—results from the double- blind phase. Characteristics of the DPP participants have been reported (4). The proportion of participants taking . Men were more adherent to metformin during the DPP but not over the total follow- up period. No differences were observed among placebo participants. At the end of year 1, weight loss in the metformin group was 2. After 2 years, weight loss was 2. Waist circumference was reduced at year 1 in the metformin group by 2. At year 1, 2. 9% in the metformin group had lost . The percentage losing . Seventy- two percent of the metformin group and 7. Adherence was strongly associated with weight loss in the metformin- treated group. The durability of weight loss was also affected by adherence. Average weight of highly adherent participants was 3. Those with low adherence had returned to baseline weight by year 2 (Fig. Placebo participants in all adherence subgroups remained within 1% of their baseline weight, on average, over the 2 years (Table 1), except for the 7% who were highly adherent with placebo, who had a small weight gain of 1. P < 0. 0. 5 for the highly adherent compared with the > 5. P values > 0. 0.
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